Real‐world prevalence of the inclusion criteria for the LEADER trial: Data from a national general practice network

Abstract

Aims To explore the prevalence and describe the clinical characteristics of people with type 2 diabetes with a similar cardiovascular (CV) profile to that of the LEADER trial participants in a primary care setting in England. Materials and methods In this cross‐sectional analysis, using the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network database, we identified people with type 2 diabetes meeting the LEADER inclusion criteria. We identified people's CV risk factors using computerized medical records. Additionally, we assessed the prescription pattern of glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs) in this cohort. Results Of 1 275 461 adults, we identified 84 394 with type 2 diabetes, of whom 14 000 (16.6%) met the LEADER inclusion criteria for established or high‐risk CV disease (RCGP RSC‐CVD group). The LEADER cohort was younger than the RCGP RSC‐CVD group (64.2 vs 73.2 years), had higher mean glycated haemoglobin (71.6 vs 67.1 mmol/mol) and blood pressure (BP) values (systolic BP: 135.9 vs 132.9 mmHg; diastolic BP: 77.2 vs 72.7 mmHg), and a higher mean body mass index (32.5 vs 30.9 kg/m 2 ). In the RCGP RSC‐CVD group, only 1215 people (8.7%) had ever been prescribed a GLP‐1RA and 760 (5.4%) had ever received liraglutide. Conclusions In a cohort of English general practice patients, one in six people with type 2 diabetes met the LEADER inclusion criteria, and less than one in 10 of these received liraglutide, a drug which has demonstrated CV benefits amongst others. There is scope to improve the outlook in people with type 2 diabetes and high CV risk through evidence‐based use of specific GLP‐1RAs.

Potential unrealized mortality benefit of glucagon‐like peptide‐1 receptor agonists and sodium‐glucose co‐transport‐2 inhibitors: A report from the Veterans Health Administration Clinical Assessment, Reporting and Tracking program

“…However, a majority of eligible patients remain untreated with these medications 9 . Our findings of low prevalent use of GLP‐1RAs and SGLT2is despite trial eligibility are consistent with prior reports 21–24 . Low utilization of GLP‐1RAs and SGLT2is, despite large‐scale cardiovascular outcomes trials showing efficacy published as early as 2015, may be related to unfamiliarity with the drugs, a lack of knowledge regarding their cardiovascular benefits, hesitancy to prescribe additional medications, reluctance to overstep traditional specialist prescriber roles for diabetes therapy, and the cost of therapy 24–26 .…”

Positioning sulphonylureas in a modern treatment algorithm for patients with type 2 diabetes: Expert opinion from a European consensus panel

“…Overall, GLP‐1RAs and SGLT‐2is consistently appear to have strong benefits on major adverse CV events, especially in patients with a history of cardiovascular disease (CVD) 44 . We recognize that long‐term data on the use of SGLT‐2is and GLP‐1RAs are limited, and that a minority of patients seen in routine clinical practice would satisfy trial enrolment criteria 45–47 . However, data from real‐world studies (reviewed in Newman et al 36 ) strongly support the evidence gathered from RCTs and univocally suggest that CV and renal benefits extend to the routine care population and in patients with a comparatively lower CV risk.…”

Comparative cardiovascular safety of GLP-1 receptor agonists versus other glucose-lowering agents in real-world patients with type 2 diabetes: a nationwide population-based cohort study

“…Also, physicians' or patients' adoption of new drugs may not be as fast as expected due to uncertain long-term real-world drug effectiveness and safety evidence. For instance, a recent study found that less than 10% of the real-world patients who had comparable CVD risks with the participants in the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial were actually prescribed with liraglutide [5]. Moreover, GLP-1ra is administrated by subcutaneous injection, which likely discourages physicians or patients from the early initiation of GLP-1ra until a therapy with multiple oral GLAs has failed.…”