Present affiliation: AlphaVax Inc., 2 Triangle Drive, Research Triangle Park, NC 27709-0307.Study group members are listed at the end of the article.David Overbosch, Herbert Schilthuis, Ulrich Bienzle, Ronald H. Behrens, Kevin C. Kain, Paul D. Clarke, Stephen Toovey, Jürgen Knobloch, Hans Dieter Nothdurft, Dea Shaw, Neil S. Roskell, Jeffrey D. Chulay, Malarone International Study Team, Atovaquone-Proguanil versus Mefloquine for Malaria Prophylaxis in Nonimmune Travelers: Results from a Randomized, Double-Blind Study, Concerns about the tolerability of mefloquine highlight the need for new drugs to prevent malaria.
We attempted to collect blood specimens at the time of suspected diagnosis for evaluation in a reference laboratory, as described elsewhere [In summary, results from this study show that atovaquone-proguanil was better tolerated than was mefloquine, and that it was similarly effective for malaria prophylaxis in nonimmune travelers.Other members of the Malarone International Study Team include Suni Boraston and James Salzman (Vancouver, British Columbia) and Dominique Tessier (Montreal, Quebec, Canada); Theo J. L. M. Goud (Rotterdam, The Netherlands); Klaus Fleischer (Würzburg), Manfred Peters (Hamburg), and Berndt Zieger (Dresden, Germany); and Simmy Waner (Johannesburg, South Africa).GlaxoSmithKline members of the study team include Fatima Amod (Midrand, South Africa); Clare Brennan, Gerri B. Miller, and Trevor Scott (Research Park Triangle, North Carolina, United States of America); Corinne Hedgley (Greenford) and Miriam O'Hare (Bournemouth, United Kingdom); Tine Hendrickx, Paul de Jonge, and Sanne van Delft (Zeist, The Netherlands); Raymond Marina (Mississauga, Ontario, Canada); and Heinz Richter (Hamburg, Germany).We thank Dr. Marie Louise Mittelholzer of F Hoffman La-Roche, Basel, Switzerland, for facilitating the purchase of mefloquine and matching placebo; Dr. Kent Kester and Carolyn Holland of the Walter Reed Army Institute of Research, Washington, DC, for performing the circumsporozoite antibody assays; and Marianna Wilson of the Centers for Disease Control and Prevention, Atlanta, for performing the blood-stage antibody assays.Appropriate informed consent was obtained and clinical research was conducted in accordance with guidelines for human experimentation as specified by the authors' institutions.Financial support: GlaxoSmithKline. Treatment-emergent AEs attributed to study drug occurred in a significantly higher proportion of subjects who received mefloquine, compared with those who received atovaquone-proguanil (42% vs. 30%; Treatment-emergent adverse events attributed to the study drug.Treatment-emergent adverse events attributed to the study drug.Most AEs were mild in intensity.
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In the present study, neuropsychiatric events were reported by a significantly larger proportion of subjects who received mefloquine, compared with those who received atovaquone-proguanil (The frequency of AEs attributed to mefloquine in the present study (42%) is similar to the frequency in 2 previous studies that used a questionnaire to elicit information about specific side effects. Your comment will be reviewed and published at the journal's discretion. The reasons for premature discontinuation in the atovaquone-proguanil group versus the mefloquine group were AEs (16 subjects vs. 26 subjects), protocol violation (8 vs. 10), and other (40 vs. 40). A local physician diagnosed malaria, respiratory infection, or both, and the physician prescribed orally administered antibiotics and a single injection of chloroquine. Plusieurs facteurs peuvent entrer en ligne de compte pour déterminer la dose dont une personne a besoin : son poids, son état de santé et la prise d'autres médicaments.
There were 64 neuropsychiatric events in 44 subjects that occurred after starting mefloquine placebo but before starting active chemoprophylaxis with atovaquone-proguanil.
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