title: Quantitative Evaluation of Compliance with Recommendation for Sulfonylurea Dose Co-Administered with DPP-4 Inhibitors in Japan.
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.
authors.affiliation: Epidemiology, Janssen Pharmaceutical K.K., 2-5-3, Nishi-Kanda, Chiyoda-ku, Tokyo 101-0065, Japan. tkimura1@its.jnj.com.
authors.forename: Tomomi
authors.initials: T
authors.lastname: Kimura
authors.forename: Kazuhito
authors.initials: K
authors.lastname: Shiosakai
authors.forename: Yasuaki
authors.initials: Y
authors.lastname: Takeda
authors.forename: Shinji
authors.initials: S
authors.lastname: Takahashi
authors.forename: Masahiko
authors.initials: M
authors.lastname: Kobayashi
authors.forename: Motonobu
authors.initials: M
authors.lastname: Sakaguchi