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Assessment of the cardiovascular safety of saxagliptin in patients with type 2 diabetes mellitus: pooled analysis of 20 clinical trials.

AbstractBACKGROUND:
It is important to establish the cardiovascular (CV) safety profile of novel antidiabetic drugs.
METHODS:
Pooled analyses were performed of 20 randomized controlled studies (N = 9156) of saxagliptin as monotherapy or add-on therapy in patients with type 2 diabetes mellitus (T2DM) as well as a subset of 11 saxagliptin + metformin studies. Adjudicated major adverse CV events (MACE; CV death, myocardial infarction [MI], and stroke) and investigator-reported heart failure were assessed, and incidence rates (IRs; events/100 patient-years) and IR ratios (IRRs; saxagliptin/control) were calculated (Mantel-Haenszel method).
RESULTS:
In pooled datasets, the IR point estimates for MACE and individual components of CV death, MI, and stroke favored saxagliptin, but the 95% CI included 1. IRR (95% CI) for MACE in the 20-study pool was 0.74 (0.45, 1.25). The Cox proportional hazard ratio (95% CI) was 0.75 (0.46, 1.21), suggesting no increased risk of MACE in the 20-study pool. In the 11-study saxagliptin + metformin pool, the IRR for MACE was 0.93 (0.44, 1.99). In the 20-study pool, the IRR for heart failure was 0.55 (0.27, 1.12).
CONCLUSIONS:
Analysis of pooled data from 20 clinical trials in patients with T2DM suggests that saxagliptin is not associated with an increased CV risk.
AuthorsNayyar Iqbal, Artist Parker, Robert Frederich, Mark Donovan, Boaz Hirshberg
JournalCardiovascular diabetology (Cardiovasc Diabetol) Vol. 13 Pg. 33 ( 2014) ISSN: 1475-2840 [Electronic] England
PMID24490835 (Publication Type: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)
Chemical References
  • Dipeptides
  • Dipeptidyl-Peptidase IV Inhibitors
  • saxagliptin
  • Adamantane
Topics
  • Adamantane (adverse effects, analogs & derivatives, therapeutic use)
  • Cardiovascular Diseases (chemically induced, diagnosis, epidemiology)
  • Clinical Trials as Topic (methods)
  • Diabetes Mellitus, Type 2 (drug therapy, epidemiology)
  • Dipeptides (adverse effects, therapeutic use)
  • Dipeptidyl-Peptidase IV Inhibitors (adverse effects, therapeutic use)
  • Humans
  • Randomized Controlled Trials as Topic (methods)

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