The results from a new pooled analysis of phase III data for the dipeptidyl peptidase-4 ( DPP-4 ) inhibitor Linagliptin ( Trajenta ) were presented at the American Diabetes Association ( ADA ) 73rd Scientific Sessions, compared the incidence of cardiovascular events with Linagliptin for the treatment of adults with type 2 diabetes ( T2D ) with the incidence of cardiovascular events for a number of comparators ( placebo, Glimepiride and Voglibose ).
People with T2D have a significantly elevated risk for myocardial infarction, stroke and other cardiovascular events, compared with the general population.
For the post-hoc analysis, researchers pooled results from 19 double-blind studies, including data from 9,459 patients treated with either Linagliptin ( 5mg: 5,687, 10mg: 160 ) or a comparator group of placebo and other oral antihyperglycemic treatments ( placebo: 2,675, Glimepiride: 775, Voglibose: 162 ).
The cumulative patient exposure ( the total length of time all patients had been exposed to treatment ) was 4,421 patient-years in the Linagliptin group and 3,255 patient-years in the comparator group.
The primary endpoint of the pooled analysis was a composite of cardiovascular death, non-fatal stroke, non-fatal myocardial infarction and hospitalization for unstable angina pectoris.
Cardiovascular events were prospectively adjudicated by a blinded independent expert Committee.
The post-hoc meta-analysis showed a lower incidence rate of the composite cardiovascular endpoint for the Linagliptin group ( 13.4 per 1,000 patient years ), versus the comparator group ( 18.9 per 1,000 patient years ), and a hazard ratio of 0.78 ( CI: 0.55, 1.12, p=NS ). ( Xagena )
Source: Lilly, 2013