Trial Outcomes & Findings for The Comparative Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-valvular Atrial Fibrillation Population With Humana Healthcare Coverage (NCT NCT02061748)
NCT ID: NCT02061748
Last Updated: 2017-06-08
Results Overview
This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the primary analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy. Hemorrhagic stroke includes: Subarachnoid hemorrhage (SAH) and Intracerebral hemorrhage (ICH) but excludes previous listed diagnoses if "traumatic brain injury" or "rehabilitation care" is present. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
COMPLETED
38499 participants
From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)
2017-06-08
Participant Flow
A non-interventional study based on existing data was conducted. This is a retrospective database analysis to assess the safety and effectiveness of dabigatran compared to warfarin in patients diagnosed with non-valvular atrial fibrillation (NVAF) in the real-world setting using the Humana population.
Participant flow and demographic section is based on Pre-propensity score matching data however to analyze the outcome measures Post-propensity score matching data were used.
Participant milestones
| Measure |
Dabigatran
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Overall Study
STARTED
|
7646
|
30853
|
|
Overall Study
COMPLETED
|
7646
|
30853
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Comparative Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-valvular Atrial Fibrillation Population With Humana Healthcare Coverage
Baseline characteristics by cohort
| Measure |
Dabigatran
n=7646 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=30853 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
Total
n=38499 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.2 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
74.8 Years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
74.5 Years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
3316 Participants
n=5 Participants
|
13944 Participants
n=7 Participants
|
17260 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
4330 Participants
n=5 Participants
|
16906 Participants
n=7 Participants
|
21236 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the primary analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy. Hemorrhagic stroke includes: Subarachnoid hemorrhage (SAH) and Intracerebral hemorrhage (ICH) but excludes previous listed diagnoses if "traumatic brain injury" or "rehabilitation care" is present. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Stroke (Primary Analysis)
|
21.9 Events per 1000 patient-years
Interval 17.4 to 26.5
|
29.3 Events per 1000 patient-years
Interval 25.7 to 32.9
|
PRIMARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Stroke (Post-hoc Analysis)
|
12.4 Events per 1000 patient-years
Interval 9.0 to 15.8
|
16.1 Events per 1000 patient-years
Interval 13.4 to 18.7
|
PRIMARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of major bleeding (hemorrhagic stroke, major intracranial bleeding and major extracranial bleeding) for dabigatran and warfarin in the primary analysis. Major Intracranial Bleeding includes subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid hemorrhage following injury without mention of open intracranial wound, subdural hemorrhage following injury without mention of open intracranial wound, extradural hemorrhage following injury without mention of open intracranial wound, other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if major trauma was present. Major extracranial bleeding includes major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding. Either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization were used.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Major Bleeding (Primary Analysis)
|
61.7 Events per 1000 patient-years
Interval 54.1 to 69.3
|
76.7 Events per 1000 patient-years
Interval 70.9 to 82.4
|
PRIMARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of major bleeding (Inclusive of hemorrhagic stroke, major intracranial bleeding and major extracranial bleeding) for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Major Bleeding (Post-hoc Analysis)
|
35.6 Events per 1000 patient-years
Interval 29.8 to 41.4
|
46.9 Events per 1000 patient-years
Interval 42.4 to 51.4
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of ischemic stroke for dabigatran and warfarin in the primary analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Ischemic Stroke (Primary Analysis)
|
21.7 Events per 1000 patient-years
Interval 17.2 to 26.2
|
26.4 Events per 1000 patient-years
Interval 23.0 to 29.8
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of ischemic stroke for dabigatran and warfarin in the post-hoc analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Ischemic Stroke (Post-hoc Analysis)
|
11.2 Events per 1000 patient-years
Interval 8.0 to 14.5
|
12.9 Events per 1000 patient-years
Interval 10.6 to 15.3
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of hemorrhagic stroke for dabigatran and warfarin in the primary analysis. Hemorrhagic stroke includes: subarachnoid hemorrhage, intracerebral hemorrhage but excludes these codes if "traumatic brain injury" or "rehabilitation care" as primary code is present. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Hemorrhagic Stroke (Primary Analysis)
|
1.5 Events per 1000 patient-years
Interval 0.3 to 2.6
|
4.4 Events per 1000 patient-years
Interval 3.0 to 5.8
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of hemorrhagic stroke for dabigatran and warfarin in the post-hoc analysis. Hemorrhagic stroke includes: Subarachnoid hemorrhage and intracerebral hemorrhage but excludes these codes if "traumatic brain injury" or "rehabilitation care" as primary code is present. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Hemorrhagic Stroke (Post-hoc Analysis)
|
1.2 Events per 1000 patient-years
Interval 0.2 to 2.3
|
3.3 Events per 1000 patient-years
Interval 2.1 to 4.4
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of major intracranial bleeding for dabigatran and warfarin in the primary analysis. Major intracranial bleeding includes: Subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid, subdural or extradural hemorrhage following injury without mention of open intracranial wound other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if concomitant discharge diagnosis of major trauma was present. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Major Intracranial Bleeding (Primary Analysis)
|
8.0 Events per 1000 patient-years
Interval 5.3 to 10.8
|
11.3 Events per 1000 patient-years
Interval 9.1 to 13.6
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of major intracranial bleeding for dabigatran and warfarin in the post-hoc analysis. Major intracranial bleeding includes: Subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid, subdural or extradural hemorrhage following injury without mention of open intracranial wound other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if concomitant discharge diagnosis of major trauma was present. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Major Intracranial Bleeding (Post-hoc Analysis)
|
4.4 Events per 1000 patient-years
Interval 2.4 to 6.4
|
8.6 Events per 1000 patient-years
Interval 6.7 to 10.6
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of major extracranial bleeding for dabigatran and warfarin in the primary analysis. Major extracranial bleeding includes: major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Major Extracranial Bleeding (Primary Analysis)
|
54.4 Events per 1000 patient-years
Interval 47.2 to 61.5
|
66.1 Events per 1000 patient-years
Interval 60.8 to 71.5
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of major extracranial bleeding for dabigatran and warfarin in the post-hoc analysis. Major extracranial bleeding includes: major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Major Extracranial Bleeding (Post-hoc Analysis)
|
31.2 Events per 1000 patient-years
Interval 25.8 to 36.6
|
38.3 Events per 1000 patient-years
Interval 34.2 to 42.3
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of major GI bleeding for dabigatran and warfarin in the primary analysis. Major GI bleeding includes major upper GI bleeding and major lower GI bleeding. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Major GI Bleeding (Primary Analysis)
|
44.4 Events per 1000 patient-years
Interval 37.9 to 50.8
|
44.0 Events per 1000 patient-years
Interval 39.7 to 48.4
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of major GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major GI bleeding includes major upper GI bleeding and major lower GI bleeding. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Major GI Bleeding (Post-hoc Analysis)
|
28.5 Events per 1000 patient-years
Interval 23.4 to 33.7
|
28.7 Events per 1000 patient-years
Interval 25.2 to 32.2
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of major upper GI bleeding for dabigatran and warfarin in the primary analysis. Major upper GI bleeding includes acute gastric ulcer, chronic or unspecified gastric ulcer, acute duodenal ulcer, chronic or unspecified duodenal ulcer, acute, chronic or unspecified peptic ulcer, acute gastrojejunal ulcer, chronic or unspecified gastrojejunal ulcer with hemorrhage with/without obstruction and with hemorrhage and perforation with/without obstruction, hematemesis, endoscopic control of gastric or duodenal bleeding, upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Major Upper GI Bleeding (Primary Analysis)
|
6.6 Events per 1000 patient-years
Interval 4.1 to 9.1
|
9.0 Events per 1000 patient-years
Interval 7.0 to 10.9
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of major upper GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major upper GI bleeding includes acute, chronic or unspecified gastric ulcer, acute duodenal ulcer, chronic or unspecified duodenal ulcer, acute, chronic or unspecified peptic ulcer, acute, chronic or unspecified gastrojejunal ulcer with hemorrhage with/without (w/wo) obstruction and with hemorrhage and perforation w/wo obstruction, hematemesis, endoscopic control of gastric or duodenal bleeding, upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. This was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Major Upper GI Bleeding (Post-hoc Analysis)
|
5.4 Events per 1000 patient-years
Interval 3.1 to 7.6
|
6.8 Events per 1000 patient-years
Interval 5.1 to 8.6
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of major lower GI bleeding for dabigatran and warfarin in the primary analysis. Major lower GI bleeding includes diverticulosis or diverticulitis of small intestine or of colon with hemorrhage, hemorrhage of rectum and anus, angiodysplasia of intestine with hemorrhage, blood in stool and hemorrhage of GI tract (unspecified). Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Major Lower GI Bleeding (Primary Analysis)
|
43.4 Events per 1000 patient-years
Interval 37.0 to 49.8
|
42.8 Events per 1000 patient-years
Interval 38.5 to 47.1
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of major lower GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major lower GI bleeding includes diverticulosis or diverticulitis of small intestine or of colon with hemorrhage, hemorrhage of rectum and anus, angiodysplasia of intestine with hemorrhage, blood in stool and hemorrhage of GI tract (unspecified). A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Major Lower GI Bleeding (Post-hoc Analysis)
|
23.6 Events per 1000 patient-years
Interval 18.9 to 28.3
|
22.7 Events per 1000 patient-years
Interval 19.6 to 25.8
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of major urogenital bleeding for dabigatran and warfarin in the primary analysis. Major urogenital bleeding includes hematuria and excessive/frequent menstruation and secondary diagnosis indicating acute bleeding (anemia). Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Major Urogenital Bleeding (Primary Analysis)
|
5.8 Events per 1000 patient-years
Interval 3.5 to 8.2
|
12.1 Events per 1000 patient-years
Interval 9.8 to 14.4
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of major urogenital bleeding for dabigatran and warfarin in the post-hoc analysis. Major urogenital bleeding includes hematuria and excessive/frequent menstruation and secondary diagnosis indicating acute bleeding (anemia). A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Major Urogenital Bleeding (Post-hoc Analysis)
|
0.2 Events per 1000 patient-years
Interval 0.0 to 0.7
|
4.5 Events per 1000 patient-years
Interval 3.1 to 5.9
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of other major bleeds for dabigatran and warfarin in the primary analysis. Other major bleeds includes hemarthrosis, hemopericardium, hemoptysis, epistaxis, hemorrhage (not specified) and acute posthemorrhagic anemia. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Other Major Bleeds (Primary Analysis)
|
12.7 Events per 1000 patient-years
Interval 9.2 to 16.1
|
18.2 Events per 1000 patient-years
Interval 15.4 to 21.0
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of other major bleeds for dabigatran and warfarin in the post-hoc analysis. Other major bleeds includes hemarthrosis, hemopericardium, hemoptysis, epistaxis, hemorrhage (not specified) and acute posthemorrhagic anemia. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Other Major Bleeds (Post-hoc Analysis)
|
2.7 Events per 1000 patient-years
Interval 1.1 to 4.3
|
5.8 Events per 1000 patient-years
Interval 4.3 to 7.4
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of TIA for dabigatran and warfarin in the primary analysis. TIA includes transient cerebral ischemia as the principal (primary) discharge diagnosis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Transient Ischemic Attack (TIA) (Primary Analysis)
|
10.7 Events per 1000 patient-years
Interval 7.6 to 13.9
|
13.0 Events per 1000 patient-years
Interval 10.7 to 15.4
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of TIA for dabigatran and warfarin in the post-hoc analysis. TIA includes transient cerebral ischemia as the principal (primary) discharge diagnosis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
TIA (Post-hoc Analysis)
|
3.4 Events per 1000 patient-years
Interval 1.6 to 5.2
|
4.4 Events per 1000 patient-years
Interval 3.0 to 5.8
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of MI for dabigatran and warfarin in the primary analysis. MI includes the acute myocardial infarction. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Myocardial Infarction (MI) (Primary Analysis)
|
13.6 Events per 1000 patient-years
Interval 10.1 to 17.2
|
16.1 Events per 1000 patient-years
Interval 13.4 to 18.7
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of MI for dabigatran and warfarin in the post-hoc analysis. MI includes the acute myocardial infarction. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
MI (Post-hoc Analysis)
|
8.0 Events per 1000 patient-years
Interval 5.3 to 10.8
|
7.5 Events per 1000 patient-years
Interval 5.7 to 9.3
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of venous thromboembolism for dabigatran and warfarin in the primary analysis. Venous thromboembolism includes the deep vein thrombosis and the pulmonary embolism. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Venous Thromboembolism (Primary Analysis)
|
12.2 Events per 1000 patient-years
Interval 8.8 to 15.6
|
23.0 Events per 1000 patient-years
Interval 19.9 to 26.2
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of venous thromboembolism for dabigatran and warfarin in the post-hoc analysis. Venous thromboembolism includes the deep vein thrombosis and the pulmonary embolism. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Venous Thromboembolism (Post-hoc Analysis)
|
2.2 Events per 1000 patient-years
Interval 0.8 to 3.6
|
3.5 Events per 1000 patient-years
Interval 2.3 to 4.7
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of deep vein thrombosis for dabigatran and warfarin in the primary analysis. Deep vein thrombosis includes phlebitis and thrombophlebitis and other venous embolism and thrombosis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Deep Vein Thrombosis (Primary Analysis)
|
9.5 Events per 1000 patient-years
Interval 6.5 to 12.5
|
15.9 Events per 1000 patient-years
Interval 13.3 to 18.6
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of deep vein thrombosis for dabigatran and warfarin in the post-hoc analysis. Deep vein thrombosis includes phlebitis and thrombophlebitis and other venous embolism and thrombosis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Deep Vein Thrombosis (Post-hoc Analysis)
|
1.0 Events per 1000 patient-years
Interval 0.0 to 1.9
|
1.3 Events per 1000 patient-years
Interval 0.6 to 2.1
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of pulmonary embolism for dabigatran and warfarin in the primary analysis. Pulmonary embolism includes acute pulmonary heart disease. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Pulmonary Embolism (Primary Analysis)
|
3.4 Events per 1000 patient-years
Interval 1.6 to 5.2
|
9.1 Events per 1000 patient-years
Interval 7.1 to 11.1
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of pulmonary embolism for dabigatran and warfarin in the post-hoc analysis. Pulmonary embolism includes acute pulmonary heart disease. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
Pulmonary Embolism (Post-hoc Analysis)
|
1.2 Events per 1000 patient-years
Interval 0.2 to 2.3
|
2.1 Events per 1000 patient-years
Interval 1.2 to 3.1
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of death for dabigatran and warfarin in the primary analysis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
All-cause Death (Primary Analysis)
|
36.6 Events per 1000 patient-years
Interval 30.7 to 42.4
|
49.8 Events per 1000 patient-years
Interval 45.2 to 54.5
|
SECONDARY outcome
Timeframe: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)Population: A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.
This outcome measure describes the incidence of death for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.
Outcome measures
| Measure |
Dabigatran
n=7245 Participants
Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
|
Warfarin
n=14490 Participants
Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
|
|---|---|---|
|
All-cause Death (Post-hoc Analysis)
|
36.6 Events per 1000 patient-years
Interval 30.7 to 42.4
|
49.8 Events per 1000 patient-years
Interval 45.2 to 54.5
|
Adverse Events
Dabigatran
Warfarin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER