Finasterid in der Behandlung der benignen Prostatahyperplasie

Zusammenfassung

Hintergrund

In den letzten Jahren sind die operativen Interventionen zur Behandlung der benignen Prostatahyperplasie (BPH) rückläufig, vor allem wegen der größeren Wirksamkeit der medikamentösen Kombinationstherapie (am häufigsten Finasterid und α-Blocker). Ziel der Studie ist die Bewertung der Wirksamkeit von Finasterid bei der Behandlung der BPH.

Material und Methoden

Die Studie wurde von 10/2008 bis 11/2009 durchgeführt, mit 4315 Patienten aus 50 polnischen Polikliniken, Altersdurchschnitt 66,5 (46–91; Mittel 67; Standardabweichung 8,1) Jahre]. Mess- bzw. Untersuchungsinstrumente waren IPSS- und QoL-Fragebögen, PSA-Serumkonzentration, Ultrasonographie, Urinuntersuchungen und Biopsie. Einschlusskriterium war eine Einnahme von Finasterid über ≥2 Wochen, eine Kombinationstherapie (Finasterid und α-Blocker) war in der Studie nicht ausgeschlossen.

Ergebnisse

Initial wurde bei 30 Patienten (0,7%) eine Prostatitis diagnostiziert, bei 69 (1,6%) ein maligner Prostatatumor. Schließlich eingeschlossen wurden 4216 Patienten, während der folgenden zwölf Monate schieden 392 aus. Mittels IPSS-Fragebogen wurde bei 16% eine milde, bei 67% eine mäßige und bei  17% eine schwere BPH-Symptomatik festgestellt. Bei 2677 Patienten (70%), die sowohl α-Blocker als auch Finasterid eingenommen hatten, zeigte sich eine Verringerung der Krankheitsprogression, eine erhebliche Verbesserung der Miktion und die Reduktion des Prostataadenoms um 40%. Bei 956 Patienten (25%), die nur Finasterid oder Finasterid + Phytotherapie erhalten hatten, zeigte sich ebenfalls eine Reduktion der Masse des Prostataadenoms um 40%. Nach Studienende wurden 212 Patienten (5%), bei denen die Finasterid- und die α-Blockertherapie nicht erfolgreich waren, operativ behandelt. Für eine Fortsetzung der medikamentösen Therapie entschieden sich 85% der Patienten.

Abstract

Background

Benign prostatic hyperplasia (BPH) is one of the most common urinary disorders in elderly men. The symptoms of this disease are increased prostate size, bladder outlet obstruction and lower urinary tract disorders. It influences bladder infections, bladder stone formation and increases the risk of urinary retention which can cause renal failure. It is necessary for the disease to be treated operatively. The number of conducted surgical interventions for pharmacotherapy has been significantly reduced in recent years due to increased efficacy in conservative therapy including combined treatment mostly with two groups of drugs: finasteride and alpha-blockers with different pharmacological activities. The aim of the study was to evaluate finasteride efficacy in the treatment of benign prostatic hyperplasia.

Materials and methods

The clinical trial was conducted from October 2008 to November 2009. According to the urologist‘s recommendation the patients took finasteride at a dose of 5 mg daily. A total of 4,315 patients participated in the clinical trial and were enrolled in 50 urological centres in Poland. The average age of the patients was 66.5 years, the youngest patient was 46 and the oldest was 91 (median 67.00 years, standard deviation SD±8.101). The use of finasteride at least for 2 weeks was the criterion for the patient to be included in the study. The medical trial lasted 12 months and consisted of 6 visits at which data relating to IPSS, QoL, intensification of urinary system symptoms, the results of the additional studies, PSA serum concentrations, the urinary tract USG with evaluation of residual urine and prostate, urine analysis with evaluation of crystalline, uroflowmetry, transrectal ultrasonography (TRUS) and biopsy were recorded. The study did not exclude the combined treatment with finasteride and alpha-adrenergic blocking drugs.

Results

Prostatocystitis was diagnosed in 30 men among the patients treated at the first visit after the digital rectal examination (DRE) trial and they qualified for antibiotic therapy. Suspicion of a tumor was diagnosed in 69 (1.59 %) patients of the study group at the first visit after the DRE trial and they qualified for biopsy of the prostate after the PSA trial and TRUS at the second visit. Therefore, 4,216 patients took part in the clinical trial. In the course of 12 months 392 patients were excuded from the study for different reasons: cardiac infarct, apoplexy, resignation without reason and change of address. According to the IPSS scale (International Prostate Symptom Score) a small intensification of symptoms was diagnosed in 676 patients (16%), in 2,830 patients (67%) moderate and in 718 patients (17 %) considerable. Prostate cancer was confirmed histopathologically in 50 (1.15%) out of 69 patients who qualified for biopsy of the prostate. In 2,677 (70%) patients taking both alpha-blocker and finasteride, the progression of disease reduced, the micturation improved considerably and the mass of adenoma of the prostate diminished by 40%. However, in 956 (25%) patients taking only finasteride or finasteride + phytotherapy the mass of adenoma of the prostate diminished by 40%, too. When the medical trial was finished, 212 patients (5.02 %) of the study group who showed intensive symptoms of BPH and the finasteride and alfa-blocker treatment proved not to be effective enough qualified for surgical therapy. A total of 3,824 out of 4,216 (90.7%) patients finished the medical trial and 3,612 (85.6 %) were willing to continue the further therapy.