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Titolo:
A clinical and pharmacokinetic trial of six doses of artemether-lumefantrine for multidrug-resistant Plasmodium falciparum malaria in Thailand
Autore:
Lefevre, G; Looareesuwan, S; Treeprasertsuk, S; Krudsood, S; Silachamroon, U; Gathmann, I; Mull, R; Bakshi, R;
Indirizzi:
Mahidol Univ, Fac Trop Med, Bangkok, Thailand Mahidol Univ Bangkok Thailand dol Univ, Fac Trop Med, Bangkok, Thailand Novartis Pharma AG, Int Clin Dev, CH-4002 Basel, Switzerland Novartis Pharma AG Basel Switzerland CH-4002 CH-4002 Basel, Switzerland
Titolo Testata:
AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE
fascicolo: 5-6, volume: 64, anno: 2001,
pagine: 247 - 256
SICI:
0002-9637(200105/06)64:5-6<247:ACAPTO>2.0.ZU;2-Z
Fonte:
ISI
Lingua:
ENG
Soggetto:
PERFORMANCE LIQUID-CHROMATOGRAPHY; ANTIMALARIAL DRUG; CO-ARTEMETHER; ARTESUNATE-MEFLOQUINE; CGP-56697 ARTEMETHER; BLOOD-PLASMA; BENFLUMETOL; HALOFANTRINE; COMBINATION; EFFICACY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
40
Recensione:
Indirizzi per estratti:
Indirizzo: Lefevre, G Novartis Pharma AG, Int Clin Dev, WSJ-27-7-029, CH-4002 Basel, Switzerland Novartis Pharma AG WSJ-27-7-029 Basel Switzerland CH-4002 land
Citazione:
G. Lefevre et al., "A clinical and pharmacokinetic trial of six doses of artemether-lumefantrine for multidrug-resistant Plasmodium falciparum malaria in Thailand", AM J TROP M, 64(5-6), 2001, pp. 247-256

Abstract

The efficacy-safety and pharmacokinetics of the six-dose regimen of artemether-lumefantrine (Coartem(R)/Riamet(R); Novartis Pharma AG, Basel, Switzerland) were assessed in a randomized trial in 219 patients (greater than or equal to 12 years old) with acute. uncomplicated Plasmodium falciparum malaria in Thailand. One hundred and sixty-four patients received artemether-lumefantrine and 55 received the standard treatment combination of mefloquine-artesunate. Both drugs induced rapid clearance of parasites and malaria symptoms. The 28-day cure rates were 95.5% (90% confidence interval [CI] = 91.7, 97.9%) for artemether-lumefantrine and 100% (90% CI = 94.5, 100%) for mefloquine-artesunate. This high-dose regimen of artemether-lumefantrine wasvery well tolerated, with very good compliance. The most frequent adverse events were headache, dizziness, nausea, abdominal pain, dyspepsia, vomiting, and skin rash. Overall, only 2% of patients in both groups showed QTc prolongations but without any cardiac complication, and no differences were seen between patients with and without measurable baseline plasma levels of quinine or mefloquine. Plasma levels of artemether, dihydroartemisinin, andlumefantrine were consistent with historical data for the same dose regimen, and were higher, particularly for lumefantrine. than those previously observed with the four-dose regimen, explaining the greater efficacy of the six-dose regimen in a drug-resistant setting. These results confirm the excellent safety and efficacy of the six-dose regimen of artemether-lumefantrine in the treatment of multidrug-resistant P. falciparum malaria.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 13/07/20 alle ore 05:12:47