The U.K.’s National Institute for Health and Clinical Excellence (NICE) recommended the anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) as an option for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF).
In the U.K., dabigatran has marketing authorization for the prevention of stroke and systemic embolism in, among others, adult patients with non-valvular AF who have had a previous stroke, transient ischemic attack or systemic embolism and in patients with AF who are 65 years old or older who have diabetes, coronary heart disease or hypertension.
The guidance recommends physicians discuss the risks and benefits of dabigatran vs. warfarin with patients before starting treatment. The announcement comes on the heels of calls for caution after a meta-analysis found that dabigatran compared with different controls was associated with an increased risk of MI or acute coronary syndrome in a broad spectrum of patients.
The European Medicines Agency (EMA) gave dabigatran thumbs up in 2011 for preventing stroke and systemic embolism in non-valvular AF patients and the FDA approved its use in 2010 in that patient population. Yet, the EMA and FDA have since said they are looking into reports of serious bleeding events in patients taking the drug.
Carole Longson, PhD, director of the NICE Health Technology Evaluation Centre, said dabigatran is an alternative to warfarin for AF patients who don’t tolerate warfarin’s regime well. “The independent Appraisal Committee accepted evidence from clinical trials that showed dabigatran 150 mg twice daily is more clinically effective than warfarin in reducing the risk of stroke or systemic embolism, and that dabigatran 110 mg twice daily is as effective as warfarin,” she said in a statement. She added that NICE considered dabigatran to be a cost-effective option.