Trial Outcomes & Findings for Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use (NCT NCT01332435)
NCT ID: NCT01332435
Last Updated: 2017-06-27
Results Overview
Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes.
Recruitment status
COMPLETED
Target enrollment
6896 participants
Primary outcome timeframe
Day 1 of a 1-day study
Results posted on
2017-06-27
Participant Flow
Participant milestones
| Measure |
IHCIS; Early 5ARI Initiation
Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI \[dutasteride and finasteride\]) within 30 days of an alpha-blocker (AB \[doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin\]).
|
IHCIS; Late 5ARI Initiation
Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
PharMetrics; Early 5ARI Initiation
Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
PharMetrics; Late 5ARI Initiation
Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1572
|
1064
|
2604
|
1656
|
|
Overall Study
COMPLETED
|
1572
|
1064
|
2604
|
1656
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use
Baseline characteristics by cohort
| Measure |
IHCIS; Early 5ARI Initiation
n=1572 Participants
Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI \[dutasteride and finasteride\]) within 30 days of an alpha-blocker (AB \[doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin\]).
|
IHCIS; Late 5ARI Initiation
n=1064 Participants
Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
PharMetrics; Early 5ARI Initiation
n=2604 Participants
Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
PharMetrics; Late 5ARI Initiation
n=1656 Participants
Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
Total
n=6896 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
>=50 years old
|
1572 Participants
n=99 Participants
|
1064 Participants
n=107 Participants
|
2604 Participants
n=206 Participants
|
1656 Participants
n=7 Participants
|
6896 Participants
n=31 Participants
|
|
Age, Customized
<50 years old
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1572 Participants
n=99 Participants
|
1064 Participants
n=107 Participants
|
2604 Participants
n=206 Participants
|
1656 Participants
n=7 Participants
|
6896 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Day 1 of a 1-day studyPopulation: Enrolled Population: Men aged \>=50 years old between 7/1/2000 and 12/31/2006 with a diagnosis of benign prostatic hyperplasia and who were treated with an AB and concomitant 5-ARI therapy within 6 months of starting AB therapy
Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes.
Outcome measures
| Measure |
IHCIS; Early 5ARI Initiation
n=1572 Participants
Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI \[dutasteride and finasteride\]) within 30 days of an alpha-blocker (AB \[doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin\]).
|
IHCIS; Late 5ARI Initiation
n=1064 Participants
Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
PharMetrics; Early 5ARI Initiation
n=2604 Participants
Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
PharMetrics; Late 5ARI Initiation
n=1656 Participants
Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
|---|---|---|---|---|
|
Number of Participants With Clinical Progression
|
176 participants
|
202 participants
|
266 participants
|
232 participants
|
PRIMARY outcome
Timeframe: Day 1 of a 1-day studyPopulation: Enrolled Population
Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.
Outcome measures
| Measure |
IHCIS; Early 5ARI Initiation
n=1572 Participants
Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI \[dutasteride and finasteride\]) within 30 days of an alpha-blocker (AB \[doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin\]).
|
IHCIS; Late 5ARI Initiation
n=1064 Participants
Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
PharMetrics; Early 5ARI Initiation
n=2604 Participants
Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
PharMetrics; Late 5ARI Initiation
n=1656 Participants
Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
|---|---|---|---|---|
|
Number of Participants With Acute Urinary Retention
|
127 participants
|
140 participants
|
182 participants
|
166 participants
|
PRIMARY outcome
Timeframe: Day 1 of a 1-day studyPopulation: Enrolled Population
Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.
Outcome measures
| Measure |
IHCIS; Early 5ARI Initiation
n=1572 Participants
Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI \[dutasteride and finasteride\]) within 30 days of an alpha-blocker (AB \[doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin\]).
|
IHCIS; Late 5ARI Initiation
n=1064 Participants
Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
PharMetrics; Early 5ARI Initiation
n=2604 Participants
Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
PharMetrics; Late 5ARI Initiation
n=1656 Participants
Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
|---|---|---|---|---|
|
Number of Participants Who Needed Prostate-Related Surgery
|
75 participants
|
101 participants
|
130 participants
|
104 participants
|
SECONDARY outcome
Timeframe: Day 1 of a 1-day studyPopulation: Enrolled Population
All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
Outcome measures
| Measure |
IHCIS; Early 5ARI Initiation
n=1572 Participants
Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI \[dutasteride and finasteride\]) within 30 days of an alpha-blocker (AB \[doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin\]).
|
IHCIS; Late 5ARI Initiation
n=1064 Participants
Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
PharMetrics; Early 5ARI Initiation
n=2604 Participants
Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
PharMetrics; Late 5ARI Initiation
n=1656 Participants
Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
|---|---|---|---|---|
|
Total BPH-related Costs
|
1417 United States dollars
Standard Deviation 1670
|
1606 United States dollars
Standard Deviation 1878
|
1735 United States dollars
Standard Deviation 1687
|
1686 United States dollars
Standard Deviation 2098
|
SECONDARY outcome
Timeframe: Day 1 of a 1-day studyPopulation: Enrolled Population
Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
Outcome measures
| Measure |
IHCIS; Early 5ARI Initiation
n=1572 Participants
Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI \[dutasteride and finasteride\]) within 30 days of an alpha-blocker (AB \[doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin\]).
|
IHCIS; Late 5ARI Initiation
n=1064 Participants
Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
PharMetrics; Early 5ARI Initiation
n=2604 Participants
Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
PharMetrics; Late 5ARI Initiation
n=1656 Participants
Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
|---|---|---|---|---|
|
BPH-related Medical Costs
|
349 United States dollars
Standard Deviation 1535
|
618 United States dollars
Standard Deviation 1812
|
344 United States dollars
Standard Deviation 1458
|
449 United States dollars
Standard Deviation 2001
|
SECONDARY outcome
Timeframe: Day 1 of a 1-day studyPopulation: Enrolled Population
Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
Outcome measures
| Measure |
IHCIS; Early 5ARI Initiation
n=1572 Participants
Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI \[dutasteride and finasteride\]) within 30 days of an alpha-blocker (AB \[doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin\]).
|
IHCIS; Late 5ARI Initiation
n=1064 Participants
Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
PharMetrics; Early 5ARI Initiation
n=2604 Participants
Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
PharMetrics; Late 5ARI Initiation
n=1656 Participants
Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
|
|---|---|---|---|---|
|
BPH-related Pharmacy Costs
|
1068 United States dollars
Standard Deviation 645
|
1417 United States dollars
Standard Deviation 1670
|
1392 United States dollars
Standard Deviation 851
|
1237 United States dollars
Standard Deviation 733
|
Adverse Events
IHCIS; Early 5ARI Initiation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IHCIS; Late 5ARI Initiation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PharMetrics; Early 5ARI Initiation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PharMetrics; Late 5ARI Initiation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER