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Старый 11.11.2012, 08:52
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Несколько цитат из дискуссии экспертов на medscape "в защиту" дабигатрана по поводу риска ИМ в сравнении с варфарином и другими новыми антикоагулянтами
[Ссылки доступны только зарегистрированным пользователям ] (речь про дополнительный анализ RE-LY)
...looked for new Q waves (silent MIs) in patients who were not reported to have had a MI. They found 28 further cases.
Now the total number of MIs were distributed as roughly 98 and 97 in the dabigatran arms vs 75 in the warfarin group. There was no longer a significant trend pointing to a signal of concern with dabigatran.
....We went further and said MI is not the only myocardial ischemic event that can happen and we therefore included acute coronary syndrome. We included coronary vascularization by coronary artery bypass graft or percutaneous coronary intervention. We included cardiac arrest, which is oftentimes caused by ischemia. We included cardiovascular death. If we enrich our endpoints by combining this then we can see that there is absolutely no difference in terms of outcomes between the 3 groups. If anything, the dabigatran groups tended to have lower event rates than the warfarin group.
What we also did is we looked at the predefined net clinical benefit in this analysis, which is a composite of mortality with MI, stroke, peripheral embolism, and major bleeding pulmonary embolism. If we do this analysis we again increase the number of outcome events and then we can find that there is no statistical difference between the low-dose dabigatran and warfarin but that there is, in fact, a significant reduction in the high-dose dabigatran group as far as net clinical benefit is concerned.
...(и непрямое сравнение новых антикоагулянтов между собой) The comparability of the trial populations has just been published in the Journal of the American College of Cardiology online. RE-LY and ARISTOTLE were very close in their profile. In fact, when you look at the indirect comparison, the MI hazard ratio was not statistically significant between dabigatran and apixaban.
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