APPRAISE With Apixaban and STARR With Rosiglitazone and Ramipril Published

June 03, 2009

June 3, 2009 (Durham, North Carolina and Hamilton, Ontario) — The Apixaban for Prevention of Acute Ischemic Safety Events (APPRAISE) trial and the Study of Atherosclerosis with Ramipril and Rosiglitazone (STARR), both first presented at international cardiology meetings in the past two years, are now published in Circulation and the Journal of the American College of Cardiology, respectively [1,2].

The STARR study, led by Dr Eva Lonn (McMaster University, Hamilton, ON), was presented at the American College of Cardiology 2007 Scientific Sessions and showed the thiazolidinedione (TZD) rosiglitazone (Avandia, GlaxoSmithKline) reduced glycemia and modestly reduced carotid intima media thickness (IMT) in patients with prediabetes. The ACE inhibitor ramipril (Altace, King Pharmaceuticals), on the other hand, did not show any change in carotid IMT compared with placebo.

An editorial by Dr Juan Carlos Kaski (St George's University, London, UK) notes that the STARR investigators might have overestimated the effect on carotid IMT progression, thus limiting the ability to detect a 30% inhibitory effect in only 1425 patients [3]. The most important question, however, concerns the true effect of TZDs on cardiovascular end points and all-cause mortality and their role in clinical practice. Kaski, along with the STARR investigators, urge further studies to conclusively determine its effect on cardiovascular outcomes, especially since this study hinted that rosiglitazone might retard the progression of vascular disease in addition to improving glycemic control.

The APPRAISE study, led by Dr John Alexander (Duke University Medical Center), showed that the addition of the novel factor Xa inhibitor apixaban (Bristol-Myers Squibb, NY) to antiplatelet therapy resulted in a dose-dependent increase in bleeding and a trend toward a reduction in clinically relevant ischemic events. The increase in bleeding was more pronounced and the reduction in clinical events less in patients receiving aspirin and clopidogrel than patients taking aspirin alone. Larger phase 3 studies with apixaban are in the works.

APPRAISE was first presented at the European Society of Cardiology 2008 Congress in Munich, Germany. Both STARR and APPRAISE were previously reported by heartwire.

Lonn reports research funding, consulting, and lecture fees from Sanofi-Aventis and GlaxoSmithKline. Alexander has received research grants from Bristol-Myers Squibb, Regado Biosciences, and Schering-Plough and has consulted for AstraZeneca, Bristol-Myers Squibb, Daiichi-Sankyo, Johnson & Johnson, Momenta, Pfizer, and Sanofi-Aventis.

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