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Kombinationsbehandlung des BPS mit Tamsulosin und Finasterid

Literaturübersicht und Verordnungsdaten

Combined treatment of BPS with tamsulosin and finasteride

Literature review and prescription data

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Zusammenfassung

Die Kombinationstherapie des benignen Prostatasyndroms (BPS) mit α1-Blockern und 5α-Reduktase (5AR)-Inhibitoren wird basierend auf zwei Leitstudien zu Doxazosin/Finasterid und Tamsulosin/Dutasterid für alle 10 in Deutschland möglichen Kombinationen (5-mal α1-Blocker und 2-mal 5AR-Inhibitoren) empfohlen. Da in der BPS-Therapie in Deutschland Tamsulosin und Finasterid überwiegen, wurde die Rolle der Kombination Tamsulosin/Finasterid sowie deren wissenschaftliche Grundlagen gemäß klinischen Studien untersucht. Eine pharmakoepidemiologische Hochrechnung basierend auf GKV-Rezepten der Apothekenrechenzentren ergibt eine starke Zunahme der Kombination Tamsulosin/Finasterid seit 2003. Diese macht heute als freie Kombination neben einem Präparat der fixen Kombination Tamsulosin/Dutasterid etwa 50 % aller α1-Blocker/5AR-Inhibitorkombinationen aus. Klinische Studien zu Tamsulosin/Finasterid wurden publiziert, einschließlich kontrollierter Studien des Vergleichs der Kombination mit den Monotherapien. Die Ergebnisse hinsichtlich Besserung von Symptomen des unteren Harntraktes (LUTS), maximalem Harnfluss (Qmax), Prostatavolumen (PV) und prostataspezifischem Antigen (PSA) sowie Nebenwirkungen und Arzneimittelsicherheit stimmen mit den Ergebnissen der Leitstudien überein. Zufällige Ergebnisse können jedoch aufgrund von Mängeln des Studiendesigns nicht ausgeschlossen werden. Ein zuverlässiger Vergleich des Risikos von Progression unter Tamsulosin/Finasterid gegenüber den Monotherapien fehlt vollständig. Aufgrund der großen Kohärenz und kontinuierlichen Bewertung der verfügbaren Daten aller Kombinationen und mit dem anerkannt starken Klasseneffekt der Monotherapien scheint eine Fortsetzung der therapeutischen Praxis mit der Kombination Tamsulosin/Finasterid möglich zu sein.

Abstract

Combined therapy of benign prostatic syndrome (BPS) with α1-blockers and 5α-reductase (5AR)-inhibitors is recommended according to two leading studies on doxazosin/finasteride and tamsulosin/dutasteride for all 10 in Germany possible combinations (five α1-blockers and two 5AR inhibitors). Because tamsulosin and finasteride predominate in the treatment of BPS in Germany, the role of the combination tamsulosin/finasteride and its scientific basis from clinical studies has been investigated. A pharmacoepidemiological extrapolation from receipts of pharmacy data centres showed a strong increase of the combination tamsulosin/finasteride since 2003. As a free combination, tamsulosin/finasteride beside the fixed combination tamsulosin/dutasteride accounts to about 50% of all α1-blocker/5AR-inhibitor combinations today. Clinical studies on tamsulosin/finasteride have been published including controlled studies of the combination and both monotherapies. The results of improvement of lower urinary tract symptoms (LUTS), maximum urinary flow rate (Qmax), prostate volume (PV) and prostate-specific antigen (PSA) as well as adverse events and drug safety are in agreement with the leading studies. However, results due to chance cannot be excluded because of deficiencies in study design. A reliable comparison of the risk of progression between tamsulosin/finasteride and both monotherapies is lacking completely. Because of the great coherence and continuous evaluation of available data of all combinations, and with the established strong class effect of monotherapies, a continuation of the therapeutic practice with the combination tamsulosin/finasteride is possible.

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Authors and Affiliations

  1. Ev. Krankenhaus, Virchowstr. 20, 46047, Oberhausen, Deutschland

    K. Höfner

  2. Med.-wiss. Abteilung, Aristo Pharma GmbH, Berlin, Deutschland

    S. Ulrich

  3. PAN Klinik am Neumarkt, Köln, Deutschland

    R. Berges

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  2. S. Ulrich
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  3. R. Berges
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Correspondence to K. Höfner.

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Interessenkonflikt

K. Höfner ist als Berater für die Firma Aristo Pharma tätig. S. Ulrich ist Mitarbeiter der Aristo Pharma GmbH, die urologische Arzneimittel entwickelt und vermarktet. R. Berges gibt an, dass kein Interessenkonflikt besteht.

Dieser Beitrag beinhaltet keine von den Autoren durchgeführten Studien an Menschen oder Tieren.

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Höfner, K., Ulrich, S. & Berges, R. Kombinationsbehandlung des BPS mit Tamsulosin und Finasterid. Urologe 56, 645–653 (2017). https://doi.org/10.1007/s00120-016-0296-x

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