The results of two new large scale trials show that the combination of dihydroartemisinin and piperaquine (DHA+PQP) not only is effective against uncomplicated malaria in a way which is comparable to other artemisinin-based combination therapies (ACTs), but it also protects patients against new infections for at least two months after treatment.
The DHA/PQP combination is very well tolerated with no significant side effects.
These notable results were presented at the 57th Annual Meeting of the American Society of Tropical Medicine & Hygiene (ASTMH) held in New Orleans, Louisiana, USA, (December 7-11, 2008). The results demonstrate the benefits of a treatment which is effective against a neglected disease contracted by 400-500 million people worldwide every year and the cause of death of over 1 million people, sadly largely children under 5 in Sub-Saharan Africa.
"If not promptly and effectively treated, malaria can kill in just a few days after the onset of symptoms," said Prof. Umberto D'Alessandro, Prince Leopold Institute of Tropical Medicine, Antwerp, Belgium, coordinator of one of the trials. "This novel medication expands the treatment arsenal available to us, delivers immediate benefits because it acts rapidly, and unquestionably provides help to the populations of Africa and Asia, who are the hardest hit by the disease, but also to Westerners who visit those countries for business or pleasure."
Developed by sigma-tau, the new ACT meets WHO clinical evidence-based treatment strategy recommendation as it is a medication combining in a single tablet the highly potent artemisinin-based active ingredient which does not stay long in the body with a second antimalarial which stays longer in the body. This combination treatment is to be taken only for three days and facilitates the mutual protection of the two active ingredients against drug resistance.
The results presented in New Orleans come from a development program for worldwide drug approval. The most important trials in the program were two large phase III comparative clinical trials conducted in Africa (Burkina Faso, Zambia, Kenya, Mozambique and Uganda) and Asia (Thailand, India and Laos) respectively, which involved a total of about 2,700 patients, of whom 1,600 children under 5, all with uncomplicated malaria caused by Plasmodium falciparum, the most widespread and dangerous parasite and the cause of the highest mortality in infected individuals.