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

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(Continued) Mutabingwa 2004 TZA (1022 participants) Staedke 2003 UGA (268 participants) Yeka 2004 UGA (1461 participants) Footnotes AE = adverse event DHA-P = dihydroartemisinin-piperaquine AS = artesunate MQ = mefloquine AL = artemether-lumefantrine AQ = amodiaquine SP = sulfadoxine-pyrimethamine SAE = serious adverse event GI = gastrointestinal system CVS = cardiovascular system RS = respiratory system CNS = central nervous system ECG = electrocardiogram Parents or guardians were asked to report on side effects, tolerability, and usefulness of the treatment (days 0, 14, and 28) Assessed at each visit with a standardized history and examination. Neurological assessment on days 0, 7, 14, and 28. CBC, creatine and alanine transferase on days 0, 7, and 28. Adverse event monitoring not described QT = interval between the Q and T waves of an ECG U&E = urea and electrolytes FBC = full blood count LFT = liver function tests Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Unclear SAE: 1 death in the AQ+SP group died on the day of randomization No other reporting of AE Single blind (outcome assessors) Single blind (outcome assessors) SAE: 16 serious adverse events (1/134 AS+AQ vs 6/134 AQ+SP CNS: ‘No important neurological events were seen’ Biochem: 1 severe anaemia with AS+AQ, 1 severe neutropenia with AQ+SP, 1 elevated alanine transaminase with AQ+SP No other comment on adverse events SAE: 4/731 AS+AQ vs 10/730 AQ+SP. 2 additional patients died in the AQ+SP group No other reporting of AE 236
PCR = polymerase chain reaction PCV = packed cell volume WBC = white blood cells Appendix 5. Anaemia tables Dihydroartemisinin-piperaquine vs Artesunate plus mefloquine Study ID Outcome measure and result Significance test Ashley 2003b THA Median decrease in haematocrit by day 7: DHA-P 6.3% (0% to 13.6%) vs AS+MQ 9.4% (2.6% to 14.3%) Mean haematocrit weekly from day 0 to 63: Presented graphically Ashley 2004 THA Median change in haematocrit in each group, each week, from day 0 to 63: ’a decrease in haematocrit in both groups between days 0 and 7 followed by recovery in both groups’. Figures presented graphically. Janssens 2003 KHM Mean haematocrit at day 63: DHA-P 40.0% vs AS+MQ 40.2% (No differences at baseline) Mayxay 2004 LAO Mean haematocrit following treatment (days 7 to 42): ’did not significantly differ between groups’. Figures not given. Smithuis 2004 MMR Mean haemoglobin at day 28 (supervized treatment): DHA-P 10.4g/dl vs AS+MQ 10.5g/dl Proportion anaemic (Hb < 10g/dl) on day 28 (superviZed treatment): DHA-P 56/152 vs AS+MQ 59/156 (no differences at baseline) Artesunate plus mefloquine vs Artemether-lumefantrine P = 0.21 Not reported Not reported Not significant P > 0.05 P = 0.65 P = 0.85 Study ID Outcome measure and result Significance test between groups Artemisinin-based combination therapy for treating uncomplicated malaria (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 237
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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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Analysis 9.8. Comparison 9 Artemeth
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