Criterios para el uso e investigación de medicamentos off-label frente al covid-19 en Latinoamérica

La pandemia por COVID-19 representa una de los retos más importantes en materia de salud pública. La ausencia de evidencia científica sólida y la severidad del cuadro clínico han justificado el uso compasivo de medicamentos off-label. No obstante, el uso indiscriminado de estos medicamentos, sin un...

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Autores:
Carlosama Rosero, Yeison Harvey
Tipo de recurso:
Article of investigation
Fecha de publicación:
2021
Institución:
Universidad Cooperativa de Colombia
Repositorio:
Repositorio UCC
Idioma:
OAI Identifier:
oai:repository.ucc.edu.co:20.500.12494/49074
Acceso en línea:
https://doi.org/10.47373/rfcs.2021.v23.1778
https://hdl.handle.net/20.500.12494/49074
Palabra clave:
Pedagogía
Ivermectina
COVID-19
Educación médica
Off.label
Rights
openAccess
License
NINGUNA
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repository_id_str
dc.title.none.fl_str_mv Criterios para el uso e investigación de medicamentos off-label frente al covid-19 en Latinoamérica
title Criterios para el uso e investigación de medicamentos off-label frente al covid-19 en Latinoamérica
spellingShingle Criterios para el uso e investigación de medicamentos off-label frente al covid-19 en Latinoamérica
Pedagogía
Ivermectina
COVID-19
Educación médica
Off.label
title_short Criterios para el uso e investigación de medicamentos off-label frente al covid-19 en Latinoamérica
title_full Criterios para el uso e investigación de medicamentos off-label frente al covid-19 en Latinoamérica
title_fullStr Criterios para el uso e investigación de medicamentos off-label frente al covid-19 en Latinoamérica
title_full_unstemmed Criterios para el uso e investigación de medicamentos off-label frente al covid-19 en Latinoamérica
title_sort Criterios para el uso e investigación de medicamentos off-label frente al covid-19 en Latinoamérica
dc.creator.fl_str_mv Carlosama Rosero, Yeison Harvey
dc.contributor.author.none.fl_str_mv Carlosama Rosero, Yeison Harvey
dc.subject.none.fl_str_mv Pedagogía
Ivermectina
COVID-19
Educación médica
Off.label
topic Pedagogía
Ivermectina
COVID-19
Educación médica
Off.label
description La pandemia por COVID-19 representa una de los retos más importantes en materia de salud pública. La ausencia de evidencia científica sólida y la severidad del cuadro clínico han justificado el uso compasivo de medicamentos off-label. No obstante, el uso indiscriminado de estos medicamentos, sin un fundamento sólido por parte de los médicos puede representar un peligro para la salud de los pacientes. Por otra parte, la comunidad médica y científica de Latinoamérica está llamada a evaluar hipótesis de investigación que mitiguen el impacto de la pandemia en nuestras poblaciones.Tomando como ejemplo pedagógico el uso de la ivermectina, se proponen criterios como la plausibilidad biológica, la evidencia metodológica y estadísticamente aceptable, una respuesta clínica favorable, un perfil farmacológico seguro, la factibilidad y el interés altruista como sustento para el empleo de medicamentos off-label durante la pandemia. Estos criterios posibilitarían un uso racional de medicamentos y priorizar en el contexto de una investigación las opciones terapéuticas posiblemente más efectivas.
publishDate 2021
dc.date.issued.none.fl_str_mv 2021-05-18
dc.date.accessioned.none.fl_str_mv 2023-03-29T19:42:14Z
dc.date.available.none.fl_str_mv 2023-03-29T19:42:14Z
dc.type.none.fl_str_mv Artículos Científicos
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dc.identifier.uri.none.fl_str_mv https://doi.org/10.47373/rfcs.2021.v23.1778
https://hdl.handle.net/20.500.12494/49074
dc.identifier.bibliographicCitation.none.fl_str_mv Carlosama-Rosero, Y. H. Criterios Para El Uso E investigación De Medicamentos off-Label Frente Al Covid-19 En Latinoamérica. Rev. Fac. Cienc. Salud Univ. Cauca 2021, 23, 39-46.
url https://doi.org/10.47373/rfcs.2021.v23.1778
https://hdl.handle.net/20.500.12494/49074
identifier_str_mv Carlosama-Rosero, Y. H. Criterios Para El Uso E investigación De Medicamentos off-Label Frente Al Covid-19 En Latinoamérica. Rev. Fac. Cienc. Salud Univ. Cauca 2021, 23, 39-46.
dc.relation.isversionof.none.fl_str_mv https://revistas.unicauca.edu.co/index.php/rfcs/article/view/1778/1541
dc.relation.references.none.fl_str_mv Roman YM, Burela PA, Pasupuleti V, Piscoya A, Vidal JE, Hernandez AV. Ivermectin for the Treatment of Coronavirus Disease 2019: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Clin Infect Dis. 2021. https://doi.org/10.1093/cid/ciab591
López-Medina E, López P, Hurtado IC, Dávalos DM, Ramirez O, Martínez E, et al. Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19 A Randomized Clinical Trial. JAMA. 2021;325(14):1426-1435. https://doi.org/10.1001/ jama.2021.3071
Marina AM, Jaime KJ, Consuelo MB, Francisco LN, Manuel MNJ. Las enfermedades “olvidadas” de América Latina y el Caribe: un problema de salud pública global. Revista mexicana de ciencias farmacéuticas. 2012; 43(1):33-41
Lupkin S. Remdesivir Priced At More Than $3100 For A Course Of Treatment [Internet]. National Public Radio. 2020. [Citado: octubre 27, 2020). Disponible en: https://www.npr.org/sections/healthshots/2020/06/29/884648842/remdesivir-priced-atmore-than-3-100-for-a-course-of-treatment
Ahmed S, Johnson K. Operaciones bursátiles en Gilead por fármaco contra COVID-19 podrían llamar atención de reguladores [Internet]. Reuters. 2020. [Citado: noviembre 02, 2021]. Disponible en: https:// www.reuters.com/article/salud-coronavirus-gileadidLTAKBN2382VS
Sanders JM, Monogue ML, Jodlowski TZ, Cutrell JB. Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19): A Review. JAMA. 2020; 323(18):1824- 36. https://doi.org/10.1001/jama.2020.6019
Gritti G, Raimondi F, Ripamonti D, Riva I, Landi F, Alborghetti L, et al. Use of siltuximab in patients with COVID-19 pneumonia requiring ventilatory support. MedRxiv. 2020: 04.01.20048561. https://doi.org/10.11 01/2020.04.01.20048561
Zhong M, Sun A, Xiao T, Yao G, Sang L, Zheng X, et al. A Randomized, Single-blind, Group sequential, Activecontrolled Study to evaluate the clinical efficacy and safety of α-Lipoic acid for critically ill patients with coronavirus disease 2019(COVID-19). MedRxiv. 2020:04.15.20066266. https://doi.org/10.1101/2020.04.15.20066266
McCreary EK, Pogue JM. Coronavirus Disease 2019 Treatment: A Review of Early and Emerging Options. Open Forum Infect Dis. 2020; 7(4):ofaa105. https:// doi.org/10.1093/ofid/ofaa105
Bray M, Rayner C, Noël F, Jans D, Wagstaff K. Ivermectin and COVID-19: A report in Antiviral Research, widespread interest, an FDA warning, two letters to the editor and the authors’ responses. Antiviral Res. 2020; 178:104805. https://doi.org/10.1016/j.antiviral.2020.104805
Schmith VD, Zhou J, Lohmer LR. The Approved Dose of Ivermectin Alone is not the Ideal Dose for the Treatment of COVID-19. Clin Pharmacol Ther. 2020; 108(4):762-765. https://doi.org/10.1002/cpt.1889
Momekov G, Momekova D. Ivermectin as a potential COVID-19 treatment from the pharmacokinetic point of view: antiviral levels are not likely attainable with known dosing regimens. MedRxiv. 2020.04.11.20061804. https:// doi.org/10.1101/2020.04.11.20061804
Osei-Atweneboana MY, Eng JK, Boakye DA, Gyapong JO, Prichard RK. Prevalence and intensity of Onchocerca volvulus infection and efficacy of ivermectin in endemic communities in Ghana: a two-phase epidemiological study. The Lancet. 2007; 369(9578):2021-9. https:// doi.org/10.1016/S0140-6736(07)60942-8
Kyelem D, Biswas G, Bockarie MJ, Bradley MH, El-Setouhy M, Fischer PU, et al. Determinants of success in national programs to eliminate lymphatic filariasis: a perspective identifying essential elements and research needs. Am J Trop Med Hyg. 2008; 79:480-4
Lespine A, Dupuy J, Alvinerie M, Comera C, Nagy T, Krajcsi P, et al. Interaction of macrocyclic lactones with the multidrug transporters: the bases of the pharmacokinetics of lipidlike drugs. Curr Drug Metab. 2009; 10:272–88. https:// doi.org/10.2174/138920009787846297
Chandler RE. Serious Neurological Adverse Events after Ivermectin-Do They Occur beyond the Indication of Onchocerciasis?. Am J Trop Med Hyg. 2018; 98(2):382- 8. https://doi.org/10.4269/ajtmh.17-0042
Ch JV. Ivermectina: Sus Múltiples Usos, Seguridad y Toxicidad. Educación Médica Continua. 2010; 26(4):358-368
Rajter JC, Sherman MS, Fatteh N, Vogel F, Sacks J, Rajter J-J. Use of Ivermectin Is Associated With Lower Mortality in Hospitalized Patients With Coronavirus Disease 2019. Chest Journal. 2020; 159(1):85-92. https://doi.org/10.1016/j. chest.2020.10.009
Silva-Aycaguer LC. Las pruebas de significación estadística: seis décadas de fuegos artificiales. Rev Fac Nac Salud Pública. 2016; 34 (3):372-9. https://doi. org/10.17533/udea.rfnsp.v34n3a11
Veiga de Cabo J, Fuente Díez E de la, Zimmermann Verdejo M. Modelos de estudios en investigación aplicada: conceptos y criterios para el diseño. Med Segur Trab. 2008; 54:81-8
Hernández-Avila M, Garrido-Latorre F, López-Moreno S. Diseño de estudios epidemiológicos. Salud Pública México. 2000; 42:144–54. https://doi.org/10.1590/ S0036-36342000000200010
Kindler E, Thiel V. SARS-CoV and IFN: Too Little, Too Late. Cell Host Microbe. 2016; 19:139–41. https://doi. org/10.1016/j.chom.2016.01.012
Billiau A. Interferon-gamma: biology and role in pathogenesis. Adv Immunol. 1996; 62:61–130. https:// doi.org/10.1016/s0065-2776(08)60428-9
Frieman M, Yount B, Heise M, Kopecky-Bromberg SA, Palese P, Baric RS. Severe Acute Respiratory Syndrome Coronavirus ORF6 Antagonizes STAT1 Function by Sequestering Nuclear Import Factors on the Rough Endoplasmic Reticulum/ Golgi Membrane. J Virol. 2007; 81:9812-24. https://doi. org/10.1128/JVI.01012-07
Petrosillo N, Viceconte G, Ergonul O, Ippolito G, Petersen E. COVID-19, SARS and MERS: are they closely related?. Clin Microbiol Infect. 2020; 26:729–34. https://doi.org/10.1016/j.cmi.2020.03.026
Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020; 178:104787. https://doi.org/10.1016/j.antiviral.2020.104787
Varghese FS, Kaukinen P, Gläsker S, Bespalov M, Hanski L, Wennerberg K, et al. Discovery of berberine, abamectin and ivermectin as antivirals against chikungunya and other alphaviruses. Antiviral Res. 2016; 126:117-24. https://doi. org/10.1016/j.antiviral.2015.12.012
Tay MYF, Fraser JE, Chan WKK, Moreland NJ, Rathore AP, Wang C, et al. Nuclear localization of dengue virus (DENV) 1-4 non-structural protein 5; protection against all 4 DENV serotypes by the inhibitor Ivermectin. Antiviral Res. 2013; 99:301-6. https://doi.org/10.1016/j. antiviral.2013.06.002
Manterola DC, Zavando MD. Cómo interpretar los “Niveles de Evidencia” en los diferentes escenarios clínicos. Rev Chil Cir. 2009; 61:582–95. https://doi. org/10.4067/S0718-40262009000600017
WHO COVID-19 Solidarity Therapeutics Trial [Internet]. World Healt Organization. 2020. [Citado: octubre 27, 2020]. Disponible en: https://www.who. int/emergencies/diseases/novel-coronavirus-2019/ global-research-on-novel-coronavirus-2019-ncov/ solidarity-clinical-trial-for-covid-19-treatments
Paumgartten FJR, Oliveira ACAX de, Paumgartten FJR, Oliveira ACAX de. Off label, compassionate and irrational use of medicines in Covid-19 pandemic, health consequences and ethical issues. Ciênc Amp Saúde Coletiva. 2020; 25(9):3413–9. https://doi. org/10.1590/1413-81232020259.16792020
Mehra MR, Desai SS, Ruschitzka F, Patel AN. RETRACTED: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis. The Lancet. 2020: S0140-6736(20)31180-6. https://doi.org/10.1016/ S0140-6736(20)31180-6
Ongoing Living Update of Potential COVID-19 Therapeutics: summary of rapid systematic reviews [Internet]. Pan American Health Organization. 2020. [Citado: mayo 08, 2020]. Disponible en: https://iris.paho.org/bitstream/ handle/10665.2/52025/PAHOIMSCovid19200008_eng. pdf?sequence=1&isAllowed=y
Kalil AC. Treating COVID-19—Off-Label Drug Use, Compassionate Use, and Randomized Clinical Trials During Pandemics. JAMA. 2020; 323(19):1897-8. doi:10.1001/jama.2020.4742
Launch of a European clinical trial against COVID-19 [Internet]. Institut national de la santé et de la recherche médicale. 2020. [Citado: mayo 06, 2021]. Disponible en: https://presse.inserm.fr/en/launch-ofa-european-clinical-trial-against-covid-19/38737/
WHO, UN Foundation and partners launch first-of-its-kind COVID-19 Solidarity Response Fund [Internet]. World Healt Organization. 2020 [Citado: mayo 06, 2020]. Disponible en: https://www.who.int/news/item/13-03-2020-who-unfoundation-and-partners-launch-first-of-its-kind-covid-19- solidarity-response-fund
Kupferschmidt K, Cohen J. Race to find COVID-19 treatments accelerates. Science 2020; 367:1412–3. Doi: 10.1126/science.367.6485.1412
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spelling Carlosama Rosero, Yeison Harvey2023-03-29T19:42:14Z2023-03-29T19:42:14Z2021-05-18https://doi.org/10.47373/rfcs.2021.v23.1778https://hdl.handle.net/20.500.12494/49074Carlosama-Rosero, Y. H. Criterios Para El Uso E investigación De Medicamentos off-Label Frente Al Covid-19 En Latinoamérica. Rev. Fac. Cienc. Salud Univ. Cauca 2021, 23, 39-46.La pandemia por COVID-19 representa una de los retos más importantes en materia de salud pública. La ausencia de evidencia científica sólida y la severidad del cuadro clínico han justificado el uso compasivo de medicamentos off-label. No obstante, el uso indiscriminado de estos medicamentos, sin un fundamento sólido por parte de los médicos puede representar un peligro para la salud de los pacientes. Por otra parte, la comunidad médica y científica de Latinoamérica está llamada a evaluar hipótesis de investigación que mitiguen el impacto de la pandemia en nuestras poblaciones.Tomando como ejemplo pedagógico el uso de la ivermectina, se proponen criterios como la plausibilidad biológica, la evidencia metodológica y estadísticamente aceptable, una respuesta clínica favorable, un perfil farmacológico seguro, la factibilidad y el interés altruista como sustento para el empleo de medicamentos off-label durante la pandemia. Estos criterios posibilitarían un uso racional de medicamentos y priorizar en el contexto de una investigación las opciones terapéuticas posiblemente más efectivas.The COVID-19 pandemic represents one of the most important challenges in public health’s history. Severity of the clinical picture and lack of supporting scientific evidence have led to compassionate use of off-label medications. Indiscriminate use of these medications, however, can be harmful for patients. The Latin American medical and scientific community is called upon to evaluate research hypotheses of treatments that could mitigate the impact of the pandemic on our populations.Taking the use of ivermectin as an example, various criteria such as biological plausibility, methodological and statistically acceptable evidence, a favorable clinical response, a safe pharmacological profile, feasibility, and altruistic interest are proposed to support the use of off-label treatments during the pandemic. These criteria would allow a more rational use of medications and prioritize research on potentially effective therapeutic options.0000-0002-6529-9758yeison.carlosama@campusucc.edu.coGrupo Interdisciplinario de Investigaciòn Salud-Enfermedad. Universidad Cooperativa de ColombiaMedicinaPastohttps://revistas.unicauca.edu.co/index.php/rfcs/article/view/1778/1541Roman YM, Burela PA, Pasupuleti V, Piscoya A, Vidal JE, Hernandez AV. Ivermectin for the Treatment of Coronavirus Disease 2019: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Clin Infect Dis. 2021. https://doi.org/10.1093/cid/ciab591López-Medina E, López P, Hurtado IC, Dávalos DM, Ramirez O, Martínez E, et al. Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19 A Randomized Clinical Trial. JAMA. 2021;325(14):1426-1435. https://doi.org/10.1001/ jama.2021.3071Marina AM, Jaime KJ, Consuelo MB, Francisco LN, Manuel MNJ. Las enfermedades “olvidadas” de América Latina y el Caribe: un problema de salud pública global. Revista mexicana de ciencias farmacéuticas. 2012; 43(1):33-41Lupkin S. Remdesivir Priced At More Than $3100 For A Course Of Treatment [Internet]. National Public Radio. 2020. [Citado: octubre 27, 2020). Disponible en: https://www.npr.org/sections/healthshots/2020/06/29/884648842/remdesivir-priced-atmore-than-3-100-for-a-course-of-treatmentAhmed S, Johnson K. Operaciones bursátiles en Gilead por fármaco contra COVID-19 podrían llamar atención de reguladores [Internet]. Reuters. 2020. [Citado: noviembre 02, 2021]. Disponible en: https:// www.reuters.com/article/salud-coronavirus-gileadidLTAKBN2382VSSanders JM, Monogue ML, Jodlowski TZ, Cutrell JB. Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19): A Review. JAMA. 2020; 323(18):1824- 36. https://doi.org/10.1001/jama.2020.6019Gritti G, Raimondi F, Ripamonti D, Riva I, Landi F, Alborghetti L, et al. Use of siltuximab in patients with COVID-19 pneumonia requiring ventilatory support. MedRxiv. 2020: 04.01.20048561. https://doi.org/10.11 01/2020.04.01.20048561Zhong M, Sun A, Xiao T, Yao G, Sang L, Zheng X, et al. A Randomized, Single-blind, Group sequential, Activecontrolled Study to evaluate the clinical efficacy and safety of α-Lipoic acid for critically ill patients with coronavirus disease 2019(COVID-19). MedRxiv. 2020:04.15.20066266. https://doi.org/10.1101/2020.04.15.20066266McCreary EK, Pogue JM. Coronavirus Disease 2019 Treatment: A Review of Early and Emerging Options. Open Forum Infect Dis. 2020; 7(4):ofaa105. https:// doi.org/10.1093/ofid/ofaa105Bray M, Rayner C, Noël F, Jans D, Wagstaff K. Ivermectin and COVID-19: A report in Antiviral Research, widespread interest, an FDA warning, two letters to the editor and the authors’ responses. Antiviral Res. 2020; 178:104805. https://doi.org/10.1016/j.antiviral.2020.104805Schmith VD, Zhou J, Lohmer LR. The Approved Dose of Ivermectin Alone is not the Ideal Dose for the Treatment of COVID-19. Clin Pharmacol Ther. 2020; 108(4):762-765. https://doi.org/10.1002/cpt.1889Momekov G, Momekova D. Ivermectin as a potential COVID-19 treatment from the pharmacokinetic point of view: antiviral levels are not likely attainable with known dosing regimens. MedRxiv. 2020.04.11.20061804. https:// doi.org/10.1101/2020.04.11.20061804Osei-Atweneboana MY, Eng JK, Boakye DA, Gyapong JO, Prichard RK. Prevalence and intensity of Onchocerca volvulus infection and efficacy of ivermectin in endemic communities in Ghana: a two-phase epidemiological study. The Lancet. 2007; 369(9578):2021-9. https:// doi.org/10.1016/S0140-6736(07)60942-8Kyelem D, Biswas G, Bockarie MJ, Bradley MH, El-Setouhy M, Fischer PU, et al. Determinants of success in national programs to eliminate lymphatic filariasis: a perspective identifying essential elements and research needs. Am J Trop Med Hyg. 2008; 79:480-4Lespine A, Dupuy J, Alvinerie M, Comera C, Nagy T, Krajcsi P, et al. Interaction of macrocyclic lactones with the multidrug transporters: the bases of the pharmacokinetics of lipidlike drugs. Curr Drug Metab. 2009; 10:272–88. https:// doi.org/10.2174/138920009787846297Chandler RE. Serious Neurological Adverse Events after Ivermectin-Do They Occur beyond the Indication of Onchocerciasis?. Am J Trop Med Hyg. 2018; 98(2):382- 8. https://doi.org/10.4269/ajtmh.17-0042Ch JV. Ivermectina: Sus Múltiples Usos, Seguridad y Toxicidad. Educación Médica Continua. 2010; 26(4):358-368Rajter JC, Sherman MS, Fatteh N, Vogel F, Sacks J, Rajter J-J. Use of Ivermectin Is Associated With Lower Mortality in Hospitalized Patients With Coronavirus Disease 2019. Chest Journal. 2020; 159(1):85-92. https://doi.org/10.1016/j. chest.2020.10.009Silva-Aycaguer LC. Las pruebas de significación estadística: seis décadas de fuegos artificiales. Rev Fac Nac Salud Pública. 2016; 34 (3):372-9. https://doi. org/10.17533/udea.rfnsp.v34n3a11Veiga de Cabo J, Fuente Díez E de la, Zimmermann Verdejo M. Modelos de estudios en investigación aplicada: conceptos y criterios para el diseño. Med Segur Trab. 2008; 54:81-8Hernández-Avila M, Garrido-Latorre F, López-Moreno S. Diseño de estudios epidemiológicos. Salud Pública México. 2000; 42:144–54. https://doi.org/10.1590/ S0036-36342000000200010Kindler E, Thiel V. SARS-CoV and IFN: Too Little, Too Late. Cell Host Microbe. 2016; 19:139–41. https://doi. org/10.1016/j.chom.2016.01.012Billiau A. Interferon-gamma: biology and role in pathogenesis. Adv Immunol. 1996; 62:61–130. https:// doi.org/10.1016/s0065-2776(08)60428-9Frieman M, Yount B, Heise M, Kopecky-Bromberg SA, Palese P, Baric RS. Severe Acute Respiratory Syndrome Coronavirus ORF6 Antagonizes STAT1 Function by Sequestering Nuclear Import Factors on the Rough Endoplasmic Reticulum/ Golgi Membrane. J Virol. 2007; 81:9812-24. https://doi. org/10.1128/JVI.01012-07Petrosillo N, Viceconte G, Ergonul O, Ippolito G, Petersen E. COVID-19, SARS and MERS: are they closely related?. 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