medigraphic.com
Colegio de Medicina Interna de México.

2020, Número 5

<< Anterior Siguiente >>

Med Int Mex 2020; 36 (5)


Rifaximina-α en la encefalopatía hepática. Consideraciones fármaco-económicas para México

Frati-Munari R, Galindo-Suárez M

Idioma: Español
Referencias bibliográficas: 56
Paginas: 621-632
Archivo PDF: 266.01 Kb.


RESUMEN

Antecedentes: La encefalopatía hepática es una manifestación de enfermedad hepática grave que puede llevar a la muerte y en cuyo tratamiento se prescriben diversos fármacos. La rifaximina-α se ha prescrito con éxito en el tratamiento de la encefalopatía hepática abierta, la prevención de recaídas de encefalopatía hepática y en la encefalopatía hepática mínima.
Objetivo: Realizar un análisis sencillo de los costos del tratamiento de la encefalopatía hepática con los precios de México.
Material y Método: Estudio retrospectivo efectuado con los datos publicados de eficacia, el precio máximo al público de rifaximina-α, neomicina, lactulosa y L-ornitina, L-aspartato y los costos hospitalarios del IMSS publicados para 2018, se calculó un análisis de minimización de costos, el costo de la atención de un episodio de encefalopatía hepática abierta y el de prevención de recaídas.
Resultados: Considerando eficacia similar, el análisis de minimización de costos mostró que el tratamiento con rifaximina fue costo-ahorrador respecto a las otras alternativas terapéuticas. Para el tratamiento de la encefalopatía hepática abierta la combinación rifaximina-lactulosa se ha observado con mejores resultados clínicos, fue costo-efectiva principalmente por menor duración de hospitalización. En la prevención de recaídas, el costo del tratamiento continuo durante un año con rifaximina se calculó en 64,330 pesos y con lactulosa de 172,012 pesos por paciente.
Conclusiones: La rifaximina-α es una alternativa dominante en el tratamiento de episodios agudos de encefalopatía hepática y para prevenir sus recaídas.


REFERENCIAS (EN ESTE ARTÍCULO)

  1. MEXICO, Principales causas de mortalidad desde 1938. Recopilación: Ing. Manuel Aguirre Botello, con datos de INEGI, OMS y SINAIS. http://www.mexicomexico.org/Voto/ MortalidadCausas.htm

  2. Leise MD, Poterucha JJ, Kamath PS, Kim WR. Management of hepatic encephalopathy in the hospital. Mayo Clin Proc 2014; 89: 241-253. doi: 10.1016/j.mayocp.2013.11.009.

  3. Torre Delgadillo A. Encefalopatía hepática. Rev Gastroenterol Mex 2010; 75 (supl 1): 190-92.

  4. D’Amico G, García-Tsao G, Pagliaro L. Natural history and prognostic indicators of survival in cirrhosis: a systematic review of 118 studies. J Hepatol 2006; 44: 217-231. doi: 10.1016/j.jhep.2005.10.013.

  5. Roggeri DP, Roggeri P, Rossi E, Cinconze E, Gasbarrini A, Monici Preti PA, De Rosa M. Overt hepatic encephalopathy in Italy: clinical outcomes and healthcare costs. Hepatic Med: Evidence Res 2015; 7: 37-42. doi: 10.2147/HMER. S87594

  6. Saab S. Evaluation of the impact of rehospitalization in the management of hepatic encephalopathy. Int J Gen Med 2015; 8: 165-173. doi: 10.2147/IJGM.S81878

  7. Bajaj JS, O’Leary JG, Tandon P, Wong F, García-Tsao G, Kmath PS, et al. Hepatic encephalopathy is associated with mortality in patients with cirrhosis independent of other extrahepatic organ failures. Clin Gastroenterol Hepatol 2017; 15: 565-74. doi: 10.1016/j.cgh.2016.09.157

  8. Bajaj JS, Schubert CM, Heuman DM, Wade JB, Gibson DP, Tpaz A, et al. Persistence of cognitive impairment after resolution of overt hepatic encephalopathy. Gastroenterol 2010; 138: 2332-40. doi: 10.1053/j.gastro.2010.02.015

  9. Patidar K, Thacker L, White N, Noble N, Sterling NK, Stravitz R, et al. Minimal hepatic encephalopathy is independently associated with poor survival and increased rate of hospitalization: a prospective study of 170 patients. J Hepatol 2014; 60 (suppl): S236

  10. Bajaj JS, Saeian K, Schubert CM, Hafezullah M, Franco J, Varma RR et al. Minimal hepatic encephalopathy is associated with motor vehicle crashes: the reality beyond the driving test. Hepatology 2009; 50: 1175-83.

  11. Dia r io Ofic i a l de la Federación. ACDO.AS3. HCT.291117/275.P.DF. 28 diciembre 2017

  12. Torre A. Conceptos actuales sobre fisiopatología y diagnóstico de la encefalopatía hepática. Rev Invest Clin 2008; 60: 321-331.

  13. Guías de Práctica Clínica. Diagnóstico y tratamiento de la encefalopatía hepática en el adulto. Secretaría de Salud 2013. http://www.cenetec.salud.gob.mx/interior/catalogoMaestroGPC. htlm

  14. Scarpignato C, Pelosini I. Experimental and clinical pharmacology of rifaximin, a gastrointestinal selective antibiotic. Digestion 2006; 73 (suppl 1): 13-27. doi: 10.1159/000089776

  15. Blandizzi C, Viscomi GC, Marzo A, Scarpignato C. Is generic rifaximin still a poorly absorbed antibiotic? A comparison of branded and generic formulations in healthy volunteers. Pharm Res 2014; 85: 39-44. doi: 10.1016/j. phrs.2014.05.001

  16. Calanni F, Renzulli C, Barbanti M, Viscomi GC. Rifaximin: beyond the traditional antibiotic activity. J Antibiot 2014; 67: 667-70.

  17. Kimer N, Krag A, Maller S, Bendtsen F, Gluud LL. Systematic review with meta-analysis: the effects of rifaximin in hepatic encephalopathy. Aliment Pharmacol Ther 2014; 40: 123-32. doi: 10.1111/apt.12803

  18. Sharma BC, Sharma P, Lunia MK, Srivastava S, Goyal R, Sarin SK. A randomized, double-blind, controlled trial comparing rifaximin plus lactulose with lactulose alone in the treatment of overt hepatic encephalopathy. Am J Gastroenterol 2013; 108: 1458-63. doi: 10.1038/ajg.2013.219

  19. Wang Z, Chu P, Wang W. Combination of rifaximin and lactulose improves clinical efficacy and mortality in patients with hepatic encephalopathy. Drug Des Devel Ther 2019; 13: 1-11. DOI https://doi.org/10.2147/DDDT.S172324

  20. Leevy C, Phillips JA. Hospitalizations during the use of rifaximin versus lactulose for the treatment of hepatic encephalopathy. Dig Dis Sci 2007; 52: 737-41. DOI: 10.1007/ s10620-006-9442-4

  21. Bass NM, Mullen KD, Sanyal A, Poordad F, Neff G, Leevy CB, et al. Rifaximin treatment in hepatic encephalopathy. New Eng J Med 2010, 362: 1071-81. doi: 10.1056/NEJMoa0907893

  22. Mullen KD, Sanyal AJ, Bass NM, Poordad FF, Sheikh MY, Frederick T, et al. Rifaximin is safe and well tolerated for long-term mantainance of remission from overt hepatic encephalopathy. Clin Gastroenterol Hepatol 2014; 12: 1390-7. https://doi.org/10.1016/j.cgh.2013.12.021

  23. Kimer N, Krag A, Gluud LL. Safety, efficacy, and patient acceptability of rifaximin for hepatic encephalopathy. Patient Pref Adherence 2014; 8: 331-8. doi: 10.2147/PPA.S41565

  24. Bajaj JS, Barrett C, Bortey E, Paterson C, Forbes WR. Prolonged remission from hepatic encephalopathy with rifaximin: results of a placebo crossover analysis. Aliment Pharmacol Ther 2015; 41: 39-45. doi: 10.1111/apt.12993

  25. Hudson M, Radwan A, Di Maggio P, Cipelli R, Ryder SD, Dillon JF et al. The impact of rifaximin-α on the hospital resource use associated with the management of patients with hepatic encephalopathy: a retrospective observational study (IMPRESS). Frontine Gastroenterol 2017; 8: 243-51. doi: 10.1136/flgastro-2016-100792

  26. Bajaj JS, Heuman DM, Wade JB, Gibson DP, Saeian K, Wegelin JA, et al. Rifaximin improves driving simulator performance in a randomized trial of patients with minimal hepatic encephalopathy. Gastroenterology 2011; 140: 478- 87. doi: 10.1053/j.gastro.2010.08.061

  27. Sidhu SS, Goyal O, Mishra BP, Sood A, Chhina RS, Soni RK. Rifaximin improves psychometric performance and healthrelated quality of life of patients with minimal hepatic encephalopathy (the RIME trial). Am J Gastroenterol 2011; 106: 307-16. doi: 10.1038/ajg.2010.455

  28. Sloan F. Valuing health care. Cost, benefits and effectiveness of pharmaceuticals and other medical technologies. New York: Cambridge University Press, 1998.

  29. Abdo-Francis JM, Pérez-Hernández JL, Hinojosa-Ruiz A, Hernández-Vásquez JF. Disminución de la estancia hospitalaria con el uso de L-ornitina L-aspartato (LOLA) en pacientes con encefalopatía hepática. Rev Gastroenterol Mex 2010; 75: 135-41.

  30. Goh E, Stokes CS, Sidhu SS, Vistrup H, Gluud L. Morgan MY. L-ornithine L-aspartate for the prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Systematic Reviews 2018; Issue 5. Ast N° CD012410. DOI: 10.002/14651858.CD0124 10.pub2

  31. Sidhu SS, Goyal O, Parker RA, Kishorel T, Sood A. Rifaximin vs lactulose in treatment of minimal hepatic encephalopathy. Liver Int 2016; 36: 378-85. https://doi.org/10.1111/ liv.12921

  32. Rathi S, Chopra M, Chouduri G, Sharma P, Madan K, Chhabra M, et al. Prevalence of minimal hepatic encephalopathy in patients with liver cirrhosis: a cross-sectional, clinic-epidemiological, multicenter, nationwide study in India: the predict study. J Clin Exper Hepatol 2019. doi: 10.1016/j.jceh.2018.09.009

  33. Bai M, Yang Z, QiX, Fan D, Han G. L-ornithine-L-aspartate for hepatic encephalopathy in patients with cirrosis: a metaanalysis of randomized controlled trials. J Gastroenterol Hepatol 2013; 28: 783-92. doi: 10.1111/jgh.12142

  34. Goyal O, Sidhu SS, Kishore N. Minimal hepatic encephalopathy in cirrhosis. How long to treat? Ann Hepatol 2017; 16: 115-22. DOI: 10.5604/16652681.1226822

  35. Berger M, Bingefors K, Hedblom E, Smith MD, Pashos C, Torrance G. Health care cost, quality and outcomes. New Jersey, ISPOR Book of Terms, 2003.

  36. Coronel-Castillo CE, Contreras-Carmona J, Frati-Munari AC, Ménez-Sánchez N. Eficacia de la rifaximina en los diferentes escenarios clínicos de la encefalopatía hepática. Rev Gastroenterol Mex 2020. https://doi.org/10.1016/j. rgmx.2019.09.001

  37. Morgan MH, Read AE, Speller DC. Treatment of hepatic encephalopathy with metronidazole. Gut 1982; 23: 1-7. doi: 10.1136/gut.23.1.1

  38. Mekky MA, Riad AR, Gaber MA, Abdel-Malek MO, Swifee YM. Rifaximin versus metronidazole in management of acute episode of hepatic encephalopathy: an open labeled randomized clinical trial. Arab J Gastroenterol 2018; 19: 76-9. doi: 10.1016/j.ajg.2018.06.001

  39. Phillips MA, Stanley SL. Quimioterapia de infecciones por protozoos. En: Brunton LL, Lazo JS, Parker KL. Goodman & Gilman Las bases farmacológicas de la terapéutica. 11ª ed. McGraw Hill, 2008; 1049-1071.

  40. Strauss F, Tramote R, Silva EP, Caly WR, Honain NZ, Maffei RA, et al. Double-blind, randomized clinical trial comparing neomycin and placebo in the treatment of exogenous hepatic hencephalopathy. Hepatogastroenterology 1992; 39: 542-45.

  41. Curioso WH, Mokemuller KE. Neomycin should not be used to treat hepatic encephalopathy. BMJ 2001; 323: 233.

  42. Chambers HE. Aminoglucósidos. En: Brunton LL, Lazo JS, Parker KL. Goodman & Gilman Las bases farmacológicas de la terapéutica. 11ª ed. McGraw Hill, 2008; 1155-72.

  43. Zhu GQ, Shi KQ, Huang S, Wang LR, Lin YQ, Huang GQ, et al. Systematic review with network meta-analysis. The comparative effectiveness and safety of interventions in patients with overt hepatic encephalopathy. Aliment Pharmacol Ther 2015; 41: 624-35. doi: 10.1111/apt.13122

  44. Sidhu SS, Sharma BC, Goyal O, Kishore H, Kaur N. L-ornithine- L-aspartate in bouts of overt hepatic encephalopathy. Hepatology 2018; 67: 700-10. doi: 10.1002/hep.29410

  45. Varakanahalli S, Sharma BC, Srivastava S, Sachdeva S, Dahale AC. Secondary prophylaxis of hepatic encephalopathy in cirrhosis of the liver: a double-blind randomized controlled trial of L-ornithine-L-aspartate versus placebo. Eur J Gastroenterol Hepatol 2018; 30: 951-8. doi: 10.1097/ MEG.0000000000001137

  46. Higuera de la Tijera F, Servín-Caamaño A, Salas-Gordillo F, Pérez-Hernández JL, Abdo-Francis JM, Camacho Aguilera J, et al. Primary prophylaxis to prevent hepatic encephalopathy in cirrhotic patients with acute variceal bleeding. Can J Gastroenterol Hepatol 2018; 2018: 3015891. doi: 10.1155/2018/3015891

  47. Hanouneh MA, Hanouneh IA, Hashash IG, Law R, Modaresi Esfeh J, Lopez R, et al. The role of rifaximin in the primary prophilaxis of spontaneous bacterial peritonitis in patients with liver cirrhosis. J Clin Gastroenterol 2012; 46: 709-715. DOI: 10.1097/MCG.0b013e3182506dbb

  48. Shokoohi S, Zivony A, Le TD, Zaman A, Jou J. Rifaximin is associated with decreased incidence of spontaneous bacterial peritonitis in cirrhotic with ascites. Hepatology 2013; 58 (suppl): 858A Abst 1337.

  49. Kamal F, Kahn MA, Kahn Z, Cholankeril G, Hammad TA, Lee WM et al. Rifaximin for the prevention of spontaneous bacterial peritonitis and hepatorenal syndrome in cirrhosis: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol 2017; 29: 1109-17. doi: 10.1097/ MEG.0000000000000940

  50. Ibrahim ES, Alsebaey A, Zaghla H, Abdelmageed SM, Gameel K, Abdelsameea E. Long-term rifaximin therapy as a primary prevention of hepatorenal syndrome. Eur J Gastroenterol Hepatol 2017; 29: 1247-50. doi: 10.1097/ MEG.0000000000000967

  51. Kang SH, Lee YB, Lee JH, Nam JY, Chang Y, Cho H et al. Rifaximin treatment is associated with reduced risk of cirrhotic complications and prolonged overall survival in patients experiencing hepatic encephalopathy. Aliment Pharmacol Ther 2017; 46: 845-55. doi: 10.1111/ apt.14275

  52. Arieira C, Cúrdia Goncalves C, Dias de Castro F, Maghaläes J, Marinho C, Cotter J. Hospital readmission rates in hepatic cirrhosis: which patients present higher risk? UEG journal 2018; 6 (8S): A347.

  53. Berni E, Poole CD, Conway P, Radwan A, Currie CJ. Costeffectiveness of rifaximin-A 550 mg (Xifaxan/Tagaxan) in the reduction of recurrence of overt hepatic encephalopathy. UEG journal 2015; 3 (5S): A510.

  54. Berni E, Murphy D, Whitehouse J, Conway P, Di Maggio P, Currie CJ, et al. Evaluation of the cost-effectiveness of rifaximina-α for the management of patients with hepatic encephalopathy in the United Kingdom. Curr Med Res Opin 2018; 34: 2001-2008. doi: 10.1080/03007995.2018.1499506

  55. Kabeshova A, Hariz S, Tsakeu E, Benamouzig R, Launois R. Cost-effectiveness analysis of rifaximin-α administration for the reduction of episodes of overt hepatic encephalopathy in recurrence compared with standard treatment in France. Therap Adv Gastroenterol 2016; 9141: 473-82. doi: 10.1177/1756283X16644249

  56. Roggeri DP, Roggeri A. Economic impact of the use of rifaximin 550 mg twice daily for the treatment of overt hepatic encephalopathy. Hepat Med 2017; 9: 37-43. doi: 10.2147/ HMER.S146438




2020     |     www.medigraphic.com