This article in the May edition of the Drug and Therapeutics Bulletin (DTB) relates to and updates recommendations given in a previous article on artemisinins in malaria treatment in the UK.
The previous article stated that “intravenous artesunate produced by pharmaceutical companies in China and Vietnam, mainly for use in developing countries, does not comply with international Good Manufacturing Practice (GMP) standards…This means that the drug cannot be licensed in the European Union and certain other countries (e.g. the USA, Australia).” However this product was subsequently assessed as part of the World Health Organization Prequalification Programme (WHO PQP) and the relevant manufacturing site for intravenous artesunate was found to comply with GMP at the time of inspection.
In addition, a further trial of artesunate versus quinine (both given parenterally) in the treatment of African children with severe falciparum malaria (AQUAMAT) has now been published. This found that artesunate substantially reduced the primary endpoint of in-hospital mortality (8.5% vs. 10.9%, odds ratio for death 0.75, 95% CI 0.63 to 0.90), and the authors concluded that parenteral artesunate should replace quinine as the treatment of choice for severe falciparum malaria worldwide.
Based on these new developments, the authors of the current DTB article “believe that artesunate should be endorsed as first-line treatment of severe malaria in both adults and children”.