Background: The LEADER trial showed in persons with type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD) or at high CVD risk the efficacy of liraglutide in reducing CVD events. We projected the impact of applying the LEADER trial results on reducing CVD events in U.S. adults with T2DM.
Methods: We identified U.S. adults eligible for LEADER from available inclusion criteria in the U.S. NHANES Survey. We estimated the number of primary (CVD death, myocardial infarction and stroke) and secondary CVD and microvascular events based on LEADER published event rates in the liraglutide and placebo groups, the difference being the number of preventable events.
Results: Among 29,629 adults aged >18 years (representing 231.9 million [M]), 4,672 (27.3 M) were identified with T2DM; 1,299 (7.2M) had an HbA1c of >7% and were aged >50 years, of which 595 (3.3M) had CVD or chronic kidney disease and 205 (0.9M) were aged >60 years with microalbuminuria or proteinuria for a total of 800 (4.2 M) who fit LEADER eligible criteria. Other criteria such as carotid or peripheral arterial disease or left ventricular hypertrophy were not available. From LEADER primary endpoint event rates of 13.0% and 14.9% over 3.8-year follow-up in the liraglutide and placebo groups, respectively, we estimated 551,420 and 632,012 events would occur, respectively, for a total of 80,592 (21,209/yr) preventable CVD events. Estimated preventable expanded composite outcomes were 101,800 (29,691/yr), myocardial infarctions 42,417 (12,725/yr), microvascular events 55,142 (12,725/yr), nephropathy occurrences 63,625 (19,967/yr), and all-cause 59,384 (16,967/yr) and CVD 55,142 (16,967/yr) deaths.
Conclusion: We show many CVD events (including myocardial infarctions, CVD and total deaths, as well as microvascular complications) in U.S. adults with DM could be prevented from liraglutide therapy highlighting the need for interventions with proven cardioprotective effects.
N.D. Wong: Advisory Panel; Self; Novartis Pharmaceuticals Corporation. Consultant; Self; Akcea Therapeutics, AstraZeneca. Research Support; Self; Amarin Corporation, Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc. W. Fan: None. C.A. Tong: None.