Sublingual apomorphine: new preparation. In erectile disorders: a narrow therapeutic margin

(1) When drug treatment is indicated for erectile dysfunction, sildenafil is the first line oral treatment. Overall, about half of patients with erectile dysfunction can achieve satisfactory penetrative sex with sildenafil. (2) Apomorphine, a dopamine agonist, is now licensed in France for treatment of erectile dysfunction. It is available as sublingual tablets of 2 mg and 3 mg. (3) The evaluation dossier contains no data comparing apomorphine with sildenafil. Dose-finding studies and placebo-controlled trials in patients without a serious organic disorder show that about 90% consider the 2 mg dose of apomorphine to be insufficient. The 3-mg tablets are hardly more effective. Nearly 90% of patients prefer a dose of at least 4 mg. (4) The main side effects of sublingual apomorphine are nausea, dizziness, severe sweating and drowsiness. These effects are dose-dependent. Syncope and hypotension are also relatively common. Serious consequences of these side effects were reported during some clinical trials. (5) The safety profile of sublingual apomorphine is no better than that of sildenafil. Both drugs interact with nitrates, increasing the risk of hypotension. (6) In practice, sildenafil remains the first line treatment for men with erectile dysfunction.