Chicago—Prostate-cancer patients prescribed the drug abiraterone acetate are usually advised to take the drug on an empty stomach.

A new study suggests, however, that following the advice causes patients to have to take higher dosages of the expensive drug and also are more likely to experience digestive issues.

The article in the Journal of Clinical Oncology (JCO) points out that abiraterone, which was FDA approved for treatment of metastatic prostate cancer in 2011, has a “food effect” greater than any other marketed drug.

The University of Chicago–led research calculates that taking the drug with a low-fat meal—7% fat or about 300 calories—could multiply the amount absorbed by four or five times, A high-fat meal—57%, 825 calories—could increase that to 10 times more.

Patients are instructed to take four of the 250 milligram abiraterone acetate pills when they awaken in the morning and then wait an hour before eating breakfast. 

“This schedule is not only inconvenient for patients, it’s also wasteful, in several ways,” emphasized lead author Russell Szmulewitz, MD, associate professor of medicine at the University of Chicago.

On the other hand, following the study’s suggestions could cut costs by 75%, researchers note. That is important because a 1-month supply of abiraterone at the recommended dose can be $8,000 to $11,000 wholesale, totaling about $100,000 each year for a drug that many patients take for 2 to 3 years.

The study team designed a randomized clinical trial to see if the drug could be used more efficiently and at lower cost. 

To do that, researchers began in 2012, enrolling 72 patients with advanced prostate cancer. Half followed the recommended regimen, while the other half took a fourth of the standard dose—just one 250-milligram pill—with a low-fat breakfast. 

The research found the results to be similar, with abiraterone’s effectiveness at lowering levels of prostate-specific antigen, a surrogate marker for prostate cancer, slightly better for patients in the low-dose with food group after 12 weeks.

Measured at around 8.6 months, progression-free survival for patients in both the low- and high-dose groups was identical, the study authors note. They write that the protocol cut costs by as much as $300,000 per patient and was more convenient.

“The patient gets a simplified schedule, slightly more control over his daily life, the convenience of eating whenever he chooses and the opportunity to share the cost-savings with his insurance company,” Szmulewitz said. “Taking this medicine while fasting is wasteful.”

“Although it should be validated with a larger trial with more robust clinical endpoints,” he added, “given the pharmacoeconomic implications, these data warrant consideration by prescribers, payers and patients.”

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