Efficacy and safety of empagliflozin in type 2 diabetes mellitus

a meta-analysis of randomized controlled trials

R. Devi, Ghanshyam Mali, Indrani Chakraborty, Mazhuvancherry Kesavan Unnikrishnan, Suhaj Abdulsalim

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)382-392
Number of pages11
JournalPostgraduate Medicine
Volume129
Issue number3
DOIs
Publication statusPublished - 03-04-2017
Externally publishedYes

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Type 2 Diabetes Mellitus
Meta-Analysis
Randomized Controlled Trials
Safety
Placebos
Reproductive Tract Infections
Drug Therapy
Hypoglycemia
Urinary Tract Infections
empagliflozin
Therapeutics
Body Weight
Blood Pressure
Morbidity
Mortality

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Devi, R. ; Mali, Ghanshyam ; Chakraborty, Indrani ; Unnikrishnan, Mazhuvancherry Kesavan ; Abdulsalim, Suhaj. / Efficacy and safety of empagliflozin in type 2 diabetes mellitus : a meta-analysis of randomized controlled trials. In: Postgraduate Medicine. 2017 ; Vol. 129, No. 3. pp. 382-392.
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title = "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.",
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Efficacy and safety of empagliflozin in type 2 diabetes mellitus : a meta-analysis of randomized controlled trials. / Devi, R.; Mali, Ghanshyam; Chakraborty, Indrani; Unnikrishnan, Mazhuvancherry Kesavan; Abdulsalim, Suhaj.

In: Postgraduate Medicine, Vol. 129, No. 3, 03.04.2017, p. 382-392.

Research output: Contribution to journalArticle

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T1 - Efficacy and safety of empagliflozin in type 2 diabetes mellitus

T2 - a meta-analysis of randomized controlled trials

AU - Devi, R.

AU - Mali, Ghanshyam

AU - Chakraborty, Indrani

AU - Unnikrishnan, Mazhuvancherry Kesavan

AU - Abdulsalim, Suhaj

PY - 2017/4/3

Y1 - 2017/4/3

N2 - 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.

AB - 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.

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