ADA: CV Risk with Linagliptin in Patients with Type 2 Diabetes: A Pre-Specified, Prospective, and Adjudicated Meta-Analysis from a Large Phase III Program
The cardiovascular (CV) benefit of glucose lowering, particularly if too intensive, in type 2 diabetes mellitus (T2DM) is currently debated. Some modalities have even been reported, unexpectedly, to be associated with worse CV outcomes. To investigate the CV profile of the novel DPP-4 inhibitor linagliptin, a pre-specified meta-analysis of all CV events from 8 phase III randomized, double blind, controlled trials (≥12 weeks) was conducted....
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CV events were prospectively adjudicated by a blinded independent expert committee. The primary endpoint of this analysis was a composite of CV death, non-fatal stroke, non-fatal myocardial infarction (MI), and hospitalization for unstable angina pectoris (UAP). Other secondary and tertiary CV endpoints were also assessed, including FDA-custom major adverse CV events (MACE).
Of 5239 patients included (mean baseline HbA1c 8.0%) 3319 received linagliptin once daily (5 mg: 3159, 10 mg: 160) and 1920 comparator (placebo: 977, glimepiride: 781, voglibose: 162). Cumulative exposure (person yrs) was 2060 for linagliptin and 1372 for comparators. Overall, adjudicated primary CV events occurred in 11 (0.3%) patients receiving linagliptin and 23 (1.2%) receiving comparator. The hazard ratio for the primary endpoint was significantly lower for linagliptin vs. comparator and hazard ratios were similar or significantly lower with linagliptin vs. comparator for all other CV endpoints (TABLE). This is the first pre-specified, prospective, and independently adjudicated CV meta-analysis of a DPP-4 inhibitor in a large Phase III program. Although a meta-analysis, with distinct limitations, the data support a potential reduction of CV events with linagliptin. This hypothesis will be tested prospectively in CAROLINA, an ongoing outcomes trial. [Figure1]
Authors: ODD-ERIK JOHANSEN, DIETMAR NEUBACHER, MAXIMILIAN VON EYNATTEN, SANJAY PATEL, HANS-JUERGEN WOERLE: ADA Scientific Sessions Late Breaking Abstract Sunday, June 26, 2011 Abstract No: 0030-LB
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