Safety, side effects and patient acceptance of the luteinizing hormone releasing hormone agonist leuprolide in treatment of benign prostatic hyperplasia.

Abstract

The luteinizing hormone releasing hormone agonist leuprolide was investigated in a double-blind, randomized, placebo-controlled study comprising 50 evaluable patients with moderate to severe symptoms resulting from benign prostatic hyperplasia. Patients received 3.75 mg. leuprolide depot or placebo as an injection every 28 days for 24 weeks. Hemoglobin level decreased by 0.8 gm/100 ml. (p = 0.0052) for patients receiving leuprolide. Mean testicular volume decreased by 28.9% (p < 0.001) compared to placebo. Of 26 patients receiving leuprolide 5 had a weight gain of more than 3 kg. Almost all patients receiving leuprolide experienced hot flushes. Breast changes, and loss of energy and vigor were not more pronounced than for patients receiving placebo. Erectile function and sexual activity were lost during treatment. Libido also decreased but was still partially retained. Despite this, patients receiving leuprolide were generally contented with their sexual life during treatment. Side effects were bothersome for some patients but were reversible. 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 benign prostatic hyperplasia.