SAN FRANCISCO — Linagliptin is safe for patients with type 2 diabetes (T2D) and cardiorenal disease, according to research results presented at the American Diabetes Association 79th Scientific Sessions, held June 7 to 11, 2019 in San Francisco, California.
The CARMELINA study (Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus; ClinicalTrials.gov Identifier: NCT01897532) was a randomized placebo-controlled clinical trial designed to assess the cardiovascular safety of linagliptin in T2D and concomitant cardiorenal disease. The researchers used a negative binomial model to assess the effects of linagliptin compared with placebo for all first and recurrent cardiovascular events as well as any-cause hospitalizations.
Of the 6979 enrolled participants (mean age, 66 years; average estimated glomerular filtration rate, 54.6 mL/min/1.73 m2; median urinary albumin-to-creatinine ratio, 162 mg/g), 26.8% had a history of heart failure and 58.5% had a history of ischemic heart disease. When recurrent events were added, the number of events for analysis increased from 5.3% to 57.5% across cardiovascular/heart failure outcomes and 112.4% for hospitalizations.
Compared with the placebo group (n = 3485), patients receiving linagliptin (n = 3494) showed a similar risk for both first and recurrent cardiovascular or hospitalization events. For all fatal/nonfatal myocardial infarction, there were 220 events recorded in patients receiving linagliptin compared with 211 for placebo (relative risk [RR] 1.03; 95% CI, 0.79-1.35; P =.83). For all fatal/nonfatal stroke, there were 84 events recorded in patients receiving linagliptin compared with 94 for placebo (RR, 0.89; 95% CI, 0.65-1.22; P =.48). For all-cause hospitalization, there were 2459 events for the linagliptin group compared with 2575 for placebo (RR, 0.96; 95% CI, 0.87-1.06; P =.40).
Study investigators concluded, “These data support the overall and [cardiovascular] safety of linagliptin and, considering the number of recurrent events, underscores the significant [cardiovascular] disease burden experienced by [patients with T2D] and cardiorenal disease.”
Disclosures: CARMELINA was sponsored by Boehringer Ingelheim in a collaboration with Eli Lilly and Company. Several study authors disclosed associations with pharmaceutical companies. Please see the original abstract for a full list of authors’ disclosures.
Marx N, McGuire DK, Johansen OE, et al. Analyses of first plus recurrent cardiovascular and hospitalization events in the cardiovascular and renal microvascular outcome study with linagliptin (CARMELINA) in patients with type 2 diabetes and cardiorenal disease. Presented at: American Diabetes Association 79th Scientific Sessions; June 7-11, 2019; San Francisco, CA. Poster 432-P.