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Clin Infect Dis ; 62(8): 964-971, 2016 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-26908796

RESUMO

BACKGROUND: Artemisinins, which are derived from plants, are subject to risk of supply interruption due to climatic changes. Consequently, an effort to identify a new synthetic antimalarial was initiated. A fixed-dose combination of arterolane maleate (AM), a new synthetic trioxolane, with piperaquine phosphate (PQP), a long half-life bisquinoline, was evaluated in patients with uncomplicatedPlasmodium falciparummalaria. METHODS: In this multicenter, randomized, double-blind, comparative, parallel-group trial, 1072 patients aged 12-65 years withP. falciparummonoinfection received either AM-PQP (714 patients) once daily or artemether-lumefantrine (A-L; 358 patients) twice daily for 3 days. All patients were followed up until day 42. RESULTS: Of the 714 patients in the AM-PQP group, 638 (89.4%) completed the study; of the 358 patients in the A-L group, 301(84.1%) completed the study. In both groups, the polymerase chain reaction corrected adequate clinical and parasitological response (PCR-corrected ACPR) on day 28 in intent-to-treat (ITT) and per-protocol (PP) populations was 92.86% and 92.46% and 99.25% and 99.07%, respectively. The corresponding figures on day 42 in the ITT and PP populations were 90.48% and 91.34%, respectively. After adjusting for survival ITT, the PCR-corrected ACPR on day 42 was >98% in both groups. The overall incidence of adverse events was comparable. CONCLUSIONS: AM-PQP showed comparable efficacy and safety to A-L in the treatment of uncomplicatedP. falciparummalaria in adolescent and adult patients. AM-PQP demonstrated high clinical and parasitological response rates as well as rapid parasite clearance. CLINICAL TRIALS REGISTRATION: India. CTRI/2009/091/000101.


Assuntos
Antimaláricos/administração & dosagem , Artemisininas/administração & dosagem , Etanolaminas/administração & dosagem , Fluorenos/administração & dosagem , Compostos Heterocíclicos com 1 Anel/administração & dosagem , Malária Falciparum/tratamento farmacológico , Malária Falciparum/parasitologia , Peróxidos/administração & dosagem , Quinolinas/administração & dosagem , Compostos de Espiro/administração & dosagem , Adolescente , Adulto , África/epidemiologia , Idoso , Antimaláricos/uso terapêutico , Artemeter , Artemisininas/uso terapêutico , Ásia/epidemiologia , Criança , Método Duplo-Cego , Quimioterapia Combinada , Etanolaminas/uso terapêutico , Feminino , Fluorenos/uso terapêutico , Meia-Vida , Compostos Heterocíclicos com 1 Anel/uso terapêutico , Humanos , Índia/epidemiologia , Lumefantrina , Malária Falciparum/epidemiologia , Masculino , Pessoa de Meia-Idade , Peróxidos/uso terapêutico , Plasmodium falciparum/efeitos dos fármacos , Quinolinas/uso terapêutico , Compostos de Espiro/uso terapêutico , Adulto Jovem
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