Dipeptidyl peptidase-4 inhibitors as preferable oral hypoglycemic agents in terms of treatment satisfaction: Results from a multicenter, 12-week, open label, randomized controlled study in Japan (PREFERENCE 4 study)

Abstract

Aims/introduction: To compare the treatment satisfaction of four classes of oral hypoglycemic agents (OHAs): dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase inhibitors (αGI), biguanides (BG) and sulfonylureas (SU), which are common initial treatments for type 2 diabetes mellitus patients in Japan, and to identify the best oral hypoglycemic agent in terms of treatment satisfaction.

Materials and methods: In this 12-week, randomized, controlled, open-label study, Japanese outpatients with type 2 diabetes mellitus who were naïve to pharmacological treatment were randomly assigned a DPP-4 inhibitor, a BG., an αGI or a SU. The primary end-point was the Oral Hypoglycemic Agent Questionnaire (OHA-Q) total and subscale scores (treatment convenience, somatic symptoms and satisfaction) at week 4. Adherence, glycated hemoglobin (HbA1c) level and safety were also evaluated.

Results: The DPP-4 inhibitor group scored highest in the OHA-Q total and all subscale scores at week 4. The total score was significantly higher in the DPP-4 inhibitor group than in the BG or αGI groups (P = 0.0084 and 0.0147, respectively). The mean total score at week 12 was also highest in the DPP-4 inhibitor group, with a significant difference compared with the αGI group (P = 0.0293). The mean HbA1c decreased from baseline to week 12 in all groups. The DPP-4 inhibitor group had the highest adherence at weeks 4 and 12. A total of 11 patients reported adverse events, including one hypoglycemic event in the SU group.

Conclusions: The DPP-4 inhibitor was the most preferable option in terms of treatment satisfaction.

Keywords: Oral hypoglycemic agents; Randomized controlled study; Treatment satisfaction.

Figure 1

Patient disposition. αGI, α‐glucosidase inhibitor; BG, biguanide; DPP‐4, dipeptidyl peptidase‐4; HbA1c, glycated hemoglobin; OHA‐Q, Oral Hypoglycemic Agent Questionnaire; SU, sulfonylurea.

Figure 2

Mean OHA‐Q total and subscale scores at weeks 4 and 12. Pairwise comparison of least square means of Oral Hypoglycemic Agent Questionnaire scores with the corresponding 95% confidence intervals. The treatment convenience, somatic symptom, and satisfaction subscales consist of nine, eight and three items, respectively. Each item score ranges from 0 (worst) to 3 points (best); the higher score indicates better treatment satisfaction. αGI, α‐glucosidase inhibitor; BG, biguanide; DPP‐4, dipeptidyl peptidase‐4; OHA‐Q, Oral Hypoglycemic Agent Questionnaire; SU, sulfonylurea.