Safety of VIAGRA® (sildenafil citrate) in men with erectile dysfunction and arterial hypertension who are taking multiple antihypertensive treatments

Abstract

Men on antihypertensive medications (anti-HTNs) often have erectile dysfunction (ED). We evaluated the safety of VIAGRA® (sildenafil citrate) in men with ED and taking >2 anti-HTNs. 568 men (≥18 years) with ED and taking ≥2 anti-HTNs were randomized to receive sildenafil (50-mg starting dose) or placebo for a 6-week, double-blind (DB) flexible dose phase followed by a 6-week, open-label (OL) extension. Patients completing DB were eligible for OL. Patients started OL with 50-mg sildenafil. Observed/volunteered adverse events (AEs) and suspected causality were recorded. At week 6, 40% of sildenafil- and 26% of placebo-treated patients experienced at least 1 AE (any cause). 95% of patients completed the study; 4 (1.4%) in each group discontinued due to AEs. Two patients (0.7%) in each group had serious adverse events (SAEs). The most common AEs in sildenafil- versus placebo-treated patients were headache (10% vs 4%), flushing (6% vs 0.4%), dyspepsia (5% vs 1%), dizziness (4% vs 0.4%), and abnormal vision (3% vs 0%). At the end of OL (week 12), 36% and 40% of patients who took DB sildenafil and placebo, respectively, experienced AEs. The most common OL AEs are listed in the table. AEs associated with changes in blood pressure were (sildenafil vs placebo): hypotension (0.7% vs 0%), postural hypotension (0.4% vs 0.4%), and dizziness (2% vs 2%). 3 DB placebo patients (1.1%) discontinued due to AEs during OL. There were no SAEs. MOST FREQUENT AES DURING OL EXTENSION MOST FREQUENT AES DURING OL EXTENSION Sildenafil was well tolerated among men with ED who were taking multiple anti-HTNs. The incidence of AEs was similar in men taking 2 (n=307) and 3+ (n=222) anti-HTNs and consistent with that previously reported. Less than 2% of patients discontinued because of AEs. Thus, men who are taking multiple anti-HTNs are not at increased risk for more frequent or severe AEs while taking sildenafil for ED.