Pharmaceutics 2012, 4(3), 479-493; doi:10.3390/pharmaceutics4030479
Quantitative Evaluation of Compliance with Recommendation for Sulfonylurea Dose Co-Administered with DPP-4 Inhibitors in Japan
1
Epidemiology, Janssen Pharmaceutical K.K., 2-5-3, Nishi-Kanda, Chiyoda-ku, Tokyo 101-0065, Japan
2
Pro-Bono Pharmacoepidemiologists Committee in Japan, Japan
3
Clinical Data and Biostatistics, Daiichi Sankyo Co. Ltd., 1-2-58, Hiromachi, Shinagawa-ku, Tokyo 140-8710, Japan
4
Sales planning group, Japan Medical Research Institute Co. Ltd. 9-1 Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-6739, Japan
5
Nihon Chouzai Co. Ltd. 9-1 Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-6737, Japan
*
Author to whom correspondence should be addressed.
Received: 11 June 2012 / Revised: 8 August 2012 / Accepted: 30 August 2012 / Published: 19 September 2012
(This article belongs to the Special Issue Drug Safety and Pharmacovigilance)
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. View Full-TextKeywords:
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 (CC BY 3.0).
Scifeed alert for new publications
Never miss any articles matching your research from any publisher- Get alerts for new papers matching your research
- Find out the new papers from selected authors
- Updated daily for 49'000+ journals and 6000+ publishers
- Define your Scifeed now
Share & Cite This Article
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.
Related Articles
Article Metrics
Comments
[Return to top]
Pharmaceutics
EISSN 1999-4923
Published by MDPI AG, Basel, Switzerland
RSS
E-Mail Table of Contents Alert