Limits...
Artesunate-mefloquine combination therapy in acute Plasmodium falciparum malaria in young children: a field study regarding neurological and neuropsychiatric safety.

Frey SG, Chelo D, Kinkela MN, Djoukoue F, Tietche F, Hatz C, Weber P - Malar. J. (2010)

Bottom Line: Eleven drug-related neurological and neuropsychiatric adverse events occurred in eight patients.African children showed a low percentage of self-limited neurological and neuropsychiatric adverse events, confirming studies on neurological safety in Asian children treated with artesunate and mefloquine.Sleeping disorders were most frequently observed.

View Article: PubMed Central - HTML - PubMed

Affiliation: Division of Neuropaediatrics and Developmental Medicine, University Children's Hospital Basel, Switzerland. sarabelperugia@yahoo.com

ABSTRACT

Background: Mefloquine-artesunate combination therapy for uncomplicated falciparum malaria is one of the treatments used in African children. Data concerning neurological safety in adults and children treated with mefloquine and artesunate combination therapy is well documented in Asia. Safety data for neurological and neuropsychiatric side effects of mefloquine and artesunate combination therapy in African children are scarce, although WHO recommends this therapy in Africa.

Methods: A phase IV, open label, single arm study was conducted among African children between 10 and 20 kg with acute uncomplicated falciparum malaria. They were treated over three consecutive days with a paediatric fixed-dose combination of artesunate (50 mg/d) and mefloquine (125 mg/d). Parasitological, clinical and neurological examinations and standardized questions about neuropsychiatric symptoms were carried out on days 0, 4, 7, 28 and 63. The primary objective was to assess the neurological and neuropsychiatric safety of artesunate-mefloquine combination therapy in young children.

Results: From December 2007 to March 2009, 220 children with uncomplicated Plasmodium falciparum malaria were treated with artesunate and mefloquine. 213 children were analysed according to study protocol. 50 neurological and neuropsychiatric adverse events occurred in 28 patients. Eleven drug-related neurological and neuropsychiatric adverse events occurred in eight patients. Sleeping disorders were present in 2.3%, neurological disorders in 1.4%, neuropsychiatric disorders in 1% and eating disorders in 0.5% of the patients. Adverse events were of mild to moderate intensity and resolved spontaneously.

Conclusion: African children showed a low percentage of self-limited neurological and neuropsychiatric adverse events, confirming studies on neurological safety in Asian children treated with artesunate and mefloquine. Sleeping disorders were most frequently observed.

Show MeSH

Related in: MedlinePlus

Number and intensity of drug related N+N adverse events.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC2984569&req=5

Figure 1: Number and intensity of drug related N+N adverse events.

Mentions: Fifty neuropsychiatric and neurological adverse events occurred in 28 children (13%). Eleven neuropsychiatric and neurological adverse events in eight children (out of 213; 5.16%) were related to the study medication. (Table 1 and Figure 1). The frequency of the occurrence of at least one neuropsychiatric and neurological adverse event related to the study medication was 3.77%, (95% CI 1.6-7.3%). The age distribution of drug-related neuropsychiatric and neurological adverse events did not reveal any differences (age group <1.5 years 3.7%, 1.5-3.5 years: <3.8%, 3.5-5 years: 3.9%, >5 years: 3.7%).


Artesunate-mefloquine combination therapy in acute Plasmodium falciparum malaria in young children: a field study regarding neurological and neuropsychiatric safety.

Frey SG, Chelo D, Kinkela MN, Djoukoue F, Tietche F, Hatz C, Weber P - Malar. J. (2010)

Number and intensity of drug related N+N adverse events.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2984569&req=5

Figure 1: Number and intensity of drug related N+N adverse events.
Mentions: Fifty neuropsychiatric and neurological adverse events occurred in 28 children (13%). Eleven neuropsychiatric and neurological adverse events in eight children (out of 213; 5.16%) were related to the study medication. (Table 1 and Figure 1). The frequency of the occurrence of at least one neuropsychiatric and neurological adverse event related to the study medication was 3.77%, (95% CI 1.6-7.3%). The age distribution of drug-related neuropsychiatric and neurological adverse events did not reveal any differences (age group <1.5 years 3.7%, 1.5-3.5 years: <3.8%, 3.5-5 years: 3.9%, >5 years: 3.7%).

Bottom Line: Eleven drug-related neurological and neuropsychiatric adverse events occurred in eight patients.African children showed a low percentage of self-limited neurological and neuropsychiatric adverse events, confirming studies on neurological safety in Asian children treated with artesunate and mefloquine.Sleeping disorders were most frequently observed.

View Article: PubMed Central - HTML - PubMed

Affiliation: Division of Neuropaediatrics and Developmental Medicine, University Children's Hospital Basel, Switzerland. sarabelperugia@yahoo.com

ABSTRACT

Background: Mefloquine-artesunate combination therapy for uncomplicated falciparum malaria is one of the treatments used in African children. Data concerning neurological safety in adults and children treated with mefloquine and artesunate combination therapy is well documented in Asia. Safety data for neurological and neuropsychiatric side effects of mefloquine and artesunate combination therapy in African children are scarce, although WHO recommends this therapy in Africa.

Methods: A phase IV, open label, single arm study was conducted among African children between 10 and 20 kg with acute uncomplicated falciparum malaria. They were treated over three consecutive days with a paediatric fixed-dose combination of artesunate (50 mg/d) and mefloquine (125 mg/d). Parasitological, clinical and neurological examinations and standardized questions about neuropsychiatric symptoms were carried out on days 0, 4, 7, 28 and 63. The primary objective was to assess the neurological and neuropsychiatric safety of artesunate-mefloquine combination therapy in young children.

Results: From December 2007 to March 2009, 220 children with uncomplicated Plasmodium falciparum malaria were treated with artesunate and mefloquine. 213 children were analysed according to study protocol. 50 neurological and neuropsychiatric adverse events occurred in 28 patients. Eleven drug-related neurological and neuropsychiatric adverse events occurred in eight patients. Sleeping disorders were present in 2.3%, neurological disorders in 1.4%, neuropsychiatric disorders in 1% and eating disorders in 0.5% of the patients. Adverse events were of mild to moderate intensity and resolved spontaneously.

Conclusion: African children showed a low percentage of self-limited neurological and neuropsychiatric adverse events, confirming studies on neurological safety in Asian children treated with artesunate and mefloquine. Sleeping disorders were most frequently observed.

Show MeSH
Related in: MedlinePlus