Abstract
Objective: To evaluate the safety of dapagliflozin for Type 2 Diabetes Mellitus (T2DM). Methods: A systematic search of Pubmed, Embase, Cochrance Library, Web of Science, CNKI, Wanfang Data and VIP database for randomized controlled trials (RCTs) comparing dapagliflozin with placebo was performed up to February 2018. The index words included dapagliflozin, type 2 diabetes mellitus and randomized controlled trial. Results: A total of 19 RCTs involving 7704 participants were incorporated into the study. Compared with placebo, dapagliflozin did not increase the risk of hypoglycemia [OR = 1.14, 95%CI (0.95, 1.36), P = 0.17] and hypotension [OR = 1.43, 95%CI (0.94, 2.17), P = 0.10], but significantly increased the incidences of renal adverse events [OR = 1.57, 95%CI (1.17, 2.09), P = 0.002], genital tract infection [OR = 3.65, 95%CI (2.93, 4.56), P < 0.00001] and urinary tract infection [OR = 1.36, 95%CI (1.15, 1.61), P = 0.0004] and related doses. Conclusions: Generally, dapagliflozin had no risk of hypoglycemia and hypotension in patients with T2DM, but there were risks of renal adverse events and urogenital tract infection. Due to the limitations of this study, larger samples and RCTs with long-term follow-up are needed for further verification.
Highlights
As a common disease in China, the incidence of Type 2 Diabetes Mellitus (T2DM) has been increasing year by year, and drug therapy is the main method of treatment
Dapagliflozin did not increase the risk of hypoglycemia [odds ratio (OR) = 1.14, 95%confidence intervals (CIs) (0.95, 1.36), P = 0.17] and hypotension [OR = 1.43, 95%CI (0.94, 2.17), P = 0.10], but significantly increased the incidences of renal adverse events [OR = 1.57, 95%CI (1.17, 2.09), P = 0.002], genital tract infection [OR = 3.65, 95%CI (2.93, 4.56), P < 0.00001] and urinary tract infection [OR = 1.36, 95%CI (1.15, 1.61), P = 0.0004] and related doses
A total of 19 randomized controlled trials (RCTs) involving 7704 participants was incorporated into the study, including 5304 cases of dapagliflozin group and 2400 cases of the placebo group
Summary
As a common disease in China, the incidence of T2DM has been increasing year by year, and drug therapy is the main method of treatment. The. SGLT-2 inhibitor, dapagliflozin is a novel oral hypoglycemic drug for the treatment of T2DM, which is independent from islet β-cell function and insulin sensitivity. SGLT-2 inhibitor, dapagliflozin is a novel oral hypoglycemic drug for the treatment of T2DM, which is independent from islet β-cell function and insulin sensitivity It functions by increasing renal clearance of glucose, attenuating renal reabsorption of glucose and excreting excess glucose from the urine, thereby reducing blood glucose [2]. Studies have shown that dapagliflozin has multiple benefits such as reduction in blood glucose, weight and blood pressure. The safety is further analyzed by retrieving RCTs of dapagliflozin versus placebo through meta-analysis
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