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DOI: 10.1055/s-0035-1549618
Efficacy and safety of Empagliflozin in younger, overweight/obese patients with Type 2 diabetes with HbA1c ≥8%
Aim: To assess the efficacy and safety of empagliflozin in younger, overweight/obese patients with type 2 diabetes (T2DM) with HbA1c ≥8%.
Methods: Using pooled data from 4 randomized Phase III trials in patients with T2DM, we conducted a post-hoc analysis of patients aged < 65 years with BMI ≥25 to < 35 kg/m2 and HbA1c ≥8% at baseline, who received empagliflozin 10 mg (n = 193), empagliflozin 25 mg (n = 179) or PBO (n = 188) for 24 weeks.
Results: Baseline mean (SD) age was 52.1 (7.9) years, BMI was 29.0 (2.7)kg/m2 and HbA1c was 8.72 (0.64)%. Compared with placebo, empagliflozin 10 mg and 25 mg significantly reduced HbA1c (adjusted mean differences [95% CI] -0.89% [-1.07, -0.70] and -0.99% [-1.17, -0.80], respectively; both p < 0.001), body weight (-1.6 kg [2.1, -1.1] and -2.0 kg [-2.5, -1.5], respectively; both p < 0.001) and systolic blood pressure (-2.6 mmHg [-4.9, -0.4] and -2.5 mmHg [-4.8, -0.3], respectively; both p < 0.05) at week 24. Adverse events (AEs) were reported in 58.7 – 60.1% and 56.4% of patients on empagliflozin and placebo, respectively. Hypoglycaemic AEs (glucose ≤3.9 mmol/l and/or requiring assistance) were reported in 3.9 – 4.7% of patients on empagliflozin and 3.2% on placebo; none needed assistance. AEs consistent with urinary tract infection were reported in 4.5 – 8.3% of patients on empagliflozin and 5.9% on placebo. AEs consistent with genital infection were reported in 3.6 – 4.5% of patients on empagliflozin and 1.1% on placebo.
Conclusions: In younger, overweight/obese patients with HbA1c ≥8%, empagliflozin significantly reduced HbA1c, body weight and blood pressure, and was well tolerated.