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Chronic therapy with sildenafil not beneficial for HFpEF
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SAN FRANCISCO — Twenty-four weeks of treatment with sildenafil did not improve quality of life or exercise capacity for patients with HF with preserved ejection fraction in the RELAX study.
Researchers investigated the effects of sildenafil (Viagra, Pfizer; Revatio, Pfizer) in 216 patients (mean age, 69 years; 48% women) with diastolic HF. Upon enrollment, all patients had NYHA Class II to IV HF symptoms, EF ≥ 50%, elevated NT-proBNP (>400 pg/mL) or elevated rest/exercise filling pressures, and peak VO2 ≤60% predicted with respiratory exchange ratio ≥1 on screening cardiopulmonary exercise test, according to the study abstract.
Patients were randomly assigned sildenafil 20 mg for 12 weeks following by 60 mg for 12 weeks or placebo.
Compared with the placebo group, at 24 weeks, researchers found no beneficial effect of sildenafil on primary endpoints of maximum exercise capacity measured by peak oxygen consumption or secondary endpoints of submaximal exercise capacity, clinical status, or CV structure and function.
Adverse events occurred in 80% of patients assigned sildenafil vs. 76% assigned placebo. Serious adverse events were also more common with sildenafil (22% vs. 16%).
Although sildenafil and other PDE-5 inhibitors are not labeled for HF, it is possible that some clinicians may be prescribing these drugs for their HF patients based on the results of preliminary studies, which have suggested a benefit, the researchers said.
“The rationale for looking at an erectile dysfunction drug was [based on] its proven effects for erective dysfunction. Second, it is a proven drug for pulmonary arterial hypertension,” Margaret M. Redfield, MD, professor of medicine at Mayo Clinic in Rochester, Minn., said during a press conference.
“There was no signal of benefit with the drug. …There was a signal that was quite unexpected: worsening renal function with sildenafil,” she said.
The researchers concluded that future studies should be conducted in this subset of patients with HF with preserved EF (HFpEF). Ongoing trials in the United States and Europe are assessing the effect of PDE-5 inhibitors with HF with reduced EF, according to Redfield. - by Deb Dellapena
For more information:
Redfield M. Poster #13-LB-15755-ACC. Presented at: American College of Cardiology Scientific Sessions; March 9-11, 2013; San Francisco.
Redfield M. JAMA. 2013;doi:10.1001/jama.2013.2024.
Disclosure: The study was funded by the National Heart, Lung and Blood Institute and the Health Heart Failure Clinical Research Network. Redfield reports no relevant financial disclosures.