Linagliptin noninferior for CV risk in early type 2 diabetes

(HealthDay)—Linagliptin is noninferior to glimepiride for adults with relatively early type 2 diabetes and elevated cardiovascular risk, according to a study published online Sept. 19 in the Journal of the American Medical Association to coincide with the annual meeting of the European Association for the Study of Diabetes, held from Sept. 16 to 20 in Barcelona, Spain.

Julio Rosenstock, M.D., from the Dallas Diabetes Research Center at Medical City, and colleagues examined cardiovascular outcomes of linagliptin versus glimepiride (sulfonylurea) in 6,042 adults with type 2 diabetes, glycated hemoglobin of 6.5 to 8.5 percent, and elevated cardiovascular risk. Patients were followed for a median of 6.3 years.

The researchers found that the primary outcome (time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) occurred in 11.8 and 12.0 percent of patients in the linagliptin and glimepiride groups, respectively (hazard ratio, 0.98; 95.47 percent confidence interval, 0.84 to 1.14; P < 0.001 for noninferiority), meeting the criteria for noninferiority but not superiority (P = 0.76). Adverse events occurred in 93.4 and 94.9 percent of patients in the linagliptin and glimepiride groups, respectively, with adjudicated-confirmed acute pancreatitis in 0.5 percent of each group. Overall, 10.6 and 37.7 percent of the linagliptin and glimepiride groups had at least one hypoglycemic event (hazard ratio, 0.23; 95 percent confidence interval, 0.21 to 0.26).

"The current study demonstrates noninferior cardiovascular safety effects for linagliptin versus glimepiride when used predominantly as a second-line glucose-lowering treatment option after metformin," the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including Boehringer Ingelheim, which manufactures linagliptin and funded the study.

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