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  Propecia 5 year study results released  
 

Propecia y year clinical trials resultsMarch 15, 2001 - Scientists released the long awaited results of the Propecia 5-year user studies at the 59th Annual American Academy of Dermatology meeting in Washington DC last week.

The results showed that while Propecia did continue to prevent hair loss, there was a progressive decrease in the amount of hair grown over the 5-year period. According to one of the presenters Dr Elise Olson, the overall hair counts and percentage of responders continued to decline in the 4th and 5th years of treatment just as they did in the 2nd and 3rd years. The decrease in responders and hair counts were relatively small with the most significant decrease happening in the 2nd year where the amount of hairs grown decreased from 90 to 80 above baseline. After the 5th year the amount of hair counts above baseline was 40.

However the news is not all bad. The responders were still ahead of the game with respect to the people who were getting the placebo. If you were a good responder to Propecia, after 5 years of taking it you would still have 40 hairs more than you had when you started out. In contrast a person who was not on Propecia lost a considerable amount of hair, on average 220 less than they had started out with. So that would mean that you would have 260 more hairs than you would have had if you didn't use Propecia, i.e. 220 that did not fall out, and an additional 40 new hairs.

According to the study in the first year hair counts in responders increased by an average of over 90 hairs per square inch. By the 2nd year, the count dropped back to about 80 above baseline, then around 60 above baseline by year 3, 50 above baseline by year 4, and just over 40 hairs per square inch above baseline by year 5, showing that average hair counts rose dramatically in the first year but dropped by 50% at the end of the 5th year. (See graph below)

In contrast though, the placebo users fared a lot worse. They lost about 30 hairs per square inch during the first year, then close to 80 by the 2nd year, over 100 by the 3rd year, and over 160 by the 4th year. By the time they reach the 5th year, the placebo users have lost an average of over 220 hairs per square inch below their baseline amounts, ie what they had started out with.

According to Dr Richard Lee, operator of the Regrowth hair clinic in Los Angeles who has been prescribing Finasteride (Propecia) to thousands of patients of over many years:

"The conclusions from the 5-Year Follow-Up Study on Propecia were not unexpected. The major points are (1) patients who were positive responders continued to decline after the first year of use and (2) the overall hair counts of patients continuing on Propecia also continued to decline after the first year of use. However, comparison to a control group, on placebo for the same 5 years, proved that taking Propecia definitely helped to improve or maintain the hair on the scalp.

Although we have gained a lot of knowledge about alopecia androgenetica (more commonly referred to as male pattern baldness [MPB]) in the past two decades, there are still volumes of which we are ignorant. Undoubtedly, decreasing the DHT levels in the scalp is beneficial in treating MPB, but decreasing DHT alone is obviously not going to be the solution to MPB. Whereas, we are all eagerly anticipating the availability of dutasteride as a medication that has a dual inhibiting effect on the 5-alpha reductase enzymes, there are still reservations in regards to its effectiveness and/or safety. I theorize that these reservations would be true of any drug that would totally prevent the synthesis of DHT in the body. "

On a more positive note it seems that the better the responder you are, the better your long-term results will be. According to photographic assessments, the drop in hair counts are largely due to the people who received the least benefit from Propecia in the first place. Some of the people who did not see a change but maintained their hair through the first few years or who showed slight improvement started showing some decrease in growth. Those who showed moderate or great improvement maintained their results.


Show hair counts from patients using Propecia in the 5 year clinical studyNo Propecia user had their hair counts decrease greatly compared to about 19% of placebo users. Only a small percentage (3%) of Propecia users showed a moderate decrease in hair compared to 31% of placebo users, and 7% of patients showed a slight decrease in hair compared to 25% of placebo users. Forty-two percent of Propecia users showed no change in their hair compared to 19% of placebo users, 22% showed a slight increase in hair compared to 6% of placebo users, 21% had a moderate increase in hair compared to no placebo users, and strangely enough, 5% who were the best responders showed a great increase in hair which was as much as the previous years.

In terms of sexual side effects in year 1, 3.8% of patients experienced drug related sexual side effects compared to 2.1% of placebo users. 1.8% of Propecia users had a decrease in libido, 1.3% showed erectile dysfunction, and 1.2% had ejaculation disorder. This compares to 1.3% of placebo users having a libido decrease, 0.7% with erectile dysfunction, and 0.7% of placebo users with ejaculation disorder. This decreased in successive years until in year 5 only 0.6% of Propecia users had sexual side effects including 0.3% with libido decrease, 0.3% with erectile dysfunction, and none with ejaculation disorder. No placebo users showed sexual side effects after 5 years, however only a small percent (23 of the original 934) of theplacebo group were still on placebo and in the studies after 5 years.

However according to Dr Lee the data may not tell the whole story:

"I have never agreed with Merck's report of the incidence of side effects due to initial Propecia use. My experience with finasteride is that the percentage of patients with side effects of decreased libido, erectile dysfunction and/or ejaculatory disorder is approximately 5 or 6 times higher than the 3.8% that Merck reports. Initially, Merck claimed that the incidence of side effects was less than 2%. Since assessing 'decreased libido' is of such a subjective nature, I have repeatedly asked for a copy of Merck's original clinical trials. On each occasion, I've been denied a copy of that study. It is not surprising that the incidence of side effects declined dramatically in the fifth year of use. Patients who did have sexual side effects simply wouldn't tolerate those side effects for five years. With this in mind, the report of 0.6% of Propecia users having sexual side effects after five years of use sounds incorrect and misleading.

 


So the conclusion is clear from the 5-year results. For those people using Propecia who do respond positively, Propecia will at best grow some more hairs, and at worse maintain your existing hair with minimal hair growth. This makes more of a case for using a multi-agent treatment program to maximize the possible results. There is no doubt that the results would have been a lot better had the participants been using Rogaine in addition to Propecia.

The final words come from Dr Lee, "I will continue to recommend and prescribe Propecia, because I think that Propecia is a safe and effective treatment for MPB. It is gratifying to have the results of the 5-year Propecia study because it gives us additional information in regards to its effectiveness as well to some of its limitations. "

 


 

 

2 Year Propecia Clinical Studies Results
     
Start of Treatment 6 Month 24 Month
Great Improvement 5%
Moderate Improvement 31%
Slight Improvement 30%
No change 33%
Decrease 1%

 

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