SAFETY, SIDE-EFFECTS AND PATIENT ACCEPTANCE OF THE LUTEINIZING-HORMONE-RELEASING HORMONE AGONIST LEUPROLIDE IN TREATMENT OF BENIGN PROSTATIC HYPERPLASIA

The luteinizing hormone releasing hormone agonist leuprolide was inves tigated in a double-blind, randomized, placebo-controlled study compri sing 50 evaluable patients with moderate to severe symptoms resulting from benign prostatic hyperplasia. Patients received 3.75 mg. leuproli de depot or placebo as an injection every 28 days for 24 weeks. Hemogl obin level decreased by 0.8 gm./100 ml. (p = 0.0052) for patients rece iving leuprolide. Mean testicular volume decreased by 28.9% (p < 0.001 ) compared to placebo. Of 26 patients receiving leuprolide 5 had a wei ght gain of more than 3 kg. Almost all patients receiving leuprolide e xperienced hot flushes. Breast changes, and loss of energy and vigor w ere not more pronounced than for patients receiving placebo. Erectile function and sexual activity were lost during treatment. Libido also d ecreased but was still partially retained. Despite this, patients rece iving leuprolide were generally contented with their sexual life durin g treatment. Side effects were bothersome for some patients but were r eversible. Of the patients in our study 73% expressed that they could repeat or continue treatment if that had been possible. The high cost of these drugs will limit their use for a benign condition, such as be nign prostatic hyperplasia.