The writer of the piece below researched the value of Propecia for our review. If you choose not to go to the source, at least read what is written here.
Dr Rassman
Brilliant site. In response to a post dated April 16 (Propecia Success Rates), you asked your readers for a link related to the success rate of Propecia use. While the clinical studies supporting drug approval (links below) involved many endpoints and durations of observation (from 12 months to 5 years), the most dramatic evidence is at the 5-year assessment for men with vertex baldness:
“ An independent analysis of photographs (of the entire head)….. showed that at 5 years, 48% of men using Propecia had increased hair growth, 42% of men had no change (from pre-Propecia baseline photos), and 10% were rated as having lost hair. For placebo, 6% of men had increased hair growth, 19% of men had no change (from baseline photos), and 75% were rated as having lost hair.”
For your readers, the best link to summarize the clinical studies supporting regulatory approval in the US for any drug is at the FDA’s web site and will contain both the “Product Label” or “Summary Basis of Approval”. The Product Label is a brief summary similar to what is found in the package insert that comes with the medication, and the “Summary Basis of Approval” (also termed “Review”) is a detailed submission often involving thousands of pages. However, the “Medical Review” in the Summary Basis of Approval is a document that is well indexed and usually contains the clinical studies supporting safety and efficacy.
This information can be accessed without charge. For any drug, the link is Drugs@FDA. One can then choose the drug as listings are by alphabetical order and trade (brand) name. Once the drug is chosen, then choose the link with “Label Information.” For Propecia, therefore, the link that takes the reader to the “Review” from 1997 Drug Approval Package #020788.
For Propecia, three double-blind, placebo-controlled randomized studies of 12 months duration were conducted with 1879 men. The two main endpoints were hair count by photography of selected areas and patient self-assessment. Secondary endpoints were investigator ratings and ratings of photographs (by independent counters). Main results were as follows:
Combined data from Study 1 and 2 in men with vertex baldness (number of men = 1533): At 12 months, there was a 107-hair difference within a 1-inch diameter circle compared with those in the placebo group. An extension study showed that the hair count was maintained for up to 2 years in men taking Propecia, compared with the placebo group (38-hair placebo-adjusted difference at 2 years). Related to the figures your poster of April 17 noted, at 12 months, the investigators rated 65% of men treated with Propecia as having increase growth compared with 37% in the placebo group. At 2 years, the same investigators rated 80% of men using Propecia (compared with 47% of men using placebo) as having increased growth. These figures were 77% (Propecia) and 15% (placebo) at 5 years.
An independent analysis of photographs of the entire head (without reader knowledge of treatment assignment of person is photo) showed that at 12 months approximately 50% of men treated with Propecia (compared with 7% using placebo) had increased growth. At 5 years, 48% of men using Propecia had increased hair growth, 42% of men had no change (from pre-Propecia baseline photos), and 10% were rated as having lost hair. For placebo, 6% of men had increased hair growth, 19% of men had no change (from baseline photos), and 75% were rated as having lost hair.
Additional data including info on Study 3 (hair loss in anterior mid-scalp with or without vertex baldness) can also be evaluated.
This is a scholar’s view of the long term studies on Propecia, as published. This writer’s review from a practical view shows that the drug Propecia works for hair retention. I have never understood the focus on unproven alternatives by much of the balding male population who read this blog and write to me. Rather than get predictable hair retention, men seem to be willing to take ‘things’ that have not been shown to have hair retention value and during the period that they take these compounds, they are losing hair that will never grow back.
So where Propecia seems to hold the ‘status quo’ for years, too many men seem to be willing to accept progressive balding when psychologically, they obsess over their hair loss. And far too many men believe what they see on television or the Internet and don’t think that pictures of hair growth they’re shown may be fraudulent.
