Hormone Drugs Might Not Raise Heart-Related Deaths in Prostate Patients

But those with a history of heart disease, stroke may be at higher risk, researchers caution

By Steven Reinberg
HealthDay Reporter

TUESDAY, Dec. 6 (HealthDay News) -- Men with prostate cancer who are being treated with hormone therapy do not appear to be at increased risk of dying from heart disease, according to a large new review of evidence.

Hormone therapy called "androgen deprivation therapy" is a basic of prostate cancer treatment. Several previous studies found that the therapy might increase the risk of cardiac events or even death from prostate cancer.

Growing concern led to a U.S. Food and Drug Administration warning and a consensus statement from multiple medical societies, said Dr. Paul Nguyen. But his new research -- an analysis of eight randomized clinical trials of more than 4,000 patients, followed for about a decade -- reached a different conclusion.

"For the majority of men with aggressive prostate cancer, androgen deprivation therapy was associated with better survival and no increased risk of dying from cardiovascular causes," said Nguyen, the director of prostate brachytherapy at the Dana-Farber Cancer Institute, Brigham and Women's Hospital and Harvard Medical School in Boston.

However, he added, "It should be noted that men in randomized trials tend to be healthier than the average patient, and it's still possible that those with underlying heart disease, such as a history of a prior heart attack or congestive heart failure, could still be harmed by androgen deprivation therapy."

The FDA warning and consensus statement "may have led some men who would have benefited from androgen deprivation therapy to avoid it for concern that it would cause cardiovascular death," Nguyen said. "The pendulum may have swung too far away from androgen deprivation therapy, which has been shown to save lives in men with aggressive prostate cancer. This study should be reassuring to the vast majority of men who need androgen deprivation therapy for their prostate cancer."

The study is published in the Dec. 7 issue of the Journal of the American Medical Association.

Nguyen's team performed a meta-analysis, which attempts to uncover trends from a group of studies to determine a pattern that the original trials may not have actually been designed to find.

Over a range of seven to 13 years of follow-up, 255 of the 2,200 men receiving hormone therapy died from a cardiovascular condition, compared with 252 of the 1,941 men not on hormone therapy, the researchers found. For men on hormone therapy that's an overall incidence of 11 percent, compared with 11.2 percent for men not on hormone therapy, the study authors noted.

For men who took hormones for six months, the overall incidence of cardiovascular death was 10.5 percent, compared with 10.3 percent for men not on hormone therapy. For those who took hormones for three years or more, the incidence of cardiovascular death was 11.5 percent, the same as for men not receiving hormone therapy, the investigators found.

Age seemed to play no role in these findings, Nguyen's group said.

Among men receiving hormone therapy, 443 died from prostate cancer as did 522 of the men not receiving hormone therapy.

Of the more than 1,100 deaths of men receiving hormone therapy and more than 1,200 deaths of men not receiving hormone therapy, those on hormone therapy had a 14 percent lower risk of dying from any cause, the researchers found.

"The use of hormone therapy and radiation is of benefit for patients," said Dr. William Kelly, a professor of medical oncology and urology at Thomas Jefferson University's Kimmel Cancer Center in Philadelphia and co-author of an accompanying journal editorial.

In this study, the benefits of hormone therapy outweighed the risks, Kelly said. However, he noted that these were selected patients in clinical trials, not patients in the general population, in which sicker patients might be at risk for cardiovascular events from hormone therapy.

"In the future, studies should be open to all comers so you get more realistic outcomes based on all patients, not just a subset," Kelly said. From that basis, men taking hormone therapy should be concerned about the risk of cardiovascular problems, he said.

Men taking hormone therapy need to be monitored for potential cardiovascular problems, especially men with a history of heart disease or stroke, Kelly added. For some patients, like men who will not die from their prostate cancer, the risk of hormone therapy may be greater than the benefit, he said.

"You have to understand the risk-benefit ratio in each population. You can't just apply it across the board to all patients," Kelly said.

More information

For more on prostate cancer, visit the U.S. National Cancer Institute.

SOURCES: Paul L. Nguyen, M.D., director, prostate brachytherapy, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Harvard Medical School, Boston; William K. Kelly, D.O., professor of medical oncology and urology, Thomas Jefferson University, Kimmel Cancer Center, Philadelphia; Dec. 7, 2011, Journal of the American Medical Association

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