This article is an evaluation of the 5 year propecia trial (year 4 and 5),
Any comments?
Sorry if its old news
-------------------------------------------------------------------------------------
Propecia Phase III 5 Year Results
By John Ertel
March 3, 2001
The 4th and 5th year Propecia results were announced today
at the American Academy of Dermatology Meeting in
Washington, DC. Dr. Elise Olsen presented the results
during her presentation on pattern hair loss in men and
women at the 'Hair' symposium of the meeting. The 5 year
results presented a mixture of good and bad news to
Propecia users.
The bad news is that overall hair counts and percentage of
responders continued to decline in the 4th and 5th years of
treatment just like they did in the 2nd and 3rd years. The
decrease in responders and hair counts was small, in fact
the decrease was largest in the 2nd year and was smaller in
each sucessive year and seems to almost even out by year 5.
The good news is that as you will read below the results
were generally maintained. According to one of the
presenters, Dr. Wilma Bergfeld, the people who were still
responders at the 5th year were still seeing increases in
hair quality even after five years. "Every year they get an
increment better," said Bergfeld.
Even though the news that hair counts and responder
percentages continued their gradual, slight decline, the
data for people not using Propecia may put the news in
proper perspective. After 5 years, 65% of Propecia users
saw no further hair loss while 35% showed some hair loss
after five years. In placebo users, however, 100% of
participants continued losing hair. Not only that, but just
as the hair counts in responders slightly decreased over
each successive year after the first, hair counts in
placebo users dropped faster each year, showing that even
though some individuals did see a decrease in hair count
from their initial gains, if they were not continuing to
use Propecia they would be losing hair at an even faster
rate.
Hair Counts
The tale of the haircounts tells the tale. In the first
year, hair counts in responders rose 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 about 50% from their first year
increase above baseline by the 5th year.
The tale of the placebo users is even more dramatic. They
lose about 30 hairs per square inch during the first year,
then close to 80 below baseline 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.
Photographic Assessment
Photographic assessments show that the drop in hair count
average drops are due more to the people who received the
least benefit from Propecia in the first place. Basically,
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 backsliding. Those who showed moderate
or great improvement maintained their results. Here are the
numbers.
No Propecia users had their hair counts decrease greatly
compared to about 19% of placebo users. A small 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
interestingly enough, 5% showed a great increase in hair
(the same as in previous years). So apparently the better a
responder you are, the more likely you are to maintain your
results.
Patient Self-Assessment
In the patient self-assessment, 48% of Propecia users said
they were satisfied with their frontal hairline, 59% were
satisfied with the top of their head, and 63% were
satisfied with their hair overall. This compares to 7% of
placbo users satisfied with the front, 13% satisfied with
the top, and 20% satisfied overall with their hair.
Side Effects
Perhaps the best news was in the area of 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, an 0.7% of
placebo users with ejaculation disorder. This dropped 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 erectyle 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 the placebo group were still on
placebo and in the studies after 5 years.
Investigator Assessment
When the investigator assessment results were compiled,
they were fairly similar to the photographic assessments,
although oddly the percentage showing no change was much
smaller and the percentage of great responders was much
higher. No propecia users were judged to have a great
decrease in hair compared to 8% of placebo users; 3% of
Propecia users showed a moderate decrease in hair compared
to 23% of placebo users; 4% of Propecia users showed a
slight increase compared to 8% of placebo users; 15% showed
no change in their hair compared to 46% of placebo users;
26% of people showed a slight increase compared to 15% of
placebo users; 29% of Propecia users showed a moderate
increase in hair compared to no placebo users. No placebo
users showed a great increase in hair, but investigators
assessed that 22% of Propecia users showed a great
increase.
Conclusions
While the fact that some people stop responding by year 5
and start losing hair again is bad news, the fact that they
don't lose hair as fast while they stay on Propecia still
leaves hope that they can maintain as much as possible
until something better comes along. The good news is there
are other treatments in the pipeline. And for the
pessimists among our readers you have to consider that
these figures are for people using 1mg Finasteride and NO
other treatments. There is no information about whether a
stronger dose might help those responders who lost results
maintain them, or if other treatments such as Minoxidil
would have helped prevent the drop in results. What this
tells me is that if you don't get minimal results with
Propecia but you do get results, you should make sure to
add other things to your hair loss arsenal so you will
maintain your results or consult with your doctor about
using a higher dose.
Any comments?
Sorry if its old news
-------------------------------------------------------------------------------------
Propecia Phase III 5 Year Results
By John Ertel
March 3, 2001
The 4th and 5th year Propecia results were announced today
at the American Academy of Dermatology Meeting in
Washington, DC. Dr. Elise Olsen presented the results
during her presentation on pattern hair loss in men and
women at the 'Hair' symposium of the meeting. The 5 year
results presented a mixture of good and bad news to
Propecia users.
The bad news is that overall hair counts and percentage of
responders continued to decline in the 4th and 5th years of
treatment just like they did in the 2nd and 3rd years. The
decrease in responders and hair counts was small, in fact
the decrease was largest in the 2nd year and was smaller in
each sucessive year and seems to almost even out by year 5.
The good news is that as you will read below the results
were generally maintained. According to one of the
presenters, Dr. Wilma Bergfeld, the people who were still
responders at the 5th year were still seeing increases in
hair quality even after five years. "Every year they get an
increment better," said Bergfeld.
Even though the news that hair counts and responder
percentages continued their gradual, slight decline, the
data for people not using Propecia may put the news in
proper perspective. After 5 years, 65% of Propecia users
saw no further hair loss while 35% showed some hair loss
after five years. In placebo users, however, 100% of
participants continued losing hair. Not only that, but just
as the hair counts in responders slightly decreased over
each successive year after the first, hair counts in
placebo users dropped faster each year, showing that even
though some individuals did see a decrease in hair count
from their initial gains, if they were not continuing to
use Propecia they would be losing hair at an even faster
rate.
Hair Counts
The tale of the haircounts tells the tale. In the first
year, hair counts in responders rose 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 about 50% from their first year
increase above baseline by the 5th year.
The tale of the placebo users is even more dramatic. They
lose about 30 hairs per square inch during the first year,
then close to 80 below baseline 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.
Photographic Assessment
Photographic assessments show that the drop in hair count
average drops are due more to the people who received the
least benefit from Propecia in the first place. Basically,
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 backsliding. Those who showed moderate
or great improvement maintained their results. Here are the
numbers.
No Propecia users had their hair counts decrease greatly
compared to about 19% of placebo users. A small 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
interestingly enough, 5% showed a great increase in hair
(the same as in previous years). So apparently the better a
responder you are, the more likely you are to maintain your
results.
Patient Self-Assessment
In the patient self-assessment, 48% of Propecia users said
they were satisfied with their frontal hairline, 59% were
satisfied with the top of their head, and 63% were
satisfied with their hair overall. This compares to 7% of
placbo users satisfied with the front, 13% satisfied with
the top, and 20% satisfied overall with their hair.
Side Effects
Perhaps the best news was in the area of 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, an 0.7% of
placebo users with ejaculation disorder. This dropped 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 erectyle 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 the placebo group were still on
placebo and in the studies after 5 years.
Investigator Assessment
When the investigator assessment results were compiled,
they were fairly similar to the photographic assessments,
although oddly the percentage showing no change was much
smaller and the percentage of great responders was much
higher. No propecia users were judged to have a great
decrease in hair compared to 8% of placebo users; 3% of
Propecia users showed a moderate decrease in hair compared
to 23% of placebo users; 4% of Propecia users showed a
slight increase compared to 8% of placebo users; 15% showed
no change in their hair compared to 46% of placebo users;
26% of people showed a slight increase compared to 15% of
placebo users; 29% of Propecia users showed a moderate
increase in hair compared to no placebo users. No placebo
users showed a great increase in hair, but investigators
assessed that 22% of Propecia users showed a great
increase.
Conclusions
While the fact that some people stop responding by year 5
and start losing hair again is bad news, the fact that they
don't lose hair as fast while they stay on Propecia still
leaves hope that they can maintain as much as possible
until something better comes along. The good news is there
are other treatments in the pipeline. And for the
pessimists among our readers you have to consider that
these figures are for people using 1mg Finasteride and NO
other treatments. There is no information about whether a
stronger dose might help those responders who lost results
maintain them, or if other treatments such as Minoxidil
would have helped prevent the drop in results. What this
tells me is that if you don't get minimal results with
Propecia but you do get results, you should make sure to
add other things to your hair loss arsenal so you will
maintain your results or consult with your doctor about
using a higher dose.