“Take medication on an empty stomach.” Patients dread seeing this warning on their pill bottles, knowing that it often means skipped meals and hungry rumbles in the hours before and after taking their medicine. The rationale for the empty stomach is to avoid the unpredictable effects of food on drug metabolism — depending on what you’ve eaten, different amounts of the medication can be absorbed into the bloodstream. But a new clinical trial at the University of Chicago Medicine is testing whether just the right mixture of food and drug could be more convenient for patients while saving a whole lot of money.
Abiraterone (trade named Zytiga), is a drug prescribed to men with castration-resistant prostate cancer. It also is more sensitive to food’s effects 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.
“This clinical trial is designed to assess the risks and benefits of taking this effective but costly drug with food,” said Russell Szmulewitz, 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, since 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 also 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.
In the clinical trial, one-half of the study participants will take the standard 1,000 mg dose of Zytiga — four pills each morning while fasting. The other half will take one 250 mg pill each morning with a low-fat breakfast. All trial participants also will take prednisone, a steroid that helps prevent common side effects of Zytiga such as high blood pressure, low potassium levels and fluid accumulation.
Patients who are already taking Zytiga for prostate cancer should not “conduct such experiments on their own,” cautions co-investigator Mark Ratain, the Leon O. Jacobson professor of medicine and director of the Center for Personalized Therapeutics at the University of Chicago Medicine. The drug has not been carefully studied when taken with food. Careful monitoring of drug levels in the blood and its ability to stop or slow the growth of the cancer are central to the study.
“We do not yet know how well the drug will be absorbed or how it will impact the patient and his disease when delivered in this way,” Ratain said. “We know only what happens when it is taken on an empty stomach. In that setting, most of it gets flushed away at considerable expense.”
[ABC7Chicago recently did a story on the study featuring one of the trial participants, which you can watch below.]