Quantitative Evaluation of Compliance with Recommendation for Sulfonylurea Dose Co-Administered with DPP-4 Inhibitors in Japan

Pharmaceutics

Tomomi Kimura²  Kazuhito Shiosakai¹  Yasuaki Takeda³  Shinji Takahashi⁴  Masahiko Kobayashi³ 

[1] Pro-Bono Pharmacoepidemiologists Committee in Japan, Japan;Epidemiology, Janssen Pharmaceutical K.K., 2-5-3, Nishi-Kanda, Chiyoda-ku, Tokyo 101-0065, Japan;Sales planning group, Japan Medical Research Institute Co. Ltd. 9-1 Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-6739, Japan;Nihon Chouzai Co. Ltd. 9-1 Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-6737, Japan

关键词: Sulfonylurea;    DPP-4 inhibitors;    hypoglycemia;    evaluation of risk minimization action;    pharmacy claims;    labeling change;   

DOI  :  10.3390/pharmaceutics4030479

来源: mdpi

【 摘 要 】

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.

【 授权许可】

CC BY   
© 2012 by the authors; licensee MDPI, Basel, Switzerland.