[Alpha-blockers or hexanic extract of Serenoa repens for 6 months: sub-analysis of the PERSAT study]

Abstract

Objective: The objective of this sub-analysis of the PERSAT study was to evaluate the efficacy of hexanic extract of S. Repens (HESr) and alpha-blockers (AB), at 6 months in patients with moderate to severe LUTS/BPH.

Methods: The PERSAT observational study was conducted in France by general practitioners on patients with BPH with an IPSS≥12 score. The primary endpoint was the percentage of responders (decrease in total IPSS score ≥ 3) at 6 months. Improvement in quality of life (IPSS-QoL) as well as patient satisfaction were also measured.

Results: Of the 759 patients in the study, 324 treated with HESr and 309 with AB were reviewed at 6 months, with no change in treatment during follow-up. Characteristics at inclusion were globally similar with a mean IPSS of 18.2±4.9. The response rates at 6 months (IPSS-total decrease ≥ 3) were 93.7% and 94.8% for patients treated with HESr and AB, with a mean decrease in IPSS score of 10.1±5.6 points, which reached 13.6 and 14.8 points respectively, in severe patients (IPSS>19), without major difference between groups. More than 95% of HESr or AB patients reported a significant overall improvement in their LUTS/BPH. The most frequently reported adverse events with AB were ejaculation disorders (4.9%) and hypotension (4.2%) and with HESr digestive disorders (1.5%).

Conclusion: This sub-analysis of the PERSAT cohort reported the clinical efficacy of HESr and AB as a first-line treatment in the management of moderate or severe LUTS/BPH patients.

Keywords: Alpha-blocker; Alpha-bloquants; Benign prostatic hyperplasia (BPH); Extrait hexanique de Serenoa Repens; Hexanic extract of Serenoa Repens; Lower urinary tract symptoms (LUTS); Real-word evidence; Symptômes du bas appareil urinaire liés à une HBP (SBAU/HBP); Étude de vraie vie.