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Randomized clinical trial of aspirin and simvastatin for pulmonary arterial hypertension: ASA-STAT.

Author(s): Kawut SM, Bagiella E, Lederer DJ, Shimbo D, Horn EM, Roberts KE, Hill NS, Barr RG, Rosenzweig EB, Post W, Tracy RP, Palevsky HI, Hassoun PM, Girgis RE

Affiliation(s): Penn Cardiovascular Institute, Department of Medicine and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, 423 Guardian Drive, Philadelphia, PA 19104, USA. kawut@upenn.edu

Publication date & source: 2011-06-28, Circulation., 123(25):2985-93. Epub 2011 May 18.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't

BACKGROUND: Pulmonary arterial hypertension (PAH) is a progressive disease that causes exercise limitation, heart failure, and death. We aimed to determine the safety and efficacy of aspirin and simvastatin in PAH. METHODS AND RESULTS: We performed a randomized, double-blind, placebo-controlled 2x2 factorial clinical trial of aspirin and simvastatin in patients with PAH receiving BACKGROUND: =0.97) or between simvastatin (n=32) and placebo (n=33; placebo-corrected difference -27.6 m, 95% confidence interval -59.6 to 4.3 m; P=0.09). There tended to be more major bleeding episodes with aspirin than with placebo (4 events versus 1 event, respectively; P=0.17). CONCLUSIONS: Neither aspirin nor simvastatin had a significant effect on the 6-minute walk distance, although patients randomized to simvastatin tended to have a lower 6-minute walk distance at 6 months. These results do not support the routine treatment of patients with PAH with these medications.

Page last updated: 2011-12-09

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