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New therapy effective for enlarged prostates

  A combination of two widely used drugs can sharply reduce the risk that enlarged prostates will get worse, offering millions of men a dramatically more effective way to fend off the most miserable effects of one of the most common male afflictions, researchers reported yesterday.

The largest and longest study of its kind found the two-drug therapy cut by a surprising two-thirds the likelihood that the condition would progress, sparing many from deteriorating to the point where they could not urinate and needed surgery.

"This reduction in risk is as dramatic as anything you see in medicine," said Claus Roehrborn of the University of Texas Southwestern Medical Center in Dallas, who led the study. "This condition affects a huge number of men. This study shows we can prevent what ultimately are the most feared outcomes of the disease."

Because of the large number of men affected by enlarged prostates and the extra cost of giving two drugs, the treatment should probably be reserved for men at highest risk that the disease will progress, Roehrborn and others cautioned. About 3 million men probably fall into that category, Roehrborn said.

"This is a big-impact disease, and this will have a big impact," he said.

Starting in their 50s, at least half of all men suffer from enlarged prostates, a condition known as benign prostatic hyperplasia. About half of them require treatment to alleviate symptoms that can start out as annoyances but often go on to become debilitating — usually having to urinate repeatedly at night, having difficulty urinating, and then, sometimes suddenly, being unable to urinate at all. The prostate is a walnut-size gland located below the bladder and surrounds the urethra, the passageway for urine.

To stave off the need for surgery to remove part or all of the prostate to relieve the blockage, doctors try one of two types of drugs: alpha blockers, which are a kind of a muscle relaxer for the prostate; or another type of pill that shrinks the prostate by blocking the hormone testosterone.

Previous studies evaluating whether combining the two types of drugs worked better than using either alone failed to show any additional benefit. But that research typically followed men for only about a year. In the new study, researchers for the first time tested a combination over nearly five years.

The federally financed Medical Therapy of Prostatic Symptoms study involved 3,047 men at 17 centers around the country. They received an inert placebo, the alpha blocker doxazosin alone, the testosterone blocker finasteride alone, or the two drugs together.

Compared with the placebo, the two-drug combination reduced by 66 percent the risk that the condition would get worse. Progression of symptoms was cut by 39 percent by doxazosin alone and by 34 percent by finasteride alone, the researchers reported in today's issue of the New England Journal of Medicine.

"To have a risk reduced by almost 70 percent is almost unheard of in a medical trial," said John McConnell, the study's lead author. "We think this study will have great impact on the field."

The combination therapy also reduced by 81 percent the risk that men would develop extreme problems urinating, and by 67 percent the need for surgery.

"This is a truly landmark study," said Michael Manyak, a prostate expert speaking on behalf of the American Urological Association. "There's a sea change here in understanding the medical management of this problem."

Manyak, chairman of the department of urology at the George Washington University Medical Center, said he and other urologists who had heard about the results informally had started using the two-drug treatment on their patients.

The best candidates for the therapy, which costs about $3 a day, are those at high risk for progression of their disease. In estimating the risk, doctors rely on the amount of enlargement of the prostate and the patient's score on a prostate specific antigen (PSA) test, which is commonly used to detect the condition and prostate cancer.