Teruo Shiba1, So Ishii2, Tomoo Okamura3, Rika Mitsuyoshi4, Egon Pfarr5, Kazuki Koiwai6. 1. Division of Diabetes and Metabolism, Toho University Ohashi Medical Center, 2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan. Electronic address: teruo.shiba@med.toho-u.ac.jp. 2. Eli Lilly Japan K.K., 4-15-1, Akasaka, Minato-ku, Tokyo 107-0052, Japan. Electronic address: ishii_so@lilly.com. 3. Nippon Boehringer Ingelheim Co., Ltd., 2-1-1 Osaki, Shinagawa-ku, Tokyo 141-6017, Japan. Electronic address: tomoo.okamura@boehringer-ingelheim.com. 4. Nippon Boehringer Ingelheim Co., Ltd., 2-1-1 Osaki, Shinagawa-ku, Tokyo 141-6017, Japan. Electronic address: rika.mitsuyoshi@boehringer-ingelheim.com. 5. Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany. Electronic address: egon.pfarr@boehringer-ingelheim.com. 6. Nippon Boehringer Ingelheim Co., Ltd., 2-1-1 Osaki, Shinagawa-ku, Tokyo 141-6017, Japan. Electronic address: kazuki.koiwai@boehringer-ingelheim.com.
Abstract
AIMS: To investigate the efficacy and safety of empagliflozin in subgroups based on body mass index (BMI) and age, using a pooled data set from Japanese patients with type 2 diabetes mellitus (T2DM). METHODS: Pooled data from 1403 patients treated with empagliflozin at 10mg/day or 25mg/day in three clinical studies (≥52week treatment) were stratified by baseline BMI (<22, 22 to <25 and ≥25kg/m2) and baseline age (<50, 50 to <65 and ≥65years). RESULTS: Empagliflozin at 10mg/day and 25mg/day reduced mean glycated hemoglobin (HbA1c) (-0.77 to -0.87% and -0.76 to -0.97%, respectively), mean fasting plasma glucose (FPG) (-20.79 to -27.06mg/dL and -26.08 to -29.60mg/dL) and mean body weight (-3.4 to -4.7% and -3.7 to -4.7%) in all subgroups of baseline BMI and age, regardless of age and degree of obesity. Adverse events were observed in approximately 70-80% patients in BMI and age subgroups of both empagliflozin groups. No hypoglycemia requiring assistance was observed. Neither UTI nor genital infection rates differed markedly among the BMI and age subgroups. Volume depletion was increased in patients ≥65years of age as compared to younger patients. CONCLUSIONS: Empagliflozin was well tolerated and improved HbA1c, FPG and body weight in all BMI and age subgroups of Japanese patients with T2DM, regardless of age and degree of obesity. Empagliflozin is considered to be effective and well tolerated for treating a wide range of Japanese patients with T2DM. TRIAL REGISTRATION: Study 1 (NCT01193218), Study 2 (NCT01289990) and Study 3 (NCT01368081).
AIMS: To investigate the efficacy and safety of empagliflozin in subgroups based on body mass index (BMI) and age, using a pooled data set from Japanese patients with type 2 diabetes mellitus (T2DM). METHODS: Pooled data from 1403 patients treated with empagliflozin at 10mg/day or 25mg/day in three clinical studies (≥52week treatment) were stratified by baseline BMI (<22, 22 to <25 and ≥25kg/m2) and baseline age (<50, 50 to <65 and ≥65years). RESULTS:Empagliflozin at 10mg/day and 25mg/day reduced mean glycated hemoglobin (HbA1c) (-0.77 to -0.87% and -0.76 to -0.97%, respectively), mean fasting plasma glucose (FPG) (-20.79 to -27.06mg/dL and -26.08 to -29.60mg/dL) and mean body weight (-3.4 to -4.7% and -3.7 to -4.7%) in all subgroups of baseline BMI and age, regardless of age and degree of obesity. Adverse events were observed in approximately 70-80% patients in BMI and age subgroups of both empagliflozin groups. No hypoglycemia requiring assistance was observed. Neither UTI nor genital infection rates differed markedly among the BMI and age subgroups. Volume depletion was increased in patients ≥65years of age as compared to younger patients. CONCLUSIONS:Empagliflozin was well tolerated and improved HbA1c, FPG and body weight in all BMI and age subgroups of Japanese patients with T2DM, regardless of age and degree of obesity. Empagliflozin is considered to be effective and well tolerated for treating a wide range of Japanese patients with T2DM. TRIAL REGISTRATION: Study 1 (NCT01193218), Study 2 (NCT01289990) and Study 3 (NCT01368081).