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In Brief
Vitamin E Does Not Protect Against Cancer, Cardiovascular Events, Study Finds
A new study has found that, among patients with vascular disease or diabetes mellitus, long-term vitamin E supplementation is not associated with a reduced risk of cancer or cardiovascular events but may be associated with an increased risk of heart failure.
The Heart Outcomes Prevention Evaluation (HOPE) trial—a randomized, double-blind, placebo-controlled trial of 9,541 patients with vascular disease or diabetes mellitus that was conducted between 1993 and 1999—tested a daily dose of vitamin E versus a placebo. The trial was extended, with nearly 4,000 of the original participants, between 1999 and 2003 in the HOPE—The Ongoing Outcomes (HOPE-TOO) trial.
In the March 16 issue of the Journal of the American Medical Association, the HOPE and HOPE-TOO trial investigators report that, among patients in the HOPE trial, there were no differences in cancer incidence, cancer death, or major cardiovascular events between patients taking vitamin E and those taking placebo. HOPE-TOO found similar results but also found higher rates of heart failure and hospitalizations for heart failure among participants taking vitamin E supplements.
Participants in Phase I Oncology Trials May Benefit More Than Had Been Believed
Overall response rates among participants in phase I oncology trials are higher than has been reported in the past, and rates of toxicity-related deaths have remained stable, according to a new study.
Reviews of phase I oncology trials—which traditionally study the safety, toxicity, and appropriate dose of a drug in patients with advanced cancer—have reported response rates of 4% to 6% and a rate of toxicity-related death of 0.5%. In the March 3 issue of the New England Journal of Medicine, Christine Grady, R.N., Ph.D., of the National Institutes of Health, and colleagues reviewed 460 nonpediatric phase I oncology trials sponsored by the National Cancer Institute between 1991 and 2002.
The overall response rate was 10.6%, but rates varied among trials. "Classic" phase I studies of single investigational chemotherapeutic agents (20% of the trials studied) had an average response rate of just 4.4%, whereas studies that included at least one anticancer agent already approved by the U.S. Food and Drug Administration (46.3% of the trials studied) had an average response rate of 17.8%. The overall rate of toxicity-related death was 0.49%, similar to what has been previously reported.
See also News, Vol. 96, No. 18, p. 1354, "For Phase I Studies, Ethical and Practical Concerns Abound."
U.N. Committee Recommends Reducing Acrylamide Levels in Food
A Joint Expert Committee of the United Nations Food and Agriculture Organization and the World Health Organization has recommended that efforts to reduce levels of acrylamide in food be continued.
High occupational and accidental exposure to acrylamide is known to have neurotoxic effects in humans, and studies have shown that the chemical can cause cancer and reproductive problems in animals. Public health concerns about the chemical grew after a study revealed that acrylamide is formed during the frying or baking of potatoes and cereal products.
The U.N. joint committee, which includes 35 experts from 15 countries, considered the possible health risks associated with acrylamide at a meeting in February. They concluded that, on the basis of the possible cancer risks, consumption of foods containing acrylamide is a potential public health concern. They recommended that industry efforts to reduce levels of acrylamide in foods continue and that the chemical be reevaluated when the results of ongoing toxicological studies become available.
The U.S. Food and Drug Administration has said that it will review the committee's report. In addition, the FDA will release new data on acrylamide levels in the U.S. diet this spring.
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