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DOI: 10.1055/s-0034-1374999
Empagliflozin improves glycemic parameters and cardiovascular risk factors in patients with Type 2 Diabetes (T2DM): Pooled data from four pivotal phase III trials
Background, methods: We analyzed pooled data from 2477 patients with T2DM (mean [SD] age 55.6 [10.2] years, HbA1c 7.99 [0.85]%, BMI 28.7 [5.5] kg/m2) from four randomized, placebo-controlled Phase III trials that investigated empagliflozin (EMPA) 10 mg or 25 mg given for 24 weeks as monotherapy, add-on to metformin (MET), add-on to MET + SU, or add-on to pioglitazone ± MET.
Results: EMPA significantly reduced HbA1c (in %; EMPA 10 mg: -0.70, EMPA 25 mg: -0.76, placebo [PBO]: -0.08), fasting plasma glucose (in mg/dL; EMPA 10 mg: -20.5, EMPA 25 mg: -23.2, PBO: +7.4), weight (in kg; EMPA 10 mg: -2.05, EMPA 25 mg: -2.25, PBO: -0.24), systolic blood pressure (BP) (in mmHg; EMPA 10 mg: -3.9, EMPA 25 mg: -4.3, PBO: -0.5) and diastolic BP (in mmHg; EMPA 10 mg: -1.8, EMPA 25 mg: -2.0, PBO: -0.6) at week 24 vs. PBO. BP reductions were more pronounced in patients with uncontrolled BP at baseline. Small increases in HDL-cholesterol (in mmol/L; EMPA 10 mg: 0.07, EMPA 25 mg: 0.07, PBO: 0.00) and LDL-cholesterol (in mmol/L; EMPA 10 mg: 0.08, EMPA 25 mg: 0.10, PBO: 0.02) and small decreases in triglycerides were observed with EMPA vs. PBO. EMPA significantly reduced uric acid vs. PBO (in µmol/L; EMPA 10 mg: -28.95, EMPA 25 mg: -29.55, PBO: +1.03).
Conclusion: In pooled data from four Phase III trials, 24 weeks' treatment with EMPA provided clinically meaningful improvements in glycemic parameters, weight, and BP, with small effects on lipids and positive effects on uric acid.