Study: Finasteride Does Not Increase Mortality From Prostate Cancer

Study: Finasteride Does Not Increase Mortality From Prostate Cancer

The results of an 18-year study, just published in the New England Journal of Medicine, showed that finasteride does not increase the likelihood of death from prostate cancer in men who take the drug. Early results from the same study had suggested that finasteride might increase the risk of developing higher grade tumors; however, follow-up results from the long-term study show that men taking the drug do not have an increased risk.

Additionally, the results of the study show that taking finasteride actually decreases the likelihood of a diagnosis of prostate cancer in men by 30% and a diagnosis of “low-grade” cancer in men by 43%. By shrinking the healthy prostate tissue, finasteride decreases the chances of a false positive result in PSA screening tests and can avoid unnecessary surgery.

From the article in the NEJM:

“Finasteride reduced the risk of prostate cancer by about one third. High-grade prostate cancer was more common in the finasteride group than in the placebo group, but after 18 years of follow-up, there was no significant between-group difference in the rates of overall survival or survival after the diagnosis of prostate cancer.”

Read a summary of the NEJM article below:

Long-Term Survival of Participants in the Prostate Cancer Prevention Trial

Ian M. Thompson, Jr., M.D., Phyllis J. Goodman, M.S., Catherine M. Tangen, Dr.P.H., Howard L. Parnes, M.D., Lori M. Minasian, M.D., Paul A. Godley, M.D., Ph.D., M. Scott Lucia, M.D., and Leslie G. Ford, M.D.
N Engl J Med 2013; 369:603-610 August 15, 2013

BACKGROUND
In the Prostate Cancer Prevention Trial (PCPT), finasteride significantly reduced the risk of prostate cancer but was associated with an increased risk of high-grade disease. With up to 18 years of follow-up, we analyzed rates of survival among all study participants and among those with prostate cancer.

METHODS
We collected data on the incidence of prostate cancer among PCPT participants for an additional year after our first report was published in 2003 and searched the Social Security Death Index to assess survival status through October 31, 2011.

RESULTS
Among 18,880 eligible men who underwent randomization, prostate cancer was diagnosed in 989 of 9423 (10.5%) in the finasteride group and 1412 of 9457 (14.9%) in the placebo group (relative risk in the finasteride group, 0.70; 95% confidence interval [CI], 0.65 to 0.76; P<0.001). Of the men who were evaluated, 333 (3.5%) in the finasteride group and 286 (3.0%) in the placebo group had high-grade cancer (Gleason score, 7 to 10) (relative risk, 1.17; 95% CI, 1.00 to 1.37; P=0.05). Of the men who died, 2538 were in the finasteride group and 2496 were in the placebo group, for 15-year survival rates of 78.0% and 78.2%, respectively. The unadjusted hazard ratio for death in the finasteride group was 1.02 (95% CI, 0.97 to 1.08; P=0.46). Ten-year survival rates were 83.0% in the finasteride group and 80.9% in the placebo group for men with low-grade prostate cancer and 73.0% and 73.6%, respectively, for those with high-grade prostate cancer. CONCLUSIONS
Finasteride reduced the risk of prostate cancer by about one third. High-grade prostate cancer was more common in the finasteride group than in the placebo group, but after 18 years of follow-up, there was no significant between-group difference in the rates of overall survival or survival after the diagnosis of prostate cancer.

Posted by Robert M. Bernstein M.D.

Is Hair Loss Treatment with Avodart Safe?

Q: My friend is taking Avodart, he bought it over the internet. Is it safe to take? — T.G., Denver, Colorado

A: Avodart (dutasteride 0.5mg) was approved by the FDA for the treatment of prostate enlargement in men in 2002. Avodart has not been approved for the treatment of androgenetic hair loss, although physicians can use an approved medication in ways other than for which it was specifically approved. That said, the use of dutasteride certainly requires a doctor’s supervision.

Like finasteride (the active ingredient in Proscar and Propecia), dutasteride blocks the enzyme 5-alpha reductase that converts testosterone to DHT (DHT is a key hormone that causes hair loss). However, unlike finasteride, which only inhibits the Type I form of the enzyme, dutasteride inhibits both the Type I and Type II forms. This combined effect lowers circulating DHT more with dutasteride than with finasteride, but also increases the incidence of its side effects.

The Type II form of the enzyme (blocked by finasteride) is found predominantly in the hair follicle. The Type I form of the enzyme has been found in the scalp and sebaceous glands, and many other parts of the body, but its exact role in hair growth has not been determined. It is felt that dutasteride’s ability to dramatically lower serum levels of DHT is what makes it a more potent medication in hair loss.

When considering the safety of dutasteride, one should consider the following:

It acts on other parts of the body besides the hair follicle.
Unlike finasteride, where families that had a deficiency of the Type II 5-alpha reductase enzyme were followed for years without any adverse effects, there is no natural biologic model to show the safety of dutasteride.
Dutasteride has been approved for prostate enlargement in an older male population. It is not approved for hair loss and, in fact, the clinical trials for hair loss were discontinued, so there is no safety data for its use in younger patients. There is a greater incidence of sexual side effects with dutasteride compared to finasteride.
The 1/2 life of dutasteride is 5 weeks compared to 6-8 hours for finasteride. Serum concentrations of dutasteride are detectable up to 4-6 months after discontinuation of treatment.

Posted by Robert M. Bernstein M.D.

Was Propecia Originally for Treatment of Prostate Enlargement?

Q: I heard that Propecia was being used originally for shrinking the prostate, is this true? — M.D., New Hyde Park, N.Y.

A: Propecia (finasteride 1mg) is not a prostate medication that was serendipitously noted to have a side effect of re-growing hair, it is a medication that was known all along that it might be able to slow hair loss and/or to grow hair.

Although finasteride was first approved for the treatment of prostate enlargement, the researchers at Merck knew, at the outset, that there were families whose members were deficient in the 5-alpha reductase Type II enzyme and that the men in these families neither developed prostate disease nor went bald. In addition they had no long-term problems from the lack of this enzyme.

Merck used this natural model to develop a medication that could block the 5-alpha reductase Type II enzyme – the result was finasteride. Because the only approved treatment for symptoms related to prostate enlargement at the time was surgery, Merck developed finasteride as a medical treatment for this condition prior to developing finasteride as a potential treatment for men with male pattern hair loss.

This also meant that Merck would understand the safety profile of finasteride, and have it approved for a medical disease (symptomatic prostate enlargement), before developing it for a cosmetic condition.

The drug was first submitted to the FDA for the treatment of prostate enlargement as Proscar (finasteride 5mg) in 1991 and it was approved for this use in 1992. The drug was submitted for the treatment of men with male pattern hair loss as Propecia (finasteride 1mg) in 1996 and was approved for this use in 1997.

Posted by Robert M. Bernstein M.D.

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