Sitagliptin for Elderly Patients Aged 75 Years or Older with Inadequately Controlled Type 2 Diabetes with Common Antidiabetes Treatments
Affiliation(s)
1 Division of Endocrinology and Metabolism, Saiseikai Niigata Daini Hospital, Niigata, Japan. 2 Department of Nutrition, Saiseikai Niigata Daini Hospital, Niigata, Japan.
1 Division of Endocrinology and Metabolism, Saiseikai Niigata Daini Hospital, Niigata, Japan. 2 Department of Nutrition, Saiseikai Niigata Daini Hospital, Niigata, Japan.
ABSTRACT
Background: The purpose of this study was to evaluate the effects of sitagliptin in elderly patients with type 2 diabetes aged 75 years or older versus those aged 65 - 74 years. Methods: Outpatients aged 65 years or older with type 2 diabetes who received sitagliptin at a dose of 50 mg daily for 6 months were divided into two groups: those who were 75 years and older and those who were 65 - 74 years. The efficacy and safety were retrospectively evaluated by comparison of laboratory values before and after the administration of sitagliptin and by review of adverse events after treatment. Results: One hundred and twelve older patients with type 2 diabetes were studied. Six months after the initiation of sitagliptin, participants’ hemoglobin A1c was significantly decreased by 1.09% ± 0.8% in 65 - 74-year-olds (66 patients; mean age, 69.1 ± 3.0 years; mean HbA1c before administration, 8.4% ± 0.8%) and by 1.05% ± 0.8% in patients 75 years or older (46 patients; mean age, 79.8 ± 4.1 years; mean HbA1c before administration, 8.5% ± 0.7%). There was no significant difference in hemoglobin A1c between the two groups. Furthermore, sitagliptin was well tolerated in both age groups. Conclusions: In elderly patients (75 years or older) with type 2 diabetes, the effect of sitagliptin was similar that in older patients (younger than 75 years) with type 2 diabetes.
Background: The purpose of this study was to evaluate the effects of sitagliptin in elderly patients with type 2 diabetes aged 75 years or older versus those aged 65 - 74 years. Methods: Outpatients aged 65 years or older with type 2 diabetes who received sitagliptin at a dose of 50 mg daily for 6 months were divided into two groups: those who were 75 years and older and those who were 65 - 74 years. The efficacy and safety were retrospectively evaluated by comparison of laboratory values before and after the administration of sitagliptin and by review of adverse events after treatment. Results: One hundred and twelve older patients with type 2 diabetes were studied. Six months after the initiation of sitagliptin, participants’ hemoglobin A1c was significantly decreased by 1.09% ± 0.8% in 65 - 74-year-olds (66 patients; mean age, 69.1 ± 3.0 years; mean HbA1c before administration, 8.4% ± 0.8%) and by 1.05% ± 0.8% in patients 75 years or older (46 patients; mean age, 79.8 ± 4.1 years; mean HbA1c before administration, 8.5% ± 0.7%). There was no significant difference in hemoglobin A1c between the two groups. Furthermore, sitagliptin was well tolerated in both age groups. Conclusions: In elderly patients (75 years or older) with type 2 diabetes, the effect of sitagliptin was similar that in older patients (younger than 75 years) with type 2 diabetes.
Cite this paper
Suzuki, K. , Mistuma, Y. , Sato, T. and Hatta, M. (2015) Sitagliptin for Elderly Patients Aged 75 Years or Older with Inadequately Controlled Type 2 Diabetes with Common Antidiabetes Treatments. International Journal of Clinical Medicine, 6, 672-681. doi: 10.4236/ijcm.2015.69090.
Suzuki, K. , Mistuma, Y. , Sato, T. and Hatta, M. (2015) Sitagliptin for Elderly Patients Aged 75 Years or Older with Inadequately Controlled Type 2 Diabetes with Common Antidiabetes Treatments. International Journal of Clinical Medicine, 6, 672-681. doi: 10.4236/ijcm.2015.69090.
References
[1] Japan Ministry of Health, Labor and Welfare: The 2012 National Health and Nutrition Survey in Japan.
http://www.mhlw.go.jp/stf/houdou/0000032074.html [2] Lakey, W.C., Barnard, K., Batch, B.C., Chiwell, K., Tasneem, A. and Green, J.B. (2013) Are Current Clinical Trials in Diabetes Addressing Importance Issues in Diabetes Care? Diabetologia, 56, 1226-1235.
http://dx.doi.org/10.1007/s00125-013-2890-4 [3] Fravel, M.A., McDanel, D.L., Ross, M.B., Moores, K.G. and Starry, M.J. (2011) Special Considerations for Treatment of Type 2 Diabetes Mellitus in the Elderly. American Journal of Health-System Pharmacy, 68, 500-509.
http://dx.doi.org/10.2146/ajhp080085 [4] Kirkman, M.S., Briscoe, V.J., Clark, N., et al. (2012) Diabetes in Older Adults. Diabetes Care, 35, 2650-2664.
http://dx.doi.org/10.2337/dc12-1801 [5] Sinclair, A., Morley, J.E., Rodriguez-Mañas, L., et al. (2012) Diabetes Mellitus in Older People: Position Statement on Behalf of the International Association of Gerontology and Geriatrics (IAGG), the European Diabetes Working Party for Older eople (EDWPOP), and the International Task Force of Experts in Diabetes. Journal of the American Medical Directors Association, 13, 497-502.
http://dx.doi.org/10.1016/j.jamda.2012.04.012 [6] Inzucchi, S.E., Bergenstal, R.M., Buse, J.B., et al., the American Diabetes Association (ADA), and the European Association for the Study of Diabetes (EASD) (2012) Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach: Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care, 35, 1364-1379.
http://dx.doi.org/10.2337/dc12-0413 [7] Halimi, S., Raccah, D., Schweizer, A. and Dejager, S. (2010) Role of Vildagliptin in Managing Type 2 Diabetes Mellitus in the Elderly. Current Medical Research and Opinion, 26, 1647-1656.
http://dx.doi.org/10.1185/03007995.2010.485881 [8] Mathieu, C. and Bollaerts, K. (2007) Antihyperglycaemic Therapy in Elderly Patients with Type 2 Diabetes: Potential Role of Incretinmimetics and DPP-4 Inhibitors. International Journal of Clinical Practice, 154, 29-37.
http://dx.doi.org/10.1111/j.1742-1241.2007.01437.x [9] Abbatecola, A.M., Maggi, S. and Paolisso, G. (2008) New Approaches to Treating Type 2 Diabetes Mellitus in the Elderly: Role of Incretin Therapies. Drugs Aging, 25, 913-925.
http://dx.doi.org/10.2165/0002512-200825110-00002 [10] Maeda, H., Kubota, A., Tanaka, Y., Terauchi, Y. and Matsuba, I. (2012) The Safety, Efficacy and Predictors for HbA1c Reduction of Sitagliptin in the Treatment of Japanese Type 2 Diabetes. Diabetes Research and Clinical Practice, 95, e20-e22.
http://dx.doi.org/10.1016/j.diabres.2011.10.011 [11] Kubota, A., Maeda, H., Kanamori, A., Matoba, K., Jin, Y., Minagawa, F., Obana, M., et al. (2012) Efficacy and Safety of Sitagliptin Monotherapy and Combination Therapy in Japanese Type 2 Diabetes Patients. Journal of Diabetes Investigation, 3, 503-509.
http://dx.doi.org/10.1111/j.2040-1124.2012.00221.x [12] Kubota, A., Matsuba, I., Saito, T., Nabe, K. and Seino, Y. (2011) Secretory Units of Islets in Transplantation Index Is a Useful Clinical Marker to Evaluate the Efficacy of Sitagliptin in Treatment of Type 2 Diabetes Mellitus. Journal of Diabetes Investigation, 2, 377-380.
http://dx.doi.org/10.1111/j.2040-1124.2011.00109.x [13] Kubota, A., Maeda, H., Kanamori, A., Matoba, K., Jin, Y., Minagawa, F., Obana, M., et al. (2012) Pleiotropic Effects of Sitagliptin in the Treatment of Type 2 Diabetes Mellitus Patients. Journal of Clinical Medicine Research, 4, 309-313.
http://dx.doi.org/10.4021/jocmr1061w [14] Chung, H.S. and Lee, M.K. (2011) Efficacy of Sitagliptin When Added to Ongoing Therapy in Korean Subjects with Type 2 Diabetes Mellitus. Diabetes & Metabolism Journal, 35, 411-417.
http://dx.doi.org/10.4093/dmj.2011.35.4.411 [15] Nonaka, K., Kakikawa, T., Sato, A., Okuyama, K., Fujimoto, G., Kato, N., Suzuki, H., et al. (2008) Efficacy and Safety of Sitagliptin Monotherapy in Japanese Patients with Type 2 Diabetes. Diabetes Research and Clinical Practice, 79, 291-298.
http://dx.doi.org/10.1016/j.diabres.2007.08.021 [16] Tajima, N., Kadowaki, T., Odawara, M., Nishii, M., Taniguchi, T. and Arjona Ferreira, J.C. (2011) Addition of Sitagliptin to Ongoing Glimepiride Therapy in Japanese Patients with Type 2 Diabetes over 52 Weeks Leads to Improved Glycemic Control. Diabetology International, 2, 32-44.
http://dx.doi.org/10.1007/s13340-011-0022-2 [17] Kashiwagi, A., Kadowaki, T., Tajima, N., Nonaka, K., Taniguchi, T., Nishii, M., Arjona Ferreira, J.C. and Amatruda, J.M. (2011) Sitagliptin Added to Treatment with Ongoing Pioglitazone for Up to 52 Weeks Improves Glycemic Control in Japanese Patients with Type 2 Diabetes. Journal of Diabetes Investigation, 2, 381-390.
http://dx.doi.org/10.1111/j.2040-1124.2011.00120.x [18] Kadowaki, T., Tajima, N., Odawara, M., Nishii, M., Taniguchi, T. and Arjona Ferreira, J.C. (2013) Addition of Sitagliptin to Ongoing Metformin Monotherapy Improves Glycemic Control in Japanese Patients with Type 2 Diabetes over 52 Weeks. Journal of Diabetes Investigation, 42, 174-181.
http://dx.doi.org/10.1111/jdi.12001 [19] Tajima, N., Kadowaki, T., Okamoto, T., Sato, A., Okuyama, K., Minamide, T. and Arjona Ferreira, J.C. (2013) Sitagliptin Added to Voglibose Monotherapy Improves Glycemic Control in Patients with Type 2 Diabetes. Journal of Diabetes Investigation, 4, 595-604. [20] Kadowaki, T., Tajima, N., Odawara, M., Minamide, T., Kawashima, M., Yanagida, D., Okamoto, T. and Arjona Ferreira, J.C. (2013) Efficacy and Safety of Sitagliptin Add-On Therapy in Japanese Patients with Type 2 Diabetes on Insulin Monotherapy. Diabetology International, 4, 160-172.
http://dx.doi.org/10.1007/s13340-013-0109-z [21] Johnston, S.S., Conner, C., et al. (2012) Association between Hypoglycaemic Events and Fall-Related Fractures in Medicare-Covered Patients with Type 2 Diabetes. Diabetes, Obesity and Metabolism, 14, 634-643.
http://dx.doi.org/10.1111/j.1463-1326.2012.01583.x [22] Whitmer, R.A., Karter, A.J., et al. (2009) Hypoglycemic Episodes and Risk of Dementia in Older Patients with Type 2 Diabetes Mellitus. JAMA, 301, 1565-1572.
http://dx.doi.org/10.1001/jama.2009.460 [23] Bonds, D.E., Miller, M.E., et al. (2010) The Association between Symptomatic Severe Hypoglycemia and Mortality in Type 2 Diabetes: Retrospective Epidemiological Analysis of the ACCORD Study. BMJ, 340, b4909.
http://dx.doi.org/10.1136/bmj.b4909 [24] Iwakura, T., Sasaki, S., et al. (2012) Clinical Analysis of 135 Type 2 Diabetes Patients with Severe Drug-Induced Hypoglycemia. Journal of the Japan Diabetes Society, 55, 857-865. [25] Pratley, R.E., Rosenstock, J., et al. (2007) Management of Type 2 Diabetes in Treat-Nañve Elderly Patients: Benefits and Risks of Vildagliptin Monotherapy. Diabetes Care, 30, 3017-3022.
http://dx.doi.org/10.2337/dc07-1188 [26] Schweizer, A., Dejager, S., et al. (2011) Clinical Experience with Vidagliptin in the Management of Type 2 Diabetes in a Patient Population ≥75 Years: A Pooled Analysis from a Database of Clinical Trials. Diabetes, Obesity and Metabolism, 13, 55-64.
http://dx.doi.org/10.1111/j.1463-1326.2010.01325.x [27] Barnett, A.H., Huisman, H., et al. (2013) Linagliptin for Patients Aged 70 Years or Older with Type 2 Diabetes Inadequately Controlled with Common Anti-Diabetes Treatments: A Randomized, Double-Blind, Placebo-Controlled Trials. The Lancet, 382, 1413-1423.
http://dx.doi.org/10.1016/S0140-6736(13)61500-7
[1] Japan Ministry of Health, Labor and Welfare: The 2012 National Health and Nutrition Survey in Japan.
http://www.mhlw.go.jp/stf/houdou/0000032074.html [2] Lakey, W.C., Barnard, K., Batch, B.C., Chiwell, K., Tasneem, A. and Green, J.B. (2013) Are Current Clinical Trials in Diabetes Addressing Importance Issues in Diabetes Care? Diabetologia, 56, 1226-1235.
http://dx.doi.org/10.1007/s00125-013-2890-4 [3] Fravel, M.A., McDanel, D.L., Ross, M.B., Moores, K.G. and Starry, M.J. (2011) Special Considerations for Treatment of Type 2 Diabetes Mellitus in the Elderly. American Journal of Health-System Pharmacy, 68, 500-509.
http://dx.doi.org/10.2146/ajhp080085 [4] Kirkman, M.S., Briscoe, V.J., Clark, N., et al. (2012) Diabetes in Older Adults. Diabetes Care, 35, 2650-2664.
http://dx.doi.org/10.2337/dc12-1801 [5] Sinclair, A., Morley, J.E., Rodriguez-Mañas, L., et al. (2012) Diabetes Mellitus in Older People: Position Statement on Behalf of the International Association of Gerontology and Geriatrics (IAGG), the European Diabetes Working Party for Older eople (EDWPOP), and the International Task Force of Experts in Diabetes. Journal of the American Medical Directors Association, 13, 497-502.
http://dx.doi.org/10.1016/j.jamda.2012.04.012 [6] Inzucchi, S.E., Bergenstal, R.M., Buse, J.B., et al., the American Diabetes Association (ADA), and the European Association for the Study of Diabetes (EASD) (2012) Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach: Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care, 35, 1364-1379.
http://dx.doi.org/10.2337/dc12-0413 [7] Halimi, S., Raccah, D., Schweizer, A. and Dejager, S. (2010) Role of Vildagliptin in Managing Type 2 Diabetes Mellitus in the Elderly. Current Medical Research and Opinion, 26, 1647-1656.
http://dx.doi.org/10.1185/03007995.2010.485881 [8] Mathieu, C. and Bollaerts, K. (2007) Antihyperglycaemic Therapy in Elderly Patients with Type 2 Diabetes: Potential Role of Incretinmimetics and DPP-4 Inhibitors. International Journal of Clinical Practice, 154, 29-37.
http://dx.doi.org/10.1111/j.1742-1241.2007.01437.x [9] Abbatecola, A.M., Maggi, S. and Paolisso, G. (2008) New Approaches to Treating Type 2 Diabetes Mellitus in the Elderly: Role of Incretin Therapies. Drugs Aging, 25, 913-925.
http://dx.doi.org/10.2165/0002512-200825110-00002 [10] Maeda, H., Kubota, A., Tanaka, Y., Terauchi, Y. and Matsuba, I. (2012) The Safety, Efficacy and Predictors for HbA1c Reduction of Sitagliptin in the Treatment of Japanese Type 2 Diabetes. Diabetes Research and Clinical Practice, 95, e20-e22.
http://dx.doi.org/10.1016/j.diabres.2011.10.011 [11] Kubota, A., Maeda, H., Kanamori, A., Matoba, K., Jin, Y., Minagawa, F., Obana, M., et al. (2012) Efficacy and Safety of Sitagliptin Monotherapy and Combination Therapy in Japanese Type 2 Diabetes Patients. Journal of Diabetes Investigation, 3, 503-509.
http://dx.doi.org/10.1111/j.2040-1124.2012.00221.x [12] Kubota, A., Matsuba, I., Saito, T., Nabe, K. and Seino, Y. (2011) Secretory Units of Islets in Transplantation Index Is a Useful Clinical Marker to Evaluate the Efficacy of Sitagliptin in Treatment of Type 2 Diabetes Mellitus. Journal of Diabetes Investigation, 2, 377-380.
http://dx.doi.org/10.1111/j.2040-1124.2011.00109.x [13] Kubota, A., Maeda, H., Kanamori, A., Matoba, K., Jin, Y., Minagawa, F., Obana, M., et al. (2012) Pleiotropic Effects of Sitagliptin in the Treatment of Type 2 Diabetes Mellitus Patients. Journal of Clinical Medicine Research, 4, 309-313.
http://dx.doi.org/10.4021/jocmr1061w [14] Chung, H.S. and Lee, M.K. (2011) Efficacy of Sitagliptin When Added to Ongoing Therapy in Korean Subjects with Type 2 Diabetes Mellitus. Diabetes & Metabolism Journal, 35, 411-417.
http://dx.doi.org/10.4093/dmj.2011.35.4.411 [15] Nonaka, K., Kakikawa, T., Sato, A., Okuyama, K., Fujimoto, G., Kato, N., Suzuki, H., et al. (2008) Efficacy and Safety of Sitagliptin Monotherapy in Japanese Patients with Type 2 Diabetes. Diabetes Research and Clinical Practice, 79, 291-298.
http://dx.doi.org/10.1016/j.diabres.2007.08.021 [16] Tajima, N., Kadowaki, T., Odawara, M., Nishii, M., Taniguchi, T. and Arjona Ferreira, J.C. (2011) Addition of Sitagliptin to Ongoing Glimepiride Therapy in Japanese Patients with Type 2 Diabetes over 52 Weeks Leads to Improved Glycemic Control. Diabetology International, 2, 32-44.
http://dx.doi.org/10.1007/s13340-011-0022-2 [17] Kashiwagi, A., Kadowaki, T., Tajima, N., Nonaka, K., Taniguchi, T., Nishii, M., Arjona Ferreira, J.C. and Amatruda, J.M. (2011) Sitagliptin Added to Treatment with Ongoing Pioglitazone for Up to 52 Weeks Improves Glycemic Control in Japanese Patients with Type 2 Diabetes. Journal of Diabetes Investigation, 2, 381-390.
http://dx.doi.org/10.1111/j.2040-1124.2011.00120.x [18] Kadowaki, T., Tajima, N., Odawara, M., Nishii, M., Taniguchi, T. and Arjona Ferreira, J.C. (2013) Addition of Sitagliptin to Ongoing Metformin Monotherapy Improves Glycemic Control in Japanese Patients with Type 2 Diabetes over 52 Weeks. Journal of Diabetes Investigation, 42, 174-181.
http://dx.doi.org/10.1111/jdi.12001 [19] Tajima, N., Kadowaki, T., Okamoto, T., Sato, A., Okuyama, K., Minamide, T. and Arjona Ferreira, J.C. (2013) Sitagliptin Added to Voglibose Monotherapy Improves Glycemic Control in Patients with Type 2 Diabetes. Journal of Diabetes Investigation, 4, 595-604. [20] Kadowaki, T., Tajima, N., Odawara, M., Minamide, T., Kawashima, M., Yanagida, D., Okamoto, T. and Arjona Ferreira, J.C. (2013) Efficacy and Safety of Sitagliptin Add-On Therapy in Japanese Patients with Type 2 Diabetes on Insulin Monotherapy. Diabetology International, 4, 160-172.
http://dx.doi.org/10.1007/s13340-013-0109-z [21] Johnston, S.S., Conner, C., et al. (2012) Association between Hypoglycaemic Events and Fall-Related Fractures in Medicare-Covered Patients with Type 2 Diabetes. Diabetes, Obesity and Metabolism, 14, 634-643.
http://dx.doi.org/10.1111/j.1463-1326.2012.01583.x [22] Whitmer, R.A., Karter, A.J., et al. (2009) Hypoglycemic Episodes and Risk of Dementia in Older Patients with Type 2 Diabetes Mellitus. JAMA, 301, 1565-1572.
http://dx.doi.org/10.1001/jama.2009.460 [23] Bonds, D.E., Miller, M.E., et al. (2010) The Association between Symptomatic Severe Hypoglycemia and Mortality in Type 2 Diabetes: Retrospective Epidemiological Analysis of the ACCORD Study. BMJ, 340, b4909.
http://dx.doi.org/10.1136/bmj.b4909 [24] Iwakura, T., Sasaki, S., et al. (2012) Clinical Analysis of 135 Type 2 Diabetes Patients with Severe Drug-Induced Hypoglycemia. Journal of the Japan Diabetes Society, 55, 857-865. [25] Pratley, R.E., Rosenstock, J., et al. (2007) Management of Type 2 Diabetes in Treat-Nañve Elderly Patients: Benefits and Risks of Vildagliptin Monotherapy. Diabetes Care, 30, 3017-3022.
http://dx.doi.org/10.2337/dc07-1188 [26] Schweizer, A., Dejager, S., et al. (2011) Clinical Experience with Vidagliptin in the Management of Type 2 Diabetes in a Patient Population ≥75 Years: A Pooled Analysis from a Database of Clinical Trials. Diabetes, Obesity and Metabolism, 13, 55-64.
http://dx.doi.org/10.1111/j.1463-1326.2010.01325.x [27] Barnett, A.H., Huisman, H., et al. (2013) Linagliptin for Patients Aged 70 Years or Older with Type 2 Diabetes Inadequately Controlled with Common Anti-Diabetes Treatments: A Randomized, Double-Blind, Placebo-Controlled Trials. The Lancet, 382, 1413-1423.
http://dx.doi.org/10.1016/S0140-6736(13)61500-7