Accusation of misleading claims for antimalarial
GlaxoSmithKline's claims over the efficacy of atovaquone
plus proguanil (Malarone) are misleading and should be withdrawn, according
to the Drug and Therapeutics Bulletin.
The bulletin points out that there is a lack of
published evidence to support the use of atovaquone plus proguanil in
non-immune travellers despite the manufacturer's claims that it is 97
per cent effective and as well tolerated as placebo. Some trials have
been conducted in long-term residents of malarious areas but it was unclear
whether results from these trials can be extrapolated to non-immune travellers.
However, the bulletin does state that atovaquone
plus proguanil is a potentially important addition to currently available
chemoprophylaxis for malaria. The short duration of therapy with atovaquone
plus proguanil needed after a trip (one week compared with four for other
regimens) is a real benefit, it says.
The drawbacks of atovaquone plus proguanil therapy
are that it costs more than alternative drugs and there is limited evidence
on its efficacy, the bulletin concludes (2001;39:73).
A spokeswoman for GlaxoSmithKline told The Journal
on 23 October that the company is standing by its claims with respect
to the drug's efficacy.
Trials had been carried out in semi-immune people
(ie, those living in a malarious area) because efficacy trials that exposed
a non-immune person to malaria were unethical, she added.
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