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

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

^* Für die Deutsche Diabetes Gesellschaft (DDG).

Publication History

Received: 02 July 2023

Accepted: 02 August 2023

Article published online:
12 October 2023

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