Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease History or Cardiovascular Risk Factors:

Results of a Pooled Analysis of Phase 3 Clinical Trials

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William Cook, PhD; Brian Bryzinski, MD; Jill Slater, PharmD; Robert Frederich, MD; Elsie Allen, MD

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Postgraduate Medicine:

Volume 125 No. 3

Category:

Clinical Focus

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DOI: 10.3810/pgm.2013.05.2657
Abstract: Objective: This post hoc analysis sought to assess the efficacy, safety, and tolerability of saxagliptin in patients with type 2 diabetes mellitus and cardiovascular (CV) risk factors or disease (CVD). Methods: Data from 5 randomized controlled trials were pooled to compare saxagliptin 5 mg with placebo: 2 studies of saxagliptin as monotherapy in drug-naïve patients and 1 each of saxagliptin as add-on therapy to metformin, glyburide, or a thiazolidinedione. Analysis was performed according to the following baseline/trial entry criteria: 1) history/no history of CVD; 2) ≥ 2 versus 0 to 1 CV risk factors; 3) statin use versus no statin use; and 4) hypertension versus no hypertension. Change from baseline glycated hemoglobin (HbA1c), fasting plasma glucose, and postprandial glucose levels; and the proportion of patients achieving an HbA1c level < 7% were analyzed (week 24). Safety was assessed by adverse events, hypoglycemia, and body weight. Results: In total, 882 patients received saxagliptin 5 mg and 799 received placebo. Differences in adjusted mean change from baseline HbA1c (95% CI) were greater with saxagliptin compared with placebo in patients with a history of CVD (–0.64% [−0.90 to −0.38]) and no history of CVD (−0.68% [−0.78 to −0.58]); with ≥ 2 CV risk factors (−0.73% [−0.85 to −0.60]) and 0 to 1 CV risk factor (−0.62% [−0.75 to −0.48]); with statin use (−0.70% [−0.89 to −0.52]) and no statin use (−0.66% [−0.77 to −0.56]); and with hypertension (−0.69% [−0.82 to −0.57]) and no hypertension (−0.66% [−0.80 to −0.52]). Saxagliptin was well tolerated, with similar adverse event rates and types compared with placebo. There was a < 1% rate of confirmed hypoglycemia in all groups except in patients with CV history who received placebo (2.1%). Conclusion: Saxagliptin improved glycemic measures, resulted in low rates of confirmed hypoglycemia, and was well tolerated in patients with or without CVD and CV risk factors.

Keywords: cardiovascular disease; dipeptidyl peptidase-4 inhibitor; incretin; saxagliptin; type 2 diabetes mellitus