Safety profile of Coartem®: The evidence base

Malaria Journal

Volumn 8, Issue SUPPL. 1, 2009, Pages

  Falade, Catherine ^a   Manyando, Christine ^b  

^a UNIVERSITY OF IBADAN   (Nigeria)

^b TROPICAL DISEASES RESEARCH CENTRE   (Zambia)

Author keywords

[No Author keywords available]

Indexed keywords

AMODIAQUINE; AMODIAQUINE PLUS ARTESUNATE; ARTEMETHER PLUS BENFLUMETOL; ARTESUNATE; CHLOROQUINE; DIHYDROARTEMISININ; FANSIDAR; MEFLOQUINE; PIPERAQUINE; PYRIMETHAMINE; SULFADOXINE; ANTIMALARIAL AGENT; ARTEMISININ DERIVATIVE; ETHANOLAMINE DERIVATIVE; FLUORENE DERIVATIVE;

ANEMIA; ANOREXIA; ARTICLE; ATAXIA; BLOOD DISEASE; BLOOD TOXICITY; CARDIOTOXICITY; CHILD; CLINICAL TRIAL; CONCURRENT INFECTION; COUGHING; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DRUG EFFECT; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; ELECTROCARDIOGRAM; FOLLOW UP; GASTROINTESTINAL DISEASE; GASTROINTESTINAL TOXICITY; HEADACHE; HUMAN; IC 50; LABORATORY TEST; LIVER TOXICITY; MALARIA; NEPHROTOXICITY; NEUROTOXICITY; NYSTAGMUS; PREGNANCY OUTCOME; RISK ASSESSMENT; SIDE EFFECT; SLEEP DISORDER; SLURRED SPEECH; TREMOR; URTICARIA; VOMITING; DRUG COMBINATION; REVIEW;

ANTIMALARIALS; ARTEMISININS; DRUG COMBINATIONS; ETHANOLAMINES; FLUORENES; HUMANS; MALARIA;

EID: 70350007950     PISSN: None     EISSN: 14752875     Source Type: Journal    
DOI: 10.1186/1475-2875-8-S1-S6     Document Type: Article

References (58)

1. WHO World Malaria Report 2008: Chapter 1 - Introduction. http://www.who.int/malaria/wmr2008/
2. WHO Guidelines for the treatment of malaria 2006. http://www.who.int/ malaria/docs/TreatmentGuidelines2006.pdf
3. WHO Prequalified Medicines List. http://apps.who.int/prequal/default.htm
4. Coartem®/Riamet® Basic Prescribing Information. Novartis Drug Regulatory Affairs, 2009
5. The clinical efficacy of artemether/lumefantrine (Coartem®). M Makanga S Krudsood, Malar J 2009 8 Suppl 1 5
6. Efficacy of six doses of artemether/lumefantrine (benflumetol) in multidrug-resistant Plasmodium falciparum malaria. M van Vugt P Wilairatana B Gemperli I Gathmann L Phaipun A Brockman C Luxemburger NJ White F Nosten S Looareesuwan, Am J Trop Med Hyg 1999 60 936 942 10403324
7. Artemether/lumefantrine for the treatment of multi-drug resistant falciparum malaria. M van Vugt S Looareesuwan P Wilairatana R McGready L Villegas I Gathmann R Mull A Brockman NJ White F Nosten, Trans R Soc Trop Med Hyg 2000 94 545 548 10.1016/S0035-9203(00)90082-8 11132386 (Pubitemid 30793838)
8. A clinical and pharmacoki-netic trial of six doses of artemether/lumefantrine for multidrug-resistant Plasmodium falciparum malaria in Thailand. G Lefèvre S Looareesuwan S Treeprasertsuk S Krudsood U Silachamroon I Gathmann R Mull R Bakshi, Am J Trop Med Hyg 2001 64 247 256 11463111
9. Efficacy and safety of artemether/lumefantrine (Coartem®) tablets (six-dose regimen) in African infants and children with acute, uncomplicated falciparum malaria. C Falade M Makanga Z Premji CE Ortmann M Stockmeyer PI de Palacios, Trans R Soc Trop Med Hyg 2005 99 459 467 10.1016/j.trstmh.2004.09.013 15837358
10. Treatment of acute uncomplicated falciparum malaria with artemether/lumefantrine in non-immune populations: a safety, efficacy and pharmacokinetic study. C Hatz J Soto HD Nothdurft T Zoller T Weitzel L Loutan F Bricaire F Gay GD Burchard K Andriano G Lefèvre PI De Palacios B Genton, Am J Trop Med Hyg 2008 78 241 247 18256423
11. Efficacy and safety of artemether/lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multi-centre trial. S Abdulla I Sagara S Borrmann U D'Alessandro R Gonzlez M Hamel B Ogutu A Mårtensson J Lyimo H Maiga P Sasi A Nahum Q Bassat E Juma L Otieno A Björkman HP Beck K Andriano M Cousin G Lefèvre D Ubben Z Premji, Lancet 2008 372 1819 1827 10.1016/S0140-6736(08)61492-0 18926569
12. Artemisinin combination therapies for treatment of uncomplicated malaria in Uganda. H Bukirwa A Yeka MR Kamya A Talisuna K Banek N Bakyaita JB Rwakimari PJ Rosenthal F Wabwire-Mangen G Dorsey SG Staedke, PLoS Clin Trials 2006 1 7 16871329 10.1371/journal.pctr.0010007
13. Combination therapy for uncomplicated falciparum malaria in Ugandan children. G Dorsey S Staedke TD Clark D Njama-Meya B Nzarubara C Maiteki-Sebuguzi C Dokomajilar MR Kamya PJ Rosenthal, JAMA 2007 297 2210 2219 10.1001/jama.297.20.2210 17519410
14. Ototoxicity of artemether/lumefantrine in the treatment of falciparum malaria: a randomized trial. R Gürkov T Eshetu IB Miranda N Berens-Riha Y Mamo T Girma E Krause M Schmidt JM Hempel T Löscher, Malar J 2008 7 179 18796142 10.1186/1475-2875-7-179
15. Artemether/lumefantrine versus dihydroartemisinin-piperaquine for treatment of malaria: a randomized trial. MR Kamya A Yeka H Bukirwa M Lugemwa JB Rwakimari SG Staedke AO Talisuna B Greenhouse F Nosten PJ Rosenthal F Wabwire-Mangen G Dorsey, PLoS Clin Trials 2007 2 20 17525792 10.1371/journal.pctr.0020020 (Pubitemid 46860146)
16. Efficacy of artesunate plus amodiaquine versus that of artemether/lumefantrine for the treatment of uncomplicated childhood Plasmodium falciparum malaria in Zanzibar, Tanzania. A Mårtensson J Strömberg C Sisowath MI Msellem JP Gil SM Montgomery P Olliaro AS Ali A Björkman, Clin Infect Dis 2005 41 1079 1087 10.1086/444460 16163624
17. The efficacies of artesunate-sulfadoxine-pyrimethamine and artemether/lumefantrine in the treatment of uncomplicated, Plasmodium falciparum malaria, in an area of low transmission in central Sudan. AO Mohamed EH Eltaib OA Ahmed SB Elamin EM Malik, Ann Trop Med Parasitol 2006 100 5 10 10.1179/136485906X86239 16417707
18. Artemether/lumefantrine versus dihydroartemisinin-piperaquine for treating uncomplicated malaria: a randomized trial to guide policy in Uganda. A Yeka G Dorsey MR Kamya A Talisuna M Lugemwa JB Rwakimari SG Staedke PJ Rosenthal F Wabwire-Mangen H Bukirwa, PLoS ONE 2008 3 2390 18545692 10.1371/journal.pone. 0002390
19. Safety and efficacy of lumefantrine-artemether (Coartem®) for the treatment of uncomplicated Plasmodium falciparum malaria in Zambian adults. M Mulenga J-P Van geertruyden L Mwananyanda V Chalwe F Moerman R Chilengi C Van Overmeir JC Dujardin U D'Alessandro, Malar J 2006 5 73 16923176 10.1186/1475-2875-5-73 (Pubitemid 44481293)
20. Amodiaquine-artesunate vs artemether/lumefantrine for uncomplicated malaria in Ghanaian children: a randomized efficacy and safety trial with one year follow-up. GO Adjei JA Kurtzhals OP Rodrigues M Alifrangis LC Hoegberg ED Kitcher EV Badoe R Lamptey BQ Goka, Malar J 2008 7 127 18620577 10.1186/1475-2875-7-127 (Pubitemid 352033070)
21. High efficacy of two artemisinin-based combinations (artemether/ lumefantrine and artesunate plus amodiaquine) for acute uncomplicated malaria in Ibadan, Nigeria. CO Falade AO Ogundele BO Yusuf OG Ademowo SM Ladipo, Trop Med Int Health 2008 13 35 643
22. Efficacy and tolerability of four antimalarial combinations in the treatment of uncomplicated Plasmodium falciparum malaria in Senegal. B Faye JL Ndiaye D Ndiaye Y Dieng O Faye O Gaye, Malar J 2007 6 80 17570848 10.1186/1475-2875-6-80 (Pubitemid 47064368)
23. Comparative efficacy of antimalarial drugs including ACTs in the treatment of uncomplicated malaria among children under 5 years in Ghana. KA Koram B Abuaku N Duah N Quashie, Acta Trop 2005 95 194 203 10.1016/j. actatropica.2005.06.018 16054584
24. An open label, randomised trial of artesunate+amodiaquine, artesunate+chlorproguanil-dapsone and artemether/lumefantrine for the treatment of uncomplicated malaria. S Owusu-Agyei KP Asante R Owusu M Adjuik S Amenga-Etego DK Dosoo J Gyapong B Greenwood D Chandramohan, PLoS ONE 2008 3 2530 18575626 10.1371/journal.pone.0002530
25. A randomized trial of artesunate-sulfamethoxypyrazine-pyrimethamine versus artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Mali. I Sagara A Dicko A Djimde O Guindo M Kone Y Tolo MA Thera M Sogoba M Fofana A Ouattara M Sissoko HF Jansen OK Doumbo, Am J Trop Med Hyg 2006 75 630 636 17038684
26. Therapeutic efficacy and effects of artemether/lumefantrine and amodiaquine-sulfalene-pyrimethamine on gametocyte carriage in children with uncomplicated Plasmodium falciparum malaria in southwestern Nigeria. A Sowunmi GO Gbotosho CT Happi AA Adedeji FA Fehintola OA Folarin E Tambo BA Fateye, Am J Trop Med Hyg 2007 77 235 241 17690392
27. Reduction of malaria transmission to Anopheles mosquitoes with a six-dose regimen of co-artemether. CJ Sutherland R Ord S Dunyo M Jawara CJ Drakeley N Alexander R Coleman M Pinder G Walraven GA Targett, PLoS Med 2005 2 92 15839740 10.1371/journal.pmed.0020092 (Pubitemid 40721079)
28. Artemether/lumefantrine versus amodiaquine plus sulfadoxine-pyrimethamine for uncomplicated falciparum malaria in Burkina Faso: a randomised non-inferiority trial. I Zongo G Dorsey N Rouamba H Tinto C Dokomajilar RT Guiguemde PJ Rosenthal JB Ouedraogo, Lancet 2007 369 91 498 10.1016/S0140- 6736(07)60236-0 (Pubitemid 46223467)
29. Randomized comparison of amodiaquine plus sulfadoxine-pyrimethamine, artemether/lumefantrine, and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Burkina Faso. I Zongo G Dorsey N Rouamba C Dokomajilar Y Séré PJ Rosenthal JB Ouédraogo, Clin Infect Dis 2007 45 1453 1461 10.1086/522985 17990228
30. A randomised trial to assess the safety and efficacy of artemether/lumefantrine (Coartem®) for the treatment of uncomplicated Plasmodium falciparum malaria in Rwanda. CI Fanello C Karema W van Doren C van Overmeir D Ngamije U D'Alessandro, Trans R Soc Trop Med Hyg 2007 101 344 350 10.1016/j.trstmh.2006.06.010 17005222 (Pubitemid 46196260)
31. [Efficacité de combinaisons thérapeutiques avec des dérivés de l'artémisinine dans le traitement de l'accès palustre non-compliqué au Burundi]. A Ndayiragije D Niyungeko J Karenzo E Niyungeko M Barutwanayo A Ciza A Bosman R Moyou-Somo A Nahimana JP Nyarushatsi T Barihuta L Mizero J Ndaruhutse C Delacollette P Ringwald J Kamana, Trop Med Int Health 2004 9 673 679 10.1111/j.1365-3156.2004. 01255.x 15189457
32. Efficacy of three artemisinin combination therapies for the treatment of uncomplicated Plasmodium falciparum malaria in the Republic of Congo. I van den Broek C Kitz S Al Attas F Libama M Balasegaram JP Guthmann, Malar J 2006 5 113 17125496 10.1186/1475-2875-5-113 (Pubitemid 44915803)
33. Comparative clinical trial of two-fixed combinations dihydroartemisinin- napthoquine-trimethoprim (DNP®) and artemether/lumefantrine (Coartem®/Riamet®) in the treatment of acute uncomplicated falciparum malaria in Thailand. S Krudsood K Chalermrut C Pengruksa S Srivilairit U Silachamroon S Treeprasertsuk S Kano GM Brittenham S Looareesuwan, Southeast Asian J Trop Med Public Health 2003 34 316 321 12971556
34. Therapeutic efficacy of artemether/lumefantrine and artesunate-mefloquine for treatment of uncomplicated Plasmodium falciparum malaria in Luang Namtha Province, Lao People's Democratic Republic. JM Stohrer S Dittrich V Thongpaseuth V Vanisaveth R Phetsouvanh S Phompida F Monti EM Christophel N Lindegardh A Annerberg T Jelinek, Trop Med Int Health 2004 9 1175 1183 10.1111/j.1365-3156. 2004.01320.x 15548313
35. Randomized comparison of chloroquine plus sulfadoxine-pyrimethamine versus artesunate plus mefloquine versus artemether/lumefantrine in the treatment of uncomplicated falciparum malaria in the Lao People's Democratic Republic. M Mayxay M Khanthavong N Lindegårdh S Keola M Barends T Pongvongsa R Yapom A Annerberg S Phompida R Phetsouvanh NJ White PN Newton, Clin Infect Dis 2004 39 1139 1147 10.1086/424512 15486837
36. Two fixed-dose artemisinin combinations for drug-resistant falciparum and vivax malaria in Papua, Indonesia: an open-label randomised comparison. A Ratcliff H Siswantoro E Kenangalem R Maristela RM Wuwung F Laihad EP Ebsworth NM Anstey E Tjitra RN Price, Lancet 2007 369 757 765 17336652 10.1016/S0140- 6736(07)60160-3 (Pubitemid 46335820)
37. A randomized trial of artemether/lumefantrine versus mefloquine- artesunate for the treatment of uncomplicated multi-drug resistant Plasmodium falciparum on the western border of Thailand. R Hutagalung L Paiphun EA Ashley R McGready A Brockman KL Thwai P Singhasivanon T Jelinek NJ White FH Nosten, Malar J 2005 4 46 16179089 10.1186/1475-2875-4-46 (Pubitemid 41455936)
38. Efficacy of chloroquine + sulfadoxine-pyrimethamine, mefloquine + artesunate and artemether + lumefantrine combination therapies to treat Plasmodium falciparum malaria in the Chittagong Hill Tracts, Bangladesh. IV van den Broek UA Maung A Peters L Liem M Kamal M Rahman MR Rahman AM Bangali S Das M Barends AM Faiz, Trans R Soc Trop Med Hyg 2005 99 727 735 10.1016/j.trstmh. 2005.02.007 16095643
39. Comparison of artemether/lumefantrine with sulfadoxine-pyrimethamine for the treatment of uncomplicated falciparum malaria in Eastern Nepal. S Thapa J Hollander M Linehan J Cox-Singh MB Bista GD Thakur WA Davis TM Davis, Am J Trop Med Hyg 2007 77 423 430 17827354
40. Efficacy and safety of the six-dose regimen of artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in adolescents and adults: a pooled analysis of individual patient data from randomized clinical trials. EA Mueller M van Vugt W Kirch K Andriano P Hunt PI de Palacios, Acta Tropica 2006 100 41 53 10.1016/j.actatropica.2006.09.007 17045558 (Pubitemid 44830005)
41. Efficacy and safety of the six-dose regimen of artemether-lumefantrine in pediatrics with uncomplicated Plasmodium falciparum malaria: a pooled analysis of individual patient data. M Makanga Z Premji C Falade J Karbwang EA Mueller K Andriano P Hunt PI De Palacios, Am J Trop Med Hyg 2006 74 991 998 16760509
42. Toxic Brainstem Encephalopathy after Artemisinin Treatment for Breast Cancer. LA Panossian NI Garga D Pelletier, Ann Neurol 2005 58 812 813 10.1002/ana.20620 16240360
43. Ataxia and slurred speech after artesunate treatment for falciparum malaria. LG Miller CB Panosian, N Eng J Med 1997 336 1328 10.1056/ NEJM199705013361818
44. Neurotoxicity due to antimalarials therapy associated with misdiagnosis of malaria. C Franco-Paredes R Dismukes D Nicolls PE Kozarsky, Clin Infect Dis 2005 40 1710 1711 10.1086/430180 15889385
45. Toxic brainstem encephalopathy after artemisinin treatment for breast cancer. NJ White EA Ashley F Nosten, Ann Neurol 2006 59 725 726 10.1002/ana.20815 16566014
46. Artesunate and cerebellar dysfunction in falciparum malaria. TME Davis GO Edwards JS McCarthy, N Engl J Med 1997 337 792 793 10.1056/NEJM199709113371116 9289650
47. Misattribution of Central Nervous System Dysfunction to Artesunate. PN Newton PJ Day NJ White, Clin Infect Dis 2005 41 1687 1688 10.1086/498033 16267750
48. Clinical and neurophysiological study of the effects of multiple doses of artemisinin on brain-stem function in Vietnamese patients. E Kissinger TT Hien NT Hung ND ND Nam NL Tuyen BV Dinh C Mann NH Phu PP Loc JA Simpson NJ White J Farrar, Am J Trop Med Hyg 2000 63 48 55 11357994
49. A case-control auditory evaluation of patients treated with artemisinin derivatives for multidrug-resistant Plasmodium falciparum malaria. M van Vugt BJ Angus RN Price C Mann JA Simpson C Poletto SE Htoo S Looareesuwan NJ White F Nosten, Am J Trop Med Hyg 2000 62 65 69 10761725
50. A randomized trial of artemether-lumefantrine versus mefloquine- artesunate for the treatment of uncomplicated multi-drug resistant Plasmodium falciparum on the western border of Thailand. R Hutagalung L Paiphun EA Ashley R McGready A Brockman KL Thwai P Singhasivanon T Jelinek NJ White FH Nosten, Malar J 2005 4 46 51 16179089 10.1186/1475-2875-4-46 (Pubitemid 41455936)
51. No hearing loss associated with the use of artemether-lumefantrine to treat experimental human malaria. MBB McCall AJ Beynon EAM Mylanus AJ van der Ven RW Sauerwein, Trans R Soc Trop Med Hyg 2006 100 1098 1104 10.1016/j.trstmh.2006.02.017 16808940
52. M Cousin S Kummerer G Lefèvre AC Marrast D Stein M Weaver, Advisory Committee Briefing Book. Coartem (artemether/lumefantrine) Tablets for the treatment of malaria in patients with acute, uncomplicated infections due to Plasmodium falciparum or mixed infections including P. falciparum. NDA 22-268 2008 http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4388b1-02-Novartis.pdf
53. Cardiotoxicity of antimalarial drugs. NJ White, Lancet Infect Dis 2007 7 549 558 10.1016/S1473-3099(07)70187-1 17646028
54. An integrated assessment of the clinical safety of artemether- lumefantrine: a new oral fixed-dose combination antimalarial drug. R Bakshi I Hermeling-Fritz I Gathmann E Alteri, Trans R Soc Trop Med Hyg 2000 94 419 424 10.1016/S0035-9203(00)90126-3 11127248
55. Amodiaquine-artesunate vs artemether-lumefantrine for uncomplicated malaria in Ghanaian children: a randomized efficacy and safety trial with one year follow-up. GO Adjei1 JAL Kurtzhals OP Rodrigues M Alifrangis LCG Hoegberg ED Kitcher EV Badoe1 R Lamptey BQ Goka, Malar J 2008 7 127 138 18620577 10.1186/1475-2875-7-127 (Pubitemid 352033070)
56. Safety and tolerability of combination antimalarial therapies for uncomplicated falciparum malaria in Ugandan children. C Maiteki-Sebuguzi P Jagannathan VM Yau TD Clark D Njama-Meya1 B Nzarubara1 AO Talisuna MR Kamya1 PJ Rosenthal G Dorsey SG Staedke, Malar J 2008 7 106 117 18547415 10.1186/1475-2875-7-106 (Pubitemid 351904896)
57. Artemisinin antimalarial in pregnancy: a prospective treatment study of 539 episodes of multidrug-resistant Plasmodium falciparum. R McGready T Cho NK Keo KL Thwai L Villegas S Looareesuwan NJ White F Nosten, Clin Infect Dis 2001 33 2009 2016 10.1086/324349 11712093
58. Safety profile of artemether-lumefantrine (AL; Coartem®) compared with sulfadoxine-pyrimethamine (SP) in pregnant women with symptomatic malaria: preliminary results of an observational study. C Manyando R Mkandawire L Puma M Sinkala E Njunju M Gomes K Andriano R Schlienger M Virtanen, Abstract 570, 57th Meeting of the American Society of Tropical Medicine and Hygiene (ASTMH), New Orleans, Louisiana, USA 2008