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ASA-STAT: Aspirin, simvastatin failed to benefit patients with PAH
Kawut S. Circulation. 2011;doi:10.1161/circulationaha.110.015693.
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Researchers of the ASA-STAT trial have reported that aspirin or simvastatin use among patients with pulmonary arterial hypertension did not produce any benefit on 6-minute walk distance test or biomarkers associated with endothelial dysfunction.
According to researchers, this was the first randomized controlled trial of traditional CVD therapies targeting platelet and endothelial function and the first NIH–funded randomized controlled trial in patients with PAH.
In this phase 2 trial, 92 patients with PAH were randomly assigned to 81 mg aspirin or matching placebo and 40 mg simvastatin (Zocor, Merck) or matching placebo. The primary endpoint was 6-minute walk distance (6MWD) at 6 months.
However, only 65 patients (86.1% women) were randomly assigned by the time the trial was stopped after an interim analysis by the Data Safety and Monitoring Board showed futility in reaching the primary endpoint for simvastatin. In all, 32 patients receiving aspirin were compared with 33 patients receiving placebo, and 32 patients receiving simvastatin were compared with 33 patients receiving placebo.
At 6 months, there was no difference in 6MWD among patients taking aspirin vs. placebo (P=.97), although patients taking aspirin tended to have more major bleeding episodes, but not to a significant extent (P=.17). Similarly, 6MWD among those taking simvastatin did not significantly differ from the placebo arm (P=.09), nor did the rate of adverse events.
“On the basis of these findings, neither drug can be recommended for the treatment of PAH,” the researchers wrote. “These drugs should be used according to usual indications in PAH.”
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