Plavix plus aspirin reduced stroke in patients with atrial fibrillation: study

In Phase III study findings presented at the American College of Cardiology conference on Tuesday, sanofi-aventis and Bristol-Myers Squibb reported that the combination of Plavix (clopidogrel) and aspirin significantly reduced the occurrence of major vascular events, compared with aspirin alone, in patients with atrial fibrillation who cannot take oral anticoagulants.

The ACTIVE A trial involved 7554 patients with atrial fibrillation, and with at least one major risk factor for stroke, who were given Plavix once-daily in combination with aspirin, or aspirin alone, to prevent the first occurrence of a major vascular event. After a median follow-up of 3.6 years, results showed that patients treated with Plavix experienced a significant 11-percent reduction in vascular events and a significant 28-percent reduction in the incidence of stroke.

The companies also reported significantly increased rates of major bleeding and intracranial haemorrhage in the combination Plavix-aspirin arm, but noted that there were non-significant increases in fatal bleeding and haemorrhagic stroke. Principal investigator Stuart Connolly remarked that "for most people, a stroke is much worse than a bleed....we're reducing far more strokes than major bleeds caused." Connolly added "for patients unsuitable for warfarin, [Plavix plus aspirin] provides an important benefit at an acceptable risk. It will hopefully be incorporated into medical guidelines quite soon."

Deutsche Bank analyst Barbara Ryan remarked that "the question is, for patients who can't take warfarin, how many are already taking Plavix? [Plavix] already has a broad range of indications in this field...I just don’t suspect it will be much of an addition." Bristol-Myers Squibb spokesperson Laura Hortas commented that "we will continue to evaluate [the ACTIVE A study findings] and assess our regulatory options."

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