STORRS, Conn.– The most commonly prescribed class of medications in the United States does not reduce cancer risk after all, despite numerous studies suggesting the cholesterol-lowering drugs known as statins pack the added punch of cancer prevention, according to a new University of Connecticut study to be published in the Jan. 4 issue of the Journal of the American Medical Association.
Researchers in UConn’s School of Pharmacy and School of Medicine led by Pharmacy Professor C. Michael White found that all statins, regardless of brand or form, had a neutral effect on all forms of cancer studied including melanoma and cancers of the breast, prostate, lung, colon and gastrointestinal tract. The research team, which examined rates of both cancer incidence and cancer death, arrived at its findings by combining the results of all relevant randomized clinical trials, involving more than 73,000 patients, through a process known as meta-analysis.
“We could find no type of cancer that statins affected,” White said.
“There’s good and bad news here,” he added. “The good news is that statins, which have been shown conclusively to lower cholesterol, prevent heart attacks and prevent death from heart attacks, do not increase cancer risk as originally thought. The bad news is that they also don’t live up to the more recent hype of being cancer prevention in a pill and, if the only reason you’re taking a statin is because you’re at high risk for cancer, you’re getting all of the risks associated with statins with none of the benefits.”
Risks of statin use include liver toxicity, muscle pain and muscle damage, White said.
The team’s conclusive results stand in marked contrast to recent hypothesis-generating studies, including one published in the New England Journal of Medicine in May, that have reported cancer risk reduction ranging from 20 percent to 50 percent for various forms of the disease.
Statins are the top-selling class of prescription drugs in the United States, with $15.5 billion in sales in 2004, and Lipitor and Zocor, two brand name statins, are the two top-selling medications in the United States, with $7.7 billion and $4.6 billion in sales in 2004 respectively.
It is not known how many physicians are currently prescribing statins for the off-label purpose of cancer prevention, but White and the UConn team suspect the number could be high based on the recent slate of encouraging studies published.
“Sometimes people get caught up in the fervor. ‘It’s a wonder drug. Everyone should be taking it. We should put it in the water,’” White said. “There are some health care providers who are avant-garde and want to try the newest treatment because it is the newest treatment while others are extremely conservative. Most fall somewhere in between.”
White said the greatest concern is that patients with increased cancer risk may be pinning their hopes for cancer prevention on a pill based on inconclusive studies that have received media attention rather than opting for traditional preventative measures, such as quitting smoking and establishing a consistent exercise routine, both of which are proven to lower their risk. And, he added, their chances of getting a prescription for a statin for cancer may be good based on previous studies suggesting physicians are more apt to prescribe a drug if a patient asks specifically for it.
The UConn study also stands to save government and pharmaceutical industry researchers millions of dollars, because the earlier results were encouraging enough to lead to funding of time-consuming, multi-million dollar clinical trials, now made moot.
“When you look at all of the relevant research literature combined, as we did, it suggests
that undertaking costly clinical trials of statins for cancer prevention would not be prudent,” White said.
“I applaud my colleagues for undertaking this large review of the recent literature analyzing the effects of statins on the prevention of cancer. Based on this review, patients should not be placed on these drugs outside of a clinical trial. Prospective studies need to be done to fully evaluate the relationship of statins and cancer prevention,” said Carolyn D. Runowicz, M.D., Director of the Carole and Ray Neag Comprehensive Cancer Center at the UConn Health Center and the President of the American Cancer Society.
The other UConn researchers involved in the study were: Craig Coleman, a pharmacy professor; Krista Dale, a School of Pharmacy fellow; Nickole N. Henyan, a School of Pharmacy fellow; and Dr. Jeffrey Kluger, a professor in the School of Medicine.