Abstract: After the launch of dipeptidyl peptidase-4 (DPP-4), a new oral hypoglycemic drug (OHD), in December 2009, severe hypoglycemia cases were reported in Japan. Although the definite cause was unknown, co-administration with sulfonylureas (SU) was suspected as one of the potential risk factors. The Japan Association for Diabetes Education and Care (JADEC) released a recommendation in April 2010 to lower the dose of three major SUs (glimepiride, glibenclamide, and gliclazide) when adding a DPP-4 inhibitor. To evaluate the effectiveness of this risk minimization action along with labeling changes, dispensing records for 114,263 patients prescribed OHDs between December 2008 and December 2010 were identified in the Nihon-Chouzai pharmacy claims database. The adherence to the recommended dosing of SU co-prescribed with DPP-4 inhibitors increased from 46.3% before to 63.8% after the JADEC recommendation (p < 0.01 by time-series analysis), while no change was found in those for SU monotherapy and SU with other OHD co-prescriptions. The adherence was significantly worse for those receiving a glibenclamide prescription. The JADEC recommendation, along with labeling changes, appeared to have a favorable effect on the risk minimization action in Japan. In these instances, a pharmacy claims database can be a useful tool to evaluate risk minimization actions.
Keywords: Sulfonylurea; DPP-4 inhibitors; hypoglycemia; evaluation of risk minimization action; pharmacy claims; labeling change
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Kimura, T.; Shiosakai, K.; Takeda, Y.; Takahashi, S.; Kobayashi, M.; Sakaguchi, M. Quantitative Evaluation of Compliance with Recommendation for Sulfonylurea Dose Co-Administered with DPP-4 Inhibitors in Japan. Pharmaceutics 2012, 4, 479-493.
Kimura T, Shiosakai K, Takeda Y, Takahashi S, Kobayashi M, Sakaguchi M. Quantitative Evaluation of Compliance with Recommendation for Sulfonylurea Dose Co-Administered with DPP-4 Inhibitors in Japan. Pharmaceutics. 2012; 4(3):479-493.
Kimura, Tomomi; Shiosakai, Kazuhito; Takeda, Yasuaki; Takahashi, Shinji; Kobayashi, Masahiko; Sakaguchi, Motonobu. 2012. "Quantitative Evaluation of Compliance with Recommendation for Sulfonylurea Dose Co-Administered with DPP-4 Inhibitors in Japan." Pharmaceutics 4, no. 3: 479-493.