Dapagliflozin, a novel oral antidiabetic with an uncertain future;Dapagliflozina, novedoso antidiabético oral de futuro incierto

Farmacia Hospitalaria

Volumn 38, Issue 6, 2014, Pages 468-474

  Vilaplana, Belén Escudero ^a   Carretón, María José Almodovar ^b   Hernández, Silvia Herrero ^b  

^a HOSPITAL UNIVERSITARIO PUERTA DE HIERRO   (Spain)

^b Laboratorio de Microbiologia   (Spain)

Author keywords

Cost; Dapagliflozin; Diabetes mellitus; Effectiveness; Evidence; Hypoglycemic agents; Safety; Sodium glucose co transporter 2 inhibitor

Indexed keywords

2-(3-(4-ETHOXYBENZYL)-4-CHLOROPHENYL)-6-HYDROXYMETHYLTETRAHYDRO-2H-PYRAN-3,4,5-TRIOL; ANTIDIABETIC AGENT; BENZHYDRYL DERIVATIVE; GLUCOSIDE;

DIABETES MELLITUS; DIABETES MELLITUS, TYPE 2; ECONOMICS; HUMAN; META ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC);

BENZHYDRYL COMPOUNDS; DIABETES MELLITUS; DIABETES MELLITUS, TYPE 2; GLUCOSIDES; HUMANS; HYPOGLYCEMIC AGENTS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 85017330610     PISSN: 11306343     EISSN: 21718695     Source Type: Journal    
DOI: 10.7399/fh.2014.38.6.7963     Document Type: Article

References (25)

1. Soriguer, F, Goday, A, Bosch-Comas, A, Bordiú, E, Calle-Pascual, A, Carmena, R, et al. Prevalence of diabetes mellitus and impaired glucose regulation in Spain: the Di@bet.es Study. Diabetologia. 55 (2012), 88–93.
2. Menéndez Torre, E, Lafita Tejedor, J, Artola Menéndez, S, Millán Núñez-Cortés, J, Alonso García, A, Puig Domingo, M, et al. Recomendaciones para el tratamiento farmacológico de la hiperglucemia en la diabetes tipo 2. Av Diabetol. 26 (2010), 331–338.
3. Agencia Española del Medicamento y Productos Sanitarios: Forxiga. Ficha técnica [Acceso en marzo 2014]. Disponible en: http://www.ema.europa.eu/docs/es_ES/document_library/EPAR_-_Product_Information/human/002322/WC500136026.pdf.
4. Advisory Committee, 2011. Silver Spring: U. S. Food and Drugs Administration. [Acceso en marzo de 2014]. Disponible en: http://www.fda.gov/DOWNLOADS/ADVISORYCOMMITTEES/COMMIT-TEESMEETINGMATERIALS/DRUGS/ENDOCRINOLOGICANDMETA-BOLICDRUGSADVISORYCOMMITTEE/UCM262994.PDF.
5. FDAnews release (888-INFO-FDA), 2014, Silver Spring, Silver Spring [Acceso en marzo de 2014]. Disponible en: http://www.fda.gov/NewsEvents/Newsroom/PressAnnounce-ments/ucm381053.htm.
6. Wright, EM, Turk, E, The sodium/glucose cotransport family SLC5. Eur J Physiol. 447 (2004), 510–518.
7. Carlos Crespo, Max Brosa, Aitana Soria-Juan, Alfonso Lopez-Alba, Noemí López-Martínez, Bernat Soria. Costes directos de la diabetes mellitus y de sus complicaciones en España (Estudio SECCAID: Spain estimated cost Ciberdem-Cabimer in Diabetes). Av Diabetol. 29 (2013), 182–189.
8. Catálogo de Especialidades Farmacéuticas 2013. Consejo General de Colegios Oficiales de Farmacéuticos. Madrid. 2013.
9. European Public Assessment Reports: Forxiga (documento en internet), 1995, Londres, Londres [acceso en febrero 2014]. Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002322/WC500136025.pdf.
10. Ferrannini, E, Ramos, SJ, Salsali, A, Tang, W, List, JF, Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care. 33:10 (2010), 2217–2224.
11. Bailey, CJ, Iqbal, N, T’ joen, C, List, JF, Dapagliflozin monotherapy in drug-naïve patients with diabetes: a randomized-controlled trial of low-dose range. Diabetes Obes Metab. 14:10 (2012), 951–959.
12. Bailey, CJ, Gross, JL, Pieters, A, Bastien, A, List, JF, Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 375:9733 (2010), 2223–2233.
13. Strojek, K, Yoon, KH, Hruba, V, Elze, M, Langkilde, AM, Parikh, S, Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab. 13:10 (2011), 928–938.
14. Rosenstock, J, Vico, M, Wei, L, Salsali, A, List, JF, Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care. 35:7 (2012), 1473–1478.
15. Wilding, JP, Woo, V, Soler, NG, Pahor, A, Sugg, J, Rohwedder, K, et al., Dapagliflozin 006 Study Group. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann Intern Med. 156:6 (2012), 405–415.
16. Nauck, MA, Del Prato, S, Meier, JJ, Durán-García, S, Rohwedder, K, Elze, M, et al. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 34:9 (2011), 2015–2022.
17. Informes 2014: dapagliflozina. Centro Andaluz de Documentación e Información de Medicamentos.
18. Stratton, IM, Adler, AI, Neil, HA, Matthews, DR, Manley, SE, Cull, CA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 321:7258 (2000), 405–412.
19. New Drug Evaluation, N° 121. Dapaglitozin. Regional Drug and Therapeutics Center, 2012, London, London.
20. Dapagliflozin 5 mg and 10 mg film-coated tablets (Forxiga®). Scottish Medicines Consortium. Glasgow: 2012. National Health System Scotland.
21. Menéndez Torre, E, Lafita Tejedor, J, Artola Menéndez, S, Millán Núñez-Cortés, J, Alonso García, A, Puig Domingo, M, et al., Sociedad Española de Diabetes. Recomendaciones para el tratamiento farmacológico de la hiperglucemia en la diabetes tipo 2. Rev Clin Esp. 211:3 (2011), 147–155.
22. Belcher, G, Lambert, C, Edwards, G, Urquhart, R, Matthews, DR, Safety and tolerability of pioglitazone, metformin, and gliclazide in the treatment of type 2 diabetes. Diabetes Res Clin Pract. 70:1 (2005), 53–62.
23. Scott, R, Wu, M, Sanchez, M, Stein, P, Efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy over 12 weeks in patients with type 2 diabetes. Int J Clin Pract. 61:1 (2007), 171–180.
24. World Health Organization. Diabetes. WHO Technical Report Series #312. Geneva: 2012.
25. Musso, G, Gambino, R, Cassader, M, Pagano, G, A novel approach to control hyperglycemia in type 2 diabetes: sodium glucose co-transport (SGLT) inhibitors: systematic review and meta-analysis of randomized trials. Ann Med. 44:4 (2012), 375–393.