Efficacy and safety of sitagliptin in elderly patients with type 2 diabetes mellitus and comparison of hypoglycemic action of concomitant medications: a subanalysis of the JAMP study
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To determine the efficacy and safety of sitagliptin when used with some therapeutic drugs to treat elderly patients.
Sitagliptin (50 mg/day) was added to the pre-existing therapy for type 2 diabetes. Changes in the glycated hemoglobin (HbA1c) level after 3 months of treatment were compared with the baseline, and exploratory analysis was performed. These analyses were conducted as subanalyses of the JAMP study, which was an open-label observational study.
For patients who were ≥65 years of age, the change in HbA1c level from baseline ranged from −0.50 to −0.87% at 3 months after starting treatment. There was no significant difference in the change in HbA1c level between the patients treated with different concomitant drugs. No significant difference in HbA1c variations at 3 and 12 months from baseline was noted among the three age groups (≥75, 65–74, and <65 years). Multiple regression analysis was performed, and it revealed that patients with higher HbA1c levels at baseline were likely to show decreased HbA1c levels, while those with higher triglyceride (TG) levels were unlikely to show decreased HbA1c levels.
Sitagliptin has the potential to both improve glycemic control and prevent hypoglycemia, and can be considered a potent alternative drug.
KeywordsDPP-4 inhibitor Prospective observational study Elderly patients Sitagliptin JAMP subanalysis Type 2 diabetes mellitus
We would like to express our sincere gratitude to Mr. Shogo Shishikura (MSD K.K.) (Teikyo University Graduate School of Public Health, MPH) for scientific advice, including references, when revising the manuscript. We would also like to thank Nouvelle Place Inc. for conducting the data analyses.
Compliance with ethical standards
This study was funded by the Japan Diabetes Foundation.
Conflict of interest
Hiroshi Sakura received honoraria from Mitsubishi Tanabe Pharma Corporation and a research grant from Ono Pharmaceutical Co., Ltd. The other authors declare that they have no conflict of interest.
JAMP Study Investigators
Akiko Sato (Maruyama Internal Medicine Clinic); Akira Miyashita (Miyashita Surgery Clinic); Asako Kokubo (Kokubo Clinic); Atsuro Tsuchiya (Tsuchiya Clinic); Dai Hirohara (Hanazono Clinic); Daiji Kogure (Kogure Clinic); Daijo Kasahara (Kasahara Clinic); Hideki Tanaka (Internal Medicine, Seiwa Clinic); Hideki Tanaka (Internal Medicine, Nishiarai Hospital); Hideo Tezuka (Tezuka Clinic); Hiroyuki Kuroki (Internal Medicine, Johsai Hospital); Jun Ogino (Department of Diabetes, Endocrine and Metabolic Diseases, Tokyo Women’s Medical University Yachiyo Medical Center); Kanu Kin (Internal Medicine, Nishiarai Lifestyle-Related Diseases Clinic); Kanu Kin (Internal Medicine, Nishiarai Hospital); Kazuko Muto (Tokyo Women’s Medical University); Kazuo Suzuki (Kenkokan Suzuki Clinic of Internal Medicine); Keiko Iseki (Iseki Clinic); Keita Watanabe (Watanabe Clinic); Kenshi Higami (Higami Hospital); Kenzo Matsumura (Matsumura Gastroenterological Clinic); Kiyotaka Nakajima (Ebisu Clinic); Koki Shin (Shin Clinic); Kuniya Koizumi (Kuniya Clinic); Maki Saneshige (Mugishima Medical Clinic); Makio Sekine (Sekine Clinic); Makoto Yaida (Urban Heights Clinic); Mari Kiuchi (physician, Kanauchi Medical Clinic); Mari Mugishima (Mugishima Medical Clinic); Mari Osawa (Department of Diabetes Mellitus, Institute of Geriatrics, Tokyo Women’s Medical University); Masae Banno (Banno Medical Clinic); Masahiro Yamamoto (Internal Medicine 1, Shimane University Faculty of Medicine); Masatake Hiratsuka (Higashishinagawa Clinic); Masumi Hosoya (Yasui Clinic); Michika Atsuta (Internal Medicine, Nishiarai Lifestyle-Related Diseases Clinic); Mitsutoshi Kato (Kato Clinic of Internal Medicine); Miwa Morita (Internal Medicine 1, Shimane University Faculty of Medicine); Munehiro Miyamae (Johsai Hospital); Mutsumi Iijima (Abe Hospital); Naomi Okuyama (Shinjuku Mitsui Building Clinic); Nobuo Hisano (Mejiro Medical Clinic); Norihiro Tsuchiya (Omotesando Naika Ganka); Rie Wada (Kanauchi Medical Clinic); Rie Wada (Nerimasakuradai Clinic); Ryuji Momose (Momo Medical Clinic); Sachiko Otake (Tokyo Women’s Medical University); Satoko Maruyama (Shinjuku Mitsui Building Clinic); Satoru Takada (Internal Medicine, Social Welfare Corporation, Shineikai Takinogawa Hospital); Shigeki Dan (Ube Internal Medicine and Pediatrics Hospital); Shigeki Nishizawa (Nishizawa Medical Clinic); Shigeo Yamashita (Department of Diabetes and Endocrinology, JR Tokyo General Hospital); Shingo Saneshige (Internal Medicine, Kamiochiai Shin Clinic); Shinichi Teno (Teno Clinic); Shinji Tsuruta (Diabetic Medicine, Itabashi Chuo Medical Center); Shinobu Kumakura (Kumakura Medical Clinic); Sumiko Kijima (Abe Hospital); Takashi Kondo (Kondo Clinic); Takeo Onishi (Internal Medicine, Onishi Clinic); Taku Kudo (Internal Medicine, Social Welfare Corporation, Shineikai Takinogawa Hospital); Tatsushi Sugiura (Internal Medicine, Seiwa Clinic); Toshihiko Ishiguro (Kaname Clinic); Yasue Suzuki (Suzuki Medical Clinic); Yasuhiro Tomita (Nakanobu Clinic); Yasuko Takano (Department of Diabetes, Shiseikai Daini Hospital); Yoshihisa Akimoto (Akimoto Yoshi Medical Clinic); Yoshiko Odanaka (Ito Internal Medicine Pediatrics Clinic); Yoshimasa Tasaka (Tokyo Women’s Medical University); Yoshitaka Aiso (Internal Medicine, Diabetes, Aiso Clinic); Yukiko Inoue (Inoue Medical Clinic); Yukinobu Kobayashi (Kobayashi Clinic).
Ethical approval and consent to participate
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions. The ethics committee at the Tokyo Women’s Medical University approved the study (approval number: 2064) on 11 January 2011. Informed consent or a substitute for it was obtained from all patients before they were included in the study.
- 1.Ministry of Health, Labour and Welfare. Summary of “Patient Survey”. Tokyo: Ministry of Health, Labour and Welfare; 2015. http://www.mhlw.go.jp/english/database/db-hss/sps_2014.html. Accessed 26 Jul 2017
- 2.Ministry of Health, Labour and Welfare. Results of “National Health and Nutrition Survey”. Tokyo: Ministry of Health, Labour and Welfare; 2015. http://www.mhlw.go.jp/stf/houdou/0000106405.html. Accessed 26 Jul 2017
- 9.Bremer JP. Hypoglycemia unawareness in older compared with middle-aged patients with type 2 diabetes. Diabetes Care. 2009;32(8):1513–7.Google Scholar
- 12.Rosenstock J. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006;28(10):1556–68.CrossRefPubMedGoogle Scholar
- 14.Hartley P. Efficacy and tolerability of sitagliptin compared with glimepiride in elderly patients with type 2 diabetes mellitus and inadequate glycemic control: a randomized, double-blind, non-inferiority trial. Drugs Aging. 2015;32(6):469–76.Google Scholar
- 15.Umezawa S. Two-year assessment of the efficacy and safety of sitagliptin in elderly patients with type 2 diabetes: post hoc analysis of the ASSET-K study. BMC Endocr Disord. 2015;15(34):1–8.Google Scholar
- 17.Sakura H. Effect of sitagliptin on blood glucose control in patients with type 2 diabetes mellitus who are treatment naive or poorly responsive to existing antidiabetic drugs: the JAMP study. BMC Endocr Disord. 2016;16(1):70.Google Scholar
- 18.Seino Y, Nanjo K, Tajima N, Kadowaki T, Kashiwagi A, Araki E, Ito C, Inagaki N, Iwamoto Y, Kasuga M, Hanafusa T, Haneda M, Ueki K. Report of the Committee on the Classification and Diagnostic Criteria of Diabetes Mellitus (revision for international harmonization of HbA1c in Japan). J Jpn Diabetes Soc. 2012;55(7):485–504.Google Scholar
- 23.The Japan Diabetes Society. Diabetes in the elderly (including dementia). In: Guideline for the treatment for diabetes in Japan 2016. Tokyo: Nankodo; 2016. p. 411–48.Google Scholar
- 27.Ching-Jung H. The durability of sitagliptin in elderly patients with type 2 diabetes. Clin Interv Aging. 2014;7(9):1905–11.Google Scholar
- 32.Zhuravlyova LV. The factors of the progression of metabolic disorders in the pancreas in patients with associated clinical variants of the chronic pancreatitis and type 2 diabetes mellitus. Lik Sprava. 2015;2015(5–6):46–51.Google Scholar