Safety and tolerability of apomorphine SL in men with cardiovascular disorders

Objective: Since many men with erectile dysfunction (ED) also have cardiovascular (CV) disease and are likely to be taking antihypertensive medications, nitrates, or other medications, the risk of side effects of oral drug therapy for ED in the presence of these conditions was evaluated. Methods: Clinical trials involving apomorphine SL for ED were evaluated to determine the safety and tolerability profile in men with coronary artery disease, hypertension, hyperlipidemia, and diabetes mellitus in comparison to other oral agents. Results: None of the subpopulations of men, whether analyzed by specific CV disease, presence of diabetes, or any concomitant medication were at increased risk for side effects and adverse events associated with apomorphine SL treatment. In particular, there were no substantive changes in the adverse event rates in those patients concurrently receiving antihypertensive medications nor in those men treated with short- or long-acting nitrates. Conclusions: Apomorphine SL is well tolerated and safe in men with ED associated with concomitant CV disorders or risk factors. Furthermore, apomorphine SL is not contraindicated in men with stable coronary artery disease who take nitrate medication and is well tolerated and safe in men concurrently receiving CV medications including nitrates and various classes of antihypertensives. (C) 2002 Published by Elsevier Science B.V.