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

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Hb = haemoglobin IQR = interquartile range PCV = packed call volume SD = standard deviation Appendix 6. Summary of findings tables Is Dihydroartemisinin-piperaquine as effective as Artesunate plus mefloquine for uncomplicated malaria? Patient or population: Patients with uncomplicated malaria Settings: Endemic areas worldwide Intervention: Dihydroartemisinin-piperaquine Comparison: Artesunate plus mefloquine Outcomes Illustrative comparative risks* (95% CI) Relative effect (95% CI) Efficacy: Total Failure (P. falciparum) Day 63 PCR adjusted - Asia Efficacy: Total Failure (P. falciparum) Day 63 PCR unadjusted - Asia Efficacy: Total Failure (P. falciparum) Day 63 PCR adjusted - South America Efficacy: Total Failure (P. falciparum) Day 63 PCR unadjusted - South America Assumed risk Corresponding risk Artesunate plus mefloquine Dihydroartemisininpiperaquine 46 per 1000 18 per 1000 (9 to 36) 151 per 1000 110 per 1000 (82 to 148) RR 0.39 (0.19 to 0.79) RR 0.73 (0.54 to 0.98) 0 per 1000 Not estimable RR 9.55 (0.52 to 176.35) 9 per 1000 56 per 1000 (13 to 246) RR 6.19 (1.4 to 27.35) Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. No of participants (studies) 1062 (3) 1182 (3) 435 (1) 445 (1) Quality of the evidence (GRADE) ⊕⊕⊕⊕ high 1,2,3,4,5,6 ⊕⊕⊕⊕ high 1,2,3,4,5,6 ⊕ very low 7,8,9,10 ⊕⊕⊕ moderate 7,8,9,11 240
(Continued) Vivax efficacy: P. vivax parasitaemia by day 63 Transmission potential: Gametocytedevelopment (in those negative at baseline) Harms: Serious adverse events (including deaths) Harms: Early vomiting 180 per 1000 200 per 1000 (164 to 241) 9 per 1000 28 per 1000 (10 to 79) 7 per 1000 6 per 1000 (3 to 15) 88 per 1000 79 per 1000 (61 to 102) RR 1.11 (0.91 to 1.34) RR 3.06 (1.13 to 8.83) RR 0.9 (0.38 to 2.15) RR 0.90 (0.69 to 1.16) 1661 (4) 1234 (3) 2617 (8) 2473 (7) ⊕⊕⊕ moderate 4,12,13,14,15 ⊕⊕⊕⊕ high 4,11,13,16 ⊕⊕ low 4,10,13,17 ⊕⊕ low 4,13,18,19 *The assumed risk is the mean risk from the studies included in this review, calculated as the number of patients in the control groups with the event divided by the total number of patients in control groups. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. Footnotes 1 Data on treatment failure at days 42 and 28 were also available and no differences between the two drugs were shown. 2 Ashley 2003b THA, Ashley 2004 THA and Janssens 2003 KHM. 3 No serious limitations: Allocation concealment was judged to be at ’low risk of bias’ in two trials and ’unclear’ in one. Sensitivity analysis only including trials with adequate concealment did not substantially change the result. Laboratory staff were blinded in two of the trials. 4 No serious inconsistency: Heterogeneity was low. 5 No serious indirectness: Trials were conducted in Asia (Thailand and Cambodia) in areas of low and unstable transmission. Children age < one year and pregnant or lactating women were excluded. 6 No serious imprecision: The 95% CI of the pooled estimate includes appreciable benefit with DHA-P over AS+MQ and no appreciable benefit. 7 Grande 2005 PER. 8 No serious limitations: Allocation concealment was assessed as ’low risk of bias’. No blinding was described in this trial. Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 241
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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 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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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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(... Continued) Study or subgroup A
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Analysis 6.6. Comparison 6 Artesuna
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Analysis 9.2. Comparison 9 Artemeth
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Analysis 9.8. Comparison 9 Artemeth
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