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Disappointing trial results for Plavix

A study has shown that adding Bristol-Myers Squibb and Sanofi-Aventis' co-marketed heart drug Plavix to aspirin did not significantly reduce the risk of heart attack, stroke or cardiovascular related death in high-risk patients, compared with taking aspirin alone.

The results from the trial are a blow to the companies which are seeking to expand the approved usage of Plavix which is used to help keep platelets in the blood from sticking together and forming clots.

The study suggests that the combination of Plavix and aspirin did not help patients with multiple risk factors but no clearly established vascular disease. In this patient subgroup the companies said that there was an “excess in cardiovascular mortality as well as a non-statistically significant increase in bleeding” observed in patients treated with Plavix and aspirin.

An analysis of patients with established vascular disease did found that the addition of Plavix to aspirin was associated with a 12.5% reduction in a recurrent heart attack, stroke or cardiovascular death.