Safety and effectiveness of dulaglutide 0.75 mg in Japanese patients with type 2 diabetes in real-world clinical practice: 36 month post-marketing observational study.

AIMS/INTRODUCTION: This study evaluated the safety and effectiveness of dulaglutide in patients with type 2 diabetes in the real-world setting in Japan. MATERIALS AND METHODS: This prospective, observational post-marketing surveillance study was conducted for 36 months (July 2016 to July 2021) in Japan. Investigators reported data via an electronic data capture system. Data were analyzed by overall population and age group (<65, ≥65 to <75, and ≥75 years). RESULTS: The analysis population (N = 3,136) included 1,538 (49.04%), 869 (27.71%), and 729 (23.25%) patients aged <65 years, ≥65 to <75 years, and ≥75 years, respectively. Overall, 231 patients (7.37%) experienced ≥1 adverse drug reactions, with the highest frequency in the ≥75 years group. The most common adverse drug reactions were gastrointestinal disorders (n = 106; 3.38%). Severe hypoglycemia (n = 4; 0.13%), major adverse cardiovascular events (n = 4; 0.13%), and acute pancreatitis (n = 1; 0.03%) were uncommon. The mean glycated hemoglobin and bodyweight were reduced from baseline by -0.76% and -1.6 kg, respectively (last observation carried forward). The rate of dulaglutide continuation at 36 months was 58.03% overall and 59.43%, 63.13%, and 48.88% in the <65, ≥65 to <75, and ≥75 years groups, respectively. A factor analysis showed age ≥65 years was associated with a greater incidence of gastrointestinal adverse drug reactions as well as larger reductions in glycated hemoglobin and bodyweight. CONCLUSIONS: The current real-world data are in accordance with clinical trial findings and further confirm the safety and effectiveness of dulaglutide for elderly patients, whose numbers were limited in the clinical trials.