Current safety and tolerability issues in men with erectile dysfunction receiving PDE5 inhibitors

AIMS: Treatment of erectile dysfunction (ED) has been greatly advanced by the advent of phosphodiesterase type-5 (PDE5) inhibitors. Upon the introduction of these agents, their cardiovascular (CV) safety was a major concern, mainly due to their vasodilatory effects. We conducted an electronic literature review of data concerning the safety and tolerability issues of men with ED receiving PDE5 inhibitors. RESULTS: Although safety concerns have been raised, evaluation of CV safety and related adverse events in clinical trials has not revealed any atypical safety issues. DISCUSSION: No causal association has been established to date between non-arteritic anterior ischaemic optic neuropathy (NAION) and PDE5 inhibitors. In addition, there are established guidelines which provide recommendations for the safe and effective use of these agents in treating men with ED and associated comorbidities. CONCLUSIONS: Clinical trial and postmarketing surveillance data confirm the safety and tolerability profile of the PDE5 inhibitors, even in patients with endothelial dysfunction-associated comorbidities.