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Thesis
A systematic review and meta-analysis of safety outcomes of Amodiaquine and Artesunate (AS+AQ) for the treatment of acute uncomplicated Plasmodium falciparum malaria in Sub-Saharan Africa
Master of Public Health (M.P.H.), Drexel University
Jun 2011
DOI:
https://doi.org/10.17918/etd-3631
Abstract
A systematic review was conducted by compiling an inventory of published and unpublished clinical trials that assessed the safety of Artesunate + Amodiaquine (ASAQ) combination therapy for uncomplicated falciparum malaria. The search concluded in March 2011. N = 65 articles met inclusion criteria and from these safety data was extracted in a standardized manner. Of these 65 studies, 9 were non-comparative (3283 patients), and 54 were comparative (9584 patients on ASAQ). N=35 articles (54 % consisting of a patient pool of 7246 individuals), provided detailed safety summaries. Of these, the top 10 adverse events (totaling 4037 AEs) were: anorexia (8%), asthenia (8%), vomiting (8%), headache (6%), chills (5%), body pain (4%), fever (4%), perspiration (4%), cough (3%) and abdominal pain (3%). The top 5 SAEs consisted of vomiting (0.05%), convulsion (0.03%), pneumonia (0.02%), acute severe malnutrition (0.01%) and anemia (0.01%). Sensitivity analysis was utilized all available evidence to (1) increase the sample size (number of papers) included in the analysis and (2) to put upper and lower bounds on AE and SAE rates. Such an analysis was utilized to determine how different assumptions would influence the maximum possible number of events. This was performed using 2 populations and testing 3 assumptions. The first population N = 46 was determined by utilizing N= 35 studies as the base line and adding 3 qualitative articles (additional 565 patients) to the baseline denominator. We then added 282 (half of the qualitative studies) representing the total number of patients in N= 46 which includes studies discussing SAEs. In assessing the AE distribution above, the rates are not discernable. In sum, ASAQ appears to be safe with a low frequency of AEs. Improved reporting mechanisms for clinical trials and articles must be established perhaps accomplished by mandating safety assessment & reporting via the Consort Statement.
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Details
- Title
- A systematic review and meta-analysis of safety outcomes of Amodiaquine and Artesunate (AS+AQ) for the treatment of acute uncomplicated Plasmodium falciparum malaria in Sub-Saharan Africa
- Creators
- Hardeep K. Singh - DU
- Contributors
- Dennis Gallagher (Advisor) - Drexel University (1970-)
- Awarding Institution
- Drexel University
- Degree Awarded
- Master of Public Health (M.P.H.)
- Publisher
- Drexel University; Philadelphia, Pennsylvania
- Resource Type
- Thesis
- Language
- English
- Academic Unit
- School of Public Health (2002-2015); Drexel University
- Other Identifier
- 3631; 991014632205604721