Treatment with vildagliptin may cause an increase in left ventricular volume compared with placebo, but it has no major effect on left ventricular ejection fraction (LVEF) in patients with type 2 diabetes and heart failure, according to a study published in JACC: Heart Failure.
Researchers identified 254 patients from 67 sites in 15 countries who had type 2 diabetes and heart failure and randomly assigned them to receive 52 weeks of treatment with either vildagliptin 50 mg twice daily (n=128) or placebo (n=126) in a prospective, randomized, double-blind, parallel-group trial (ClinicalTrials.gov identifier: NCT00894868). The primary end point was change from baseline in echocardiographic LVEF between treatments.
Study results showed a mean change in LVEF of 4.95±1.25% in patients treated with vildagliptin, and 4.33±1.23% in patients treated with placebo, which was found to be a difference of 0.62 (95% CI, -2.21 to 3.44; P =.667). In addition, those treated with vildagliptin were noted to have increased left ventricular end diastolic volume and end systolic volumes by 17.1 mL (95% CI, 4.6-29.5 mL; P =.007) and 9.4 mL (95% CI, -0.49 to 19.4 mL; P =.062), respectively. Finally, a greater decrease in hemoglobin A1C level from baseline to 16 weeks of treatment was found in those treated with vildagliptin (0.62% [95% CI, -0.93 to -0.30%; P < .001; -6.8 mmol/mol; 95% CI, -10.2 to 3.3 mmol/mol]).
Researchers concluded that treatment with vildagliptin increased left ventricular volumes, was not inferior to placebo, and did not contribute to worsening heart failure. In addition, no statistically significant difference in LVEF was found in patients treated with vildagliptin compared with placebo. They made no recommendations regarding the use of this drug. Rather, they suggested further research on the use of dipeptidyl peptidase-4 inhibitors in this patient population.
McMurray JJV, Ponikowski P, Bolli GB, et al. Effects of vildagliptin on ventricular function in patients with type 2 diabetes mellitus and heart failure: a randomized placebo-controlled trial [published online October 11, 2017]. JACC: Heart Fail. doi:10.1016/j.jchf.2017.08.004