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 empagliflozin is safe and effective for the treatment of T2DM along with existing diabetes pharmacotherapy.

KEYWORDS:

• Type 2 diabetes mellitus
• SGLT2 inhibitor
• Empagliflozin
• oral hypoglycemic agents
• meta-analysis

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This paper was not funded