Estudio clínico para medir el impacto de los alimentos en los efectos de droga anti-cáncerContributed by: Anonymous · Views: 3,294
Contributed by: Anonymous · April 13, 2012 @ 05:53 PM MDT · Views: 3,294
Clinical trial measures impact of food on anti-cancer drug effects
Provocative trial could alter how new cancer drugs are tested
An unusual clinical trial based at the University of Chicago Medicine is seeking to determine whether a drug approved for
patients with advanced prostate cancer might be safer and just as effective if taken at a much lower dose with food instead of at the full dose on an empty stomach.
The results of the trial could affect future dosage recommendations, potentially saving patients who take the drug thousands of dollars a month.
Abiraterone acetate (trade named Zytiga) has a greater positive food effect--an increase in the mount absorbed when taken with food--than any other marketed drug that is labeled to be taken on an empty stomach. Five times as much of the drug is taken up with a low-fat meal as on an empty stomach, and up to 10 times as much with a high-fat meal. Yet patients are told not to eat for two hours before and for one hour after taking their pills. As a result, taking Zytiga as directed means the amount of the drug absorbed by the body to fight cancer is decreased by 80 to 90 percent.
|Russell Szmulewitz, MD|
"This clinical trial is designed to assess the risks and benefits of taking this effective but costly drug with food," said Russell Szmulewitz, MD, assistant professor of medicine at the University of Chicago Medicine and director of the study. "Taking one pill with a meal, rather than four pills on a empty stomach, is much more convenient for patients, so it may improve compliance. It would also reduce the cost."
The savings to patients and their insurance companies from taking lower doses of the drug would be significant. The drug costs $5,000 a month. "By taking one-fourth of the dose with a low-fat breakfast," Szmulewitz said, "patients may be able to get the full medical benefit and save about $3,750 per month."
The convenience would appeal to patients. Many dislike having to fast for hours before and after taking their medication, which can upset an empty stomach. Since patients with advanced prostate cancer tend to be older, most take multiple medications for additional health issues, fitting each medication into a complicated daily routine. Many patients who take Zytiga wake up during the night, for example, to take the medicine, then go back to sleep, allowing them to eat soon after they wake up.
View an ABC 7 News Chicago report about this study. Allen Andreasen, a patient who is participating in the trial, and Drs. Ratain and Szmulewitz are featured.
|Mark Ratain, MD|
Courtesy of The University of Chicago Medicine