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Cardiovascular and heart failure safety profile of vildagliptin: a meta-analysis.

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eMediNexus    31 October 2017

A new study published in Diabetes Obesity Metabolism reported the cardiovascular CV safety profile and heart failure HF risk of vildagliptin from a large pool of studies including trials in high risk patients with type 2 diabetes mellitus T2DM such as those with congestive HF and or moderate or severe renal impairment. This was a retrospective meta analysis of prospectively adjudicated CV events. Here patient level data were pooled from 40 double blind randomized controlled phase III and IV vildagliptin studies. The analyses included 17 8201 446 patients of which 9599 received vildagliptin and 7847 received comparators. The mean age of these patients was 57 8201 years mean body mass index was 30.5 8201 kg m2 nearly 50 obese mean glycated hemoglobin concentration was 8.1 and mean T2DM duration was 5.5 8201 years. The findings showed that major adverse cardiac events MACE occurred in 0.86 vildagliptin treated patients and 1.20 comparator treated patients with a Mantel Haenszel M H risk ratio RR of 0.82. Comparable RRs were observed for the individual events. While confirmed HF events were reported in 0.43 vildagliptin treated patients and 0.45 comparator treated patients with an M H RR of 1.08. The findings indicated that vildagliptin is not associated with an increased risk of adjudicated MACEs relative to comparators. It was stated that this analysis did not find a significant increased risk of HF in vildagliptin treated patients.

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