Abstract

To evaluate the benefits and harms of sitagliptin in people with type 2 diabetes mellitus. Randomized controlled trials (RCTs) were retrieved from PubMed, Embase, and the Cochrane central register of controlled trials (Cochrane Library). We used the method recommend by the Cochrane Collaboration to perform a meta-analysis of RCTs of sitagliptin therapy for type 2 diabetes. Of 817 studies retrieved in the literature search, 18 were eligible for inclusion. When sitagliptin was compared with placebo there was a statistically significant reduction in haemoglobin A1C (HbA1c) (MD = 0.74, 95% CI 0.63 to 0.85) and fasting plasma glucose (FPG) (MD = 1.20, 95% CI 1.03 to 1.38). Sitagliptin significantly improved the homeostasis model assessment of β-cell (HOMA-β index) (MD =-10.84, 95% CI -14.07 to -7.80) versus placebo. In participants treated with placebo, hypoglycemia adverse experiences (RR = 2.11, 95% CI 1.50 to 2.36) and serious adverse experiences (RR = 1.20, 95% CI 0.89 to 1.63) were less common. Meta-analysis did not show a significant difference in change in FPG (MD =-0.32, 95% CI -0.76 to 0.13) or HOMA-β index (MD = 4.42, 95% CI -1.22 to 10.07) between the sitagliptin and active control groups, but active treatments provided modestly greater reduction in HbA1c (MD =-0.20, 95% CI -0.37 to -0.03) compared with sitagliptin. No significant difference was observed between the sitagliptin and active treatments in incidence of hypoglycemia adverse experiences (RR = 0.38, 95% CI 0.14 to 1.08) or serious adverse experiences (RR = 1.15, 95% CI 0.83 to 1.65). Sitagliptin treatment for type 2 diabetes was effective and well tolerated. Sitagliptin offers a novel therapeutic approach for the treatment of type 2 diabetes. Continued assessment in longer term studies is required to determine the role of sitagliptin in type 2 diabetes.

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