Sildenafil does not improve outcomes in patients with heart failure

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1. There was no significant difference in oxygen consumption or 6-minute walking distance at 24-weeks in patients receiving sildenafil versus placebo.  

2. The number of deaths and adverse events between the patients receiving sildenafil versus placebo also did not significantly differ.

This randomized control trial updates recommendations regarding the use of sildenafil in patients with heart failure with preserved ejection fraction (HFPEF) ≥50% claiming no significant improvement in exercise tolerance or clinical outcomes. Despite a previous study by Guazzi et al demonstrating the benefit of sildenafil in patients with HFPEF, there are notable differences among the patient cohorts. In contrast to the present study, the patient cohort in the Guazzi study had more physiological differences consistent with right heart failure. It is thus possible that sildenafil is more useful in specific subtypes of heart failure, other than HFPEF, however additional studies are necessary to elucidate the exact niche for such pharmacological interventions.

Click to read the study in JAMA

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1. There was no significant difference in oxygen consumption at 24-weeks in patients receiving placebo versus sildenafil. 

2. There was no significant difference in 6-minute walking distance at 24-weeks in patients receiving placebo versus sildenafil.

This [multi-center, double-blind randomized] study: The study enrolled 113 patients in the sildenafil group and 103 in the placebo group. Sildenafil was given orally at 20 mg three times a day for 12 weeks followed by 60 mg three times a day for 12 weeks for a total of 24 weeks. The primary end point was peak oxygen consumption at 24 weeks. There was no significant change in peak oxygen consumption at 24-weeks in patients treated with placebo and those treated with sildenafil (P= .90). There was no significant change in 6-minute walking distance between the two groups at 12 or 24-weeks (P= .13 and .92 respectively). The number of deaths (P= 25) and adverse events (P=.49) between the two groups also did not differ.  Patients in the sildenafil group had a statistically significant increase in creatinine, cystatin C, brain naturetic peptide, uric acid, and endotherlin-1 than patients in the placebo group. There was no difference seen between the two groups in left ventricular mass, end-diastolic volume, or pulmonary artery pressures.

In sum: This randomized control trial updates recommendations regarding the use of sildenafil in patients with heart failure with preserved ejection fraction (HFPEF) ≥50% claiming no significant improvement in exercise tolerance or clinical outcomes. Despite a previous study by Guazzi et al demonstrating the benefit of sildenafil in patients with HFPEF, there are notable differences among the patient cohorts. In contrast to the present study, the patient cohort in the Guazzi study had more physiological differences consistent with right heart failure. It is thus possible that sildenafil is more useful in specific subtypes of heart failure, other than HFPEF, however additional studies are necessary to elucidate the exact niche for such pharmacological interventions.

Click to read the study in JAMA 

By Brittany Hasty and Rif Rahman

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