[e-med] L'artesunate intra-rectale est aussi efficace que la quinine IV

[pascal.millet@u-bordeaux2.fr]]

E-MED:L'artesunate intra-rectale est aussi efficace que la quinine IV
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Un article du LANCET nous informe que l'artésunate intra-rectale est aussi
efficace que la quinine intra-veineuse comme première thérapie d'urgence
chez les personnes atteintes de paludisme grave et incapables d'absorber un
médicament par voie orale (voir références ci-dessous). Il faut noter que
l'administration d'artésunate intra-rectale doit être suivie d'une thérapie
par voie orale d'artésunate ou autre antipaludique dès que le patient est
capable de l'absorber.

L'artésunate et d'autres dérivés de l'artémisinine sont déjà disponibles sur
le marché asiatique pour une administration intra-rectale, sous forme de
suppositoire ou de gélules molles (Rectocap, Laboratoires Mepha). Par
contre, les études cliniques sont rares ou doivent être complétées.

Sanofi a validé une formulation intra-rectale de quinine, basée sur
l'ampoule de Quinimax. Pour ces formulations basées sur une forme liquide,
la bio-disponibilité est très variable, et il est nécessaire de travailler
sur des formulations pharmaceutiques intra-rectrales évitant une perte trop
importante de principe actif (gel ou suppositoire stable en zone tropicale).

Pascal Millet
Université VIctor Segalen Bordeaux2

E-DRUG: rectal artesunate works as good as IV quinine
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[Important evidence for malaria cases unable to swallow, who now often get
an IV drip with quinine: rectal artesunate is equally effective as a startup
therapy. Please note rectal artesunate needs to be followed by oral
artesunate AND another drug.
Rectal artesunate is however not yet prequalified: only oral artesunate from
Sanofi is prequalified. Will Sanofi or another manufacturer be prepared to
get a rectal form prequalified soon? Malaria also kills millions... Coped as
fair use; thanks to Druginfo for spotting this. Full article freely
downloadable:
http://www.thelancet.com/journal/vol363/iss9421/full/llan.363.9421.original_
research.29573.1  WB]

Efficacy of rectal artesunate compared with parenteral quinine in
initialtreatment of moderately severe malaria in African children and
adults: arandomised study
K I Barnes, J Mwenechanya, M Tembo, H McIlleron, P I Folb, I Ribeiro, F
Little, M Gomes, M E Molyneux

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Division of Pharmacology (K I Barnes MD, F Little PhD, H McIlleron MD, Prof
P I Folb FRCP), and Department of Statistical Sciences (F Little),
University of Cape Town, South Africa; Malawi-Liverpool-Wellcome Trust
Clinical Research Programme and Malaria Project, College of Medicine,
Blantyre, Malawi (J Mwenechanya MD, M Tembo MD, Prof M E Molyneux FRCP);
Department of Paediatrics, College of Medicine, University of Malawi, Malawi
(J Mwenechanya, M Tembo); UNDP/World Bank/WHO Special Program for Research
and Training in Tropical Diseases (I Ribeiro MD, M Gomes PhD); and School of
Tropical Medicine, University of Liverpool, UK (M E Molyneux)

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Correspondence to: Prof M E Molyneux, Box 30096, Blantyre 3, Malawi
(e-mail:mmolyneux@malawi.net)

Summary

Background

Many patients with malaria of increasing severity cannot take medicines
orally, and delay in injectable treatment can be fatal. We aimed to assess
the reliability of absorption, antimalarial efficacy, and tolerability of a
single rectal dose of artesunate in the initial management of moderately
severe falciparum malaria.

Methods

109 children and 35 adults were randomly assigned to rectal artesunate
(single dose of about 10 mg/kg) or parenteral quinine treatment (10 mg/kg at
0, 4, and 12 h). The primary endpoint was the proportion of patients with
peripheral asexual parasitaemia of less than 60% of that at baseline after
12 h. Secondary endpoints were clinical response and concentrations of drug
in plasma. Analysis was by intention-to-treat.

Findings

All artesunate-treated patients had pharmacodynamic or pharmacokinetic
evidence of adequate drug absorption. 80 (92%) of 87 artesunate-treated
children had a 12 h parasite density lower than 60% of baseline, compared
with three of 22 (14%) receiving quinine (relative risk 0·09 [95% CI
0·04-0·19]; p<0·0001). In adults, parasitaemia at 12 h was lower than 60% of
baseline in 26 (96%) of 27 receiving artesunate, compared with three (38%)
of eight receiving quinine (relative risk 0·06 [0·01-0·44]; p=0·0009). These
differences were greater at 24 h. Clinical response was equivalent with
rectal artesunate and parenteral quinine.

Interpretation

A single rectal dose of artesunate is associated with rapid reduction in
parasite density in adults and children with moderately severe malaria,
within the initial 24 h of treatment. This option is useful for initiation
of treatment in patients unable to take oral medication, particularly where
parenteral treatment is unavailable.

Lancet 2004; 363: 1598-605

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