Personal
comment from Kathryn (March 99)
This new conjugated
estrogen product is called Cenestin and is made by Duramed Pharmaceuticals,
it was recently approved and I jumped in and told asm that this was probably
going to be similiar to CES the bioequivalent to Premarin available in
Canada. I said it would be a conjugated estrogen without the equine (horse)
estrogens.
Well I was wrong.
It has synthetic or copies of horse estrogens made from plant sources.
Cenestin (according to the label) contains 9 different estrogens, and six
of them have the letters equine in the chemical name. Sheeesh. This might
be good for pregnant mares but is it what women really want to put into
their bodies as replacement hormones?
Cenestin is at the
moment only approved by the FDA for treating menopause symptoms such as
hot flashes and cannot make any long term claims.
http://www.fda.gov/cder/news/cenestin/default.htm
Cenestin Questions
and Answers (Updated 03/26/1999)
Cenestin Approval
Letter (03/24/1999)
Cenestin Label
(03/24/1999)
The label includes
both the physicians package insert at the beginning and the patient package
insert at the end. I've just started reading through the label ( it is
long and on a PDF file so I cannot cut and paste) The warnings and contraindications
are the same as those of other estrogen products..
So far reading through
the physician's insert I see an interesting study
on Cenestin and hot flashes(page 5 of the label). I assume Premarin
and other estrogens would have similar results. The estrogen did do better
than placebo on hot flashes but I was surprised at how well the placebo
worked.
There were 117 menopausal
women in this 12 week study, 70 in the Cenestin group and 47 in the placebo
group. It did not give the ages of the women nor exact menopause status.
Nor did it say anything about whether these women were intact or not. No
progestin was given but that would not be required in a short 12 week study
but that should be noted when looking at the results IMO.
The Cenestin group
started with 0.625 mg daily and the placebo group with one tablet of placebo.
Titration of either Cenestin or placebo [the study was blinded so it would
not be known who was taking what] was allowed as necessary after one week.
ie dose was either increased or decreased.
By the end week 12,
and I will quote this part:
"10% of the study
participants remained on a single 0.625 mg Cenestin tablet daily, while
77% required two (0.625 mg) tablets daily"
Bearing this in mind
what were the results on hot flashes? [I am not going to reproduce the
whole table, see the website for full details about SD etc]
Clinical response,
mean change in reduction of vasomotor symptoms
|
Cenestin |
Placebo |
Difference |
| baseline |
96.8 |
94.1 |
|
| week 4 change |
-68.1 |
-48.4 |
-19.9 |
| week 8 change |
-78.3 |
-54.3 |
-24.6 |
| week12 change |
-80.3 |
-56.3 |
-24.7 |
I am not certain what
this means in actual decrease in hot flashes but it does not look like
the difference over placebo was very much, especially as 77% had to increase
the dose to get these results.
Some of the placebo
doses would have been double too and that would be the reason why placebo
also did better as the weeks went on. Interesting.
Kathryn |