Oral Sildenafil Citrate (Viagra) for Erectile Dysfunction: A Systematic Review and Meta-analysis of Harms

Alexander Tsertsvadze, Fatemeh Yazdi, Howard A Fink, Roderick MacDonald, Timothy J Wilt, Anthony J. Bella, Mohammed T. Ansari, Chantelle Garritty, Karla Soares-Weiser, Raymond Daniel, Margaret Sampson, David Moher

Research output: Contribution to journalArticlepeer-review

30 Scopus citations

Abstract

Objectives: To summarize and compare evidence on harms in sildenafil- and placebo-treated men with erectile dysfunction (ED) in a systematic review and meta-analysis. Methods: Randomized placebo-controlled trials (RCTs) were identified using an electronic search in MEDLINE, EMBASE, PsycINFO, SCOPUS, and Cochrane CENTRAL. The rates of any adverse events (AEs), most commonly reported AEs, withdrawals because of adverse events, and serious adverse events were ascertained and compared between sildenafil and placebo groups. The results of men with ED were stratified by clinical condition(s). Statistical heterogeneity was explored. Meta-analyses based on random-effects model were also performed. Results: A total of 49 RCTs were included. Sildenafil-treated men had a higher risk for all-cause AEs (RR = 1.56, 95% CI: 1.38, 1.76), headache, flushing, dyspepsia, and visual disturbances compared with placebo-treated men. The magnitude of excess risk was greater in fixed- than in flexible-dose trials. The rates of serious adverse events and withdrawals because of adverse events did not differ in sildenafil vs placebo groups. A higher dose of sildenafil corresponded to a greater risk of AEs. The increased risk of harms was observed within and across clinically defined specific groups of patients. Conclusions: There was a lack of RCTs reporting long-term (>6 months) harms data. In short-term trials, men with ED randomized to sildenafil had an increased risk of all-cause any AEs, headache, flushing, dyspepsia, and visual disturbances. The exploration of different modes of dose optimization of sildenafil may be warranted.

Original languageEnglish (US)
JournalUrology
Volume74
Issue number4
DOIs
StatePublished - Oct 2009

Fingerprint Dive into the research topics of 'Oral Sildenafil Citrate (Viagra) for Erectile Dysfunction: A Systematic Review and Meta-analysis of Harms'. Together they form a unique fingerprint.

Cite this