[Healthcare in Low-resource Settings 2013; 1:e22] [page 75] Efficacy and safety of Camosunate for the treatment of uncomplicated malaria in the University of Benin Teaching Hospital, Benin City, Nigeria Damien Uyagu, 1 Augustine Omoigberale, 2 Paul Dienye 3 1 Department of Family Medicine, University of Benin Teaching Hospital, Benin City; 2 Department of Child Health, University of Benin Teaching Hospital, Benin City; 3 Department of Family Medicine, University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria Abstract In Nigeria, nearly 110 million clinical cases of malaria are diagnosed per year, thus being a major public health problem. The problems of resistance resulted in the introduction of the artemisinin based combinations (ACT) by the WHO. Artesunate and amodiaquine (AS+AQ) is at present the world’s second most widely used ACT. This study is an assessment of the efficacy and safety of Camosunate (a brand of AS+AQ; Geneith Pharmaceutical Ltd., Oshodi, Lagos) in the treatment of uncomplicated malaria conducted at the University of Benin Teaching Hospital (UBTH). A cross-sectional assessment of the efficacy and safety of Camosunate was conducted over a period of one year using 120 patients selected after stratification, by random sampling technique. All recruited patients had slide-proven uncom- plicated malaria and were followed up for 28 days on commencement of Camosunate. Data was collected using a structured interviewer- administered questionnaire and was analysed using SPSS version 15. The overall efficacy of Camosunate was found to be 95.8%. Treatment was well tolerated as testified by the fact that there was no case withdrawal due to adverse drug reaction (ADR) or treatment emergent signs and symptoms (TESS). Also no evidence of toxicity was recorded. Camosunate is highly efficacious and well tolerated in this area of Nigeria and justifies its use as a first line treatment for uncomplicated malaria. Introduction In Nigeria, nearly 110 million clinical cases of malaria are diagnosed per year, translating to about 50% of the adult population experienc- ing at least one malaria episode per year, while young children can have up to 2-4 attacks of malaria annually, 1 accounting for 25% of under-five mortality, 30% of childhood mortali- ty and 11% of maternal mortality. Each year 70% of pregnant women suffer from malaria resulting in anaemia in pregnancy, abortions, stillbirths and low birth weight infants. The disease also accounts for 50-60% of outpatient consultations and 10-30% of overall hospital admissions in Nigeria. In addition to the direct health impact of malaria on the Nigerian pop- ulation, the economic loss linked to the dis- ease in this country is estimated to be about 132 billion Naira (around 878 million US $) per year as treatment costs, loss of man-hour, to mention but a few. 1,2 The disease is there- fore a major public health problem in Nigeria. Antimalarial chemotherapy has been the primary option in the fight against this men- ace. National drug efficacy trials conducted in 2002 in Nigeria demonstrated that the first line treatments then employed, chloroquine and sulphadoxine-pyrimethamine (SP) were no longer adequate. 2 In 2005, the highly effica- cious artemisinin-based combination therapy was adopted as first-line treatment for uncom- plicated malaria. 2 Artemisinin-based combina- tion therapy has since then remained the treatment of choice for uncomplicated Plasmodium falciparum malaria in Nigeria 3 in line with global trend, following the recom- mendation of the World Health Organization (WHO) to that effect. 4 Starting from February 2009, more than 80 countries worldwide including Nigeria have adopted ACT as first- line therapy. 3 Currently, five forms of ACT are recommended by the WHO, of which all are available in Nigeria. These include: i) artemether and lumefantrine (AL); ii) arte- sunate and amodiaquine (AS+AQ); iii) arte- sunate and mefloquine (AS+MQ); iv) arte- sunate and sulphadoxine-pyrimethamine (AS+SP); v) dihydroartemisinin and piper- aquine (DHA+PQP). Artemisinin compounds – when used in combination with longer acting antimalarial drugs – rapidly reduce parasite densities to low levels at a time when drug levels of the longer acting drug are still maximal, thereby reducing the likelihood of parasites being exposed to suboptimal levels of the longer acting drug and limiting the emergence of resistant strains. 5,6 The choice of ACT for a country or a region depends on a number of considerations. A crit- ical element is the level of underlying resist- ance to the longer-acting partner drug in the combination. This is particularly important for AQ and SP in Africa, where both drugs have been widely used as monotherapies. The WHO recommends that countries use ACTs, which are at least 90% effective, and introduce new forms of ACT that are at least 95% effective after discounting reinfections and that the Day 28 efficacy of respective part- ner drugs alone should exceed 80%. 7 Concerns have been raised over ACT including amodi- aquine meeting such criteria in areas where it has been widely used as monotherapy. The efficacy and tolerability of AS+AQ has been tested formally in several clinical trials in different epidemiological African settings. 8-10 One of the AS+AQ brands in the country is Camosunate by Geneith Pharmaceutical Ltd. (Lagos, Oshodi). This study is an assessment of the efficacy and safety of Camosunate in the treatment of uncomplicated malaria conducted at the University of Benin Teaching Hospital (UBTH). Though similar studies have been conducted in other parts of Africa including Sub-Saharan Africa and Democratic Republic of Congo, 8-10 none has been conducted using the Camosunate brand of ACT in South Nigeria to the best of our knowledge. Materials and Methods The study was conducted on patients recruited from the Departments of Family Healthcare in Low-resource Settings 2013; volume 1:e22 Correspondence: Paul Dienye, Department of Family Medicine, University of Port Harcourt Teaching Hospital, East-West Road, 6173 Port Harcourt, Nigeria. Tel./Fax: +234.8033.393806. E-mail: pdienye@yahoo.com Key words: uncomplicated malaria, Camosunate, efficacy, safety, Nigeria. Contributions: the authors contributed equally. Funding: the drug samples used for this study were donated by Geneith Pharmaceutical Ltd. (Oshodi, Lagos), which also funded the laborato- ry investigations. The company had no role in the study design, data collection and analysis, or preparation of this manuscript. Acknowledgments: we are grateful to all the per- sonnel of the Departments of Family Medicine and Child Health of the University of Benin Teaching Hospital who assisted the conduct of this study. We also wish to thank the haematolo- gist, microbiologist and chemical pathologist who performed the laboratory analysis. Received for publication: 28 March 2013. Revision received: 14 May 2013. Accepted for publication: 17 May 2013. This work is licensed under a Creative Commons Attribution 3.0 License (by-nc 3.0). ©Copyright D. Uyagu et al., 2013 Licensee PAGEPress, Italy Healthcare in Low-resource Settings 2013; 1:e22 doi:10.4081/hls.2013.e22 Non-commercial use only