Cardiovascular outcome trial with DPP-4 inhibitor met primary endpoint
Presented at the European Association for the Study of Diabetes (EASD) Annual Meeting in Berlin, Germany (1-5 October).
The long-term CV outcome trial CARMELINA, which studied the impact of linagliptin on CV and kidney safety in adults with T2DM at high risk for heart and/or kidney disease, met its primary endpoint, with linagliptin demonstrating a similar CV safety profile compared to placebo when added to standard of care. CARMELINA also included a key secondary composite endpoint, showing a similar kidney safety profile compared to placebo.
In CARMELINA, CV events that contributed to the primary endpoint (time to first occurrence of the three-point MACE (CV death, non-fatal myocardial infarction or non-fatal stroke) occurred in 12.4% (434 people) of the linagliptin group compared to 12.1% (420 people) in the placebo group, demonstrating a similar long-term CV safety profile in adults with T2DM.
Linagliptin also showed a similar long-term kidney safety profile compared to placebo. This was demonstrated on the composite endpoint reflecting declining kidney function occurring in 9.4% (327 people) of the linagliptin group compared to 8.8% (306 people) of the placebo group.
Hospitalization for heart failure was a pre-specified endpoint in CARMELINA and was assessed thoroughly via adjudication. This occurred in 6% (209 people) of the linagliptin group compared to 6.5% (226) of the placebo group.
CARMELINA was a multi-national, randomized, double-blind, placebo-controlled clinical trial that involved 6,979 adults with T2DM from 27 countries at more than 600 sites observed for a median duration of 2.2 years. The study was designed to assess the effect of linagliptin (5mg once daily) compared to placebo (both added to standard of care) on CV outcome in adults with T2DM and high CV risk, the majority of whom also had kidney disease. Compared to other recently reported outcome trials of DPP-4 inhibitors in T2DM, CARMELINA included the highest number of patients with impaired kidney function. Standard of care included both glucose lowering agents and CV drugs (including antihypertensive and lipid lowering agents).
- Our reporting is based on the information provided by the EASD press service -