DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO ASSESS THE EFFICACY AND TOLERABILITY OF MEPARTRICIN IN THE TREATMENT OF BPH

BACKGROUND. Mepartricin, a semisynthetic polyene derivative with a fav orable effect on urethro-prostatic function, was clinically evaluated, adopting the diagnostic and research criteria recommended by the Firs t International Consultation on BPH. METHODS. A multicenter, randomize d, double-blind, parallel-group study compared mepartricin 40 mg/daily to placebo in the treatment of 196 patients with newly diagnosed BPH and mild-to-moderate symptomatology. International Prostate Symptom Sc ore (I-PSS), quality of life (QoL) index and maximum urinary flow-rate (Q(max)) were determined every 4 weeks for 6 months; postvoiding volu me, prostate volume, and prostate-specific antigen (PSA) were assessed after 3 and 6 months of therapy. RESULTS. Mepartricin was shown to de termine a statistically significant improvement over placebo in I-PSS and QoL index from month 2 onwards, and a significant linear increase in Q(max) over the study period. At month 6, the improvement in the me partricin and placebo groups in I-PSS, QoL index, and Q,, was 6.3 (sta ndard error (SE) 0.51) and 4.2 (SE 0.60) points (P = 0.003), 0.99 (SE 0.14) and 0.62 (SE 0.12) points (P = 0.036), and 2.7 (SE 0.46) and 1.2 (SE 0.46) ml/sec (P = 0.051), respectively. No significant difference s were noted in postvoiding residual volume, prostate volume, or PSA. Mepartricin tolerability was good, showing no adverse events on sexual function. CONCLUSIONS. Mepartricin proved to be an effective treatmen t of benign prostatic hyperplasia, determining an improvement in sympt oms, quality of life, and peak urinary flow. (C) 1998 Wiley-Liss, Inc.