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 Malarone
"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 Malarone
The randomized double-blind cross-over study involved 22 healthy volunteers who received Malarone
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 Malarone
Malarone
Malarone
Notes to Editors:
About GSK:
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com
About TNO Human Factors:
TNO HUMAN FACTORS is one of the 15 institutes that constitute the Netherlands Organisation for Applied Scientific Research TNO, a knowledge organisation for companies, government bodies and public organisations. TNO Human Factors mission is to offer innovative solutions that enhance human performance in demanding environments. The Aerospace Medicine department of TNO Human Factors is specialised in research of the effects of medication on flight safety. Methods include performance tests, using tasks relevant for optimal pilot performance, and simulated aircraft cabin environmental conditions. For company information, visit TNO Human Factors on the World Wide Web at www.tm.tno.nl
TNO Human Factor Enquiries:
M. Simons, MD,
Research Physician Aviation Medicine
31-346-356-485
simons@tm.tno.nl
GlaxoSmithKline Enquiries:
Chris Hunter-Ward
Corporate Media UK
44-208-047-5502
References:
1 Abstract, presented May 2004, 75th Annual Scientific Meeting of the Aerospace Medical Association (AsMA) in Anchorage, USA
2 Steffen R, Holdener F, Wyss R, Nurminen L. Malaria prophylaxis and self-therapy in airline crews. Aviat Space Environ Med 1990; 61:942-945
3 Simons M. Malaria prophylaxis for aircrew: emphasis on individual measures and education. 4th International Conference on Travel Medicine, Acapulco, Mexico, April 1995
4 Paul MA, McCarthy AE, Gibson N, Kenny G, Cook T, Gray G. The impact of Malarone? and
Primaquine on psychomotor performance. Aviat Space Environ Med 2003; 74:738-745
5 Overbosch D, Schilthuis H, Bienzle U, Behrens RH, Kain KC, Clarke PD, Toovey S, Knobloch J,
Nothdurft HD, Shaw D, Roskell NS, Chulay JD. Atovaquone-proguanil versus mefloquine
for malaria prophylaxis in nonimmune travelers: results from a randomized, double blind study.
Clin Inf Diseases 2001; 33:1015-1021
6 Hogh B, Clarke PD, Camus D, Nothdurft HD, Overbosch D, Gunther M, Joubert I, Kain KC, Shaw D, Roskell NS, Chulay JD; Malarone International Study Team. Atovaquone-proguanil versus chloroquine-proguanil for malaria prophylaxis in non-immune traveller: a randomised, double-blind study. Lancet 2000; 356(9245):1888-94