Therapeutic effects of high-dose isoxsuprine in the management of mixed-type impotence.

OBJECTIVES

To determine the effectiveness and safety of high-dose isoxsuprine for the treatment of mixed-type erectile dysfunction.

METHODS

Forty-four patients who had vasculogenic impotence diagnosed on the basis of their sexual history, physical examination, laboratory analysis, polysomnographic recording of nocturnal erections, and dynamic color Doppler sonography of the cavernosal arteries were entered into a randomized, double-blind, placebo-controlled, crossover comparison of a placebo with high-dose isoxsuprine hydrochloride (60 mg/day orally). The treatment consisted of two 30-day courses. After a 14-day washout period, the patients who initially received the placebo for 30 days switched to isoxsuprine hydrochloride for 30 days and vice versa. Erectile function, ejaculation, interest in sex, and physical examination findings were investigated before treatment and at the end of each drug period.

RESULTS

Thirty-six patients (82%) completed the entire treatment schedule. Positive clinical results (complete and partial responses) were obtained in 6 men (16.6%) at the end of the isoxsuprine phase and in 7 men (19.4%) after the placebo period. The statistical analysis disclosed no significant difference when isoxsuprine was compared with placebo (P >0.05). Significant drug-related adverse effects occurred in the isoxsuprine group and treatment was discontinued in 2 patients.

CONCLUSIONS

Isoxsuprine is no better than placebo as a first-line treatment for mixed-type erectile dysfunction.