title: Is chronic sildenafil therapy safe and clinically beneficial in patients with systolic heart failure?
abstract: Sildenafil is a selective phosphodiesterase-5 inhibitor and causes vasodilatation, particularly in pulmonary circulation. Since left heart failure may be associated with pulmonary hypertension "out of proportion to left heart disease," sildenafil may have beneficial effect in such patients. The present investigation was designed as a 12-week, single-center, randomized, double-blind, placebo-controlled study evaluating the effects of sildenafil on mean blood pressure (primary endpoint) in patients with left systolic heart failure. Secondary endpoints included exercise capacity assessed by 6-minute walk test. A total of 106 patients were randomized 1:1 to sildenafil (n=53) or placebo (n=53). Patients received sildenafil 25 mg twice a day or matching placebo for the first 2 weeks and 50 mg 3 times a week for the remainder of the trial. The placebo-corrected effect on mean blood pressure was 1.16 mm Hg (95% confidence interval, -1.6 to 5.1, P>.05), demonstrating that sildenafil did not decrease mean blood pressure. Compared with placebo, sildenafil increased the 6-minute walk test by a nonsignificant treatment effect of 14 m (P=.67). Adverse effects occurred in a comparable proportion of patients taking sildenafil and placebo, and none of the patients needed to discontinue therapy. Sildenafil is well tolerated in left heart failure patients and does not decrease blood pressure. It can be safely added to standard heart failure therapy.
authors.affiliation: Department of Heart Failure and Transplantation, Rajaei Cardiovascular, Medical and Research Center, Tehran University of Medical Sciences, Tehran, Iran. amina33@gmail.com
authors.forename: Ahmad
authors.initials: A
authors.lastname: Amin
authors.forename: Ebrahim
authors.initials: E
authors.lastname: Mahmoudi
authors.forename: Hossein
authors.initials: H
authors.lastname: Navid
authors.forename: Mitra
authors.initials: M
authors.lastname: Chitsazan
mesh_terms: D000328:Adult; D001794:Blood Pressure / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D016903:Drug Monitoring / Q000379:methods; D017079:Exercise Tolerance / Q000187:drug effects*; D005260:Female; D054143:Heart Failure, Systolic / Q000150:complications / Q000503:physiopathology; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects; D011687:Purines / Q000008:administration & dosage / Q000009:adverse effects; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D058986:Phosphodiesterase 5 Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate