Next Article in Journal
Next Article in Special Issue
Previous Article in Journal
Pharmaceutics 2012, 4(3), 479-493; doi:10.3390/pharmaceutics4030479
Article

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

1,2,* , 2,3, 4, 5, 4 and 2
Received: 11 June 2012; in revised form: 8 August 2012 / Accepted: 30 August 2012 / Published: 19 September 2012
(This article belongs to the Special Issue Drug Safety and Pharmacovigilance)
View Full-Text   |   Download PDF [240 KB, uploaded 19 September 2012]
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 Sulfonylurea; DPP-4 inhibitors; hypoglycemia; evaluation of risk minimization action; pharmacy claims; labeling change
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Export to BibTeX |
EndNote


MDPI and ACS Style

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.

AMA Style

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.

Chicago/Turabian Style

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.



Pharmaceutics EISSN 1999-4923 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert