Premium
Double‐blind, placebo‐controlled trial to assess the efficacy and tolerability of mepartricin in the treatment of BPH
Author(s) -
Denis Louis,
Pagano Francesco,
is Atanasio,
Robertson Chris,
Romano Paolo,
Boyle Peter
Publication year - 1998
Publication title -
the prostate
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.295
H-Index - 123
eISSN - 1097-0045
pISSN - 0270-4137
DOI - 10.1002/(sici)1097-0045(19981201)37:4<246::aid-pros6>3.0.co;2-6
Subject(s) - medicine , tolerability , placebo , international prostate symptom score , urology , prostate , quality of life (healthcare) , adverse effect , hyperplasia , sexual function , lower urinary tract symptoms , alternative medicine , nursing , pathology , cancer
BACKGROUND Mepartricin, a semisynthetic polyene derivative with a favorable effect on urethro‐prostatic function, was clinically evaluated, adopting the diagnostic and research criteria recommended by the First International Consultation on BPH. METHODS A multicenter, randomized, 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 Score (I‐PSS), quality of life (QoL) index and maximum urinary flow‐rate (Q max ) were determined every 4 weeks for 6 months; postvoiding volume, prostate volume, and prostate‐specific antigen (PSA) were assessed after 3 and 6 months of therapy. RESULTS Mepartricin was shown to determine 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 mepartricin and placebo groups in I‐PSS, QoL index, and Q max was 6.3 (standard 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 differences 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 treatment of benign prostatic hyperplasia, determining an improvement in symptoms, quality of life, and peak urinary flow. Prostate 37:246–252, 1998. © 1998 Wiley‐Liss, Inc.