This article is more than 5 years old. Information may no longer be current.
CARMELINA results demonstrate CV neutral effect with linagliptin in diabetes
Click Here to Manage Email Alerts
Researchers with the CARMELINA cardiovascular outcomes trial announced positive top-line results for the DPP-IV inhibitor linagliptin, noting the drug demonstrated similar CV safety vs. placebo in adults with type 2 diabetes and high CV risk, according to a press release from Boehringer Ingelheim and Eli Lilly.
The study, which met its primary endpoint of first occurrence of CV death, nonfatal myocardial infarction or nonfatal stroke in adults with type 2 diabetes and high CV risk, also demonstrated an overall safety profile for linagliptin (Tradjenta) consistent with previous data, and no new safety signals were observed, according to the release.
The study included 6,979 adults with type 2 diabetes and high CV risk, and most patients also had kidney disease.
“About half of patients with type 2 diabetes worldwide also have chronic kidney disease, and the majority of deaths among people with kidney disease occur as a result of cardiovascular complications,” Thomas Seck, MD, senior vice president for medicine and regulatory affairs at Boehringer Ingelheim, said in the release. “These CARMELINA data add important information regarding the long-term clinical safety of Tradjenta in a patient population that is particularly vulnerable to poor cardiovascular outcomes.”
“Tradjenta demonstrated cardiovascular safety in adults with type 2 diabetes and high vascular risk, with no need for dose adjustments regardless of kidney function,” Jeff Emmick, MD, PhD, vice president of product development for Lilly Diabetes, said in the release. “CARMELINA provides confidence in Tradjenta as an effective and well-tolerated treatment, with a simple dosing regimen, for adults with type 2 diabetes.”
As Endocrine Today previously reported, the CARMELINA study enrolled its first patients in 2013 to assess the effect of 5 mg once-daily linagliptin. Renal outcomes included time to first occurrence of renal death, sustained end-stage renal disease or a sustained decrease in estimated glomerular filtration rate of at least 50%.
The full results of CARMELINA will be presented Oct. 4 at the 54th European Association for the Study of Diabetes Annual Meeting in Berlin. – by Regina Schaffer