HYTRIN OUTPERFORMS PROSCAR IN PROSTATE MEDICINE STUDY.

Byline: Daniel Q. Haney Associated Press 

The first head-to-head comparison of the nation's two most popular medicines for prostate trouble found that one gives significant relief while the other is virtually worthless.

The two medicines, Hytrin and Proscar, are taken by millions of older men to relieve the symptoms of an enlarged prostate gland. The study found that Hytrin eases men's discomfort by about one-third, while Proscar works no better than dummy sugar pills.

For the majority of patients, Proscar is no more than ``an expensive placebo,'' said Dr. Herbert Lepor of New York University Medical Center, the study's director. Prostate drugs generally cost $30 to $45 a month.

The study was financed by Merck & Co., which makes Proscar, and Abbott Laboratories Inc., the maker of Hytrin. It was conducted on 1,229 men at Veterans Affairs hospitals.

The results were first reported at a meeting of urologists in May, and preliminary findings from the research were reported a year ago, so the publication of the study had little effect on the pharmaceutical companies' stock.

One-on-one comparisons of popular prescription drugs by their makers are fairly unusual because of the expense and the obvious hazard of losing.

Although both companies approved the study's design, Merck discounted its significance as publication approached in today's issue of the New England Journal of Medicine.

Dr. Glenn Gormley, a Merck research official, said that in hindsight, the study was not set up properly to answer the question of which drug is better. He said experts now know that Proscar works only in men whose prostate glands are larger than those typically seen in the study.

About two-thirds of American men suffer enlargement of the walnut-size prostate gland by the time they reach their 60s, and the condition grows more common as men get older. Doctors call it benign prostatic hyperplasia, but it is ``benign'' only in the sense that it isn't cancerous.

The enlarged prostate gland squeezes the urethra, making it difficult to urinate. Often the bladder doesn't empty completely, so men are seized with an urgent need to go at inconvenient moments, often in the middle of the night.

Until a few years ago, surgery was the only solution, but it carries a small risk of impotence or partial incontinence.

Proscar, known generically as finasteride, is intended to relieve symptoms by shrinking the prostate. Its main competitors are Hytrin, or terazosin, and Pfizer Inc.'s Cardura, or doxazosin - which work instead by relaxing bladder muscles so that urine flows more freely.

Last year, Hytrin ranked 28th among all prescription drugs in the United States, with sales of $387.2 million, according to the market research firm IMS America. Proscar was 94th with sales of $141.3 million. Cardura did not make the top 100.

To find which approach is best, doctors put men on Proscar, Hytrin, a combination of the two or placebos.

Their symptoms were rated on a scale of zero to 35. At the start, they averaged 16. After a year of therapy, scores of the men on Hytrin fell an average of six points, while those of the men on Proscar dropped three points - the same as those getting placebos.

Merck, however, distributed galley proofs of an article in next month's issue of the journal Urology that comes to a different conclusion.

That analysis, by Dr. Claus G. Roehrborn of the University of Texas Southwestern Medical Center in Dallas, pooled the results of six studies of Proscar, including the VA study. Taken together, they suggest the medicine indeed works, but size matters: The larger the prostate, the more Proscar helps.

``Finasteride is clearly superior to placebo and clinically effective in men with prostates over 40 cubic centimeters,'' Roehrborn said. ``It's a stunning and exciting result.''

The average size of men's prostates in the VA study was 37 cubic centimeters - too small, in Roehrborn's view, to be helped by Proscar.

Among those who agree with this explanation is Dr. Patrick C. Walsh of Johns Hopkins University, perhaps the country's best-known prostate surgeon. He said doctors may want to use Proscar for men with significantly enlarged prostates and Hytrin for those with smaller ones.

``Benign prostatic hyperplasia is not one disease,'' Walsh said. ``It's muscles and glands. It's obstruction and constriction. We're trying to use one drug to treat all of that, and we can't.''

However, Lepor noted that even in men with very large prostates, Hytrin works better, and the benefits of Proscar are small.

``I can't identify a single subset of men who will respond better'' to Proscar than Hytrin, he said. ``The outcome, as far as I see it, is indisputable. It shows that a drug we once thought had a benefit does not.''