Abstract

PALMEX: A THERAPEUTIC OPTION FOR MANAGEMENT OF LOWER URINARY TRACT SYMPTOMS IN MEN WITH BENIGN PROSTATIC HYPERPLASIA

Dr. Julio Fernández-Travieso*, Dr. José Illnait-Ferrer, Dr. Lilia Fernández-Dorta, Dr. Sarahí Mendoza-Castaño, Dr. Raúl Guzmán-Mederos and Dr. Manuel Pedroso-Gastón

Abstract

Objective: A pooled analysis of clinical trials data of the effects of Palmex treatment on Lower Urinary Tract Symptoms (LUTS) in patients with Benign Prostatic Hyperplasia (BPH). Methods: The present analysis includes the data of all patients included in short and medium-term randomized, double-blinded, comparative clinical studies with Palmex versus Saw palmetto and Terazosin and the patients included in the long-term study with Palmex. The studies included ≥ 50 years’ men, with evidence of the LUTS of moderate intensity according to the International Symptoms of the Prostate (IPSS). The effects on the IPSS scale was the primary efficacy variable. The effects on the prostate size and the residual volume were secondary variables. Results: Four hundred night patients with diagnosis of BPH were included in the treatment phase and received Palmex, Saw palmetto or Terazosin. The groups were homogeneous in basal conditions. Twenty patients withdrawal from the studies. In the short and medium-term studies, Palmex significantly reduced the IPSS scores similar to Saw palmetto and Terazosin. Although the prostate size was reduce in the groups, this reduction only reached statistical significance for Palmex. Post-void residual volume was significantly and similar reduced in all groups. In the long-term study, Palmex also significantly reduced the IPSS scores at the end of the treatment. Conclusions: Palmex showed comparable efficacy with Saw palmetto and Terazosin in reducing LUTS, also producing a significant decrease in prostate size and post-void residual volume. Treatments were safe, with better tolerability for Palmex and Saw palmetto compared to Terazosin.

Keywords: Benign prostate hyperplasia, LUTS, IPSS, Palmex, Saw palmetto, Terazosin.