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Primärer Endpunkt: nicht signifikant

Stärken und Grenzen randomisierter Studien zur Lipidtherapie

  • Schwerpunkt_Lipidologie
  • Published:
CardioVasc Aims and scope

Zusammenfassung

Zunehmend enden Interventionsstudien zu wesentlichen therapeutischen Fragestellungen mit einem nicht signifikanten Ergebnis für den primären Endpunkt. Das prägt auch das Bild der randomisierten Studien im Bereich der Lipidtherapie. Dies muss nicht an fehlender Wirksamkeit der Prüfsubstanz liegen. Vielmehr ist häufig die Studiendauer zu kurz für eine sich chronisch auswirkende Fettstoffwechselstörung. Das Dilemma wird noch dadurch akzentuiert, dass heute lediglich ein Zusatznutzen vor dem Hintergrund konventioneller Behandlungsmöglichkeiten geprüft werden kann. Damit gehen Therapieoptionen verloren und praktische Fragen bleiben unbeantwortet. Es stellt sich daher die Frage, ob und in wie weit auch Informationen aus Studien über den primären Endpunkt hinaus gewonnen werden können, selbst aus solchen, die als „negativ“ bewertet werden.

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Author information

Authors and Affiliations

  1. Präventive Medizin, Universitäres Herzzentrum Hamburg, Universitätsklinikum Hamburg-Eppendorff, Hamburg-Eppendorff, Deutschland

    Eberhard Windler

  2. Praxis Dres. T. Beckenbauer und S. Maierhof, Am Markt 11, 28195, Bremen, Deutschland

    Gerald Klose

  3. Medizinische Klinik und Poliklinik II, Klinikum der Universität München Großhadern, Großhadern, Deutschland

    Klaus G. Parhofer

  4. Evangelisches Geriatriezentrum Berlin gGmbH, Berlin, Deutschland

    Elisabeth Steinhagen-Thiessen

Authors
  1. Eberhard Windler
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  2. Gerald Klose
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  3. Klaus G. Parhofer
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  4. Elisabeth Steinhagen-Thiessen
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Corresponding author

Correspondence to Gerald Klose.

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Windler, E., Klose, G., Parhofer, K.G. et al. Stärken und Grenzen randomisierter Studien zur Lipidtherapie. CV 14, 45–50 (2014). https://doi.org/10.1007/s15027-014-0520-9

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  • DOI: https://doi.org/10.1007/s15027-014-0520-9

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