Endpunkte zu mikrovaskulären Folgekomplikationen: klinische Endpunkte, patientenberichtete Endpunkte und Surrogatendpunkte, Methodik von Surrogatvalidierungsstudien

Baptist Gallwitz; Monika Kellerer; Dirk Müller-Wieland; Christoph Wanner; Focke Ziemssen

doi:10.1055/a-2149-3554

Diabetologie und Stoffwechsel, Inhaltsverzeichnis

CC BY-NC-ND 4.0 · Diabetologie und Stoffwechsel 2023; 18(05): 381-393
DOI: 10.1055/a-2149-3554

Übersicht

Endpunkte zu mikrovaskulären Folgekomplikationen: klinische Endpunkte, patientenberichtete Endpunkte und Surrogatendpunkte, Methodik von Surrogatvalidierungsstudien

Endpoints for microvascular complications: clinical outcomes, patient reported outcomes and surrogate endpoints, methodology for validating surrogate parameters

Baptist Gallwitz ^*

¹Medicine IV, University Hospital Tübingen, Tübingen, Germany

,

Monika Kellerer

²Zentrum für Innere Medizin, Marien Hospital Stuttgart, Stuttgart, Germany (Ringgold ID: RIN39659)

,

Dirk Müller-Wieland

³Medicine 1, Uniklinikum Aaachen, Aachen, Germany

,

Christoph Wanner

⁴Dept. Medicine 1, Universitätsklinikum Würzburg, Wurzburg, Germany (Ringgold ID: RIN27207)

,

Focke Ziemssen

⁵Augenklinik, University Hospital Leipzig, Leipzig, Germany (Ringgold ID: RIN39066)

› Institutsangaben

Abstract

Zusammenfassung

Für die Bewertung und die Vergleichbarkeit klinischer Langzeitstudien zur Sicherheit und/oder Effektivität verschiedener Therapieformen bei chronischen Erkrankungen sind möglichst vergleichbare und homogene vorab festgelegte Endpunkte und Surrogatparameter wichtig. Am Beispiel des Diabetes mellitus Typ 2 als chronische Erkrankung wird die Erhebung mikrovaskulärer Endpunkte und von Surrogatparametern bei der diabetesbedingten Retinopathie und Nephropathie dargelegt und diskutiert.

Abstract

For the assessment and comparability of clinical long-term studies on the safety and/or efficacy of different forms of therapy in chronic diseases, it is important that endpoints and surrogate parameters that are prespecified are as comparable and homogeneous as possible. Using the example of type 2 diabetes mellitus as a chronic disease, the collection of microvascular endpoints and surrogate parameters in diabetes-related retinopathy and nephropathy is presented and discussed.

Schlüsselwörter

Endpunktstudien - Typ-2-Diabetes - Retinopathie - Nephropathie - mikrovaskuläre Endpunkte - Surrogatparameter

Keywords

Outcome studies - type-2-diabetes - retinopthy - nephropathy - microvascular endpoints - surrogate parameters

Volltext

Referenzen

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