#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

Safety and tolerability of artesunate-amodiaquine, artemether-lumefantrine and quinine plus clindamycin in the treatment of uncomplicated Plasmodium falciparum malaria in Kinshasa, the Democratic Republic of the Congo


Autoři: Yves Lula Ntamba aff001;  Hypolite Muhindo Mavoko aff002;  Marion Kalabuanga aff004;  Blaise Fungula aff004;  Pierre-Michel Ntamabyaliro Nsengi aff001;  Gaston Tona Lutete aff001;  Raquel Inocencio da Luz aff002;  Jean-Pierre Van geertruyden aff002;  Pascal Lutumba aff003
Působiště autorů: Clinical Pharmacology and Pharmacovigilance Unit, University of Kinshasa, Kinshasa, Democratic Republic of the Congo aff001;  Global Health Institute, Faculty of Medicine, University of Antwerp, Antwerp, Belgium aff002;  Department of Tropical Medicine, University of Kinshasa, Kinshasa, Democratic Republic of the Congo aff003;  Lisungi Health Centre, Kinshasa, Democratic Republic of the Congo aff004
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pone.0222379

Souhrn

Introduction

Artemisinin-based combination therapy is currently the best option for the treatment of uncomplicated malaria. Quinine is recommended as a rescue treatment. Safety information during repeated treatment with the same drug is scarce. We report safety data from the Quinact randomized clinical trial (RCT) that was designed to assess efficacy and safety of artesunate-amodiaquine (ASAQ), artemether-lumefantrine (AL) and quinine+clindamycin (QnC).

Methodology

Males and females aged 12 to 59 months with uncomplicated malaria were treated with ASAQ and followed up during 42 days (preRCT). Clinical failures were randomized to one of the 3 treatments and followed up for 28 days (RCT). Subsequent failures were repeatedly treated with ASAQ several times as needed (postRCT1, postRCT2 and so on) until a 28-days follow up period without parasitaemia.

Results

Eight hundred and sixty-five, 242 and 64 patients were recruited respectively in preRCT, RCT and postRCTs. In preRCT, 433 (50.0%) patients experienced at least one drug-related adverse event (AE). The most reported AEs were anorexia (22.9%), asthenia (19.4%), and abnormal behavior (14.6%). Twenty-nine AEs (3.5%) were reported to be severe. In RCT, at least one drug-related AE was reported in 54.7%, 21.5% and 40.0% of patient randomized respectively to ASAQ, AL and QnC (p<0.001). During postRCT1 (n = 64), postRCT 2 (n = 17) and postRCT3 (n = 7), respectively 32.8%, 35.3% and 71.4% of patients experienced at least one drug-related AE. Three serious adverse events occurred but not judged related to study medication.

Conclusion

The proportion of AEs did not increase over the treatment courses with ASAQ. However, continuous monitoring is important.

Klíčová slova:

Medicine and health sciences – Parasitic diseases – Malaria – Tropical diseases – Pharmacology – Drugs – Antimalarials – Amodiaquine – Drug research and development – Randomized controlled trials – Mental health and psychiatry – Eating disorders – Anorexia nervosa – Clinical medicine – Clinical trials – Hematology – anémia – Diagnostic medicine – Signs and symptoms – Pathology and laboratory medicine – Research and analysis methods – Research design – Clinical research design – Adverse events – Biology and life sciences – Physiology – Physiological processes – Coughing


Zdroje

1. WHO. Guidelines for the treatment of malaria, third edition. Switzerland: World Health Organization, 2015. Available from http://apps.who.int/medicinedocs/en/m/abstract/Js21839en/

2. PNLP. Guide technique de prévention et de prise en charge du Paludisme, Programme National de Lutte contre le Paludisme, Ministère de la Santé Publique, République Démocratique du Congo, 2012. Available from https://www.medbox.org/drc-policies-others/drc-guide-technique-de-prevention-et-prise-en-charge-du-paludisme-hopital-general-de-reference/preview?q=

3. Dodoo AN, Fogg C, Nartey ET, Ferreira GL, Adjei GO, Kudzi W, et al. Profile of Adverse Events in Patients Receiving Treatment for Malaria in Urban Ghana: A Cohort-Event Monitoring Study. Drug Saf. 2014, 37:433–448. doi: 10.1007/s40264-014-0164-9 24788801

4. Sinclair D, Zani B, Donegan S, Olliaro P, Garner P. Artemisinin based combination therapy for treating uncomplicated malaria (Review). The Cochrane Collaboration. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007483. doi: 10.1002/14651858.CD007483.pub2 19588433

5. Falade C, Manyando C. Safety profile of Coartem: the evidence base. Malar J. 2009 Oct 12;8 Suppl 1:S6. doi: 10.1186/1475-2875-8-S1-S6 19818173

6. Kuemmerle A, Dodoo A, Olsson A, Erps JV, Burri C, Lalvani PS. Assessment of global reporting of adverse drug reactions for anti-malarials, including artemisinin based combination therapy, to the WHO programme for international drug monitoring. Malar J. 2011, 10:57. doi: 10.1186/1475-2875-10-57 21388536

7. Stergachis A, Bartlein RJ, Dodoo A, Nwokike J, Kachur SP. A situational analysis of pharmacovigilance plans in the global fund malaria and U.S. President’s Malaria initiative proposals. Malar J. 2010, 9:148. doi: 10.1186/1475-2875-9-148 20509971

8. Pirmohamed M, Atuah KN, Dodoo AN, Winstanley P. Pharmacovigilance in developing countries. BMJ. 2007, 335:462. doi: 10.1136/bmj.39323.586123.BE 17823149

9. Olsson S, Pal SN, Stergachis A, Couper M. Pharmacovigilance activities in 55 low- and middle-income countries: a questionnaire-based analysis. Drug Saf. 2010, 33:689–703. doi: 10.2165/11536390-000000000-00000 20635827

10. Sagara I, Fofana B, Gaudart J, Sidibe B, Togo A, Toure S, et al. Repeated Artemisinin-Based Combination Therapies in a Malaria Hyperendemic Area of Mali: Efficacy, Safety, and Public Health Impact. Am. J. Trop. Med. Hyg. 2012, 87(1), pp. 50–56. doi: 10.4269/ajtmh.2012.11-0649 22764291

11. Mehta U, Durrheim D, Mabuza A, Blumberg L, Allen E, Barnes KI. Malaria Pharmacovigilance in Africa. Lessons from a Pilot Project in Mpumalanga Province, South Africa. Drug Saf. 2007, 30 (10): 899–910. doi: 10.2165/00002018-200730100-00008 17867727

12. Schramm B, Valeh P, Baudin E, Mazinda CS, Smith R, Pinoges L, et al. Tolerability and safety of artesunate-amodiaquine and artemether-lumefantrine fixed dose combinations for the treatment of uncomplicated Plasmodium falciparum malaria: two open-label, randomized trials in Nimba County, Liberia. Malar J. 2013, 12:250. doi: 10.1186/1475-2875-12-250 23866736

13. Maiteki-Sebuguzi C, Jagannathan P, Yau VM, Clark TD, Njama-Meya D, Nzarubara B, et al. Safety and tolerability of combination antimalarial therapies, Ugandan children. Malar J. 2008, 7:106. doi: 10.1186/1475-2875-7-106 18547415

14. Muhindo MH, Nabasumba C, Tinto H, D'Alessandro U, Grobusch MP, Lutumba P, et al. Impact of retreatment with an artemisinin-based combination on malaria incidence and its potential selection of resistant strains: study protocol for a randomized controlled clinical trial. Trials, 2013, 14:307. Available from: doi: 10.1186/1745-6215-14-307 24059911

15. Maketa V, Mavoko HM, da Luz RI, Zanga J, Lubiba J, Kalonji A, et al. The relationship between Plasmodium infection, anaemia and nutritional status in asymptomatic children aged under five years living in stable transmission zones in Kinshasa, Democratic Republic of Congo. Malar J. 2015; 14:83. doi: 10.1186/s12936-015-0595-5 25880427

16. Mavoko H M, Nabasumba C, Inocencio da Luz R, Tinto H, D’Alessandro U, Kambugu A, et al. Efficacy and safety of re-treatment with the same artemisinin-based combination treatment (ACT) compared with an alternative ACT and quinine plus clindamycin after failure of first-line recommended ACT (QUINACT): a bicentre, open-label, phase 3, randomised controlled trial. Lancet Glob Health. November 10, 2016. Available from: doi: 10.1016/S2214-109X(16)30236-4

17. Mavoko H M, Kalabuanga M, Delgado-Ratto C, Maketa V, Mukele R, Fungula B, et al. Uncomplicated Clinical Malaria Features, the Efficacy of Artesunate-Amodiaquine and Their Relation with Multiplicity of Infection in the Democratic Republic of Congo. PLoS ONE. 2016, 1(6): e0157074. doi: 10.1371/journal.pone.0157074 27280792

18. WHO. Assessment and monitoring of antimalarial drug efficacy for the treatment of uncomplicated falciparum malaria. Switzerland: World Health Organization, 2003.

19. Neftel KA, Woodtly W, Schmid M, Frick PG, and Fehr J. Amodiaquine induced agranulocytosis and liver damage Br Med J (Clin Res Ed). 1986, Mar 15; 292(6522): 721–723.

20. Meyboom RH, Hekster YA, Egberts AC, Gribnau FW, Edwards IR. Causal or Casual? The Role of Causality Assessment in Pharmacovigilance. Drug Saf. 1997, 17(6): 374–389. doi: 10.2165/00002018-199717060-00004 9429837

21. ICH Expert Working Group. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. “ICH Harmonised Tripartite Guideline”. Guidelines for Good Clinical Practice (E6), 1996. Available from: https://ichgcp.net/.

22. WHO. The WHO Adverse Reaction Terminology “WHO-ART”. Uppsala (Sweden): The Uppsala Monitoring Centre, 2015, Quarter1. (Provided as part of a subscription). Available upon request from: https://www.who-umc.org/vigibase/services/learn-more-about-who-art.

23. WHO. A practical handbook on the Pharmacovigilance of antimalarial medicines, the World Health Organization, 2007.

24. Guidelines for preparing core clinical-safety information on drugs, second edition: report of CIOMS working group III and IV, ISBN: 92 9036 070 4, 1999

25. Talisuna AO, Staedke SG, D’Alessandro U. Pharmacovigilance of antimalarial treatment in Africa: is it possible? Malar J. 2006, 5:50. doi: 10.1186/1475-2875-5-50 16780575

26. Thiam S, Ndiaye J, Diallo I, Gatonga P, Fall FB, Diallo NE, et al. Safety monitoring of artemisinin combination therapy through a national pharmacovigilance system in an endemic malaria setting. Malar J. 2013, 12:54. doi: 10.1186/1475-2875-12-54 23384036

27. Sean C Sweetman. Martindale: The Complete Drug Reference, 35th edition, Pharmaceutical Press, London, UK, 2007.

28. Sanofi-Aventis. Artesunate/Amodiaquine tablets, Summary of Products characteristics, 2014. Available from: https://extranet.who.int/prequal.

29. Ekong MB, Igiri AO, and Mesembe OE. The effect of administration of amodiaquine on some parameters of neurobehavior of wistar rats. Nigerian Journal of Physiological Sciences. 2008, 23 (1–2): 51–54. 19434214

30. Bassi PU, Osakwe AI, Isah A, Suku C, Kalat M, Jalo I, et al. Safety of Artemisinin-Based Combination Therapies in Nigeria: A Cohort Event Monitoring Study. Drug Saf. 2013 36:747–756. doi: 10.1007/s40264-013-0044-8 23591829

31. Chinawa JM. Adverse Drug Event From Artemether/lumefantrine Ingestion: Case Series. Niger J Paed. 2013, 40 (4): 416–418.

32. Tran TH, Day NP, Ly VC, Nguyen TH, Pham PL, Nguyen HP, et al. Black water fever in Southern Vietnam. A prospective descriptive study of 50 cases. Clin Infect Dis. 1996, 23:1274–81. 8953071

33. Tran TH, Day NP, Nguyen HP, Nguyen TH, Pham PL, Dinh XS, et al. Controlled trial of artemether or quinine in Vietnamese adults with severe falciparum malaria. New Eng J Med.1996, 335:76–83. doi: 10.1056/NEJM199607113350202 8649493

34. Andrade RJ, Robles M, Fernández-Castañer A, López-Ortega S, López-Vega MC, Lucena MI. Assessment of drug-induced hepatotoxicity in clinical practice: A challenge for gastroenterologists. World J Gastroenterol. 2007, 13(3): 329–340. doi: 10.3748/wjg.v13.i3.329 17230599

35. Ndiaye JA, Faye B, Gueye A, Tine R, Ndiaye D, Tchania C, et al. Repeated treatment of recurrent uncomplicated Plasmodium falciparum malaria in Senegal with fixed dose artesunate plus amodiaquine versus fixed-dose artemether plus lumefantrine: a randomized, open-label trial. Malar J. 2011, 10:237. doi: 10.1186/1475-2875-10-237 21838909

36. Yeka A, Lameyre V, Afizi K, Fredrick M, Lukwago R, Kamya MR, et al. Efficacy and Safety of Fixed-Dose Artesunate-Amodiaquine vs. Artemether-Lumefantrine for Repeated Treatment of Uncomplicated Malaria in Ugandan Children. PLoS ONE. 2014, 9(12): e113311. doi: 10.1371/journal.pone.0113311 25436614

37. Ngouesse B, Basco L, Ringwald P, Keundjian A, Blackett KN. Cardiac effects of amodiaquine and sulfadoxine–pyrimethamine in malaria-infected African patients. Am J Trop Med Hyg. 2001, 65(6):711–6. doi: 10.4269/ajtmh.2001.65.711 11791962

38. The WorldWide Antimalarial Resistance Network (WWARN) AS-AQ Study Group. The effect of dosing strategies on the therapeutic efficacy of artesunate-amodiaquine for uncomplicated malaria: a meta- analysis of individual patient data. BMC Medicine. 2015, 13:66. doi: 10.1186/s12916-015-0301-z 25888957

39. The WorldWide Antimalarial Resistance Network (WWARN) AL Study Group TWARNA Dose Impact S Group. The effect of dose on the antimalarial efficacy of artemether-lumefantrine: a pooled analysis of individual patient data. Lancet Infect Dis. 2015, 15(6):692–702. doi: 10.1016/S1473-3099(15)70024-1 25788162

40. Bethell D, Se Y, Lon C, Socheat D, Saunders D, Teja-Isavadharm P, et al. Dose-dependent risk of neutropenia after 7-day courses of artesunate monotherapy in Cambodian patients with acute Plasmodium falciparum malaria. Clin Infect Dis. 2010, 51:e105–e114. doi: 10.1086/657402 21070142

41. Ngasala BE, Malmberg M, Carlsson AM, Ferreira PE, Petzold MG, Blessborn D, et al. Efficacy and effectiveness of artemether-lumefantrine after initial and repeated treatment in children < 5 years of age with acute uncomplicated Plasmodium falciparum malaria in rural Tanzania: a randomized trial. Clin Infect Dis. 2011, 52: 873–882. doi: 10.1093/cid/cir066 21427394

42. Price R, van Vugt M, Phaipun L, Luxemburger C, Simpson J, McGready R, et al. Adverse effects in patients with acute falciparum malaria treated with artemisinin derivatives. Am J Trop Med Hyg. 1999, 60:547–55. doi: 10.4269/ajtmh.1999.60.547 10348227

43. IFPMA. Introductory Guide for Standardised MedDRA Queries (SMQs) Version 19.0, March 2016, MSSO-DI-6226-19.0.0. (Provided as part of a subscription). Available from: https://www.meddra.org/how-to-use/support-documentation?current.

44. WHO Evidence Review Group Meeting. The cardiotoxicity of antimalarials, October 2016. Available from: https://www.who.int/malaria/mpac/mpac-mar2017-erg-cardiotoxicity-report-session2.pdf.


Článek vyšel v časopise

PLOS One


2019 Číslo 9
Nejčtenější tento týden
Nejčtenější v tomto čísle
Kurzy

Zvyšte si kvalifikaci online z pohodlí domova

Svět praktické medicíny 1/2024 (znalostní test z časopisu)
nový kurz

Koncepce osteologické péče pro gynekology a praktické lékaře
Autoři: MUDr. František Šenk

Sekvenční léčba schizofrenie
Autoři: MUDr. Jana Hořínková

Hypertenze a hypercholesterolémie – synergický efekt léčby
Autoři: prof. MUDr. Hana Rosolová, DrSc.

Význam metforminu pro „udržitelnou“ terapii diabetu
Autoři: prof. MUDr. Milan Kvapil, CSc., MBA

Všechny kurzy
Kurzy Podcasty Doporučená témata Časopisy
Přihlášení
Zapomenuté heslo

Zadejte e-mailovou adresu, se kterou jste vytvářel(a) účet, budou Vám na ni zaslány informace k nastavení nového hesla.

Přihlášení

Nemáte účet?  Registrujte se

#ADS_BOTTOM_SCRIPTS#