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Pooled analysis: Linagliptin did not increase CV event risk

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CHICAGO — Linagliptin was not associated with an increased risk for cardiovascular events or mortality, according to results of a pooled analysis of phase 3 data presented here at the ADA Scientific Sessions.

Using data from 19 double-blind, randomized, controlled trials, researchers compared the incidence of cardiovascular events and mortality among patients with type 2 diabetes assigned to linagliptin (Tradjenta, Boehringer Ingelheim and Eli Lilly) once daily (n=5,847) or non-linagliptin medications (n=3,612). All trials included in the analysis lasted ≥12 weeks, and a blinded independent expert committee prospectively adjudicated CV events.

CV death, non-fatal stroke or myocardial infarction and hospitalization for unstable angina pectoris comprised the primary endpoint; secondary and tertiary endpoints were also assessed.

Linagliptin was assigned at 5 mg (n=5,687) or 10 mg (n=160) and comparator drugs included placebo (n=2,675), glimepiride (n=775) or voglibose (Voglib, Mascot Health Series; n=162).

Primary events occurred at a rate of 60 in the linagliptin group vs. 62 in the comparator group (36 in placebo, 26 in active comparator). The primary endpoint occurred at a rate of 13.4 per 1,000 person-years in the linagliptin group vs. 18.9 per 1,000 patient-years in the comparator group (HR=0.78; 95% CI, 0.55-1.12), according to data. Additionally, the HRs were significantly lower in favor of linagliptin vs. comparators for non-fatal stroke (HR=0.34; 95% CI, 0.15-0.75) and transient ischemic attack (HR=0.09; 95% CI, 0.01-0.75).

According to Odd-Erik Johansen, MD, PhD, global senior medical director of metabolism and diabetes at Boehringer Ingelheim, who presented results of the analysis, he and colleagues are currently planning the CARMELINA study, a placebo-controlled safety trial of linagliptin to examine CV and renal outcomes among patients with type 2 diabetes. The trial has currently enrolled 8,300 patients. Results of their head-to-head trial CAROLINA, which compared linagliptin with glimepiride (n=6,103), were also presented here at the ADA Scientific Sessions. – by Stacey L. Adams

For more information:

Johansen OE. #376-OR. Presented at: ADA Scientific Sessions; June 21-25, 2013; Chicago.

Disclosure: Johansen is an employee of Boehringer Ingelheim GmbH & Co. KG.