Abstract
In April 2010, the "Committee on proper usage of incretin and sulfonylurea drugs" advocated the recommended dosage of SUs, and the attached document on sitagliptin was also revised. We studied cases of severe hypoglycemia associated with the combined use of sitagliptin plus a SU drug, and examined the changes in the daily dosage of SUs after implementation of the new safety measures using case reports of side effects and receipt data reported to the Pharmaceuticals and Medical Devices Agency. The number of hypoglycemia cases decreased from 70 before the implementation (for five months) to 47 cases after implementation of the measures (for 20 months). Among the cases of hypoglycemia, the percentage of cases receiving the recommended daily dose (2 mg/day or less) of glimepiride had increased after implementation of the measures. An analysis of the receipt data revealed that the percentage of cases receiving the recommended daily dose of glimepiride for combined use increased to 68.2 % (p=0.0015) and 81.1 % (p<0.0001) with time after the measures were implemented (compared to 52.2 % before the measures were implemented). Consequently, severe hypoglycemia developing in association with combined sitagliptin plus glimepiride use is expected to decrease in incidence with the reduction of the glimepiride dose.
