Efficacy and safety of empagliflozin in type 2 diabetes mellitus: a meta-analysis of randomized controlled trials
Abstract
OBJECTIVES: The prevalence of diabetes has increased in the recent decades and optimum glycemic control is required to reduce morbidity and mortality. We meta-analyzed randomized controlled trials in order to assess the efficacy and safety of empagliflozin compared to placebo in type 2 diabetes mellitus patients.
METHODS: We included double-blind, placebo controlled trials of empagliflozin that evaluated glycemic efficacy and safety (10 mg or 25 mg) either as monotherapy or as add-on to existing diabetes pharmacotherapy.
RESULTS: The results demonstrated significant improvements in HbA1c (SMD -0.929%, 95 % CI -1.064 to -0.793, for 10 mg and -1.064%, 95 % CI -1.184 to -0.944, for 25 mg) and FPG (SMD -0.929%, 95 % CI -1.064 to -0.793, for 10 mg and -1.064%, 95 % CI -1.184 to -0.944, for 25 mg) with empagliflozin monotherapy (n = 609) compared to placebo. Significant improvements in HbA1c [SMD -1.582%, 95% CI -2.164 to -1.000, for 10 mg (n = 1079) and -1.668%, 95% CI -2.260 to -1.077, for 25 mg (n = 1070)] and FPG [SMD -0.865 mmol/L, 95 % CI -1.309 to -0.420, for 10 mg (n = 854) and -0.996 mmol/L, 95% CI -1.456 to -0.536, for 25 mg (n = 854)] were also observed in empagliflozin add-on therapy trials. Reductions in blood pressure and body weight were also seen in both monotherapy and add-on therapy. Empagliflozin was associated with increased risk of hypoglycemia, genital and urinary tract infections (OR 1.043, 2.814, 1.119 respectively).
CONCLUSION: This meta-analysis shows…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 1,079 participants or records.
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