INDICES> Treatment of uncomplicated malaria (2)

[ktisocki@yahoo.ie]

Indices: Treatment of uncomplicated malaria (2)


Dear Sofia 

So far a small Phase II trial has been conducted with
combination of azithromycin/chloroquine in India by
Pfizer.  There is no scientific report on the results
out yet, but here is a piece from a news article
release in July 2003.
 
"Positive results from a phase II clinical trial in
India were announced by Pfizer involving the drugs
azithromycin a widely prescribed and safe antibiotic,
with chloroquine a popular cheap first-line treatment
for malaria but which has been troubled by resistance.
The combination of the two drugs not only appeared to
restore the therapeutic effects of chloroquine, but
also to actually boost them. 
Pfizer reported that the combination was shown to be
three times more effective than chloroquine alone. The
company said that 28 days after taking chloroquine or
azithromycin only 31 and 38 per cent of patients were
free of symptoms, respectively. But with the two drugs
taken in combination 96 per cent of patients were
cured. The synergistic effect is not yet understood,
early work indicates the antibiotic somehow attacks
the mechanism giving the malaria parasite resistance
to chloroquine. 
The company is planning to begin phase III clinical
trials of at least 1200 patients in India, Indonesia,
Kenya, Peru and South Africa, Dunne said. If the
results are promising, the new combined approach could
be approved as early as the beginning of 2005. Pfizer
has begun discussions about the program with officials
in these countries and with the U.S. Food and Drug
Administration.
http://new.hst.org.za/news/index.php/20030722/?comment=post


Whilst, it is true that erythromycin and
clarithromycin when given together with other
arrhytmogenic agents(like cisapride, astemizole, etc.)
may cause serious arrhytmias, azithromycin seems to be
much safer in this respect compared to the other
macrolides. 

Lets wait and see the larger clinical trial results.
The  potential lifesavings benefits of this
combination than can be weighed against the risk of
rare but serious adverse effects.

Klara
(Clinical Pharmacologist)

Dr Klara Tisocki
B. Pharm., M.Sc., Ph.D.
 
Phone: + 965 7975493
Fax: +1 775 4169388
Kuwait City

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