Trial Outcomes & Findings for Treatment Pattern of Oral Anticoagulants (OAC) in Japan (NCT NCT02982863)

NCT ID: NCT02982863

Last Updated: 2018-09-14

Results Overview

Number of patients prescribed OAC drug Warfarin at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

Recruitment status

COMPLETED

Target enrollment

48696 participants

Primary outcome timeframe

Day 1

Results posted on

2018-09-14

Participant Flow

A retrospective, observational study using health insurance claims data.48696 patients were prescribed dabigatran, warfarin, apixaban, edoxaban, or rivaroxaban as the first OACs but 50 patients were removed as they took more than one these drugs. Thus only 48646 patients were prescribed the drugs of interest.

The Japanese patients diagnosed as Non-Valvular Atrial Fibrillation (NVAF) between April 2010 and June 2016, were prescribed dabigatran, warfarin, apixaban, edoxaban, or rivaroxaban as the first OACs. DPC; Diagnosis Procedure Combination (DPC)

Participant milestones

Participant milestones
Measure
Dabigatran
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Overall Study
STARTED
5745
16745
13238
10158
2760
Overall Study
COMPLETED
4936
12484
11386
8758
2268
Overall Study
NOT COMPLETED
809
4261
1852
1400
492

Reasons for withdrawal

Reasons for withdrawal
Measure
Dabigatran
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Overall Study
Not eligible patients
809
4261
1852
1400
492

Baseline Characteristics

Treatment Pattern of Oral Anticoagulants (OAC) in Japan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dabigatran
n=4936 Participants
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
n=12484 Participants
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
n=11386 Participants
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
n=8758 Participants
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
n=2268 Participants
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Total
n=39832 Participants
Total of all reporting groups
Age, Continuous
72 Years
STANDARD_DEVIATION 10 • n=99 Participants
78 Years
STANDARD_DEVIATION 10 • n=107 Participants
77 Years
STANDARD_DEVIATION 10 • n=206 Participants
74 Years
STANDARD_DEVIATION 11 • n=7 Participants
77 Years
STANDARD_DEVIATION 10 • n=31 Participants
76 Years
STANDARD_DEVIATION 10 • n=30 Participants
Sex: Female, Male
Female
1625 Participants
n=99 Participants
5068 Participants
n=107 Participants
4737 Participants
n=206 Participants
3183 Participants
n=7 Participants
1130 Participants
n=31 Participants
15743 Participants
n=30 Participants
Sex: Female, Male
Male
3311 Participants
n=99 Participants
7416 Participants
n=107 Participants
6649 Participants
n=206 Participants
5575 Participants
n=7 Participants
1138 Participants
n=31 Participants
24089 Participants
n=30 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

Number of patients by each type of study-target OAC drug (dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban) prescribed as the first Oral Anticoagulants (OAC) with Non-valvular atrial fibrillation (NVAF)

Outcome measures

Outcome measures
Measure
Dabigatran
n=5745 Participants
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
n=16745 Participants
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
n=13238 Participants
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
n=10158 Participants
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
n=2760 Participants
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF
4936 Participants
12484 Participants
11386 Participants
8758 Participants
2268 Participants

PRIMARY outcome

Timeframe: Day 1

Population: eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

Number of patients prescribed OAC drug dabigatran at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

Outcome measures

Outcome measures
Measure
Dabigatran
n=4936 Participants
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Number of Patients Prescribed OAC Drug Dabigatran by Dosage
75 milligram (mg)
58 Participants
Number of Patients Prescribed OAC Drug Dabigatran by Dosage
110 mg
164 Participants
Number of Patients Prescribed OAC Drug Dabigatran by Dosage
150 mg
354 Participants
Number of Patients Prescribed OAC Drug Dabigatran by Dosage
220 mg
3343 Participants
Number of Patients Prescribed OAC Drug Dabigatran by Dosage
225 mg
5 Participants
Number of Patients Prescribed OAC Drug Dabigatran by Dosage
300 mg
1072 Participants
Number of Patients Prescribed OAC Drug Dabigatran by Dosage
440 mg
1 Participants

PRIMARY outcome

Timeframe: Day 1

Population: eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

Number of patients prescribed OAC drug Warfarin at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

Outcome measures

Outcome measures
Measure
Dabigatran
n=12484 Participants
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Number of Patients Prescribed OAC Drug Warfarin by Dosage
0.9 mg
2 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
1 mg
3125 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
1.2 mg
2 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
1.25 mg
62 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
1.3 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
1.5 mg
630 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
1.55 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
1.7 mg
2 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
1.75 mg
66 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
1.8 mg
2 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
1.9 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
2 mg
4711 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
2.2 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
2.25 mg
54 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
2.3 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
2.4 mg
3 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
2.5 mg
462 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
2.7 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
2.75 mg
24 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
3 mg
1913 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
3.2 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
3.25 mg
17 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
3.3 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
3.5 mg
128 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
3.7 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
3.75 mg
9 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
4 mg
421 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
4.25 mg
3 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
4.5 mg
41 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
4.6 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
4.75 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
5 mg
468 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
5.5 mg
9 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
6 mg
25 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
6.5 mg
2 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
7 mg
8 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
7.75 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
8 mg
3 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
9 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
10 mg
16 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
17.5 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
20 mg
3 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
30 mg
12 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
40 mg
3 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
50 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
0.002 mg
2 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
0.006 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
0.125 mg
3 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
0.2 mg
4 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
0.25 mg
338 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
0.3 mg
2 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
0.374 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
0.5 mg
1726 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
0.6 mg
3 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
0.625 mg
2 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
0.65 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
0.7 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
0.75 mg
256 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
0.8 mg
1 Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
0.875 mg
3 Participants

PRIMARY outcome

Timeframe: Day 1

Population: eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

Number of patients prescribed OAC drug rivaroxaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

Outcome measures

Outcome measures
Measure
Dabigatran
n=8758 Participants
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
30 mg
72 Participants
Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
5 mg
14 Participants
Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
7.5 mg
3 Participants
Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
9.9 mg
3 Participants
Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
9.99 mg
2 Participants
Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
10 mg
4372 Participants
Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
10.005 mg
4 Participants
Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
10.05 mg
10 Participants
Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
10.5 mg
1 Participants
Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
15 mg
4340 Participants
Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
20 mg
5 Participants
Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
22.5 mg
1 Participants

PRIMARY outcome

Timeframe: Day 1

Population: eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

Number of patients prescribed OAC drug Apixaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

Outcome measures

Outcome measures
Measure
Dabigatran
n=11386 Participants
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Number of Patients Prescribed OAC Drug Apixaban by Dosage
1.25 mg
2 Participants
Number of Patients Prescribed OAC Drug Apixaban by Dosage
2.5 mg
428 Participants
Number of Patients Prescribed OAC Drug Apixaban by Dosage
3.75 mg
2 Participants
Number of Patients Prescribed OAC Drug Apixaban by Dosage
5 mg
6300 Participants
Number of Patients Prescribed OAC Drug Apixaban by Dosage
7.5 mg
1 Participants
Number of Patients Prescribed OAC Drug Apixaban by Dosage
10 mg
4789 Participants
Number of Patients Prescribed OAC Drug Apixaban by Dosage
15 mg
1 Participants
Number of Patients Prescribed OAC Drug Apixaban by Dosage
20 mg
27 Participants
Number of Patients Prescribed OAC Drug Apixaban by Dosage
25 mg
2 Participants
Number of Patients Prescribed OAC Drug Apixaban by Dosage
35 mg
1 Participants

PRIMARY outcome

Timeframe: Day 1

Population: eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

Number of patients prescribed OAC drug edoxaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

Outcome measures

Outcome measures
Measure
Dabigatran
n=2268 Participants
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Number of Patients Prescribed OAC Drug Edoxaban by Dosage
15 mg
279 Participants
Number of Patients Prescribed OAC Drug Edoxaban by Dosage
30 mg
1594 Participants
Number of Patients Prescribed OAC Drug Edoxaban by Dosage
60 mg
412 Participants

SECONDARY outcome

Timeframe: 1 day

Population: eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

Baseline characteristics of patients in each treatment group: age

Outcome measures

Outcome measures
Measure
Dabigatran
n=4936 Participants
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
n=12484 Participants
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
n=11386 Participants
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
n=8758 Participants
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
n=2268 Participants
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Baseline Characteristics: Age
72 Years
Standard Deviation 10
78 Years
Standard Deviation 10
77 Years
Standard Deviation 10
74 Years
Standard Deviation 11
77 Years
Standard Deviation 10

SECONDARY outcome

Timeframe: Day 1

Population: eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

Baseline characteristics of patients in each treatment group: gender

Outcome measures

Outcome measures
Measure
Dabigatran
n=4936 Participants
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
n=12484 Participants
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
n=11386 Participants
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
n=8758 Participants
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
n=2268 Participants
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Baseline Characteristics: Gender
Female
1625 Participants
5068 Participants
4737 Participants
3183 Participants
1130 Participants
Baseline Characteristics: Gender
Male
3311 Participants
7416 Participants
6649 Participants
5575 Participants
1138 Participants

SECONDARY outcome

Timeframe: Day 1

Population: eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

Baseline characteristics of patients in each treatment group: year of initiating treatment

Outcome measures

Outcome measures
Measure
Dabigatran
n=4936 Participants
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
n=12484 Participants
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
n=11386 Participants
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
n=8758 Participants
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
n=2268 Participants
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Baseline Characteristics: Year of Initiating Treatment
2013/3/1-2014/2/28
1081 Participants
2292 Participants
188 Participants
1868 Participants
29 Participants
Baseline Characteristics: Year of Initiating Treatment
2011/3/14-2012/2/29
404 Participants
1138 Participants
0 Participants
0 Participants
8 Participants
Baseline Characteristics: Year of Initiating Treatment
2012/3/1-2013/2/28
1259 Participants
2002 Participants
0 Participants
175 Participants
32 Participants
Baseline Characteristics: Year of Initiating Treatment
2014/3/1-2015/2/28
1019 Participants
2808 Participants
3455 Participants
2182 Participants
158 Participants
Baseline Characteristics: Year of Initiating Treatment
2015/3/1-2016/2/29
919 Participants
3217 Participants
5634 Participants
3302 Participants
1289 Participants
Baseline Characteristics: Year of Initiating Treatment
2016/3/1-2016/6/30
254 Participants
1027 Participants
2109 Participants
1231 Participants
752 Participants

SECONDARY outcome

Timeframe: Day 1

Population: eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

Baseline characteristics of patients in each treatment group: speciality of prescribers of OAC. int.= internal; Med.= Medicine

Outcome measures

Outcome measures
Measure
Dabigatran
n=4936 Participants
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
n=12484 Participants
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
n=11386 Participants
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
n=8758 Participants
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
n=2268 Participants
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Baseline Characteristics: Speciality of Prescribers of OAC
Comprehensive medical care
13 Participants
56 Participants
12 Participants
9 Participants
3 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Internal medicine
1689 Participants
4316 Participants
3943 Participants
2816 Participants
654 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Psychiatry
9 Participants
38 Participants
30 Participants
20 Participants
7 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Neurology
0 Participants
1 Participants
7 Participants
3 Participants
2 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Respiratory
66 Participants
180 Participants
95 Participants
72 Participants
17 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Gastroenterology
106 Participants
283 Participants
100 Participants
125 Participants
26 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Plastic surgery
5 Participants
21 Participants
10 Participants
5 Participants
2 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Cranial nerve surgery
319 Participants
668 Participants
932 Participants
654 Participants
164 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Cardiovascular surgery
87 Participants
405 Participants
115 Participants
147 Participants
54 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Pediatric surgery
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Otorhinolaryngology
8 Participants
47 Participants
25 Participants
19 Participants
5 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Rehabilitation
30 Participants
127 Participants
86 Participants
86 Participants
12 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Radiology
4 Participants
12 Participants
8 Participants
5 Participants
0 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Neuropathic internal medicine
210 Participants
410 Participants
518 Participants
415 Participants
74 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Gastrointestinal
0 Participants
17 Participants
5 Participants
3 Participants
1 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Nephrology
13 Participants
85 Participants
27 Participants
15 Participants
7 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Hemodialysis
1 Participants
8 Participants
0 Participants
0 Participants
0 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Endocrinology
8 Participants
24 Participants
16 Participants
15 Participants
2 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Diabetes medicine
4 Participants
19 Participants
12 Participants
9 Participants
0 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Large intestine and proctology
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Connective tissue disease & iheumatic int. med.
2 Participants
8 Participants
1 Participants
1 Participants
0 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Stroke
2 Participants
6 Participants
5 Participants
0 Participants
0 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Psychiatry & neurology
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Unknown
27 Participants
59 Participants
38 Participants
83 Participants
8 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Hematology
6 Participants
27 Participants
11 Participants
20 Participants
2 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Psychodiagnosis medical
2 Participants
3 Participants
2 Participants
1 Participants
1 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Cardiology
1457 Participants
2447 Participants
2610 Participants
2268 Participants
465 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Allergy
1 Participants
9 Participants
1 Participants
0 Participants
0 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Rheumatology
7 Participants
11 Participants
6 Participants
3 Participants
2 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Pediatrics
0 Participants
5 Participants
4 Participants
4 Participants
0 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Surgery
109 Participants
514 Participants
202 Participants
175 Participants
52 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Orthopedics
113 Participants
550 Participants
212 Participants
178 Participants
317 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Thoracic surgery
10 Participants
58 Participants
27 Participants
25 Participants
3 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Obstetrics and gynecology
4 Participants
11 Participants
9 Participants
5 Participants
6 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Ophthalmology
19 Participants
38 Participants
26 Participants
36 Participants
5 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Dermatology
9 Participants
41 Participants
23 Participants
23 Participants
3 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Urology
31 Participants
161 Participants
76 Participants
55 Participants
15 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Gynecology
2 Participants
2 Participants
1 Participants
2 Participants
0 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Respiratory medicine
36 Participants
161 Participants
112 Participants
75 Participants
18 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Cardiovascular internal medicine
444 Participants
1258 Participants
1930 Participants
1218 Participants
301 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Diabetes
3 Participants
14 Participants
8 Participants
10 Participants
0 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Metabolism internal medicine
0 Participants
3 Participants
4 Participants
7 Participants
0 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Emergency medicine
18 Participants
59 Participants
54 Participants
46 Participants
11 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Gastroenterological medicine
53 Participants
270 Participants
61 Participants
85 Participants
20 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Digestive surgery
6 Participants
25 Participants
7 Participants
10 Participants
4 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Hepato-biliarypancreatic surgery
0 Participants
4 Participants
4 Participants
1 Participants
1 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Oncotherapy
2 Participants
6 Participants
0 Participants
1 Participants
1 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Breast and thyroid surgery
0 Participants
3 Participants
0 Participants
2 Participants
1 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Pediatric cardiology
0 Participants
3 Participants
0 Participants
0 Participants
0 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Palliative care
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Hematology & medical Oncology
0 Participants
1 Participants
1 Participants
1 Participants
1 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Endocrinology & metabolism
1 Participants
1 Participants
2 Participants
1 Participants
0 Participants
Baseline Characteristics: Speciality of Prescribers of OAC
Anesthesiology
0 Participants
7 Participants
6 Participants
4 Participants
1 Participants

SECONDARY outcome

Timeframe: Day 1

Population: eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

Baseline characteristics of patients in each treatment group: history of disease and hospitalization.

Outcome measures

Outcome measures
Measure
Dabigatran
n=4936 Participants
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
n=12484 Participants
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
n=11386 Participants
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
n=8758 Participants
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
n=2268 Participants
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Baseline Characteristics: History of Disease
Stroke or transient ischemic attack
63 Participants
145 Participants
128 Participants
85 Participants
21 Participants
Baseline Characteristics: History of Disease
Myocardial infarction
317 Participants
903 Participants
890 Participants
629 Participants
178 Participants
Baseline Characteristics: History of Disease
Coronary artery disease
39 Participants
87 Participants
79 Participants
53 Participants
25 Participants
Baseline Characteristics: History of Disease
Heart failure
1899 Participants
6750 Participants
5099 Participants
3580 Participants
977 Participants
Baseline Characteristics: History of Disease
Diabetes mellitus
1979 Participants
4804 Participants
4255 Participants
3324 Participants
841 Participants
Baseline Characteristics: History of Disease
Dyslipidemia
1366 Participants
2888 Participants
3109 Participants
2402 Participants
597 Participants
Baseline Characteristics: History of Disease
Arterial hypertension
2938 Participants
8501 Participants
6990 Participants
5357 Participants
1344 Participants
Baseline Characteristics: History of Disease
Peripheral artery disease
580 Participants
1538 Participants
1290 Participants
933 Participants
252 Participants
Baseline Characteristics: History of Disease
Peptic ulcer disease
958 Participants
2301 Participants
2148 Participants
1558 Participants
452 Participants
Baseline Characteristics: History of Disease
Dementia
107 Participants
447 Participants
348 Participants
268 Participants
90 Participants
Baseline Characteristics: History of Disease
Malignant lymphoma
62 Participants
171 Participants
159 Participants
109 Participants
41 Participants
Baseline Characteristics: History of Disease
Leukemia
34 Participants
161 Participants
107 Participants
82 Participants
27 Participants
Baseline Characteristics: History of Disease
Solid tumor cancer
1501 Participants
3830 Participants
3413 Participants
2524 Participants
678 Participants
Baseline Characteristics: History of Disease
Kidney impairment
199 Participants
697 Participants
527 Participants
360 Participants
118 Participants
Baseline Characteristics: History of Disease
Liver disease
784 Participants
1777 Participants
1576 Participants
1257 Participants
339 Participants
Baseline Characteristics: History of Disease
Valvular disease
1659 Participants
4294 Participants
2961 Participants
2561 Participants
615 Participants
Baseline Characteristics: History of Disease
Bleeding (gastrointestinal, etc.)
1619 Participants
3867 Participants
3567 Participants
2677 Participants
782 Participants

SECONDARY outcome

Timeframe: Day 1

Population: eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

Baseline characteristics: history of hospitalization

Outcome measures

Outcome measures
Measure
Dabigatran
n=4936 Participants
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
n=12484 Participants
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
n=11386 Participants
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
n=8758 Participants
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
n=2268 Participants
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Baseline Characteristics: History of Hospitalization
2384 Participants
9494 Participants
6517 Participants
4589 Participants
1412 Participants

SECONDARY outcome

Timeframe: Day 1

Population: eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC.

Baseline characteristics of patients in each treatment group: Atrial Fibrillation (AF) risk score CHADS2: Congestive heart failure, Hypertension, Age, Diabetes, Stroke(doubled). CHADS2 score range from 0-6, with higher scores indicating the higher risk CHA2DS2VASc: Cardiac failure or dysfunction, Hypertension, Age 75 (doubled), Diabetes, Stroke (doubled) Vascular disease, Age 65-74 and Sex category (female) score. CHA2DS2VASc score range from 1-9, with higher scores indicating the higher risk. HAS-BLED: Hypertension, Abnormal renal function, Abnormal hepatic function. HAS-BLED score range from 0-8, with higher scores indicating the higher risk.

Outcome measures

Outcome measures
Measure
Dabigatran
n=4936 Participants
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
n=12484 Participants
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
n=11386 Participants
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
n=8758 Participants
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
n=2268 Participants
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Baseline Characteristics: AF Risk Score
0 (CHADS2)
707 Participants
750 Participants
1150 Participants
1072 Participants
238 Participants
Baseline Characteristics: AF Risk Score
1 (CHA2DS2VASc)
547 Participants
585 Participants
773 Participants
783 Participants
140 Participants
Baseline Characteristics: AF Risk Score
2 (CHA2DS2VASc)
878 Participants
1500 Participants
1692 Participants
1481 Participants
305 Participants
Baseline Characteristics: AF Risk Score
3 (CHA2DS2VASc)
968 Participants
2380 Participants
2213 Participants
1735 Participants
497 Participants
Baseline Characteristics: AF Risk Score
4 (CHA2DS2VASc)
916 Participants
2685 Participants
2216 Participants
1718 Participants
432 Participants
Baseline Characteristics: AF Risk Score
5 (CHA2DS2VASc)
690 Participants
2496 Participants
2070 Participants
1348 Participants
380 Participants
Baseline Characteristics: AF Risk Score
6 (CHA2DS2VASc)
441 Participants
1482 Participants
1165 Participants
769 Participants
241 Participants
Baseline Characteristics: AF Risk Score
7 (CHA2DS2VASc)
188 Participants
738 Participants
644 Participants
402 Participants
129 Participants
Baseline Characteristics: AF Risk Score
0 (HAS-BLED)
297 Participants
245 Participants
422 Participants
432 Participants
68 Participants
Baseline Characteristics: AF Risk Score
5 (HAS-BLED)
89 Participants
403 Participants
266 Participants
162 Participants
46 Participants
Baseline Characteristics: AF Risk Score
3 (CHADS2)
1053 Participants
3458 Participants
2787 Participants
2005 Participants
523 Participants
Baseline Characteristics: AF Risk Score
4 (CHADS2)
582 Participants
1897 Participants
1611 Participants
1014 Participants
267 Participants
Baseline Characteristics: AF Risk Score
5 (CHADS2)
243 Participants
816 Participants
626 Participants
459 Participants
125 Participants
Baseline Characteristics: AF Risk Score
6 (CHADS2)
117 Participants
508 Participants
378 Participants
258 Participants
85 Participants
Baseline Characteristics: AF Risk Score
1 (CHADS2)
1103 Participants
2239 Participants
2504 Participants
1928 Participants
513 Participants
Baseline Characteristics: AF Risk Score
0 (CHA2DS2VASc)
198 Participants
182 Participants
280 Participants
295 Participants
66 Participants
Baseline Characteristics: AF Risk Score
2 (CHADS2)
1131 Participants
2816 Participants
2330 Participants
2022 Participants
517 Participants
Baseline Characteristics: AF Risk Score
7 (HAS-BLED)
1 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Baseline Characteristics: AF Risk Score
8 (CHA2DS2VASc)
96 Participants
369 Participants
257 Participants
188 Participants
61 Participants
Baseline Characteristics: AF Risk Score
9 (CHA2DS2VASc)
14 Participants
67 Participants
76 Participants
39 Participants
17 Participants
Baseline Characteristics: AF Risk Score
1 (HAS-BLED)
1276 Participants
2303 Participants
2848 Participants
2228 Participants
545 Participants
Baseline Characteristics: AF Risk Score
2 (HAS-BLED)
1616 Participants
4180 Participants
3725 Participants
2884 Participants
746 Participants
Baseline Characteristics: AF Risk Score
3 (HAS-BLED)
1192 Participants
3738 Participants
2837 Participants
2159 Participants
590 Participants
Baseline Characteristics: AF Risk Score
4 (HAS-BLED)
458 Participants
1562 Participants
1258 Participants
872 Participants
270 Participants
Baseline Characteristics: AF Risk Score
6 (HAS-BLED)
7 Participants
53 Participants
30 Participants
20 Participants
3 Participants
Baseline Characteristics: AF Risk Score
8 (HAS-BLED)
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Day 1

Population: eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

Baseline characteristics of patients in each treatment group: concomitant medication

Outcome measures

Outcome measures
Measure
Dabigatran
n=4936 Participants
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Warfarin
n=12484 Participants
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Apixaban
n=11386 Participants
Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Rivaroxaban
n=8758 Participants
Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Edoxaban
n=2268 Participants
Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Baseline Characteristics: Concomitant Medication
Aspirin
989 Participants
2848 Participants
2027 Participants
1621 Participants
377 Participants
Baseline Characteristics: Concomitant Medication
Ticlodipine
69 Participants
179 Participants
115 Participants
95 Participants
12 Participants
Baseline Characteristics: Concomitant Medication
Cilostazole
199 Participants
522 Participants
466 Participants
306 Participants
66 Participants
Baseline Characteristics: Concomitant Medication
Clopidogrel
346 Participants
1049 Participants
1031 Participants
767 Participants
153 Participants
Baseline Characteristics: Concomitant Medication
ARB or ACE
1649 Participants
4773 Participants
3650 Participants
2954 Participants
661 Participants
Baseline Characteristics: Concomitant Medication
Beta blocker
1779 Participants
4376 Participants
4272 Participants
3137 Participants
768 Participants
Baseline Characteristics: Concomitant Medication
Amiodarone
62 Participants
388 Participants
301 Participants
138 Participants
31 Participants
Baseline Characteristics: Concomitant Medication
Procainamide
14 Participants
40 Participants
43 Participants
17 Participants
8 Participants
Baseline Characteristics: Concomitant Medication
Disopyramide
102 Participants
230 Participants
180 Participants
150 Participants
34 Participants
Baseline Characteristics: Concomitant Medication
Flecainide
130 Participants
105 Participants
237 Participants
150 Participants
33 Participants
Baseline Characteristics: Concomitant Medication
Pilsicainide
582 Participants
726 Participants
970 Participants
885 Participants
145 Participants
Baseline Characteristics: Concomitant Medication
Calcium channel blockers (CCB)
2176 Participants
5755 Participants
5148 Participants
3955 Participants
955 Participants
Baseline Characteristics: Concomitant Medication
Digoxin
506 Participants
1959 Participants
944 Participants
896 Participants
134 Participants
Baseline Characteristics: Concomitant Medication
Diuretics
1277 Participants
5901 Participants
3698 Participants
2480 Participants
681 Participants
Baseline Characteristics: Concomitant Medication
Statins
1029 Participants
2736 Participants
2364 Participants
1876 Participants
407 Participants
Baseline Characteristics: Concomitant Medication
Proton pump inhibitor
1869 Participants
5512 Participants
4583 Participants
3506 Participants
970 Participants
Baseline Characteristics: Concomitant Medication
H2 receptor antagonist
761 Participants
2559 Participants
1673 Participants
1365 Participants
367 Participants

Adverse Events

Dabigatran

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Warfarin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Apixaban

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Rivaroxaban

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Edoxaban

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

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place