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 March
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.
 No
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.
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