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Drug Safety
Published in: Drug Safety 9/2013

01-09-2013 | Original Research Article

Safety of Artemisinin-Based Combination Therapies in Nigeria: A Cohort Event Monitoring Study

Authors: Peter Usman Bassi, Adeline I. Osakwe, Ambrose Isah, Comfort Suku, Musa Kalat, Iliya Jalo, Robinson Daniel Wammanda, Chika Ugochukwu, Olubukula Adesina, Eno Etim Nyong, Frank Osungwu, Shanti Pal, Sylvester Chigozie Nwoasu, Magnus Wallberg, David Coulter

Published in: Drug Safety | Issue 9/2013

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Abstract

Background

A pilot programme of Cohort Event Monitoring (CEM) was conducted across the six geopolitical zones of Nigeria on patients treated for uncomplicated malaria with artemisinin-based combination therapy (ACT). The emergence and spread of malaria parasites resistant to commonly available antimalarial drugs necessitated a shift in policy for malaria treatment by the Federal Government from the use of chloroquine and sulphadoxine-pyrimethamine (SP) as first-line treatments to ACTs. Initial reports following deployment of ACTs in clinical settings raised safety concerns regarding their use. Although artemisinin and its derivatives are generally thought to be safe, there are currently few or no data on their safety among populations in Nigeria.

Objectives

The main objectives of the CEM programme were to proactively determine the adverse event (AE) profile of artesunate/amodiaquine (AA) and artemether/lumefantrine (AL) in real-life settings and to find out the factors predisposing to AEs.

Methods

The CEM study was observational, longitudinal, prospective, and inceptional. Patients were observed in real-life situations. It was conducted in six public health facilities in Nigeria on patients with a clinical diagnosis of uncomplicated malaria treated with ACTs. Patients were prescribed one of the ACTs on an alternate basis as they enrolled into the programme. Follow-up reviews were undertaken on days 3 and 7 following commencement of ACT treatment. At follow-up, patients were evaluated for any clinical event that they might have experienced following the use of the ACTs. We report the result of this initial pilot in which 3,010 patients treated for uncomplicated malaria with AA or AL were enrolled.

Results

The seven most common AEs seen were general body weakness 25.0/36.6 % (AL/AA); dizziness 11.9/17.2 % (AL/AA); vomiting 8.0/10.2 % (AL/AA); abdominal pain 8.5/7.2 % (AL/AA); insomnia 6.3/5.9 % (AL/AA); body pains 3.4/5.2 (AL/AA) %; anorexia 8.5/4.6 % (AL/AA). Most adverse events occurred from day 1 and peaked by day 2 and 3 of medication with the mean duration of events being 3 days. By the end of the follow-up visit on day 7, the AEs had resolved in the majority of patients. Adverse events were more common in the AA group than AL revealing a better safety profile for AL (p < 0.001). Both ACTs demonstrated good ability to resolve the clinical symptoms of uncomplicated malaria.

Conclusion

In conclusion, this pilot CEM programme suggests that adverse events with ACTs were common. However, serious life-threatening events were not common. It appears that ACTs have a tolerable safety profile among Nigerians.
Appendix
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Metadata
Title
Safety of Artemisinin-Based Combination Therapies in Nigeria: A Cohort Event Monitoring Study
Authors
Peter Usman Bassi
Adeline I. Osakwe
Ambrose Isah
Comfort Suku
Musa Kalat
Iliya Jalo
Robinson Daniel Wammanda
Chika Ugochukwu
Olubukula Adesina
Eno Etim Nyong
Frank Osungwu
Shanti Pal
Sylvester Chigozie Nwoasu
Magnus Wallberg
David Coulter
Publication date
01-09-2013
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 9/2013
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.1007/s40264-013-0044-8

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