"The message is clear; that warfarin is superior to Plavix," said Stuart Connolly, the lead investigator and director of the cardiology division at McMaster University in Hamilton, Ontario at this weeks AHA meeting.
Poor BMS had hoped to show that Plavix ( clopidogrel) could be substituted for warfarin in atrial fibrillation patients as warfarin use requires extensive monitoring, a special diet and inconvenient lifestyle changes for patients due to a high risk of bleeding.
Rather than demonstrating that Plavix was just as good at stroke prevention in that patient population, however, the planned four-year study was stopped after about 17 months when safety monitors found a 47% increase in a range of adverse heart events (stroke, MI, embolism or death), including a 75% increase in stroke in the Plavix group.
This clearly has implications for Plavix, the 4th largest drug in the world with sales over $5 billion.
Could this then also have implications for the AZ Phase 2 drug AZD6140?
A 990-patient trial reported the overall incidence of major and minor bleeding events was 10.2% in patients on AstraZeneca's new drug, against 9.2% in those given Plavix.
Have they hitched their pony to the wrong waggon, Insider wonders?
5 comments:
No big deal, anyone with an understanding of the underlying pathophysiology of cardio-embolic strokes would not find this study surprising. Would it have been nice if Plavix were equal to warfarin? Yes, but not surprising it wasn't.
If its no big deal why take the risk of doing the study in the first place then?
And from a safety point of view, warfarin already has a rep of being "bad". But this study shows Plavix is worse!!
Someone should be fired for believing their own BS
I think people were hoping Plavix would be positive, but not really expecting it. It will have no real implications for the brand.
Spin alert! Last poster.
Anon 1 said it would have been nice if Plavix had been the same as Warfarin - does that mean the same price too? Even if it was the same it costs about 1000 times more!
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