Are ASA and simvastatin helpful in pulmonary arterial hypertension?

January 01, 0001

Are ASA and simvastatin helpful in pulmonary arterial hypertension?

Pulmonary arterial hypertension (PAH) carries significant morbidity and mortality, and can be a challenge to treat. These US researchers looked at aspirin and simvastatin in treating PAH via a randomized, double- blind, placebo-controlled 2x2 factorial trial. Patients with PAH recruited from 4 sites, and were randomized to aspirin 81 mg or matched placebo and simvastatin 40 mg or matched placebo. The 6-minute walk distance was measured at 6 months.

The researchers found: "Sixty-five subjects had been randomized when the trial was terminated by the Data Safety and Monitoring Board after an interim analysis showed futility in reaching the primary end point for simvastatin. After adjustment for baseline 6-minute walk distance, there was no significant difference in the 6-minute walk distance at 6 months between aspirin (n=32) and placebo (n=33, placebo-corrected difference -0.5 m) or between simvastatin (n=32) and placebo (n=33, placebo-corrected difference -27.6 m). There tended to be more major bleeding episodes with aspirin than with placebo (4 events versus 1 event, respectively)."

The researchers concluded: "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."

This randomized controlled trial found no benefit with ASA or simvastatin in PAH


For the full abstract, click here.

Circulation 123(25):2985-2993, 28 June 2011 © 2011 American Heart Association, Inc.
Randomized Clinical Trial of Aspirin and Simvastatin for Pulmonary Arterial Hypertension: ASA-STAT. Steven M. Kawut, Emilia Bagiella, David J. Lederer, et al. Correspondence to Steven M. Kawut: [email protected]

Category: K. Circulatory. Keywords: pulmonary arterial hypertension, PAH, aspirin, simvastatin, treatment, randomized controlled trial, journal watch.
Synopsis edited by Dr Paul Schaefer, Toledo, Ohio. Posted on Global Family Doctor 26 July 2011

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.

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