Efficacy and safety of empagliflozin for type 2 diabetes: a systematic review and meta-analysis.
OBJECTIVE
To assess the efficacy and safety of the novel sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin compared with placebo or other antidiabetic agents in patients with type 2 diabetes.


METHODS
We conducted a systematic review and meta-analysis of randomized controlled trials. We searched Medline, Embase and the Cochrane Library through December 2013 and grey literature. Two reviewers working independently extracted relevant data and carried out risk-of-bias assessments. We synthesized results using random-effects models and computed weighted mean differences (WMDs) and odds ratios (ORs).


RESULTS
We included 10 studies with 6203 participants. Compared with placebo, mean changes in haemoglobin A1c were -0.62% [95% confidence interval (CI) -0.68 to -0.57%] for empagliflozin 10 mg and -0.66% (-0.76 to -0.57%) for empagliflozin 25 mg. Empagliflozin 25 mg daily had glycaemic efficacy similar to metformin or sitagliptin (WMD -0.11%; 95% CI -0.25 to 0.03%), without increasing risk for hypoglycaemia. It was also associated with body weight loss (WMD -1.84; 95% CI -2.30 to -1.38 kg vs. placebo) and had a favourable effect on blood pressure. Incidence of hypoglycaemia with empagliflozin was similar to placebo (OR 1.10; 95% CI 0.87 to 1.39); nevertheless we noted an increased risk for genital tract infections (OR 3.31; 95% CI 1.55 to 7.09). Findings were similar for the 10-mg dosing regimen.


CONCLUSIONS
Empagliflozin effectively lowers blood glucose and provides additional clinical benefits including body weight and blood pressure reduction. Ongoing trials will elucidate the long-term safety and effect of empagliflozin on cardiovascular outcomes.
Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University Thessaloniki, Thessaloniki, Greece.
A
A
Liakos
T
T
Karagiannis
E
E
Athanasiadou
M
M
Sarigianni
M
M
Mainou
K
K
Papatheodorou
E
E
Bekiari
A
A
Tsapas
D001559:Benzhydryl Compounds / 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 / Q000097:blood / Q000188:drug therapy*; D005960:Glucosides / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000187:drug effects*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D016017:Odds Ratio; D016032:Randomized Controlled Trials as Topic; D051297:Sodium-Glucose Transporter 2; D000077203:Sodium-Glucose Transporter 2 Inhibitors; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects
D001559:Benzhydryl Compounds; D001786:Blood Glucose; D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D051297:Sodium-Glucose Transporter 2; D000077203:Sodium-Glucose Transporter 2 Inhibitors; C089180:SLC5A2 protein, human; C517652:hemoglobin A1c protein, human; C570240:empagliflozin
empagliflozin; meta-analysis; sodium-glucose cotransporter 2 (SGLT2); systematic review; type 2 diabetes