Kritik beim Einsatz der medikamentösen Osteoporose-Therapie

Zusammenfassung

Studien über neue Medikamente für Osteoporose berichteten über die Verhütung von radiologischen Wirbelkörper (WK)-Frakturen, aber meist mit einer zu freien Definition dieser Frakturen. Radiologische Frakturen sind häufiger als die klinischen WK-Frakturen, was die Studien erleichtert, aber sie sind zu einem Drittel asymptomatisch. Die Resultate solcher Studien wurden auch oft verschönert mit der Angabe der relativen Fraktur-Verminderung, und nicht mit der wirklichen Verminderung der Frakturinzidenz. Damit konnte eine wirkliche Frakturinzidenz-Verminderung von nur 1 % als 50 % angegeben werden. Was Hüftfrakturen angeht, ist der NNT (Number Needed to Treat), die Anzahl von Patienten, die behandelt werden müssen um eine Fraktur zu verhüten, sehr oft so hoch, dass ein günstiges Kosten/Nutzen-Verhältnis fraglich wird. Meistens ist er wahrscheinlich auch zu hoch für WK-Frakturen bei Patienten ohne vorgängige WK-Fraktur. Die Erwähnung des NNT wird nicht nur von der Pharma-Industrie vermieden, sondern auch von den meisten Autoren. Weiterhin wird oft nicht das beste und preisgünstigste Medikament verschrieben (orale versus parenterale Bisphosphonate, Calcium mit Vitamin D versus Vitamin D und Calciumreiche Nahrung). Es ist auch bedauerlich, dass Fluor von der Pharma-Industrie nicht unterstützt wurde, und dass das Medikament wegen der toxischen Dosen verurteilt wurde. Die positiven Studien mit kleinen, hoch wirksamen Dosen wurden außer Acht gelassen.

Abstract

Studies on new drugs for osteoporosis report on their effect against radiological vertebral fracture, mostly with a too tolerant definition of these fractures. Radiological fractures are more frequent than clinical fractures, which makes the studies easier to perform. But one third is asymptomatic. The results were also often artificially improved by the indication of the relative decrease of fractures and not of the real decrease of the fracture incidence. By this a real decrease of 1 % can be presented as 50 %. The NNT (Number Needed to Treat), the number of patients who have to be treated for preventing one single, is in general so high , that the cost/effectiveness ratio concerning hip fractures remains questionable, and probably very often also for vertebral fractures in patients without previous fractures. The indication of the NNT is not only avoided by the Pharma industry, but also by most authors. – In addition, very often not the best and the most advantageous drugs were prescribed (oral versus parenteral bisphosphonates, Calcium with Vitamin D versus Vitamin D and calcium rich food). It is also regrettable that Fluor was not supported by the pharma industry, and that this drug was condemned only because of its toxic doses. The positive studies with small and highly effective doses were disregarded.

Schlüsselwörter

Number needed to treat - Na Fluorid - Calcium und Vitamin D

Key words

Number needed to treat - Na Fluoride - Calcium and vitamin D

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