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

05/06/04

First study of Malarone(TM) conducted in volunteers under simulated aircraft pressure conditions

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-flight. There were no significant differences between the test results following MalaroneTM or placebo dosing. These results support those from a previous study where, under normal pressure conditions, MalaroneTM had no impact on traditional psychomotor testing, simulating flying performance nor on the subjective assessment of mood, sleepiness, or fatigue (4).

Adverse events were comparable for both study treatment arms, and all were classified as mild, short lasting and most frequently related to GI problems.

Dr Dereck Tait, Director, Clinical Development said: "These new data provide further evidence for the favourable safety profile of MalaroneTM. The safety and tolerability of MalaroneTM have been demonstrated in several clinical trials, and in two of these, conducted in nearly 2000 non-immune subjects, MalaroneTM had fewer drug related adverse events than mefloquine (5) and chloroquine/proguanil (6)."

MalaroneTM should be started 1–2 days before travel and continued daily until 7 days after travel, making it ideal for people who spend only a short period of time in an endemic area, such as aircrew.

MalaroneTM is approved for the prophylaxis and treatment of P. falciparum malaria, the most common and serious type of malaria.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
    Published on PsychCentral.com. All rights reserved.

 

 

A man can get discouraged many times, but he is not a failure until he begins to blame somebody else and stops trying.
~ John Burroughs