@article{oai:dmu.repo.nii.ac.jp:00001270, author = {Takebayashi, Kohzo and Terasawa, Tomoko and Naruse, Rika and Hara, Kenji and Suetsugu, Mariko and Tsuchiya, Takafumi and Inukai, Toshihiko}, issue = {3}, journal = {Dokkyo journal of medical sciences}, month = {Oct}, note = {Aims:This study was the retrospective analysis of the previous study named as APPLE study( study of combination effect of AlogliPtin and lansoPrazoLE on glycemic control in patients with type 2 diabetes), in which the effect of the combination therapy of alogliptin (a dipeptidyl peptidase-4 inhibitor, DPP4-I) and lansoprazole (a proton pump inhibitor, PPI) was compared with alogliptin mono-therapy without PPI on glycemic control in a randomized open-label study design. The aim of this study was to investigate whether so called legacy effect of proton pump inhibitor on glycemic control is observed. Patients and Methods:In the patients that participated in the APPLE study( 3 months observation;total: 100 patients), the patients who continued the intake of alogliptin at least more than 1 year after the registration(enrollment)in APPLE study was evaluated on glycemic control retrospectively. As a rule, the administration of lansoprazole in combination group was discontinued after the finish of 3 months- of the APPLE study. Twenty-six patients in the alogliptin mono-therapy group and 26 patients in combination group met the requirement in this analysis. Mean observation periods were respectively 16 months. In these patients, the number of patients in whom all diabetic drugs were not changed in observation-period was respectively 18 in alogliptin mono-therapy group and 17 in combination group.Results:The decrease of HbA1c was maintained also after long term observation (16 months) in both alogliptin mono-therapy and combination groups (the decrease was respectively -1.054±0.548 and - 1.123±0.723%), which was similar compared with that observed in 3 months-APPLE study. There were no significant differences in change of HbA1c and fasting plasma glucose (FPG) at the time in enrollment of APPLE study and at final visit( approximately 16 weeks) between these groups. The significant difference in change of HbA1c and FPG was not found also between alogliptin mono-therapy and combination group in the subgroup of patients where all diabetic drugs were unchanged during observation period.Conclusion:This study found that the legacy effect of PPI on glycemic control was not apparent more than 9 months after the APPLE study. Based on the results in the previous APPLE study and in this current retrospective study, we concluded that the add-on effect of PPI for DPP4-I on glycemic control in patients with type 2 diabetes is not clinically apparent., Original}, pages = {117--125}, title = {Long Term Evaluation of Glycemic Control in Patients with Type 2 Diabetes Receiving Either Alogliptin and Lansoprazole or Alogliptin Mono-therapy for 3 Months Followed by Alogliptin Mono-therapy:A Retrospective Analysis}, volume = {42}, year = {2015} }