Abstract
Introduction and objective: In Colombia, Dipeptidyl-Peptidase IV (DPP4) inhibitors are recommended as second-best choice for type 2 diabetes mellitus treatment. However, no evaluation of the accomplishment or impact of this recommendation was performed. The objective was to determine the prescription of the DPP4 inhibitor according to the Colombian Clinicial Practice Guide regarding type 2 diabetes mellitus treatment, and its effects on glycosylated hemoglobin (HbA1c). Materials and methods: A descriptive study that included patients with type 2 diabetes mellitus who attended a first level between 2016 and 2018, had a prescription for DPP4 inhibitor and at least two control appointments. Variables included were sociodemographic, clinics, treatment and comorbidities. The unadjusted prescription was defined as the lack of accomplishment of Colombian guidelines. Descriptive statistics and X2 test were used for the comparison of categorical variables. A binary logistic regression model was applied. Results: 112 out of 207 patients accomplished inclusion criteria, of which 77 were women (68.8%). Also, 68.8% of the patients had an unadjusted prescription of the iDPP4. There was a 0.21% total reduction in HbA1c levels, with a mean of 198.2 ± 124 days between the first and second control measurement (reduction of 0.55% when the prescription was adjusted to the guidelines and 0.05% if it was unadjusted). Conclusion: There is a limited impact of DPP4 inhibitors regarding the reduction of HbA1c and metabolic control, and there is a slight follow-up to the Colombian guidelines in patients who attend a first level.
References
Federación Internacional de Diabetes. Atlas de la Diabetes de la FID. 2017. http://www.fundaciondiabetes.org/upload/publicaciones_ficheros/95/IDF_Atlas_2015_SP_WEB_oct2016.pdf
Organización Mundial de la salud. Informe mundial sobre la Diabetes. Resumen de orientación. 2017. http://apps.who.int/iris/bitstream/10665/204877/1/WHO_NMH_NVI_16.3_spa.pdf?ua=1
Aschner P. Epidemiología de la diabetes en Colombia. Av Diabetol. 2010; 26: 95-100. https://doi.org/10.1016/S1134-3230(10)62005-4
Instituto Nacional de Salud. Carga de enfermedad por Enfermedades Crónicas No Transmisibles y Discapacidad en Colombia. Informe técnico. 2017. https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/IA/INS/informe-ons-5.pdf
Aschner PM, Muñoz OM, Girón D, García OM, Fernández-Ávila DG, Casas LÁ, et al. Clinical practice guideline for the prevention, early detection, diagnosis, management and follow up of type 2 diabetes mellitus in adults. Colomb Med. 2016; 47: 109-131.
American Diabetes Association. Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 ;41: S1-S159. doi: https://doi.org/10.2337/dc18-Sppc01
Hong ES, Khang AR, Yoon JW, Kang SM, Choi SH, Park KS, et al. Comparison between sitagliptin as add-on therapy to insulin and insulin dose-increase therapy in uncontrolled Korean type 2 diabetes: CSI study. Diabetes Obes Metab. 2012; 14(9): 795-802. doi: 10.1111/j.1463-1326.2012.01600.x
Sato S, Saisho Y, Kou K, Meguro S, Tanaka M, Irie J, et al. Efficacy and safety of sitagliptin added to insulin in Japanese patients with type 2 diabetes: the EDIT randomized trial. PLoS ONE. 2015; 10(3): e0121988. doi: 10.1371/journal.pone.0121988
Fonseca V, Baron M, Shao Q, Dejager S. Sustained efficacy and reduced hypoglycemia during one year of treatment with vildagliptin added to insulin in patients with type 2 diabetes mellitus. Horm Metab Res. 2008; 40: 427-430. doi: 10.1055/s-2008-105809-5
Kothny W, Foley J, Kozlovski P, Shao Q, Gallwitz B, Lukashevich V. Improved glycaemic control with vildagliptin added to insulin, with or without metformin, in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2013; 15: 252-257. doi: 10.1111/dom.12020
Hirose T, Suzuki M, Tsumiyama I. Efficacy and safety of vildagliptin as an add-on to insulin with or without metformin in Japanese patients with type 2 diabetes mellitus: a 12-week, double-blind, randomized study. Diabetes Ther. 2015; 6: 559-571.
Ning G, Wang W, Li L, Ma J, Lv X, Yang M, et al. Vildagliptin as add-on therapy to insulin improves glycemic control without increasing risk of hypoglycemia in Asian, predominantly Chinese, patients with type 2 diabetes mellitus. J Diabetes. 2016; 8(3): 345-353. doi: 10.1111/1753-0407.12303
Wu D, Li L, Liu C. Efficacy and safety of dipeptidyl peptidase-4 inhibitors and metformin as initial combination therapy and as monotherapy in patients with type 2 diabetes mellitus: a meta-analysis. Diabetes Obes Metab. 2014; 16(1): 30-37. doi: 10.1111/dom.12174
Forst T, Uhlig-Laske B, Ring A, Graefe-Mody U, Friedrich C, Herbach K, et al. Linagliptin (BI 1356), a potent and selective DPP-4 inhibitor, is safe and efficacious in combination with metformin in patients with inadequately controlled Type 2 diabetes. Diabet Med. 2010; 27(12): 1409-1419. doi: 10.1111/j.1464-5491.2010.03131.x
Sola D, Rossi L, Schianca GPC, Maffioli P, Bigliocca M, Mella R, et al. Sulfonylureas and their use in clinical practice. Arch Med Sci. 2015; 11(4): 840-848. doi: 10.5114/aoms.2015.53304
O'Brien MJ, Karam SL, Wallia A, Kang RH, Cooper AJ, Lancki N, et al. Association of second-line antidiabetic medications with cardiovascular events among insured adults with Type 2 Diabetes. JAMA Netw Open. 2018; 1(8): e186125. doi: 10.1001/jamanetworkopen.2018.6125
Monami M, Ahrén B, Dicembrini I, Mannucci E. Dipeptidyl peptidase-4 inhibitors and cardiovascular risk: a meta-analysis of randomized clinical trials. Diabetes Obes Metab. 2013; 15(2): 112-120. doi: 10.1111/dom.12000
Rosenstock J, Perkovic V, Johansen OE, Cooper ME, Kahn SE, Marx N, et al. Effect of linagliptin vs placebo on major cardiovascular events in adults with type 2 diabetes and high cardiovascular and renal risk: the CARMELINA randomized clinical trial. JAMA. 2019; 321(1): 69-79. doi: 10.1001/jama.2018.18269
Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, et al; TECOS Study Group. Effect of sitagliptin on cardiovascular outcomes in Type 2 Diabetes. N Engl J Med. 2015; 373(3): 232-242. doi: 10.1056/NEJMoa1501352
Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, et al.; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013; 369(14): 1317-1326. doi: 10.1056/NEJMoa1307684
Fadini GP, Avogaro A, Degli Esposti L, Russo P, Saragoni S, Buda S, et al; OsMed Health-DB Network. Risk of hospitalization for heart failure in patients with type 2 diabetes newly treated with DPP-4 inhibitors or other oral glucose-lowering medications: a retrospective registry study on 127,555 patients from the Nationwide OsMed Health-DB Database. Eur Heart J. 2015; 36(36): 2454-2462. doi: 10.1093/eurheartj/ehv301
Monami M, Iacomelli I, Marchionni N, Mannucci E. Dipeptydil peptidase-4 inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials. Nutr Metab Cardiovasc Dis. 2010; 20(4): 224-235. doi: 10.1016/j.numecd.2009.03.015
Penno G, Garofolo M, Del Prato S. Dipeptidyl peptidase-4 inhibition in chronic kidney disease and potential for protection against diabetes-related renal injury. Nutr Metab Cardiovasc Dis. 2016; 26(5): 361-373. doi: 10.1016/j.numecd.2016.01.001
Ceriello A, Inagaki N. Pharmacokinetic and pharmacodynamic evaluation of linagliptin for the treatment of type 2 diabetes mellitus, with consideration of Asian patient populations. J Diabetes Investig. 2017; 8(1): 19-28. doi: 10.1111/jdi.12528
Engel SS, Suryawanshi S, Stevens SR, Josse RG, Cornel JH, Jakuboniene N, et al; TECOS Study Group. Safety of sitagliptin in patients with type 2 diabetes and chronic kidney disease: outcomes from TECOS. Diabetes Obes Metab. 2017; 19(11): 1587-1593. doi: 10.1111/dom.12983.
American Diabetes Association. Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019; 42(Suppl.1): S1-S196. doi: https://doi.org/10.2337/dc19-Sint01
Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, et al; EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in Type 2 Diabetes. N Engl J Med. 2015; 373(22): 2117-2128. doi: 10.1056/NEJMoa1504720
Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, et al; CANVAS program collaborative group. canagliflozin and cardiovascular and renal events in Type 2 Diabetes. N Engl J Med. 2017; 377(7): 644-657. doi: 10.1056/NEJMoa1611925
Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A; DECLARE–TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in Type 2 Diabetes. N Engl J Med. 2019; 380(4): 347-357. doi: 10.1056/NEJMc1902837
Food and Drugs Administration. FDA Drug Safety Communication: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function. Fecha de consulta: 8 de octubre de 2018. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-revises-warnings-regarding-use-diabetes-medicine-metformin-certain.
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Copyright (c) 2022 Juan Daniel Castrillon-Spitia, Valentina Buriticá-Vega, Melissa Hiromi Emura-Vélez, María Camila Rodríguez-Escobar, Mario Andrés Quintana-Duque, Jorge Enrique Machado-Alba