Artemisinin-based combination therapy for ... - The Cochrane Library

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(Continued) Mens 2007 KEN (146 participants) Ratcliff 2005 IDN (774 participants) Yeka 2007 UGA (414 participants) Zongo 2007 BFA (375 participants) verse event monitoring not described. Adverse events were recorded at each visit in the case record form (days 0, 1, 2, 3, 7, 14, and 28). An adverse event defined as any unfavourable and unintended sign. Assessed daily until fever and parasites cleared then weekly until day 42. A symptom questionnaire and physical exam at each visit. Haemoglobin was checked at each visit. Standardized history, physical exam, and malaria film on days 0, 1, 2, 3, 7, 14, 21, 28, 35, and 42 and any other day they were unwell Assessed at each visit including neurological examination. Adverse events described as any untoward medical occurrence. Assessed daily until day 3 then weekly until day 42. A standardized history and physical exam at each visit. Haemoglobin was checked at baseline and last day of follow up. Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. study drug No other significant differences are noted between treatments Open label SAE: 1 patient treated with DHA-P died on day 14. Assessed as unrelated to treatment. GI: No difference in anorexia, abdominal pain, diarrhoea, or vomiting CVS/RS: No difference in cough CNS: Weakness more common with AL6 (P = 0.035). No difference in headache. Derm: No difference in pruritis Open label SAE: 1 death 60 days after treatment. Cause not known GI: Diarrhoea was more common with DHA-P (P = 0.003). Nausea, vomiting, abdominal pain, and anorexia not different CNS: Headache and dizziness not significantly different CVS/RS: Palpitations and cough not different Other: No difference in rash or myalgia Single Blind SAE: 2 with AL, 5 with DHA-P, all judged unrelated to study meds (2 convulsions, 2 pyomyositis, vomiting, severe anaemia, dehydration) GI: Abdominal pain more common with AL (P = 0.05). No difference in anorexia, vomiting or diarrhoea. RS/CVS: No difference in cough or coryza CNS: No difference in malaise/weakness Derm: No difference in pruritis Overall comment: Most AE were of mild to moderate severity and consistent with symptoms of malaria Open label SAE: None observed GI: Less abdominal pain with DHA-P (P < 0.05), vomiting, diarrhoea, and anorexia not different CNS: Less headache with DHA-P (P < 0.05), no difference in weakness CVS/RS: No difference in cough 222
Dihydroartemisinin-piperaquine vs Artemether plus amodiaquine Study ID Adverse event monitoring Blinding Adverse events Hasugian 2005 IDN (334 participants) Karema 2004 RWA (504 participants) Assessed at each follow-up visit (daily until afebrile and clear of parasites, then weekly to day 42) An adverse event defined as a symptom that developed after starting treatment Assessed at each follow-up visit (days 0, 1, 2, 3, 7, 14, 21, and 28) An adverse event defined as any unfavourable and unintended sign associated temporally with the use of the drug administered Differential WBC count (and liver function tests at one site only) assessed at days 0 and 14 Dihydroartemisinin-piperaquine vs artesunate plus sulfadoxine-pyrimethamine Study ID Adverse event monitoring Blinding Adverse events Karunajeewa 2007 PNG (245 participants) Adverse event monitoring not described Dihydroartemisinin-piperaquine vs amodiaquine plus sulfadoxine-pyrimethamine Study ID Adverse event monitoring Blinding Adverse events Karema 2004 RWA (510 participants) Assessed at each follow-up visit (days 0, 1, 2, 3, 7, 14, 21, and 28) Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Open label SAE: 3 with AS+AQ (2 vomiting, 1 ataxia), none with DHA-P GI: On days 1 and 2 more nausea (P = 0.004), vomiting (P = 0.02), anorexia (P = 0.007) with AS+AQ No further comment Open label SAE: Not reported (one seizure with AS+AQ) GI: More vomiting (P = 0.007) and anorexia (P = 0.005) with AS+AQ. No difference in abdominal pain, diarrhoea, nausea CNS: More fatigue with AS+AQ (P = 0.001). No difference in seizures, headache, dizziness, drowsiness CVS/RS: No difference in cough, angina, oedema Biochemical: No differences in mean PCV or mean WBC. No hepatotoxicity observed (one site only) Other: No difference in rash Open label Overall comment: No treatment withdrawals were attributable to adverse events related to a study drug No other significant differences are noted between treatments Open label SAE: Not reported (1 seizure with AQ+SP) GI: More vomiting (P = 0.007) and anorexia (P = 0.005) with AQ+SP. No difference in abdominal 223
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Artemisinin-based combination thera
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Analysis 2.2. Comparison 2 Dihydroa
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Analysis 10.5. Comparison 10 Arteme
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[Intervention Review] Artemisinin-b
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B A C K G R O U N D Malaria is a di
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drugs and the treatment comparisons
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this analysis into participants who
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Figure 1. Methodological quality su
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confidence intervals of the estimat
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Anaemia Hasugian 2005 IDN found tha
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Three trials report significantly m
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or those treated for P. vivax at ba
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Early vomiting Not reported. D I S
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Figure 4. Olliaro-Vaillant plot. Da
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Figure 10. Olliaro-Vaillant plot. D
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of findings tables’. For these ta
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Huambo and Bie provinces, central A
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References to studies excluded from
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Adjuik 2004 Adjuik M, Babiker A, Ga
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C H A R A C T E R I S T I C S O F S
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Ashley 2003a THA (Continued) Outcom
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Ashley 2003b THA (Continued) Alloca
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Ashley 2005 THA (Continued) Exclusi
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Bonnet 2004 GIN (Continued) Item Au
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Bukirwa 2005 UGA Methods Trial desi
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Djimde 2004 MLI (Continued) • AS
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Dorsey 2006 UGA (Continued) Item Au
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Fanello 2004 RWA Methods Trial desi
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Faye 2003 SEN (Continued) Outcomes
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Grande 2005 PER (Continued) Allocat
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Guthmann 2004 AGO (Continued) All d
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Hasugian 2005 IDN Methods Trial des
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Hutagalung 2002 THA (Continued) 5.
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Janssens 2003 KHM (Continued) Free
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Karema 2004 RWA (Continued) Interve
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Karunajeewa 2007 PNG (Continued) Ri
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Kobbe 2007 GHA (Continued) Exclusio
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Koram 2003 GHA (Continued) Adequate
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Martensson 2003 TZA Methods Trial d
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Mayxay 2003 LAO (Continued) 1. Feve
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Menard 2006 MDG Methods Trial desig
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Mens 2007 KEN (Continued) Risk of b
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Mutabingwa 2004 TZA (Continued) •
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Owusu-Agyei 2006 GHA (Continued) Fr
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Sagara 2005b MLI (Continued) • 25
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Smithuis 2004 MMR (Continued) Risk
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Stohrer 2003 LAO Methods Trial desi
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Swarthout 2004 ZAR (Continued) Note
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Tran 2002 VNM Methods Trial design:
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Van den Broek 2003a BGD (Continued)
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Van Vugt 1998 THA Methods Trial des
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Yeka 2004 UGA (Continued) Risk of b
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Yeka 2007 UGA (Continued) Free of o
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Zongo 2007 BFA (Continued) Novartis
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(Continued) Fofana 2005 Conference
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D A T A A N D A N A L Y S E S Compa
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2.2 Asia 1 317 Risk Ratio (M-H, Fix
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Comparison 5. Dihydroartemisinin-pi
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Comparison 8. Artesunate plus meflo
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Comparison 10. Artemether-lumefantr
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Comparison 12. Artesunate plus amod
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5.2 DHA-P 3 doses 3 1116 Risk Ratio
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Comparison 21. How does Artesunate
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(... Continued) Study or subgroup D
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Analysis 1.12. Comparison 1 Dihydro
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Analysis 6.6. Comparison 6 Artesuna
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Analysis 9.2. Comparison 9 Artemeth
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