SAN FRANCISCO—Linagliptin (Tradjenta®) is comparable to placebo in cardiovascular (CV) and renal safety in patients with type 2 diabetes (T2DM) and kidney disease, according to new data from the CARMELINA clinical trial presented at the American Diabetes Association (ADA) Scientific Sessions meeting in San Diego, CA, June 7-11.
The primary results of the CARMELINA (The Cardiovascular and Renal Microvascular Outcome Study with Linagliptin) clinical trial, published earlier in the year, had demonstrated no increased risk for cardiovascular (CV) events, heart failure, or adverse kidney outcomes in patients with T2DM at high cardiorenal risk1 who took the dipeptidyl peptidase-4 inhibitor. The primary outcome measure in that study was time to first occurrence of CV death, non-fatal myocardial infarction (MI), or non-fatal stroke (3-point major adverse CV event [MACE]).
The analysis presented here2 expanded inquiry into effects of linagliptin on global burden of CV disease as well as hospitalization in this population by comparing effects of linagliptin vs placebo on all plus first recurrent CV events and hospitalizations for any cause.
Prior to the presentation, Darren McGuire, MD, MHSc, the CARMELNA study co-chair and Distinguished Teaching Professor at the University of Texas Southwestern Medical Center, Dallas, TX, discussed the new report with ADAMeetingNews,org.
“The presentation at the Scientific Sessions will provide further updates of results from this first large and dedicated cardiorenal outcome trial in people with type 2 diabetes, including further analysis of effects in the more vulnerable participants, ie, those with the poorest renal function and the elderly,” McGuire said.