Takashi Kadowaki1, Masakazu Haneda2,3, Hiroshi Ito4, Makoto Ueno5, Miyuki Matsukawa5, Tomoko Yamakura5, Kazuyo Sasaki5, Mayumi Kimura5, Hiroaki Iijima6. 1. a Department of Diabetes and Metabolic Diseases, Graduate School of Medicine , The University of Tokyo , Tokyo , Japan. 2. b Department of Medicine , Asahikawa Medical University , Hokkaido , Japan. 3. c Medical Corporation Kyousoukai , Osaka , Japan. 4. d Department of Cardiovascular Medicine , Okayama University , Okayama , Japan. 5. e Ikuyaku. Integrated Value Development Division , Mitsubishi Tanabe Pharma Corporation , Osaka , Japan. 6. f Ikuyaku. Integrated Value Development Division , Mitsubishi Tanabe Pharma Corporation , Tokyo , Japan.
Abstract
BACKGROUND: This post-marketing surveillance examined the safety and efficacy of long-term teneligliptin therapy in Japanese patients. RESEARCH DESIGN AND METHODS: We report interim results (cut-off date: 28 June 2017) of a 3-year PMS undertaken in subjects with type 2 diabetes mellitus (T2DM). Survey items included demographics, treatments, adverse drug reactions (ADRs), and laboratory variables. A subgroup analysis was also performed across three age groups (<65 years; 65 to <75 years; ≥75 years). Main outcome measures were incidence of ADRs, laboratory variables, and change in glycated hemoglobin (HbA1c) from baseline over time. RESULTS: Of 11,677 patients registered, data from 10,532 patients (6,338 males/4,194 females) were analyzed for the safety analysis set; the median administration period was 731 days. Overall, ADRs and serious ADRs were reported in 364 (3.46%) and 91 patients (0.86%), respectively. The most common ADRs were all hypoglycemia (0.32%), constipation (0.27%), and hepatic function abnormal (0.24%). No change in mean body weight occurred, and a reduction in mean HbA1c was observed until 2 years. The safety and efficacy profiles did not differ markedly among the three age groups. CONCLUSIONS: These interim results show that teneligliptin was well tolerated and improved hyperglycemia in Japanese patients with T2DM in clinical practice.
BACKGROUND: This post-marketing surveillance examined the safety and efficacy of long-term teneligliptin therapy in Japanese patients. RESEARCH DESIGN AND METHODS: We report interim results (cut-off date: 28 June 2017) of a 3-year PMS undertaken in subjects with type 2 diabetes mellitus (T2DM). Survey items included demographics, treatments, adverse drug reactions (ADRs), and laboratory variables. A subgroup analysis was also performed across three age groups (<65 years; 65 to <75 years; ≥75 years). Main outcome measures were incidence of ADRs, laboratory variables, and change in glycated hemoglobin (HbA1c) from baseline over time. RESULTS: Of 11,677 patients registered, data from 10,532 patients (6,338 males/4,194 females) were analyzed for the safety analysis set; the median administration period was 731 days. Overall, ADRs and serious ADRs were reported in 364 (3.46%) and 91 patients (0.86%), respectively. The most common ADRs were all hypoglycemia (0.32%), constipation (0.27%), and hepatic function abnormal (0.24%). No change in mean body weight occurred, and a reduction in mean HbA1c was observed until 2 years. The safety and efficacy profiles did not differ markedly among the three age groups. CONCLUSIONS: These interim results show that teneligliptin was well tolerated and improved hyperglycemia in Japanese patients with T2DM in clinical practice.