Linagliptin was not associated with an increased risk of adverse cardiovascular (CV) events, renal events or hypoglycemia in older patients with type 2 diabetes, according to subgroup analysis from the phase 4 Carmelina® trial.
The multicenter, randomized, double-blind, placebo-controlled trial evaluated the long-term CV and kidney safety profile of linagliptin (5mg once daily) vs placebo, as an add-on to standard of care, in adults with type 2 diabetes at high renal and CV risk (N=6979). The primary composite end point was the time to first occurrence of CV death, nonfatal myocardial infarction or nonfatal stroke (3P-MACE). The prespecified subgroup analysis assessed study findings in 3 predefined age categories: <65 (n=2968), 65 to <75 (n=2800), and ≥75 years (n=1211).
Results showed that linagliptin met the primary end point demonstrating a similar CV safety profile vs placebo (hazard ratio [HR] 1.02; 95% CI, 0.89-1.17); HRs based on age group were: <65 (HR 1.11; 95% CI, 0.89-1.40); 65 to <75 (HR 1.09; 95% CI, 0.89-1.33); ≥75 years (HR 0.76; 95% CI, 0.57-1.02). Additionally, linagliptin was not associated with an increased risk of adverse kidney outcomes, hospitalization for heart failure or hypoglycemia. Patients across all age groups also showed improved glycemic control on linagliptin vs placebo.
“This subset analysis shines a spotlight on the older population living with type 2 diabetes,” said Waheed Jamal, MD, Corporate VP and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “As the older population also has the highest incidence of type 2 diabetes of any age group, this analysis will be invaluable in helping clinicians manage the treatment of this patient group, previously underrepresented in clinical studies.”
Linagliptin is marketed under the brand name Tradjenta and is currently FDA-approved as an adjunct to diet and exercise in type 2 diabetes, as monotherapy or combination therapy.
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