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.
Highlights
Dipeptidyl peptidase-4 (DPP-4) inhibitors are the most recently approved class of agent for Type 2 diabetes therapy [1]
Since the launch of the first DPP-4 inhibitor, severe hypoglycemia has been reported in Japan, including 32 cases of serious hypoglycemia in patients receiving sitagliptin reported within six months after the approval [18], the majority of which
We looked at SU combination therapies with other oral hypoglycemic drug (OHD) than DPP-4 inhibitors to evaluate the effectiveness of the Japan Association for Diabetes Education and Care (JADEC) recommendations and labeling changes with regard to the specific impact on the SU + DPP-4 inhibitor co-prescriptions
Summary
Dipeptidyl peptidase-4 (DPP-4) inhibitors are the most recently approved class of agent for Type 2 diabetes therapy [1] Their efficacy and safety, both in monotherapy and combination therapies with other antidiabetics, have been reviewed in many clinical trials [2,3]. In Japan, four DPP-4 inhibitors were available as of December 2011: sitagliptin, vildagliptin, alogliptin, and linagliptin (since December 2009, April 2010, June 2010, and September 2011, respectively) as of March 2012 They can be used as monotherapy or in combination with sulfonylureas (SU), biguanides, alpha-glucosidase inhibitors, or glitazones. A 12-week clinical trial of combination therapy with sitagliptin and glimepride showed a tendency to increase the frequency of hypoglycemia (5.6% (4/71) in the sitagliptin group and 0% (0/67) in the placebo group), compared to that in monotherapy or combination therapy with other oral hypoglycemic drugs (OHDs) (0%–3.0%) [12]. The definite cause was unknown, the Japan Association for Diabetes
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