Therapeutic efficacy and adverse events of treatments for vivax and falciparum malaria in pregnant women in the regions of Uraba and Alto San Jorge, Colombia, 2008-2011

Authors

  • Jaime Carmona-Fonseca
  • Olga María Agudelo-García
  • Eliana Arango-Flórez

DOI:

https://doi.org/10.18597/rcog.127

Keywords:

Malaria, Plasmodium, pregnancy, chloroquine, amodiaquine, mefloquine, Colombia

Abstract

Objective: To assess, using the 1998 WHO protocol, adequate clinical and parasitological response (ACPR) and adverse events (AEs) to 4 antiplasmodial treatment regimens in pregnant Colombian women diagnosed with uncomplicated P. vivax or P. falciparum malaria on the basis of thick blood smear.

Materials and methods: Parallel randomized controlled trial. The estimated sample size was 60 patients with P. vivax and 30 with P. falciparum. Four treatments were assessed: vivax malaria in any trimester treated with chloroquine or amodiaquine; falciparum malaria in second and third trimesters treated with artesunate-mefloquine or artemether-lumefantrine. Patients were followed for 28 days. Measurements included the proportion of therapeutic failures and of adverse events. Groups were compared using univariate analysis. The study protocol was registered in ClinicalTrials.gov under the Protocol Record MGP-02.

Results: Overall, 90 patients were treated. ACPR was adequate in 97-100% of vivax cases (analytical method variation) and in 100% of falciparum cases. The most common AEs were epigastric pain, dizziness, tinnitus and blurred vision. There were no serious adverse events.

Conclusions: Both chloroquine as well as amodiquine have similar adequate responses. No therapeutic failures were found for the combinations of artesunate-mefloquine and artemether-lumefantrine. Studies need to be done in other places of the country using the regimens assessed as well as others.

Author Biographies

Jaime Carmona-Fonseca

Grupo Salud y Comunidad - César Uribe Piedrahíta, Universidad de Antioquia. Medellín, Colombia.

Olga María Agudelo-García

Grupo Salud y Comunidad - César Uribe Piedrahíta, Universidad de Antioquia. Medellín, Colombia.

Eliana Arango-Flórez

Grupo Salud y Comunidad - César Uribe Piedrahíta, Universidad de Antioquia. Medellín, Colombia.

References

Matteelli A, Caligaris S, Castelli F, Carosi G. The placenta and malaria. Ann Trop Med Parasitol 1997;91:803-10.

Mcgregor I, Wilson M, Billewicz W. Malaria infection of the placenta in the Gambia, West Africa; its incidence and relationship to stillbirth, birth weight and placental weight. Trans Roy Soc Trop Med Hyg 1983;77:232-44.

Carmona-Fonseca J, Maesttre A. Incidencia de la malaria gestacional, congénita y placentaria en Urabá (Antioquia, Colombia), 2005-2007. Rev Colomb Obstet Ginecol 2009;60:12-26.

Agudelo-García O. Citoquinas y apoptosis en placentas a término con y sin infección por Plasmodium; Colombia, 2008-2011. Trabajo de investigación presentado como requisito para optar al título de Magíster en Ciencias Básicas Biomédicas, área Microbiología y Parasitología. Corporación Académica de Ciencias Básicas Biomédicas y Grupo Salud y Comunidad. Medellín: Universidad de Antioquia; 2011.

Campos I, Uribe M, Cuesta C, Franco A, Carmona- Fonseca J, Maestre A. Diagnosis of gestational, congenital, and placental malaria in Colombia: comparison of the efficacy of microscopy, nested polymerase chain reaction, and histopathology. Am J Trop Med Hyg 2011;84:929-35.

Arango E, Maestre A, Carmona-Fonseca J. Efecto de la infección submicroscópica o policlonal de Plasmodium falciparum sobre la madre y el producto gestacional. Revisión sistemática. Rev Bras Epidemiol 2010;13:373-86.

Duffy P, Fried M. Malaria in pregnancy. Deadly Parasite, Susceptible Host. New York: Taylor & Francis; 2001.

WHO. World Health Organization. Guidelines for the treatmento of malaria. 2 ed. Geneva: WHO; 2010.

Orton L, Garner P. Drugs for treating uncomplicated malaria in pregnant women. The Cochrane Database of Systematic Reviews 2005;(3):CD004912.

McGready R, White N, Nosten F. Parasitological efficacy of antimalarials in the treatment and prevention of falciparum malaria in pregnancy 1998 to 2009: a systematic review. BJOG 2011;118:123-35.

Davis T, Mueller I, Rogerson S. Prevention and treatment of malaria in pregnancy. Future Microbiol 2010;5:1599-613.

Ministerio de la Protección Social. Guía de Atención de la Malaria. Bogotá: MinProtección; 2007. Visitado 2007 Ago 29. Disponible en: http://www.dssa.gov.co/__media__/dssa/dssa.gov.co/documentos/Protocolos-Vectores-INS/Clinica-Malaria.pdf.

Carmona-Fonseca J, Tobón A, Álvarez G, Blair S. El tratamiento amodiaquina-sulfadoxina-pirimetamina tiene eficacia del 98% para la malaria falciparum no complicada (Antioquia, Colombia, 2003). Iatreia 2005;18:5-26.

Blair S, Carmona-Fonseca J, Piñeros J, Ríos A, Álvarez T, Álvarez G, et al. Therapeutic efficacy test in malaria falciparum in Antioquia, Colombia. Malaria J 2006;5:14.

Pérez MA, Cortés LJ, Guerra AP, Knudson A, Usta C, Nicholls RS. Eficacia de la combinación amodiaquina+sulfadoxine-pirimetamina y la cloroquina para el tratamiento de la malaria en Córdoba, Colombia, 2006. Biomédica 2008;28:148-59.

Carrasquilla G, Barón C, Monsell E, Cousin M, Walter V, Lefèvre G, et al. Randomized, prospective, threearm study to confirm the auditory safety and efficacy of artemether-lumefantrine in colombian patients with uncomplicated Plasmodium falciparum malaria. Am J Trop Med Hyg 2012;86:75-83.

Arango E, Upegui Y, Carmona-Fonseca J. Efficacy of different primaquine based antimalarial schemes against Plasmodium falciparum gametocytemia. Acta Trop 2012;122:177-82.

Echeverri M, Tobón A, Álvarez G, Carmona J, Blair S. Clinical and laboratory findings of Plasmodium vivax malaria in Colombia, 2001. Rev Inst Med Trop São Paulo 2003;45:29-34.

Carmona-Fonseca J, Álvarez G, Blair S. Malaria por Plasmodium vivax: curación del ataque agudo con tres dosis diferentes de primaquina y dosis fija de cloroquina. Antioquia, Colombia, 2003-2004. Biomedica 2006;26:353-65.

Carmona-Fonseca J, Uscátegui R, Correa A. Malaria vivax en niños: aspectos clínicos y respuesta a la cloroquina. Colomb Med 2008;39:364-77.

Departamento de Antioquia, Dirección Seccional de Salud y Protección Social de Antioquia. Cultura y salud en Urabá: retos para la reducción de la mortalidad materna. Medellín: DSSA; 2008.

Carmona-Fonseca J, Arias M, Correa A, Lemos L. Gestational malaria and living conditions in Turbo, Colombia. Social Medicine 2011;6:71-82.

Correa AM, Arias MM, Carmona-Fonseca J. Equidad e igualdad sociales y sanitarias. Necesidad de un marco conceptual científico. Medicina Social 2012;7(1).

OMS/OPS. Evaluación de la eficacia terapéutica de los medicamentos para el tratamiento del paludismo por Plasmodium falciparum sin complicaciones en las Américas. OPS/HCP/HCT/113/98. Washington: OMS/OPS; 1998.

Martínez-Bencardino C. Estadística, 4 ed. Bogotá: Ecoe; 1987. p. 599-601.

Martínez-Bencardino C. Muestreo. Bogotá: Ecoe; 1984. p. 45-47.

Carmona-Fonseca J. Malaria vivax en niños: recurrencias con dosis total estándar de primaquina dada en 3 vs. 7 días. Iatreia 2009;22:10-20.

Carmona-Fonseca J, Arango E, Blair S. Gametocitemia en malaria por Plasmodium falciparum tratada con amodiaquina o artesunato. Biomédica 2008;28:195-212.

Hatz C, Soto J, Nothdurft H, Zoller T, Weitzel T, Loutan L, et al. Treatment of acute uncomplicated falciparum malaria with artemether-lumefantrine in nonimmune populations: a safety, efficacy, and pharmacokinetic study. Am J Trop Med Hyg 2008;78:241-7.

Rojas DP. Evaluación de la eficacia terapéutica y la tolerabilidad de las combinaciones fijas de artesunato/amodiaquina y artemeter/lumefantrina para el tratamiento de la malaria por P. falciparum no complicada en el departamento del Chocó (Colombia). Tesis de maestría, Departamento de Salud Pública, Facultad de Medicina, Universidad Nacional de Colombia, Bogotá; 2010.

Imwong M, Boel ME, Pagornrat W, Pimanpanarak N, McGready R, Day NPJP, et al. The first Plasmodium vivax relapses of life are usually genetically homologous. JID 2012;205:680-3.

McGready R, Tan S, Ashley E, Pimanpanarak M, Viladpai-Nguen J, Jesadapanpong W, et al. A randomised controlled trial of artemether-lumefantrine versus artesunate for uncomplicated Plasmodium falciparum treatment in pregnancy. PLoS Med 2008;5:e253.

Lemma H, Lofgren C, San Sebastian M. Adherence to a six-dose regimen of artemether-lumefantrine among uncomplicated Plasmodium falciparum patients in the Tigray Region, Ethiopia. Malar J 2011;10:349.

Ward S, Sevene E, Hastings I, Nosten F, McGready R. Antimalarial drugs and pregnancy: safety, pharmacokinetics, and pharmacovigilance. Lancet Infect Dis 2007;7:136-44.

Rijken M, McGready R, Jullien V, Tarning J, Lindegardh N, Phyo A, et al. Pharmacokinetics of amodiaquine and desethylamodiaquine in pregnant and post-partum women with Plasmodium vivax malaria. Antimicrob Agents Chemother 2011;55:4338-42.

Bhattarai A, Maini-Thapar M, Ali A, Bjorkman A. Amodiaquine during pregnancy. Lancet Infect Dis 2004;4:721-2.

Tagbor H, Chandramohan D, Greenwood B. The safety of amodiaquine use in pregnant women. Expert Opin Drug Saf 2007;6:631-5.

Thomas F, Erhart A, D’Alessandro A. Can amodiaquine be used safely during pregnancy? Lancet Infect Dis 2004;4:235-9.

Orton L, Omari A. Drugs for treating uncomplicated malaria in pregnant women. Cochrane Database Syst Rev 2008;(4):CD004912.

Morris C, Onyamboko M, Capparelli E, Koch M, Atibu J, Lokomba V, et al. Population pharmacokinetics of artesunate and dihydroartemisinin in pregnant and non-pregnant women with malaria. Malar J 2011;10:114.

Rosenthal P. Antiprotozoarios. In: Katzung B, editor. Farmacología básica y clínica. 9 ed. México DF: El Manual Moderno; 2004. p. 853-972.

Vásquez A, Sanín F, Álvarez L, Tobón A, Ríos A, Blair S. Estudio piloto de la eficacia y de los efectos sobre los gametocitos del esquema artesunato-mefloquinaprimaquina para la malaria por Plasmodium falciparum. Biomédica 2009;29:307-19.

McGready R, Brockman A, Cho T, Cho D, van Vugt M, Luxemburger C, et al. Randomized comparison of mefloquine-attesunate versus quinine in the treatment of multidrug-resistant falciparum malaria in pregnancy. Trans R Trop Med Hyg 2000;94:689-93.

Achan J, Talisuna A, Erhart A, Yeka A, Tibenderana J, Baliraine F, et al. Quinine, an old anti-malarial drug in a modern world: role in the treatment of malaria. Malar J 2011;10:144.

Rodríguez E, Martínez M. Tratamiento farmacológico de la mujer embarazada: fármacos contraindicados durante la gestación. Semergen 2010;36:579-85.

Alvarez G, Piñeros J, Tobón A, Ríos A, Maestre A, Blair S, et al. Efficacy of three chloroquine-primaquine regimens for treatment of Plasmodium vivax malaria in Colombia. Am J Trop Med Hyg 2006;75:605-9.

Carmona-Fonseca J. Prevention of Plasmodium vivax malaria recurrence: Efficacy of the standard total dose of primaquine administered over 3 days. Acta Tropica 2009;112:188-92.

Galappaththy G, Omari A, Tharyan P. Primaquine for preventing relapses in people with Plasmodium vivax malaria. Review. Cochrane Database Syst Rev 2007;(1):CD004389.

How to Cite

1.
Carmona-Fonseca J, Agudelo-García OM, Arango-Flórez E. Therapeutic efficacy and adverse events of treatments for vivax and falciparum malaria in pregnant women in the regions of Uraba and Alto San Jorge, Colombia, 2008-2011. Rev. colomb. obstet. ginecol. [Internet]. 2013 Mar. 30 [cited 2024 May 17];64(1):27-3. Available from: https://revista.fecolsog.org/index.php/rcog/article/view/127

Downloads

Download data is not yet available.

Published

2013-03-30

Issue

Section

Original Research
QR Code

Altmetric

Article metrics
Abstract views
Galley vies
PDF Views
HTML views
Other views

Some similar items: