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How Generalizable Are Cardiovascular Outcome Trials of Sodium-Glucose Co-Transporter-2 Inhibitors? A National

William Hinton1, Michael D Feher1, Neil Munro1

  • 1Department of Clinical and Experimental Medicine, University of Surrey, Guildford, GU2 7XP, UK.

Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders
|May 2, 2019
PubMed
Abstract

Insights

This study assesses the prevalence of type 2 diabetes patients in English primary care matching cardiovascular risk profiles of key Sodium-glucose co-transporter-2 (SGLT2) inhibitor trials. Findings will inform real-world applicability of SGLT2 inhibitor cardiovascular benefits.

Area of Science:

  • Cardiology
  • Endocrinology
  • Pharmacology

Background:

  • Sodium-glucose co-transporter-2 (SGLT2) inhibitors are effective oral antihyperglycemic agents for type 2 diabetes (T2DM).
  • Major cardiovascular outcome trials (CVOTs) like EMPA-REG OUTCOME and CANVAS demonstrated cardiovascular benefits of SGLT2 inhibitors in high-risk T2DM patients.
  • Understanding the prevalence of patients with similar cardiovascular risk profiles in primary care is crucial for assessing trial generalizability.

Purpose of the Study:

  • To determine the prevalence of patients in English primary care with cardiovascular risk profiles equivalent to those in four major SGLT2 inhibitor CVOTs (CANVAS, DECLARE, EMPA-REG, VERTIS CV).
  • To compare the demographic and clinical characteristics of these identified subgroups with participants in each respective trial.
  • To evaluate the applicability of SGLT2 inhibitor trial findings to real-world clinical practice.

Main Methods:

  • Utilizing routinely collected primary care data from the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network database.
  • Performing a cross-sectional analysis to identify and quantify the prevalence of T2DM patients matching the inclusion criteria of the selected CVOTs.
  • Employing Read codes to define subgroups and descriptive statistics to compare characteristics with trial participants.

Main Results:

  • Prevalence data of T2DM patients with specific cardiovascular risk profiles will be calculated.
  • Demographic and clinical characteristics of identified primary care subgroups will be compared against CVOT participants.
  • The study will quantify the proportion of the T2DM population in English primary care that aligns with the high-risk profiles of SGLT2 inhibitor trial cohorts.

Conclusions:

  • The findings will provide essential insights into the generalizability of SGLT2 inhibitor CVOT results to routine English primary care.
  • This research will help clinicians understand which T2DM patients in primary care are most likely to represent trial populations.
  • The study aims to inform clinical decision-making regarding the use of SGLT2 inhibitors for cardiovascular risk reduction in T2DM.
Keywords:
Cardiovascular diseasesCross-sectional studiesDiabetes mellitus, Type 2Medical record systems, computerizedSodium-glucose transporter 2 inhibitors

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