Dabigatran Vs Warfarin
- Dabigatran is superior to warfarin, but at what cost?
- Dabigatran vs warfarin vte
- Dabigatran vs warfarin nejm
- Dabigatran vs warfarin pulmonary embolism
A new comparative study between dabigatran and warfarin finds similar ischemic stroke risks, but fewer brain bleeds for dabigatron compared with warfarin in US-based national drug surveillance network. More research is needed however, to determine whether dabigatran is associated with higher risk of heart attack or gastrointestinal bleeding in certain patients. A study of two medications that can reduce risk of ischemic stroke in people with atrial fibrillation (AF) has shown that outcomes in typical patients with AF align well with those seen in clinical trials. The findings were published in Annals of Internal Medicine. This research, led by Alan Go, director of the Comprehensive Clinical Research Unit within the Kaiser Permanente Division of Research, marks the first major study to examine outcomes of therapies for AF from the US Food and Drug Administration (FDA) Sentinel Initiative, a national multi-institution network to monitor the safety of new medical products after they reach the market.
Dabigatran is superior to warfarin, but at what cost?
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Dabigatran vs warfarin vte
During the study, patients in the warfarin group were in the therapeutic INR range 66% of the time. Patients on uninterrupted dabigatran had significantly fewer major bleeding events than patients on uninterrupted warfarin (relative risk reduction 77. 2%). The five patients in the dabigatran group with a major bleeding event had pericardial tamponade (one patient), pericardial effusion (one), groin bleed (two), and gastrointestinal (GI) bleed (one). The 23 patients in the warfarin group with a major bleeding event had pericardial tamponade (six), groin bleed (two), groin hematoma (eight), GI bleed (two), intracranial bleed (two), pseudoaneurysm (one), and hematoma (two). About 18% of patients in each group had minor bleeding events. None of the patients had a stroke and one patient on warfarin had a transient ischemic attack (TIA). No patient died. Dabigatran Concerns Refuted, Trials of Other NOACs Ongoing "This is something that we have been struggling with since concern was raised that dabigatran might be associated with more thromboembolic events, and this clearly refutes that concern, " Stevenson said.
Dabigatran vs warfarin nejm
Dabigatran vs warfarin pulmonary embolism
The study also addressed myocardial infarction rates associated with each drug, but the results were inconclusive. Patients on dabigatran were more likely to experience a heart attack than patients on warfarin, but the statistical strength and consistency of this finding was unclear. "The jury is still out, " Go says. "We need more research to rule out the possibility that there might be a higher risk of heart attack with dabigatran in certain patients, such as those who are older and men. " National collaboration The analysis incorporated data from 50, 578 adults aged 21 and older with AF. Half of the patients started dabigatran and the other half started warfarin between November 2010 and May 2014. To ensure a fair comparison, patients taking dabigatran versus warfarin were statistically matched according to similar demographics, use of additional medications and many other characteristics. Patient data was contributed by eight US-based Sentinel collaborators: Kaiser Permanente Northern California, Kaiser Permanente Washington, Aetna, Harvard Pilgrim Health Care Institute, HealthCore, HealthPartners Institute, Humana Comprehensive Health Insights, and Optum: Optum Epidemiology.
Results: A total of 30 of the 1274 patients randomly assigned to receive dabigatran (2. 4%), as compared with 27 of the 1265 patients randomly assigned to warfarin (2. 1%), had recurrent venous thromboembolism; the difference in risk was 0. 4 percentage points (95% confidence interval [CI], -0. 8 to 1. 5; P<0. 001 for the prespecified noninferiority margin). The hazard ratio with dabigatran was 1. 10 (95% CI, 0. 65 to 1. 84). Major bleeding episodes occurred in 20 patients assigned to dabigatran (1. 6%) and in 24 patients assigned to warfarin (1. 9%) (hazard ratio with dabigatran, 0. 82; 95% CI, 0. 45 to 1. 48), and episodes of any bleeding were observed in 205 patients assigned to dabigatran (16. 1%) and 277 patients assigned to warfarin (21. 9%; hazard ratio with dabigatran, 0. 71; 95% CI, 0. 59 to 0. 85). The numbers of deaths, acute coronary syndromes, and abnormal liver-function tests were similar in the two groups. Adverse events leading to discontinuation of the study drug occurred in 9.