Sodium-glucose co-transporter-2 inhibitor cardiovascular outcome trials and generalizability to English primary care

Diabet Med. 2020 Sep;37(9):1499-1508. doi: 10.1111/dme.14290. Epub 2020 Mar 28.

Abstract

Aim: To identify people in English primary care with equivalent cardiovascular risk to participants in the sodium-glucose co-transporter-2 inhibitor (SGLT-2i) cardiovascular outcome trials (CVOTs). A secondary objective was to report the usage of SGLT-2is.

Methods: Cross-sectional analysis of people registered with participating practices in the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network on the 31 December 2016. We derived: (1) proportions of the primary care population eligible for inclusion in each SGLT-2i CVOT (CANVAS, DECLARE, EMPA-REG and VERTIS); (2) characteristics of the eligible population compared with trial participants (demographics, disease duration and vascular risk); and (3) differences within the eligible population prescribed SGLT-2is.

Results: The proportions of people with type 2 diabetes (N = 84 394) meeting the inclusion criteria for each CVOT were: DECLARE 27% [95% confidence interval (CI) 26.5-27.1]; CANVAS 17% (16.6-17.1); VERTIS 7% (7.1-7.4); and EMPA-REG 7% (6.5-6.8). Primary care populations fulfilling inclusion criteria were 5-8 years older than trial cohorts, and <10% with inclusion criteria of each trial were prescribed an SGLT-2i; a greater proportion were men, and of white ethnicity.

Conclusions: There was variation in proportions of the primary care type 2 diabetes population fulfilling inclusion criteria of SGLT-2i CVOTs. The more stringent the inclusion criteria, the lower the proportion identified in a primary care setting. Prescription rates for SGLT-2is were low in this national database, and there were demographic disparities in prescribing.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Cardiovascular Diseases / complications
  • Cardiovascular Diseases / epidemiology*
  • Clinical Trials as Topic*
  • Databases, Factual
  • Diabetes Mellitus, Type 2 / complications
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / epidemiology
  • Eligibility Determination*
  • England
  • Female
  • Heart Disease Risk Factors
  • Humans
  • Male
  • Middle Aged
  • Practice Patterns, Physicians' / statistics & numerical data
  • Primary Health Care*
  • Sex Factors
  • Sodium-Glucose Transporter 2 Inhibitors / therapeutic use*
  • White People

Substances

  • Sodium-Glucose Transporter 2 Inhibitors