期刊论文详细信息
BMC Endocrine Disorders
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
Ikuro Matsuba2  Yasuo Terauchi3  Yasushi Tanaka1  Yoshikazu Naka2  Manabu Waseda2  Tetsuya Motomiya2  Hideo Machimura2  Shin Honda2  Hiroshi Takeda2  Yukiko Miyairi2  Atsuko Mokubo2  Takehiro Kawata2  Sachio Aoyagi2  Nobuo Sasai2  Tetsuro Takuma2  Nobuaki Minami2  Masashi Ishikawa2  Kazuhiko Hoshino2  Hideaki Kaneshige2  Masahiko Takai2  Mizuki Kaneshiro2  Hikaru Amamiya2  Shogo Ito2  Kotaro Iemitsu2  Mitsuo Obana2  Fuyuki Minagawa2  Yasuyuki Jin2  Kiyokazu Matoba2  Akira Kanamori2  Hajime Maeda2  Akira Kubota2  Shinichi Umezawa2 
[1] Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan;Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan;Department of Endocrinology and Diabetes, Yokohama City University Medical Center, Yokohama, Japan
关键词: Hypoglycemia;    Sulfonylurea;    Dipeptidyl peptidase 4 inhibitor;    Elderly patients;    Sitagliptin;    Type 2 diabetes;   
Others  :  1216983
DOI  :  10.1186/s12902-015-0033-2
 received in 2015-03-10, accepted in 2015-06-22,  发布年份 2015
PDF
【 摘 要 】

Background

There have only been a few reports about use of dipeptidyl peptidase 4 (DPP-4) inhibitors in elderly patients with type 2 diabetes mellitus (T2DM), suggesting that the safety of these agents has not been sufficiently demonstrated. We performed a comparative review of the efficacy and safety of sitagliptin for Japanese patients with T2DM managed in the real-world clinical setting.

Methods

An age-stratified analysis was performed of 831 patients who were treated with sitagliptin for 2 years. Parameters assessed included the hemoglobin A 1c(HbA 1c ), body weight, serum creatinine, and adverse events. HbA 1cand the incidence of hypoglycemia were also evaluated in patients treated with sitagliptin and a sulfonylurea (SU), who were divided into three age groups (<65 years, 65–74 years, and ≥75 years).

Results

Comparison of glycemic control parameters, laboratory values, and adverse events revealed significant improvement of HbA 1c , casual postprandial plasma glucose, and fasting plasma glucose in each age group with no change in body weight. Serum creatinine increased significantly in all age groups. Hypoglycemia only occurred in patients who received combined treatment with an SU and sitagliptin, and there was no age-related difference in its incidence.

Conclusions

HbA 1cwas improved by 2 years of sitagliptin therapy in all three age groups, and age did not seem to influence the incidence of hypoglycemic events. These results confirm the efficacy and safety of sitagliptin in patients ≥ 75 years old, suggesting that it is also useful for treating elderly patients with T2DM.

【 授权许可】

   
2015 Umezawa et al.

【 预 览 】
附件列表
Files Size Format View
20150704012435404.pdf 732KB PDF download
Fig. 6. 12KB Image download
Fig. 5. 33KB Image download
Fig. 4. 33KB Image download
Fig. 3. 33KB Image download
Fig. 2. 29KB Image download
Fig. 1. 37KB Image download
【 图 表 】

Fig. 1.

Fig. 2.

Fig. 3.

Fig. 4.

Fig. 5.

Fig. 6.

【 参考文献 】
  • [1]Janghorbani M, Van Dam RM, Willett WC, Hu FB. Systematic review of type 1 and type 2 diabetes mellitus and risk of fracture. Am J Epidemiol. 2007; 166(5):495-505.
  • [2]Ohara T, Doi Y, Ninomiya T, Hirakawa Y, Hata J, Iwaki T, Kanba S, Kiyohara Y. Glucose tolerance status and risk of dementia in the community: the Hisayama study. Neurology. 2011; 77(12):1126-34.
  • [3]Sinclair AJ, Robert IM, Croxson SCM. Mortality in older people with diabetes mellitus. Diabet Med. 1996; 14:639-47.
  • [4]Nathan DM, Buse JB, Davidson MB, Heine RJ, Holman RR, Sherwin R, Zinman B. Management of hyperglycemia in type 2 diabetes: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2006; 29:1963-72.
  • [5]Chiniwala N, Jabbour S. Management of diabetes mellitus in the elderly. Curr Opin Endocrinol Diabetes Obes. 2011; 18:148-52.
  • [6]Soe K, Sacerdote A, Karam J, Bahtiyar G. Management of type 2 diabetes mellitus in the elderly. Maturitas. 2011; 70:151-9.
  • [7]Pratley RE, Rosenstock J, Pi-Sunyer FX, Banerji MA, Schweizer A, Couturier A, Dejager S. Management of type 2 diabetes in treatment-naïve elderly patients: benefits and risks of vildagliptin monotherapy. Diabetes Care. 2007; 30:3017-22.
  • [8]Meneilly GS. Diabetes in the elderly. Med Clin North Am. 2006; 90:909-23.
  • [9]Chelliah A, Burge MR. Hypoglycaemia in elderly patients with diabetes mellitus: Causes and strategies for prevention. Drugs Aging. 2004; 21:511-30.
  • [10]Mulvihill EE, Drucker DJ. Pharmacology, physiology, and mechanisms of action of dipeptidyl peptidase-4 inhibitors. Endocr Rev. 2014; 35(6):992-1019.
  • [11]Seino Y, Yabe D. Glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1: Incretin actions beyond the pancreas. J Diabetes Investig. 2013; 4(2):108-30.
  • [12]Gautier JF, Fetita S, Sobngwi E, Salaün-Martin C. Biological actions of the incretins GIP and GLP-1 and therapeutic perspectives in patients with type 2 diabetes. Diabetes Metab. 2005; 31:233-42.
  • [13]Flatt PR. Effective surgical treatment of obesity may be mediated by ablation of the lipogenic gut hormone gastric inhibitory polypeptide (GIP): evidence and clinical opportunity for development of new obesity-diabetes drugs? Diab Vasc Dis Res. 2007; 4(2):151-3.
  • [14]Barzilai N, Guo H, Mahoney EM, Caporossi S, Golm GT, Langdon RB, Williams-Herman D, Kaufman KD, Amatruda JM, Goldstein BJ, Steinberg H. Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Curr Med Res Opin. 2011; 27(5):1049-58.
  • [15]Round EM, Engel SS, Golm GT, Davies MJ, Kaufman KD, Goldstein BJ. Safety of sitagliptin in elderly patients with type 2 diabetes: a pooled analysis of 25 clinical studies. Drugs Aging. 2014; 31:203-14.
  • [16]Hsieh CJ, Shen FC. The durability of sitagliptin in elderly patients with type 2 diabetes. Clin Interv Aging. 2014; 9:1905-11.
  • [17]Maeda H, Kubota A, Kanamori A, Tanaka Y, Terauchi Y, Matsuba I. Long-term efficacy and safety of sitagliptin in the treatment of Japanese Type 2 diabetes (ASSET-K1) to a target of HbA1c <7 %. J Endocrinol Invest. 2013; 36(8):568-73.
  • [18]Maeda H, Kubota A, Tanaka Y, Terauchi Y, Matsuba I. The safety, efficacy and predictors for HbA1c reduction of sitagliptin in the treatment of Japanese type 2 diabetes. Diabetes Res Clin Pract. 2012; 95(1):e20-2.
  • [19]Seaquist ER, Anderson J, Childs B, Cryer P, Dagogo-Jack S, Fish L, Heller SR, Rodriguez H, Rosenzweig J, Vigersky R. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013; 36(5):1384-95.
  • [20]El-Kebbi IM, Ziemer DC, Cook CB, Gallina DL, Barnes CS, Phillips LS. Utility of casual postprandial glucose levels in type 2 diabetes management. Diabetes Care. 2004; 27(2):335-9.
  • [21]Committee on Proper Use of Incretins (GLP-1 Receptor Agonists and DPP-4 Inhibitors): [http://www.jds.or.jp/modules/important/index.php?page=article&storyid=7] (in Japanese) Accessed 14 May 2015.
  • [22]Kanamori A, Matsuba I. Factors associated with reduced efficacy of sitagliptin therapy: analysis of 93 patients with type 2 diabetes treated for 1.5 years or longer. J Clin Med Res. 2013; 5(3):217-21.
  • [23]Kubota A, Maeda H, Kanamori A, Matoba K, Jin Y, Minagawa F, Obana M, Iemitsu K, Ito S, Amamiya H, Kaneshiro M, Takai M, Kaneshige H, Hoshino K, Ishikawa M, Minami N, Takuma T, Sasai N, Aoyagi S, Kawata T, Mokubo A, Takeda H, Honda S, Machimura H, Motomiya T, Waseda M, Naka Y, Tanaka Y, Terauchi Y, Matsuba I. Efficacy and safety of sitagliptin monotherapy and combination therapy in Japanese type 2 diabetes patients. J Diabetes Invest. 2012; 3(6):503-9.
  • [24]Kubota A, Maeda H, Kanamori A, Matoba K, Jin Y, Minagawa F, Obana M, Iemitsu K, Ito S, Amemiya H, Kaneshiro M, Takai M, Kaneshige H, Hoshino K, Ishikawa M, Minami N, Takuma T, Sasai N, Aoyagi S, Kawata T, Mokubo A, Takeda H, Honda S, Machimura H, Motomiya T, Waseda M, Naka Y, Tanaka Y, Terauchi Y, Matsuba I. Pleiotropic effects of sitagliptin in the treatment of type 2 diabetes mellitus patients. J Clin Med Res. 2012; 4(5):309-13.
  • [25]Maeda H, Kubota A, Kanamori A, Tanaka Y, Terauchi Y, Matsuba I, et al. Effects of sitagliptin on the serum creatinine in Japanese type 2 diabetes. Diabetes Res Clin Pract. 2015. doi: 10.1016/j.diabres.2015.03.008 [Epub ahead of print]
  • [26]Yabe D, Seino Y. Dipeptidyl peptidase-4 inhibitors and sulfonylureas for type 2 diabetes: Friend or foe? J Diabetes Investig. 2014; 5(5):475-7.
  • [27]Butler AE, Campbell-Thompson M, Gurlo T, Dawson DW, Atkinson M, Butler PC. Marked expansion of exocrine and endocrine pancreas with incretin therapy in humans with increased exocrine pancreas dysplasia and the potential for glucagon-producing neuroendocrine tumors. Diabetes. 2013; 62(7):2595-604.
  • [28]Yabe D, Kuwata H, Kaneko M, Ito C, Nishikino R, Murorani K, Kurose T, Seino Y. Use of the Japanese health insurance claims database to assess the risk of acute pancreatitis in patients with diabetes: comparison of DPP-4 inhibitors with other oral antidiabetic drugs. Diabetes Obes Metab. 2015; 17(4):430-4.
  • [29]Green JB, Bethel MA, Paul SK, Ring A, Kaufman KD, Shapiro DR, Califf RM, Holman RR. Rationale, design, and organization of a randomized, controlled Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes and established cardiovascular disease. Am Heart J. 2013; 166(6):983-9.
  • [30]Bethel MA, Green JB, Milton J, Tajar A, Engel SS, Califf RM et al.. Regional, age and sex differences in baseline characteristics of patients enrolled in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Diabetes Obes Metab. 2015; 17(4):395-402.
  • [31]Udell JA, Bhatt DL, Braunwald E, Cavender MA, Mosenzon O, Steg PG, Davidson JA, Nicolau JC, Corbalan R, Hirshberg B, Frederich R, Im K, Umez-Eronini AA, He P, McGuire DK, Leiter LA, Raz I. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus and moderate or severe renal impairment: observations from the SAVOR-TIMI 53 trial. Diabetes Care. 2014; 38(4):696-705.
  • [32]Leibowitz G, Cahn A, Bhatt DL, Hirshberg B, Mosenzon O, Wei C, Jermendy G, Sheu WH, Sendon JL, Im K, Braunwald E, Scirica BM, Raz I. Impact of treatment with saxagliptin on glycemic stability and β-cell function in the SAVOR-TIMI53 study. Diabetes Obes Metab. 2015; 17(5):487-94.
  文献评价指标  
  下载次数:59次 浏览次数:20次