2015, Número 4
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Med Int Mex 2015; 31 (4)
Comparación de la eficacia de los iDPP-4 actualmente disponibles y ventajas antihiperglucemiantes de linagliptina en pacientes con diabetes mellitus 2
Zúñiga-Guajardo S, Rodríguez-Gutiérrez R, Yamamoto-Cuevas J, Juárez-Comboni SC
Idioma: Español
Referencias bibliográficas: 51
Paginas: 441-453
Archivo PDF: 627.88 Kb.
RESUMEN
La diabetes mellitus tipo 2 es una enfermedad en cuya etiopatogenia intervienen múltiples defectos, hecho que ha dado lugar a que continúen investigándose sustancias que sean capaces de corregir estos defectos y mejorar el control de la glucemia. A medida que transcurre el tiempo, la cronicidad de la diabetes mellitus tipo 2 se acompaña de
la declinación progresiva en la función de la célula b y de la alteración del control de las células α en los islotes pancreáticos; en consecuencia, los fármacos convencionalmente prescritos para el tratamiento de los pacientes diabéticos pierden eficacia y exhiben gradualmente
un amplio número de limitaciones, incluidos el aumento en el riesgo de episodios de hipoglucemia, efectos cada vez más prominentes en la ganancia de peso corporal y la inducción de eventos adversos de tipo gastrointestinal, edema e incluso insuficiencia cardiaca. El desarrollo de nuevos fármacos, entre los que se encuentran los inhibidores de la enzima dipeptidilpeptidasa tipo 4 (DPP-4), ha revolucionado durante la década actual el tratamiento de la diabetes mellitus tipo 2, debido a que estos agentes son eficaces para disminuir la glucosa, de manera que es improbable que produzcan hipoglucemia y, en
modelos animales, se ha demostrado que pueden evitar la declinación progresiva en la función de la célula b y preservar la capacidad secretora de insulina. Además, no elevan el riesgo de hipoglucemia o de incremento del peso corporal. Estas características hacen de los inhibidores de la DPP-4 agentes idóneos para el tratamiento a largo plazo de los pacientes con diabetes mellitus tipo 2. En este artículo se analiza la eficacia para el control de la glucemia de estos nuevos agentes, ya sea en monoterapia o en distintas combinaciones terapéuticas. Asimismo, se evalúan la eficacia, la seguridad y la tolerabilidad del inhibidor de la DPP-4 linagliptina, administrado en monoterapia o combinado con metformina, insulina, glitazonas o sulfonilureas.
REFERENCIAS (EN ESTE ARTÍCULO)
Greischel A, Binder R, Baierl J. The dipeptidyl peptidase-4 inhibitor linagliptin exhibits time-and dose-dependent localization in kidney, liver, and intestine after intravenous dosing: results from high resolution autoradiography in rats. Drug Metab Dispos 2010;38:1443-1448.
Drucker DJ. Enhancing incretin action for the treatment of type 2 diabetes. Diabetes Care 2003;26:2929-2940.
Richter B, Bandeira-Echtler E, Bergerhoff K, Lerch C. Emerging role of dipeptidyl peptidase-4 inhibitors in the management of type 2 diabetes. Vasc Health Risk Manag 2008;4:753-768.
Green BD, Flatt PR, Bailey CJ. Dipeptidyl peptidase IV (DPP IV) inhibitors: a newly emerging drug class for the treatment of type 2 diabetes. Diab Vasc Dis Res 2006;3:159-165.
Prieto MÁ, Comas-Samper JM, Escobar-Cervantes C, Gasull-Molinera V. Seguridad cardiovascular de los antidiabéticos no insulínicos; posicionamiento científico SEMERGEN. Semergen 2014;40:261-273.
Arechavaleta-Granell R. El efecto fisiológico de las hormonas incretinas. Adv Stud Med 2006;6:581-585.
DeFronzo RA, Fleck PR, Wilson CA, Mekki Q, Aloglyptin Study 010 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control: a randomized, double-blind, placebo-controlled study. Diabetes Care 2008;31:2315-2317.
Horie Y, Hayashi N, Dugi K, Takeuchi M. Design, statistical analysis and sample size calculation of a phase IIb/III study of linagliptin versus voglibose and placebo. Trials 2009;10:82. doi:10.1186/1745-6215-10-82.
TradjentaTM. US Prescribing Information. May 2011. Disponible en: http://bidocs.boehringeringelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf.
Saxagliptin: summary of product characteristics. Disponible en: http://www.medicines.org.uk/EMC/medicine/22315/SPC/Onglyza+2.5mg+%26+5mg+filmcoated+tablets/,http://www.medicines.org.uk/EMC/medicine/22315/SPC/Onglyza+2.5mg+%26+5mg+filmcoated+tablets.
Vildagliptin: summary of product characteristics. Disponible en: http://www.medicines.org.uk/EMC/medicine/20734/SPC/Galvus+50+mg+Tablets/.
Alogliptin: summary of product characteristics (Japanese PI).
Vincent SH, Reed JR, Bergman AJ, et al. Metabolism and excretion of the dipeptidil peptidase 4 inhibitor [14C] sitagliptin in humans. Drug Metabol Dispos 2007;35:533-538.
Christopher R, Covington P, Davenport M, et al. Pharmacokinetics, pharmacodynamics, and tolerability of single increasing doses of the dipeptidyl peptidase-4 inhibitor alogliptin in healthy male subjects. Clin Ther 2008;30:513-527.
Gupta V, Kalra S. Choosing a gliptin. Indian J Endocrinol Metab 2011;15:298-308.
Deacon CF. Dipeptidyl peptidase-4 inhibitors in the treatment of type 2 diabetes: a comparative review. Diabetes Obes Metab 2011;13:7-18.
Jermendy G. Dipeptidyl-peptidase-4 inhibitors (gliptins): a new class of oral antidiabetic drugs. Orv Hetil 2011;152:1471-1476.
Messori A, Fadda V, Maratea D, et al. Testing the therapeutic equivalence of alogliptin, linagliptin, saxagliptin, sitagliptin or vildagliptin as monotherapy or in combination with metformin in patients with type 2 diabetes. Diabetes Ther 2014;5:341-344.
Blech S, Ludwig-Schwellinger E, Ulrike-Gräfe-Mody E, et al. The metabolism and disposition of the oral dipeptidyl peptidase-4 inhibitor, linagliptin, in humans. Drug Metab Dispos 2010;38:667-678.
Scheen AJ. Linagliptin for the treatment of type 2 diabetes (pharmacokinetic evaluation). Expert Opin Drug Metab Toxicol 2011;7:1561-1576.
Sortino MA, Sinagra T, Canonico PL. Linagliptin: a thorough characterization beyond its clinical efficacy. Front Endocrinol (Lausanne) 2013;4:16; doi: 10.3389/fendo.2013.00016.
Jelsing J, Vrang N, Van Witteloostuijn SB, et al. The DPP4 inhibitor linagliptin delays the onset of diabetes and preserves β-cell mass in non-obese diabetic mice. J Endocrinol 2012;214:381-387.
Scott D. Treatment of type 2 diabetes in chronic kidney disease: a case for linagliptin in the treatment of diabetes in severe renal impairment. Diabetes Metab Syndr Obes 2013;6:359-363.
Kröller-Schön S, Knorr M, Hausding M, et al. Glucoseindependent improvement of vascular dysfunction in experimental sepsis by dipeptidyl-peptidase 4 inhibition. Cardiovasc Res 2012;96:140-149.
Owens DR, Swallow R, Dugi KA, Woerle HJ. Efficacy and safety of linagliptin in persons with type 2 diabetes inadequately controlled by a combination of metformin and sulphonylurea: a 24-week randomized study. Diabet Med 2011;28:1352-1361.
Gomis R, Owens DR, Taskinen MR, Del Prato S, et al. Longterm safety and efficacy of linagliptin as monotherapy or in combination with other oral glucose-lowering agents in 2121 subjects with type 2 diabetes: up to 2 years exposure in 24-week phase III trials followed by a 78-week open-label extension. Int J Clin Pract 2012;66:731-740.
Schernthaner G, Barnett AH, Emser A, et al. Safety and tolerability of linagliptin: a pooled analysis of data from randomized controlled trials in 3572 patients with type 2 diabetes mellitus. Diabetes Obes Metab 2012;14:470-478.
Graefe-Mody U, Friedrich C, Port A, et al. Linagliptin, a novel DPP-4 inhibitor: no need for dose adjustment in patients with renal impairment (Abstract 822). Diabetologia 2010;53:326.
Graefe-Mody U, Friedrich C, Port A, et al. Effect of renal impairment on the pharmacokinetics of the dipeptidyl peptidase-4 inhibitor linagliptin. Diab Obes Metab 2011;13:939-946.
Heise T, Graefe-Mody EU, Hüttner S, et al. Pharmacokinetics, pharmacodynamics and tolerability of multiple oral doses of linagliptin, a dipeptidyl peptidase-4 inhibitor in male type 2 diabetes patients. Diab Obes Metab 2009;11:786-794.
Holst JJ, Vilsbøll T, Deacon CF. The incretin system and its role in type 2 diabetes mellitus. Mol Cell Endocrinol 2009;297:127-136.
Baggio LL, Drucker DJ. Biology of incretins: GLP-1 and GIP. Gastroenterology 2007;132:2131-2157.
Nauck MA. Unraveling the science of incretin biology. Am J Med 2009;122:3-10.
Drucker DJ. The biology of incretin hormones. Cell Metab 2006;3:153-165.
Sitagliptin: summary of product characteristics. Disponible en: http://www.medicines.org.,uk/emc/medicine/19609.
Scheen AJ. Medication of the month. Sitagliptin-metformin fixed combination (Janumet). Rev Med Liege 2010;65:648-654.
Graefe-Mody U, Rose P, Retlich S, et al. Pharmacokinetics of linagliptin in subjects with hepatic impairment. Br J Clin Pharmacol 2012;74:75-85. doi: 10.1111/j.1365-2125.2012.04173.
Johansen OE, Neubacher D, Von Eynatten M, et al. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol 2012;11:3. doi: 10.1186/1475-2840-11-3.
Williams-Herman D, Engel SS, Round E, et al. Safety and tolerability of sitagliptin in clinical studies: a pooled analysis of data from 10,246 patients with type 2 diabetes. BMC Endocr Disord 2010;10:7.
Schweizer A, Dejager S, Foley JE, et al. Assessing the cardiocerebrovascular safety of vildagliptin: meta-analysis of adjudicated events from a large phase III type 2 diabetes population. Diabetes Obes Metab 2010;12:485-494.
Frederich R. A systematic assessment of cardiovascular outcomes in the saxagliptin drug development program for type 2 diabetes. Postgrad Med 2010;122:16-27.
Scott LJ. Linagliptin in type 2 diabetes mellitus. Drugs 2011;71:611-624.
Del Prato S, Barnett AH, Huisman H, et al. Effect of linagliptin monotherapy on glycaemic control and markers of β-cell function in patients with inadequately controlled type 2 diabetes: a randomized controlled trial. Diabetes Obes Metab 2011;13:258-267.
Svacina S. Incretin therapy and the metabolic syndrome. Vnitr Lek 2011;57:417-421.
Vickers SP, Cheetham SC, Birmingham GD, et al. Effects of the DPP-4 inhibitor, linagliptin, in diet-induced obese rats: a comparison in naive and exenatide-treated animals. Clin Lab 2012;58:787-799.
Hansen HH, Hansen G, Paulsen S, et al. The DPP-IV inhibitor linagliptin and GLP-1 induce synergistic effects on body weight loss and appetite suppression in the dietinduced obese rat. Eur J Pharmacol 2014;741:254-263. doi: 10.1016/j.ejphar.2014.08.010.
Von Websky K, Reichetzeder C, Hocher B. Linagliptin as add-on therapy to insulin for patients with type 2 diabetes. Vasc Health Risk Manag 2013;9:681-694.
Graefe-Mody U, Rose P, Ring A, et al. Assessment of the pharmacokinetic interaction between the novel DPP-4 inhibitor linagliptin and a sulfonylurea, glyburide, in healthy subjects. Drug Metab Pharmacokinet 2011;26:123-129.
Freeman JS. Initial combination therapy for patients with type 2 diabetes mellitus: considerations for metformin plus linagliptin. Drugs Context 2013; doi: 10.7573/dic.212256.
Scheen AJ. Dipeptidylpeptidase-4 inhibitors (gliptins): focus on drug-drug interactions. Clin Pharmacokinet 2010;49:573-588.
Ring A, Port A, Graefe-Mody EU, et al. The DPP-4 inhibitor linagliptin does not prolong the QT interval at therapeutic and supratherapeutic doses. Br J Clin Pharmacol 2011;72:39-50.