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Effects of Linagliptin Versus Voglibose on Treatment- Related Quality of Life in Patients with Type 2 Diabetes: Sub-Analysis of the L-STEP Study

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Effects of Linagliptin Versus Voglibose on Treatment- Related Quality of Life in Patients with Type 2 Diabetes: Sub-Analysis of the L-STEP Study doi:10.1507/endocrj.EJ18-0088 ORIGINAL Effects of linagliptin versus voglibose on treatment- related quality of life in patients with type 2 diabetes: sub-analysis of the L-STEP study Hiromasa Goto1), Tomoya Mita1), Yoshio Fujitani1), 2), Shimpei Fujimoto3), Kiyohito Takahashi4), Hiroaki Satoh1), 5), Takahisa Hirose6), Toru Hiyoshi7), Masumi Ai8), Yosuke Okada9), Hideki Nishimura10), Hisamoto Kuroda11), Toshiki Matsubara12), Masahiko Gosho13), Hitoshi Ishii14) and Hirotaka Watada1) 1) Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan 2) Laboratory of Developmental Biology and Metabolism, Institute for Molecular and Cellular Regulation, Gunma University, Maebashi, Japan 3) Department of Endocrinology, Metabolism and Nephrology, Kochi Medical School, Kochi University, Nankoku, Kochi, Japan 4) Takahashi Kiyohito Clinic, Hakodate, Hokkaido, Japan 5) Department of Nephrology, Hypertension, Diabetology, Endocrinology, and Metabolism, Fukushima Medical University, Fukushima, Japan 6) Division of Diabetes, Metabolism, and Endocrinology, Department of Medicine, Toho University School of Medicine, Tokyo, Japan 7) Division of Diabetes and Endocrinology, Department of Internal Medicine, Japanese Red Cross Medical Center, Tokyo, Japan 8) Department of Insured Medical Care Management, Tokyo Medical and Dental University (TMDU), Tokyo, Japan 9) First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan 10) Kumanomae Nishimura Medical Clinic, Tokyo, Japan 11) Green Clinic, Mibu, Tochigi, Japan 12) Matsubara Clinic, Ichinomiya, Aichi, Japan 13) Department of Clinical Trial and Clinical Epidemiology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan 14) Department of Diabetology, Nara Medical University, Kashihara, Nara, Japan Abstract. Treatment-related quality of life (QOL) is an important aspect of diabetes management. However, no studies have compared the influence of dipeptidyl peptidase-4 inhibitors versus alpha-glucosidase inhibitors on treatment-related QOL. This prespecified sub-analysis of the Linagliptin Study of Effects on Postprandial blood glucose (L-STEP) compared the effects of linagliptin (5 mg once daily) and voglibose (0.2 mg/meal thrice daily) on treatment-related QOL in Japanese patients with type 2 diabetes (T2DM) inadequately controlled with diet and exercise therapy. Among 366 subjects in the original study, 182 in the linagliptin group and 173 in the voglibose group were included in this analysis. The outcome of this study was change in QOL as assessed by the Diabetes Therapy-Related Quality of Life 17 (DTR-QOL17) questionnaire from baseline to week 12. Compared with baseline data, total DTR-QOL17 scores were significantly higher after 12 weeks of linagliptin and voglibose treatment. The change in the total DTR-QOL17 score and the score of one domain, burden on social activities and daily activities, was significantly greater in the linagliptin group than in the voglibose group. In addition, only linagliptin treatment was identified as a factor associated with an increased total DTR-QOL17 score. Linagliptin is superior to voglibose in terms of improving treatment-related QOL in Japanese patients with T2DM. Key words: Dipeptidyl peptidase-4 inhibitor, Alpha-glucosidase inhibitor, Treatment-related quality of life, Type 2 diabetes mellitus THE PREVALENCE OF TYPE 2 DIABETES MEL- obesity and declines in physical activity, is increasing in LITUS (T2DM), which is influenced by the degree of many countries, including Japan. The objectives of dia- betes management in Japan are to maintain quality of life Submitted Mar. 2, 2018; Accepted Mar. 19, 2018 as EJ18-0088 (QOL) and life expectancy comparable to that of healthy Released online in J-STAGE as advance publication Apr. 10, 2018 individuals by preventing development or progression of Correspondence to: Dr. Tomoya Mita, Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medi- complications [1]. To achieve these goals, effective treat- cine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan. ment needs to take into account many factors, including E-mail: [email protected] age, disease duration, glycemic control status, physical ©The Japan Endocrine Society 2 Goto et al. status, and diabetic complications. For the proper choice on Postprandial blood glucose (L-STEP) to compare the of treatment, consideration of treatment-related QOL is effects of linagliptin, a DPP-4 inhibitor, and voglibose, important because decreased treatment-related QOL is an α-GI, on postprandial hyperglycemia and other associated with reduction in patient motivation and glycemic parameters in patients with inadequately con- adherence with treatment in patients with T2DM [2]. trolled T2DM despite diet and exercise therapy [18]. We Reduced adherence with treatment is associated with found that linagliptin monotherapy had a stronger poor glycemic control and increased risk for mortality in glucose-lowering effect than voglibose monotherapy in patients with T2DM [3]. terms of reducing HbA1c and serum fasting glucose Treatment guidelines by the American Diabetes Asso- levels, but not serum glucose levels 2 hours after the ciation and European Association for the Study of Dia- start of the meal tolerance test. Here, we conducted a betes recommend metformin as first-line therapy when sub-analysis to investigate how these treatment regimens lifestyle modification alone has not achieved or main- affect treatment-related QOL, a prespecified secondary tained optimal glycemic goals [4]. On the other hand, endpoint, using the self-administered Diabetes Therapy- treatment guidelines by the Japan Diabetes Society rec- Related QOL (DTR-QOL)-17 questionnaire that has ommend choosing suitable therapies in line with the been modified from the established questionnaire DTR- pathophysiological condition of each patient such as QOL developed especially to assess QOL related to insufficient insulin secretion or insulin resistance [5] treatment for diabetes [19]. because T2DM in East Asians are associated with more beta-cell dysfunction, less insulin resistance, and less Material and Methods adiposity [6]. Given this situation, various types of oral anti-hypoglycemic agents (OHAs), including alpha- Study design, patients, randomization, study glucosidase inhibitors (α-GIs) and dipeptidyl peptidase intervention, meal tolerance tests, and laboratory (DPP)-4 inhibitors, are chosen as first-line therapy in data Japan [7]. This prespecified sub-analysis of the L-STEP study α-GIs delay the absorption of glucose through inhibit- compared the effects of linagliptin and voglibose on ing alpha-glucosidase activity, thus reducing postprandial treatment-related QOL. The study design, inclusion and blood glucose excursion [8, 9]. A meta-analysis showed exclusion criteria, study schedule, and measurements that acarbose reduces the risk of cardiovascular events in were described in detail previously [19]. Briefly, patients patients with T2DM [10]. Supported by the evidence with inadequately controlled T2DM, who periodically from clinical trials [8-10], α-GIs are frequently pre- visited the outpatient clinic of 44 institutions in Japan scribed as first-line therapy in Japan for patients with (Supplementary Table S1) despite diet and exercise ther- T2DM [7]. However, the gastrointestinal adverse effects apy were asked to participate in this study. A total of 382 of these drugs, which include abdominal fullness and patients were recruited and randomly assigned to either borborygmi, may be significant barriers to treatment the linagliptin group (n = 192) or the voglibose group adherence [11]. (n = 190). Ultimately, 188 in the linagliptin group and On the other hand, DPP-4 inhibitors prevent the 178 in the voglibose group were included in the degradation of endogenous glucagon-like peptide-1 and intention-to-treat (ITT) analysis. After a 4-week screen- glucose-dependent insulinotropic polypeptide, which in ing period, patients in the linagliptin group took 5 mg of turn enhances glucose-dependent insulin secretion from oral linagliptin once daily and patients in the voglibose pancreatic β cells and reduces glucagon secretion from α group took 0.2 mg/meal of voglibose thrice daily. Meal cells and potentially suppresses postprandial glycemic tolerance tests were performed at baseline (week 0) and excursions [12-14]. DPP-4 inhibitors are generally safe endpoint (week 12). The meal tolerance test consisted of and well tolerated without increasing body weight [15]. a cookie test after overnight fasting [20, 21]. All adverse Indeed, sitagliptin was shown to improve QOL in a events were recorded during the study. Medication single arm-study [16]. Due to these characteristics of adherence was monitored by recording whether or not DPP-4 inhibitors, they are increasingly prescribed as patients took medicines daily. first-line therapy in Japan [17]. All patients gave written consent to participate in the We recently conducted a randomized prospective study. The study was approved by the institutional multicenter study named the Linagliptin Study of Effects review board of each participating center and was regis- Endocrine Journal Advance Publication Endocrine Journal Advance Publication DPP-4 inhibitors and quality of life 3 tered on the University Hospital Medical Information Table 1 DTQ-QOL questionnaire and domain structure Network Clinical Trials Registry (study no. UMIN00000 Domain 1:
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