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Philadelphia, October 11, 2001 - MalaroneTM (atovaquone and proguanil hydrochloride) Tablets are associated with significantly fewer neuropsychiatric treatment-related side effects (P = .001), such as strange or vivid dreams, insomnia and anxiety, than Lariam® (mefloquine, Roche Pharmaceuticals) according to the new study results. The study, published in the October issue of Clinical Infectious Diseases, also shows that study participants taking Malarone were less likely to discontinue their course of antimalarial prophylaxis (medication to prevent disease) than travelers taking mefloquine as a result of treatment-related side effects. Malaria, a potentially fatal disease, poses a serious health threat to the estimated seven million Americans who travel to malaria-endemic countries each year.
Although most cases of malaria are preventable, many travelers fail to use or comply with appropriate prophylaxis. This is largely due to the growing concern about the side effects associated with older antimalarials. For example, although effective in preventing malaria, mefloquine is associated with neuropsychiatric side effects, causing many travelers to avoid antimalarials. This study indicates that nonimmune travelers (persons without natural immunity), like Americans, taking Malarone are about five times more likely to complete their treatment regimen. Additionally, travelers taking mefloquine in this study experienced treatment-related neuropsychiatric side effects twice as often as those taking Malarone.
"In my experience, many travelers are hesitant to take an antimalarial because of stories about the neuropsychiatric side effects associated with older antimalarials, like Lariam®, said David Overbosch, M.D., lead investigator of the study and director of the Travel Clinic Harbour Hospital in Rotterdam, The Netherlands. "With an increase in travel to malaria-endemic countries, having an antimalarial that is both effective and well tolerated is extremely important. These study results provide physicians and travelers with reassurance that Malarone can effectively protect travelers from malaria with a side effect profile similar to placebo."
MalaroneTM (atovaquone and proguanil hydrochloride): Effective and Better Tolerated
In a randomized, double-blind study, nonimmune travelers received malaria prophylaxis with Malarone (n=493) or mefloquine (n=483). Information about adverse events and potential episodes of malaria was obtained 7, 28 and 60 days after travel. Overall, Malarone was better tolerated than mefloquine, similarly effective for the prevention of malaria and associated with a lower frequency of treatment-related side effects that caused prophylaxis to be discontinued. Additionally, post-travel dosing compliance was higher in the Malarone group: 88 percent of patients taking Malarone compared to 70 percent of patients taking mefloquine finished 80 percent of their prescribed course of prophylaxis. This may be because the duration of post-travel dosing is shorter with Malarone (seven days) than with mefloquine (four weeks).
Of note, subjects taking Malarone had significantly fewer treatment-related side effects of moderate or severe intensity (10% versus 19%) and significantly fewer treatment-related neuropsychiatric adverse events (14% versus 29%) including:
- Strange or vivid dreams
- Insomnia
- Dizziness or vertigo
- Anxiety
- Depression
In addition, subjects taking Malarone experienced fewer adverse events that caused prophylaxis to be discontinued (1.2% versus 5%), compared to subjects taking mefloquine. Among the mefloquine group, neuropsychiatric events were the most common adverse events that caused travelers to discontinue prophylaxis.
"Many travelers do not realize that, even if they have already returned home, it is extremely important to complete the course of prophylaxis," said Kevin Kain, director of The Center for Travel and Tropical Medicine at The Toronto General Hospital and a professor of medicine at the University of Toronto. "In my opinion, the unique dosing regimen and low rate of side effects of Malarone contribute to a higher rate of compliance among travelers in this study and in my practice."
MalaroneTM (atovaquone and proguanil hydrochloride): A Safe, Effective and Convenient Option
Malarone was approved by the U.S. Food and Drug Administration in July 2000 and is indicated in adults and children for the prevention and treatment of acute, uncomplicated malaria caused by P. falciparum, including in areas of chloroquine resistance. Malarone has the shortest pre- and post-travel dosing regimen among malaria medications, making it a convenient option for the short-term traveler. It is taken orally one to two days before traveling to a malaria-endemic area, every day during the stay and for seven days after return. The Centers for Disease Control and Prevention recommends Malarone for the prevention of P. falciparum malaria.
The most commonly reported adverse events possibly attributable to Malarone include headache and abdominal pain in adults and headache, abdominal pain and vomiting in pediatric patients, all of which occurred at rates comparable to placebo. Malarone is contraindicated for prophylaxis of P. falciparum malaria in people with severe renal impairment (creatinine clearance<30 mL/min).
Malaria: A Serious and Potentially Fatal Tropical Disease
Malaria is a serious, sometimes fatal, disease transmitted to humans by the bite of an infected mosquito. Malaria occurs in over 100 countries worldwide, placing nearly 40 percent of the world's population at risk. Large areas of Central and South America, Hispaniola, Africa, the Indian subcontinent, Southeast Asia, the Middle East and Oceania are considered malaria-endemic. If not promptly treated, malaria may cause kidney failure, seizures, mental confusion, coma, and death. Some types of malaria can relapse; some parasites can rest in the liver for several months and up to four years after an infected mosquito bites a person.
The World Health Organization estimates that 300 to 500 million cases of malaria occur yearly and more than one million people die of malaria worldwide. Travelers who are at risk for contracting malaria should take proper precautions to protect themselves against mosquito bites. Each year in the United States, seven million people including business travelers, military personnel, airline employees, vacationers and missionaries travel to malaria-endemic areas and 1,000 to 1,500 will contract the disease.
GlaxoSmithKline: A Leader In Healthcare
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 more information on MalaroneTM (atovaquone and proguanil hydrochloride) and malaria, please visit the website www.malarone.com or call 1-888-825-5249.
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