title: Efficacy and safety of empagliflozin in type 2 diabetes mellitus: a meta-analysis of randomized controlled trials.
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  This meta-analysis shows empagliflozin is safe and effective for the treatment of T2DM along with existing diabetes pharmacotherapy.
authors.affiliation: a Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences , Manipal University , Manipal , India.
authors.forename: R
authors.initials: R
authors.lastname: Devi
authors.affiliation: a Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences , Manipal University , Manipal , India.
authors.forename: Ghanshyam
authors.initials: G
authors.lastname: Mali
authors.affiliation: a Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences , Manipal University , Manipal , India.
authors.forename: Indrani
authors.initials: I
authors.lastname: Chakraborty
authors.affiliation: a Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences , Manipal University , Manipal , India.
authors.forename: Mazhuvancherry Kesavan
authors.initials: MK
authors.lastname: Unnikrishnan
authors.affiliation: a Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences , Manipal University , Manipal , India.|b Department of Pharmacy Practice, Unaizah College of Pharmacy , Qassim University , Buraidah , KSA.
authors.forename: Suhaj
authors.initials: S
authors.lastname: Abdulsalim
mesh_terms: D001559:Benzhydryl Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001786:Blood Glucose / Q000187:drug effects; D001794:Blood Pressure / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005960:Glucosides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D060737:Reproductive Tract Infections; D000077203:Sodium-Glucose Transporter 2 Inhibitors
chemical_list: D001559:Benzhydryl Compounds; D001786:Blood Glucose; D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000077203:Sodium-Glucose Transporter 2 Inhibitors; C570240:empagliflozin
keywords: Empagliflozin; SGLT2 inhibitor; Type 2 diabetes mellitus; meta-analysis; oral hypoglycemic agents