New Dabigratan meta-analisis Efectos colaterales

New dabigatran meta-analysis questions 'euphoria' 20 March, 2012 Paddy Wood 0 comments A new meta-analysis shedding “alarming” light on the cardiovascular side-effects of dabigatran is a sobering wake-up call to a medical community too quick to embrace new treatments, experts argue. In an analysis of seven core trials involving more than 30,000 patients, American researchers found the anticoagulant was associated with an average 33% increased risk of MI or ACS relative to control drugs including warfarin, enaxoparin, and placebo. The new study was prompted by the discovery, after publication, of an additional 32 cases of MI in participants in RE-LY–the original and largest study of dabigratran –which found a 38% increased risk of MI compared to warfarin. The drug has sparked contention since it was first approved by the TGA in 2008. After an extension in April 2011 to include indications for stroke in atrial fibrillation patients, the TGA issued a safety advisory in November after increasing reports of bleeding-related events. The new analysis, published in the Archives of Internal Medicine, again casts the spotlight on the drug’s side effects and highlights the risks of over eagerness to embrace new treatments, experts have said. Physicians should “step back for a moment, take their own pulse, and retain a critical view as a powerful new drug enters clinical use a potentially massive scale”, argue Israeli doctors Jeremy Jacobs and Jochanan Stressman in an accompanying editorial. Because new drugs may have dangers that become known “long after the relatively pristine data of clinical trials have given way to the gritty reality of daily clinical drug use,” continued critical appraisal was crucial. They said the enthusiasm to embrace new treatments –“nearly to the level of euphoria” –must be restrained in the interests of patient care. The editor of the journal, Rita Redberg, said the results emphasised the need to reappraise the risk and benefits of dabigatran. However, the authors of the study said the benefits probably still outweighed risks in patients with AF given the profound reduction in ischemic stroke and sundry clot risk, shown in RE-LY to be 34% relative to warfarin. Cardiac risk should be further investigated, they said. Arch Int Med;doi:10.1001/archinternmed.2011.1666

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