Full text loading...
薬理と治療
Abstract
Objectives To investigate the safety and efficacy of long-term use of the sodium-glucose cotransporter 2(SGLT2)inhibitor luseogliflozin in clinical practice as a specific surveillance of clinical use. This report presents interim results of the surveillance. Methods In luseogliflozin naive patients with type 2 diabetes mellitus (September 2014- May 2016), a specific surveillance was conducted to assess the practical long︱term use of luseogliflozin. The observation period was determined as 36 months from the start of administration. Results In this surveillance, 12,507 patients were included in the safety analysis set, and 12,433 patients were included in the efficacy analysis set. The mean age of the subjects in the safety analysis set (12,507 patients)was 58.6 years. Patients aged<65 years accounted for 65.0%, and patients aged≥65 years accounted for 35.0%. The mean duration of diabetes mellitus was 7.50 years. The mean baseline hemoglobin A1c(HbA1c)was 8.02%, the mean body mass index(BMI)was 28.35, and the mean estimated glomerular filtration rate(eGFR)was 80.93 mL/min/1.73 m2. The mean daily dose of luseogliflozin during the observation period was 2.79 mg, and the mean duration of administration was 702.6 days. As for the status of concomitant use of other antihyperglycemic agents at the start of luseogliflozin treatment, 57.9% of the patients concomitantly used 2 or less antihyperglycemic agents and 22.7% of the patients used none. Adverse reactions occurred in 1197 of the 12,507 subjects in the safety analysis set, with an incidence rate of 9.57%. According to the results from clinical study prior to the approval of this drug, adverse reactions occurred in 236 of 1262 patients, with an incidence rate of 18.7%. Patients were also stratified by eGFR at the start of the treatment, and changes in eGFR were evaluated over time; no significant worsening of eGFR was observed in any patient group. In the subjects in the efficacy analysis(12,433 patients)set, a significant decrease was observed in HbA1c, fasting blood glucose, and body weight. Conclusion The clinical use of SGLT2 inhibitor luseogliflozin was carefully observed over the two-year period, during which no additional safety or efficacy problems were claimed. The interim results of this specific surveillance did not provide additional safety information requiring precaution. In terms of efficacy, the results were similar to the clinical study data obtained prior to the approval of this drug. This surveillance is ongoing, and the results of the final data aggregation and analysis on the long-term use over the three-year period are awaited.
Data & Media loading...