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Prostate Drug Appears Safer Than Thought

(HealthDay News) — Doctors don't have to be so cautious in prescribing the drug finasteride to men at risk for prostate cancer, a new study suggests.

Physicians face a dilemma when trying to decide whether to use the drug, which has been shown to prevent prostate cancer in about one in five men who take it. However, findings from the Prostate Cancer Prevention Trial published in 2003 concluded that men who developed prostate cancer while taking finasteride were 25 percent more likely to develop an aggressive form of the disease.

But a new study from the Stanford University School of Medicine suggests that the drug does not increase the risk for aggressive prostate cancer but simply makes it easier to diagnose. The study appears in the July 7 issue of Clinical Cancer Research.

The Stanford team suspected a flaw in the analysis of data in the 2003 study, rather than a problem with the drug. To test this theory, they analyzed data on 1,304 men who'd had an abnormal digital rectal exam or high PSA test results and had been referred to Stanford. None of the men was taking finasteride. Prostate cancer was eventually diagnosed in nearly 500 of the men, including 247 who had aggressive, high-grade cancer.

Finasteride shrinks the prostate, making malignancies easier to detect, the researchers said. And the smaller the prostate, the more likely a biopsy would yield a diagnosis of high-grade cancer, they said, and the more likely a high PSA level would predict the disease. For example, the diagnostic rate for one level of high-grade cancer was 29.7 percent in men with prostates between 20 to 29.9 cubic centimeters, compared with 6.5 percent for men with prostates larger than 80 cubic centimeters.

“We're showing that this is all related to size” of the prostate, Dr. Joseph Presti Jr., a research professor in urology and director of the urologic oncology program at Stanford, said in a news release from the university.

The authors of the 2003 study reached similar conclusions after they analyzed their own results, according to Catherine Tangen, statistical principal investigator for the first study. The findings of the new study “are consistent with everything we found,” Tangen said in the news release.

Men should be given the opportunity to take finasteride if they and their doctors feel it's necessary, she added.

SOURCE: Stanford Medicine, news release, July 7, 2009

Propecia Increases Hair Weight And Quality, Improves Scalp Coverage: Presented at ADV

AMSTERDAM, THE NETHERLANDS — September 29,1999 — The first-ever pill for male hair loss holds new promise for millions of men, following the results of a new study.

The treatment, Propecia (finasteride 1mg) has been proven to significantly increase hair weight and improve hair quality - making hairs thicker and longer in addition to increasing their number. This improvement in hair quality is good news for men who are concerned about their hair loss because improved hair quality provides improved scalp coverage.

Dr. Vera Price, of the Department of Dermatology, University of California, San Francisco, CA, presented findings from the Hair Weight Study for the first time today at the 8th European Academy of Dermatology and Venereology meeting, in Amsterdam, The Netherlands.

Results from a study involving 66 men taking either one Propecia tablet daily or placebo showed that after 96 weeks of treatment, Propecia increased hair growth on the scalp by improving the weight of hair.

Furthermore, the beneficial effects of Propecia continued throughout the two-year study period. The difference in total scalp hair coverage between the men taking Propecia and those taking placebo became greater as the study progressed - that is, men taking Propecia continued to grow more hair, thicker hair and longer hair, while those taking placebo were gradually losing hair.

The net improvement in hair weight between men treated with Propecia compared to those treated with placebo was 35.8 percent (P<0.001) after 96 weeks.

“The increase in hair weight produced by treatment with finasteride 1mg as demonstrated in this latest study, reflects the beneficial effects of the drug on the key aspects of hair quality. These aspects include increased hair number, shown in previous studies as well, and additionally improved hair thickness and hair length,” said Dr. Price.

Hair weight is a quantitative, reliable measure of hair growth and provides an integrated measure of changes in hair growth rate and total hair mass (length, hair thickness and hair number). Hair growth rate and total hair mass determine hair quality, and improved hair quality provides improved coverage of the scalp. Therefore, hair weight is an accurate way to measure the cosmetic benefits of treatment for male pattern hair loss.

By using phototrichogram methodology it has been shown that Propecia actually stimulates resting hair follicles to grow, thereby increasing the total number of growing hairs at any one time (Van Neste, et al.). These additional growing hairs observed in treated patients have now been shown to grow longer and thicker, signifying an improvement in hair quality and an improvement in scalp coverage.

Evidence of the cosmetic benefits of Propecia can be fully substantiated by worldwide clinical trial results. Propecia after two years of treatment has been shown to prevent further hair loss in five out of six men treated (83 percent, v. 28 percent placebo) and to re-grow hair that visibly increased scalp coverage in two out of three men (66 percent, v. 7 percent placebo).

The world's first hair loss pill for men is only available by prescription from a doctor and has proven to be well tolerated in clinical trials. Drug-related adverse events occurred in less than 2 percent of men taking Propecia. These side effects went away in all men who discontinued therapy and also disappeared in most men who chose to continue taking Propecia.

Propecia was first launched in the United States in 1997. It is currently available in most European countries and 22 other countries worldwide.

Propecia is administered as a 1mg oral tablet once daily. It is not indicated for use in women or children. It is a product of Merck, Sharp & Dohme.