Quantitative Evaluation of Compliance with Recommendation for Sulfonylurea Dose Co-Administered with DPP-4 Inhibitors in Japan
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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.
Shirabe S, Yamazaki K, Oishi M, Arai K, Yagi N, Sato M J Diabetes Investig. 2022; 14(1):75-80.
PMID: 36268571 PMC: 9807151. DOI: 10.1111/jdi.13922.
Minamoto-Higashioka M, Kawamura R, Umakoshi H, Yokomoto-Umakoshi M, Utsunomiya D, Osawa H Intern Med. 2019; 58(8):1067-1072.
PMID: 30626812 PMC: 6522416. DOI: 10.2169/internalmedicine.1360-18.
Smith M, Russell A, Bahri P, Mol P, Frise S, Freeman E Drug Saf. 2017; 41(4):389-401.
PMID: 29218682 PMC: 5878197. DOI: 10.1007/s40264-017-0619-x.
Goedecke T, Morales D, Pacurariu A, Kurz X Br J Clin Pharmacol. 2017; 84(3):419-433.
PMID: 29105853 PMC: 5809349. DOI: 10.1111/bcp.13469.
Kim Y, Yoo W, Hong E, Ku E, Park K, Lim S Diabetes Metab J. 2015; 39(6):489-97.
PMID: 26616595 PMC: 4696985. DOI: 10.4093/dmj.2015.39.6.489.