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External validity of type 2 diabetes clinical trials on cardiovascular outcomes for a multimorbid population

Felippe Lazar Neto1, Thiago Bosco Mendes2, Paulo Marcelo Pontes Gomes Matos1

  • 1Department of Internal Medicin, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo, Brazil.

Diabetes, Obesity & Metabolism
|December 18, 2020
PubMed
Abstract

Insights

Most patients with type 2 diabetes and multiple health conditions are eligible for recent antihyperglycemic drug trials. Cardiovascular disease was the strongest predictor of trial eligibility.

Area of Science:

  • Cardiology
  • Endocrinology
  • Clinical Trials

Background:

  • Recent antihyperglycemic trials focus on cardiovascular outcomes in patients with type 2 diabetes.
  • Multimorbid populations present unique challenges for trial generalizability.
  • External validity of these trials in real-world, complex patient groups requires investigation.

Purpose of the Study:

  • To assess the external validity of recent antihyperglycemic drug trials.
  • To determine the eligibility of multimorbid patients with type 2 diabetes for these cardiovascular outcome trials.

Main Methods:

  • Applied selection criteria from 15 randomized controlled trials (RCTs) to a cohort of tertiary care patients with type 2 diabetes.
  • Evaluated patient eligibility for individual trials and an aggregate of trials.
  • Identified patient predictors of trial eligibility.

Main Results:

  • Of 1059 patients, 75.1% were eligible for at least one trial.
  • Cardiovascular disease was the strongest predictor of trial eligibility (risk ratio 2.17).
  • Patients were eligible for multiple drug classes, indicating broad applicability.

Conclusions:

  • A significant proportion of multimorbid patients with type 2 diabetes meet eligibility criteria for recent antihyperglycemic trials.
  • This suggests good external validity, potentially due to trial design guidance and aggregate analysis.
  • Findings support the inclusion of diverse, multimorbid populations in future diabetes research.
Keywords:
DPP-4 inhibitorGLP-1antidiabetic drugcanagliflozincardiovascular diseaseinsulin analogues

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