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Difficult-to-treat ED

Published in Efficacy

Erectile DysfunctionIn the two trials mentioned in the previous section, the patient population was largely a primary care population of relatively healthy men with ED of varying severities and etiologies. To the contrary, a multicentered, randomized, double-blind, placebo controlled trial evaluated how tadalafil 20 mg improved ED in men presenting to tertiary care centers with more severe, organic ED and with more comorbid medical conditions than previous studies.

One hundred and ninety-five men were allocated to receive tadalafil 20 mg or placebo up to once daily for 12 weeks with simplified dosing instructions. Efficacy was assessed using the IIEF-EF, the SEP, and a GAQ, and the EDITS was provided at the end of the trial to assess satisfaction of the patient and his partner. The mean baseline IIEF-EF was 13, with 33% of participants reporting mild ED, 23% with moderate ED, and 51% with severe ED at baseline. Organic ED predominated with 81%, followed by 3% of men with psychogenic ED, and 16% with mixed type. Comorbidities included 41% with hypertension, 36% with hyperlipidemia, 21% with diabetes mellitus, and 8% with coronary artery disease.

Tadalafil Professional 20 mg improved the IIEF-EF by 6.9 compared with −0.2 in the placebo group (p < 0.001), improved successful intercourse attempts by 34% compared with 4.5% in the placebo group (p < 0.001), and 73% of patients in the tadalafil group reported improved erections on the GAQ compared with 15% in the placebo group (p < 0.001). The overall EDITS score was 67 in the tadalafil group compared with 36 in the placebo group (p < 0.001), and a significant correlation was observed between the scores of the patient and his partner, demonstrating improved satisfaction with parallel improvement in partner satisfaction. This study concluded that even in a tertiary care population of patients with a higher incidence of severe, organic ED and comorbid medical conditions, cheap tadalafil remains a safe and well tolerated drug that significantly improves ED treatment satisfaction for patients and partners.