Trial Outcomes & Findings for Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE) (NCT NCT01270711)
NCT ID: NCT01270711
Last Updated: 2014-05-02
Results Overview
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
COMPLETED
22014 participants
Year 1 (Year 2006)
2014-05-02
Participant Flow
Part 1 recruited participants from North, Middle and South Europe and Part 2 from specialized clinical centers in Italy.
Part 1 assessed adherence (compliance) with prescribing guidelines (PG) by using automated health care data which had information on strength, indication, referrals for echocardiography, recognized reputation in area of drug utilization, safety research. Part 2 assessed effectiveness of PG for cabergoline in participants with Parkinson's disease.
Participant milestones
| Measure |
Aarhus [Part 1]
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
Cabergoline in Pre-SPC Change Period [Part 2]
Participants who started cabergoline treatment for Parkinson's disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
|
Cabergoline in Post- SPC Change Period [Part 2]
Participants who started cabergoline treatment for Parkinson's disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
|
Cabergoline in Cross-SPC Change Period [Part 2]
Participants who started cabergoline treatment for Parkinson's disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Compliance
STARTED
|
7537
|
6580
|
326
|
5486
|
2024
|
0
|
0
|
0
|
|
Part 1: Compliance
COMPLETED
|
7537
|
6580
|
326
|
5486
|
2024
|
0
|
0
|
0
|
|
Part 1: Compliance
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Effectiveness
STARTED
|
0
|
0
|
0
|
0
|
0
|
11
|
2
|
48
|
|
Part 2: Effectiveness
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
11
|
2
|
48
|
|
Part 2: Effectiveness
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)
Baseline characteristics by cohort
| Measure |
Aarhus [Part 1]
n=7537 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=6580 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=326 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
n=5486 Participants
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
n=2024 Participants
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
Cabergoline in Pre-SPC Change Period [Part 2]
n=11 Participants
Participants who started cabergoline treatment for Parkinson's disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
|
Cabergoline in Post- SPC Change Period [Part 2]
n=2 Participants
Participants who started cabergoline treatment for Parkinson's disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
|
Cabergoline in Cross-SPC Change Period [Part 2]
n=48 Participants
Participants who started cabergoline treatment for Parkinson's disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
|
Total
n=22014 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Part 1, Compliance: G02CB03
|
33.6 years
STANDARD_DEVIATION 10.7 • n=99 Participants
|
39.0 years
STANDARD_DEVIATION 12.3 • n=107 Participants
|
42.1 years
STANDARD_DEVIATION 14.0 • n=206 Participants
|
41.3 years
STANDARD_DEVIATION 15.8 • n=7 Participants
|
47.1 years
STANDARD_DEVIATION 16.2 • n=31 Participants
|
NA years
STANDARD_DEVIATION NA • n=30 Participants
|
NA years
STANDARD_DEVIATION NA • n=3 Participants
|
NA years
STANDARD_DEVIATION NA • n=6 Participants
|
40.8 years
STANDARD_DEVIATION 14.8 • n=114 Participants
|
|
Age, Customized
Part 1, Compliance: N04BC06
|
66.4 years
STANDARD_DEVIATION 13.2 • n=99 Participants
|
73.1 years
STANDARD_DEVIATION 11.3 • n=107 Participants
|
NA years
STANDARD_DEVIATION NA • n=206 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
69.7 years
STANDARD_DEVIATION 13.6 • n=31 Participants
|
NA years
STANDARD_DEVIATION NA • n=30 Participants
|
NA years
STANDARD_DEVIATION NA • n=3 Participants
|
NA years
STANDARD_DEVIATION NA • n=6 Participants
|
70.4 years
STANDARD_DEVIATION 13.0 • n=114 Participants
|
|
Age, Customized
Part 2, Effectiveness
|
NA years
STANDARD_DEVIATION NA • n=99 Participants
|
NA years
STANDARD_DEVIATION NA • n=107 Participants
|
NA years
STANDARD_DEVIATION NA • n=206 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=31 Participants
|
62.7 years
STANDARD_DEVIATION 5.6 • n=30 Participants
|
58.7 years
STANDARD_DEVIATION 8.5 • n=3 Participants
|
63.7 years
STANDARD_DEVIATION 13.9 • n=6 Participants
|
63.3 years
STANDARD_DEVIATION 12.5 • n=114 Participants
|
|
Sex: Female, Male
Female
|
7429 Participants
n=99 Participants
|
6180 Participants
n=107 Participants
|
288 Participants
n=206 Participants
|
5180 Participants
n=7 Participants
|
1468 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
13 Participants
n=6 Participants
|
20560 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=99 Participants
|
400 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
306 Participants
n=7 Participants
|
556 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
35 Participants
n=6 Participants
|
1454 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Year 1 (Year 2006)Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Outcome measures
| Measure |
Aarhus [Part 1]
n=81 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=854 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=5 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
n=277 Participants
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
n=370 Participants
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 1
N04BC06
|
87 prescriptions
|
1483 prescriptions
|
0 prescriptions
|
0 prescriptions
|
577 prescriptions
|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 1
G02CB03
|
17 prescriptions
|
1782 prescriptions
|
6 prescriptions
|
293 prescriptions
|
198 prescriptions
|
PRIMARY outcome
Timeframe: Year 2 (Year 2007)Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Outcome measures
| Measure |
Aarhus [Part 1]
n=1446 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=1475 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=31 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
n=1231 Participants
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
n=756 Participants
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 2
G02CB03
|
1925 prescriptions
|
3616 prescriptions
|
64 prescriptions
|
2698 prescriptions
|
3537 prescriptions
|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 2
N04BC06
|
741 prescriptions
|
2139 prescriptions
|
0 prescriptions
|
0 prescriptions
|
3325 prescriptions
|
PRIMARY outcome
Timeframe: Year 3 (Year 2008)Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Outcome measures
| Measure |
Aarhus [Part 1]
n=1469 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=1089 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=59 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
n=1081 Participants
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
n=279 Participants
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 3
N04BC06
|
507 prescriptions
|
807 prescriptions
|
0 prescriptions
|
0 prescriptions
|
1656 prescriptions
|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 3
G02CB03
|
2098 prescriptions
|
3493 prescriptions
|
152 prescriptions
|
2621 prescriptions
|
3556 prescriptions
|
PRIMARY outcome
Timeframe: Year 4 (Year 2009)Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Outcome measures
| Measure |
Aarhus [Part 1]
n=1539 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=1146 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=87 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
n=1039 Participants
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
n=220 Participants
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 4
G02CB03
|
2260 prescriptions
|
3629 prescriptions
|
226 prescriptions
|
2684 prescriptions
|
3240 prescriptions
|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 4
N04BC06
|
306 prescriptions
|
463 prescriptions
|
0 prescriptions
|
0 prescriptions
|
1119 prescriptions
|
PRIMARY outcome
Timeframe: Year 5 (Year 2010)Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Outcome measures
| Measure |
Aarhus [Part 1]
n=1539 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=1050 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=88 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
n=1005 Participants
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
n=201 Participants
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 5
G02CB03
|
2395 prescriptions
|
3793 prescriptions
|
283 prescriptions
|
2752 prescriptions
|
3170 prescriptions
|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 5
N04BC06
|
201 prescriptions
|
274 prescriptions
|
0 prescriptions
|
0 prescriptions
|
981 prescriptions
|
PRIMARY outcome
Timeframe: Year 6 (Year 2011)Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Outcome measures
| Measure |
Aarhus [Part 1]
n=1463 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=966 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=56 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
n=853 Participants
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
n=198 Participants
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 6
N04BC06
|
141 prescriptions
|
143 prescriptions
|
0 prescriptions
|
0 prescriptions
|
859 prescriptions
|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 6
G02CB03
|
2286 prescriptions
|
3686 prescriptions
|
183 prescriptions
|
2660 prescriptions
|
3212 prescriptions
|
PRIMARY outcome
Timeframe: Year 1 (Year 2006)Population: Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure.
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Outcome measures
| Measure |
Aarhus [Part 1]
n=64 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=231 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=242 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1
|
0 percentage of prescriptions
|
0 percentage of prescriptions
|
0 percentage of prescriptions
|
—
|
—
|
PRIMARY outcome
Timeframe: Year 2 (Year 2007)Population: Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure.
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Outcome measures
| Measure |
Aarhus [Part 1]
n=49 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=139 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=75 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2
|
4 percentage of prescriptions
|
10 percentage of prescriptions
|
10 percentage of prescriptions
|
—
|
—
|
PRIMARY outcome
Timeframe: Year 3 (Year 2008)Population: Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure.
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Outcome measures
| Measure |
Aarhus [Part 1]
n=13 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=18 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=28 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3
|
20 percentage of prescriptions
|
39 percentage of prescriptions
|
23 percentage of prescriptions
|
—
|
—
|
PRIMARY outcome
Timeframe: Year 4 (Year 2009)Population: Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure.
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Outcome measures
| Measure |
Aarhus [Part 1]
n=9 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=4 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=20 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4
|
7 percentage of prescriptions
|
22 percentage of prescriptions
|
12 percentage of prescriptions
|
—
|
—
|
PRIMARY outcome
Timeframe: Year 5 (Year 2010)Population: Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure.
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Outcome measures
| Measure |
Aarhus [Part 1]
n=6 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=4 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=13 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5
|
18 percentage of prescriptions
|
43 percentage of prescriptions
|
21 percentage of prescriptions
|
—
|
—
|
PRIMARY outcome
Timeframe: Year 6 (Year 2011)Population: Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure.
Changes to the Summary of Product Characteristics (SPC) in April 2007 included that the cabergoline should be used for Parkinson's disease only in participants who have already taken or cannot take other treatments, that is as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline is considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Outcome measures
| Measure |
Aarhus [Part 1]
n=2 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=2 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=6 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6
|
11 percentage of prescriptions
|
67 percentage of prescriptions
|
0 percentage of prescriptions
|
—
|
—
|
PRIMARY outcome
Timeframe: Year 1 (Year 2006)Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Outcome measures
| Measure |
Aarhus [Part 1]
n=81 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=854 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=5 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
n=277 Participants
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
n=370 Participants
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1
|
0 percentage of prescriptions
|
5 percentage of prescriptions
|
0 percentage of prescriptions
|
0 percentage of prescriptions
|
17 percentage of prescriptions
|
PRIMARY outcome
Timeframe: Year 2 (Year 2007)Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Outcome measures
| Measure |
Aarhus [Part 1]
n=1446 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=1475 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=31 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
n=1231 Participants
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
n=756 Participants
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2
|
0.2 percentage of prescriptions
|
5 percentage of prescriptions
|
2 percentage of prescriptions
|
0 percentage of prescriptions
|
13 percentage of prescriptions
|
PRIMARY outcome
Timeframe: Year 3 (Year 2008)Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Outcome measures
| Measure |
Aarhus [Part 1]
n=1469 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=1089 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=59 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
n=1081 Participants
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
n=279 Participants
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3
|
0 percentage of prescriptions
|
3 percentage of prescriptions
|
5 percentage of prescriptions
|
0 percentage of prescriptions
|
7 percentage of prescriptions
|
PRIMARY outcome
Timeframe: Year 4 (Year 2009)Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Outcome measures
| Measure |
Aarhus [Part 1]
n=1539 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=1146 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=87 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
n=1039 Participants
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
n=220 Participants
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4
|
0 percentage of prescriptions
|
2 percentage of prescriptions
|
1 percentage of prescriptions
|
0 percentage of prescriptions
|
5 percentage of prescriptions
|
PRIMARY outcome
Timeframe: Year 5 (Year 2010)Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Outcome measures
| Measure |
Aarhus [Part 1]
n=1539 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=1050 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=88 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
n=1005 Participants
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
n=201 Participants
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5
|
0 percentage of prescriptions
|
3 percentage of prescriptions
|
1 percentage of prescriptions
|
0 percentage of prescriptions
|
2 percentage of prescriptions
|
PRIMARY outcome
Timeframe: Year 6 (Year 2011)Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Outcome measures
| Measure |
Aarhus [Part 1]
n=1463 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=966 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=56 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
n=853 Participants
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
n=198 Participants
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6
|
0 percentage of prescriptions
|
1 percentage of prescriptions
|
0 percentage of prescriptions
|
0 percentage of prescriptions
|
2 percentage of prescriptions
|
PRIMARY outcome
Timeframe: Baseline (Week 1) up to Week 339Population: Study population included all participants who were recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson's disease during the study period.
The CHMP recommended that the prescribing information for cabergoline should be updated to include: a warning stating that participant must be monitored for signs of cardiac valve fibrosis with echocardiography before treatment is started and regularly (every 6 months) during treatment. To evaluate effectiveness with the new prescription guidelines, it was assessed whether cabergoline users were monitored by echocardiography.
Outcome measures
| Measure |
Aarhus [Part 1]
n=11 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=2 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=48 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Total Number of Echocardiography Examinations in Cabergoline Users
|
11 echocardiography examinations
|
3 echocardiography examinations
|
68 echocardiography examinations
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Week 1) up to Week 339Population: Study population:all participants recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson's disease during study period.
Incidence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment and absence of any valve damage at baseline divided by number of participants without any valve damage at baseline and at least 1 additional echocardiography examination during follow-up while on cabergoline treatment. Percentage of participants with valvular fibrosis are reported.
Outcome measures
| Measure |
Aarhus [Part 1]
n=11 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
|
HSD [Part 1]
n=2 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
|
IPCI [Part 1]
n=48 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
|
PHARMO [Part 1]
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
|
THIN [Part 1]
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
|
|---|---|---|---|---|---|
|
Incidence of Valvular Fibrosis
|
100 percentage of participants
|
0 percentage of participants
|
57.1 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Week 1) up to Week 339Population: Study population included all participants who were recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson's disease during the study period.
Prevalence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment divided by number of participants with at least 1 echocardiography examination. Percentage of participants with valvular fibrosis are reported.
Outcome measures
| Measure |
Aarhus [Part 1]
n=11 Participants
Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
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HSD [Part 1]
n=2 Participants
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
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IPCI [Part 1]
n=48 Participants
Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
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PHARMO [Part 1]
Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
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THIN [Part 1]
Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
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Prevalence of Valvular Fibrosis
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57.2 percentage of participants
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50.0 percentage of participants
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55.9 percentage of participants
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—
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Adverse Events
Aarhus [Part 1]
HSD [Part 1]
IPCI [Part 1]
PHARMO [Part 1]
THIN [Part 1]
Cabergoline in Pre-SPC Change Period [Part 2]
Cabergoline in Post- SPC Change Period [Part 2]
Cabergoline in Cross-SPC Change Period [Part 2]
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER