Effect of linagliptin vs placebo on major cardiovascular events in adults with type 2 diabetes and high cardiovascular and renal risk: The CARMELINA randomized clinical trial

JAMA Jan 12, 2019

Rosenstock J, et al. - The effect of linagliptin (a selective dipeptidyl peptidase 4 inhibitor) vs placebo on cardiovascular (CV) and kidney outcomes was assessed in patients with type 2 diabetes at high risk of CV and kidney events. Researchers performed a randomized, placebo-controlled, multicenter noninferiority trial at 605 clinic sites in 27 countries among adults with type 2 diabetes, hemoglobin A1c of 6.5% to 10.0%, high CV risk (history of vascular disease and urine-albumin creatinine ratio [UACR] >200 mg/g), and high renal risk (reduced eGFR and micro- or macroalbuminuria). They enrolled 6,979 patients and followed them up for a median 2.2 years, identifying the use of linagliptin with usual care to be associated with an incidence of the primary composite outcome (CV death, nonfatal myocardial infarction, or nonfatal stroke) of 12.4% vs 12.1% seen in the placebo group. This demonstrates linagliptin, compared with placebo, as noninferior regarding risk of major CV events over a median of 2.2 years.

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