Efficacy and safety of empagliflozin in patients with type 2 diabetes from Asian countries: pooled data from four phase III trials. Issue 10 (13th July 2016)

• Record Type: Journal Article
• Authors: Yoon, Kun‐Ho; Nishimura, Rimei; Lee, Jisoo; Crowe, Susanne; Salsali, Afshin; Hach, Thomas; Woerle, Hans J.
• Is Part Of: Diabetes, obesity & metabolism. Volume 18:Issue 10(2016)
• Page Start: 1045
• Page End: 1049
• Publication Date: 2016-07-13
• Subjects: Asia -- blood glucose -- blood pressure -- weight -- clinical trial -- SGLT2 inhibitor; Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.12699
• Languages: English
• ISSNs: 1462-8902

Abstract

Abstract : We investigated the efficacy and safety of empagliflozin over 24 weeks in Asian patients with type 2 diabetes (T2DM) using pooled data from four phase III trials. In these trials, patients were randomized to receive empagliflozin 10 mg, empagliflozin 25 mg or placebo as monotherapy or add‐on to metformin, metformin plus sulphonylurea or pioglitazone ± metformin. In total, 1326 patients from Asia received ≥1 dose of study drug. At week 24, adjusted mean differences versus placebo in change from baseline in glycated haemoglobin (HbA1c) were −0.66% [95% confidence interval (CI) −0.76, −0.56] and −0.73% (95% CI −0.83, −0.64) and in weight were −1.6 kg (95% CI −1.9, −1.3) and −1.8 kg (95% CI −2.1, −1.5) with empagliflozin 10 and 25 mg, respectively (all p < 0.001). Empagliflozin significantly reduced systolic and diastolic blood pressure. The proportion of patients reporting ≥1 adverse event was similar across treatment groups, but events consistent with genital infection were more common in patients treated with empagliflozin 10 mg (3.4%) or 25 mg (2.3%) than placebo (0.9%). Thus in Asian patients with T2DM, empagliflozin reduced HbA1c, weight and blood pressure, and was well tolerated.