Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) yesterday announced the CAROLINA® (CARdiovascular Outcome study of LINAgliptin versus Glimepiride in patients with Type 2 diabetes) trial met its primary endpoint, defined as non-inferiority of the time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3-point MACE). The results showed Tradjenta® (linagliptin) demonstrated no increased long-term cardiovascular risk compared with an active comparator (glimepiride) in adults with type 2 diabetes and cardiovascular risk.
CAROLINA is the only active-comparator cardiovascular outcome trial for a dipeptidyl peptidase-4 (DPP-4) inhibitor. CAROLINA evaluated the impact of treatment with Tradjenta (5 mg once daily) compared with the sulfonylurea glimepiride, on top of standard of care, on cardiovascular safety in 6,033 patients with early type 2 diabetes and increased cardiovascular risk or established cardiovascular disease. The overall safety profile of Tradjenta in CAROLINA was consistent with previous data, and no new safety signals were observed. Together, CAROLINA and CARMELINA® (CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin), which studied Tradjenta in adults with type 2 diabetes at high risk for cardiovascular and/or kidney disease, provide one of the most comprehensive datasets on the long-term safety of a DPP-4-inhibitor across a broad range of patients with type 2 diabetes.
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