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Vildagliptin safe in type 2 diabetes with high CV risk
The DPP-IV inhibitor vildagliptin did not increase the likelihood of cardiovascular death, myocardial infarction, stroke and other CV outcomes in adults with type 2 diabetes and recent CV complications compared with other treatments, according to findings published in the Journal of Diabetes Investigation.
“Among patients with type 2 diabetes mellitus, those with both diabetes and prior MI or ischemic stroke are at particularly high risk of further CV events,” Tien-Hsing Chen, MD, of the division of cardiology in the department of internal medicine at Chang Gung Memorial Hospital Keelung, Chang Gung University College of Medicine in Taiwan, and colleagues wrote. “Ideally, any antidiabetes treatment should lower the risks of adverse events related to CV diseases, or at least not increase it.”
Using propensity score matching, Chen and colleagues compared CV outcomes in 1,250 adults with type 2 diabetes from the National Health Insurance Research Database who received vildagliptin therapy between August 2011 and December 2013 (mean age, 68.3 years; 42.5% women) with 2,500 adults with type 2 diabetes who did not receive such treatment during that time (mean age, 67.9 years; 42.2% women). In addition to type 2 diabetes, participants had experienced acute coronary syndrome or an acute ischemic stroke in the previous 3 months, according to the researchers, who were primarily interested in instances of CV death, nonfatal MI, nonfatal stroke as well as heart failure hospitalization, percutaneous coronary intervention and coronary artery bypass grafting.
Although a numerically larger percentage of participants taking vildagliptin experienced either CV death, nonfatal MI or nonfatal stroke during follow-up compared with those who did not take the medication (10.5% vs. 9.8%), this difference did not reach significance. The researchers also noted that experiencing CV death (HR = 0.93; 95% CI, 0.56-1.52), nonfatal MI (HR = 0.79; 95% CI, 0.46-1.36), nonfatal stroke (HR = 0.96; 95% CI, 0.74-1.24), heart failure hospitalization (HR = 0.81; 95% CI, 0.53-1.22), percutaneous coronary intervention (HR = 1.16; 95% CI, 0.89-1.5) or coronary artery bypass grafting (HR = 0.71; 95% CI, 0.36-1.42) was no more likely for those taking vildagliptin compared with those not taking the medication. In addition, taking vildagliptin did not significantly alter all-cause mortality risk compared with other treatments (HR = 0.82; 95% CI, 0.59-1.13).
Findings for CV death, nonfatal MI, nonfatal stroke and heart failure hospitalization held in a subset of participants with heart failure at study onset, according to the researchers, who added that acute pancreatitis, hypoglycemia, diabetic ketoacidosis/hyperosmolar hyperglycemic state, de novo dialysis or newly diagnosed malignancy occurred at relatively similar rates in those taking vildagliptin compared with those not taking the medication.
“The strength of our research is filling the gap in evidence for CV safety with respect to vildagliptin in these patients who tend to be vulnerable to the further major CV diseases over relatively short periods,” the researchers wrote. “These findings could provide clinical physicians with real-world evidence supporting the use of vildagliptin as an antihyperglycemic agent for treatment of patients with type 2 diabetes mellitus and very high risk of further CV events.” – by Phil Neuffer
Disclosures: The authors report no relevant financial disclosures.