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Trial found no impact of Malarone(TM) on performance and alertness tasks

Results from a new study presented today at the 75th Annual Scientific Meeting of the Aerospace Medical Association (AsMA) in Anchorage, USA, suggest that MalaroneTM (atovaquone and proguanil hydrochloride) would not be expected to affect the ability of pilots and cabin crew to perform their duties while on an aircraft (1). The risk of developing clinical malaria for aircrew flying to highly endemic regions is estimated at 0.5 per 1000 persons per overnight stay (2). Considerable periods of incapacity and fatal cases in aircrew have been reported (3).

The study is the first to assess side effects of an antimalarial drug in a hypobaric chamber at aircraft cabin pressure (75.2kPa), and the results showed that clinically effective levels of MalaroneTM [250mg atovaquone + 100 mg proguanil HCl] were well tolerated and had no significant effect on vigilance, alertness, processing complex information, sleepiness and duration or quality of sleep for the volunteers.

"Use of medication for aircrew on duty is prohibited by national law and international rules, unless convincing evidence can be provided that the treatment in question has no negative effects on performance and alertness. Therefore, we submitted these data to the Civil Aviation Authorities of The Netherlands and the Joint Aviation Authorities of Europe for their consideration to recommend the use of MalaroneTM in pilots and cabin crew," said Dr Ries Simons of the TNO Human Factors Institute, Soesterberg, The Netherlands.

The randomized double-blind cross-over study involved 22 healthy volunteers who received MalaroneTM or placebo for a 14 day period, and underwent rigorous performance testing while in a hypobaric chamber that was pressurized to the minimum pressure for commercial airlines. This included tests developed by NASA to assess performance and alertness tasks similar to activities that aircraft crew members perform in-f
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Contact: Heather Bell
heather_bell@uk.bm.com
44-207-300-6319
Burson-Marsteller
6-May-2004


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