Sensipar
is a drug that can be problematic (dangerous?) when given to patients with
PRIMARY hyperparathyroidism. Sensipar (Cinacalcet) is NOT approved by the FDA for
treating patients with primary hyperparathyroidism. If your doctor
prescribed this drug for you, you should print this page of
parathyroid.com and take it to him/her. Sensipar is likely to make you
feel sick, and new evidence suggests that Sensipar can make your
osteoporosis worse if you take it. Most insurance companies will not
pay for this drug for treating primary hyperparathyroidism... and they
shouldn't! There is good evidence that taking Sensipar is worse for you
than if you took nothing and simply ignored the parathyroid tumor in your
neck! The pros and cons of taking Sensipar for primary hyperparathyroidism
will be discussed on this page. In our opinion, there is almost never a
case where a patient with primary hyperparathyroidism should be on this
drug! DANGER! Again, this drug may make you significantly worse
and is not approved for patients like you!
If you are on this page of parathyroid.com because you have
hyperparathyroidism and your doctor gave you a prescription for Sensipar
and you came home and typed "Sensipar" into Google... then you
are on the right web site... However, you may want to read about
hyperparathyroidism and parathyroid disease at the beginning
of this website and then come back here later. Make
sure you understand that taking a pill will not make the tumor in your
neck go away. Also, be careful, this is an advanced page and we will
confuse you if you haven't read more about parathyroid disease on our
other pages first.
Sensipar is a drug manufactured by Amgen. Sensipar is the trade name,
the generic name for this drug is "Cinacalcet". Sensipar comes
as a small pill in two strengths (30mg and 60mg). This drug was
designed for the treatment of SECONDARY hyperparathyroidism. SECONDARY hyperparathyroidism
is a disease that occurs in patients with kidney failure that are on
dialysis. These patients do NOT get parathyroid tumors like patients with
PRIMARY hyperparathyroidism. Patients with SECONDARY hyperparathyroidism
are usually treated with a combination of medications along with dialysis
to control all of the problems they have with the chemical balance of
their blood (due to the lack of kidney function).
Patients with PRIMARY hyperparathyroidism do NOT have kidney failure,
and are NOT on dialysis. This entire website (parathyroid.com) is
dedicated to the treatment of PRIMARY hyperparathyroidism. People with
PRIMARY hyperparathyroidism have high calcium levels, high PTH levels and
other issues (like kidney stones and osteoporosis) which are discussed on
this website extensively. We cannot confuse primary and secondary
hyperparathyroidism. Let us make this simple...if you have a parathyroid
problem, and you are not on kidney dialysis, then you have PRIMARY
hyperparathyroidism.
Sensipar was approved by the FDA for the treatment of SECONDARY
hyperparathyroidism in March 2004. This drug works well in many patients who are on
dialysis, and many thousands of patients with kidney failure are on this
drug. Sensipar is NOT approved (nor does Amgen support its use) for
patients who are not on kidney dialysis. Sensipar is NOT FDA approved for the treatment of PRIMARY
hyperparathyroidism. This is why your insurance won't pay for it. They
shouldn't! Amgen--the maker of this drug, does not say this drug can be
used for primary hyperparathyroidism... and they know why --- It can make
things worse!
Several studies of Sensipar were conducted in patients with PRIMARY
hyperparathyroidism in the past few years (mid 2000's). Patients with
primary hyperparathyroidism were given Sensipar and the doctors measured
their calcium levels and PTH levels. The biggest study had a total of 40
(forty) patients getting Sensipar, while 38 got placebo (not a very big
study, was it?). The trial was to last 1 year. Only 28 of the 40 patients
taking Sensipar (70%) were able to stay on the drug for one year--the rest
got sick and were not able to take it. Of the 28 patients that took the
drug for one year, 73% had a decrease in their blood calcium levels. Only
7% of patients had a decrease in their PTH values. All the patients still
had the parathyroid tumor still in their neck, and even in patients who
had lower calcium levels, when the drug was stopped, their calcium and PTH
levels went back up--some even higher than before. The researchers did
uncover a potential problem, however, that the bones of these people may
not be any better, and they may be worse. This paper can be read here: Peacock
M, Bilezikian JP, et al. Cinicalcet maintains long-term normocalcemia in
patients with primary hyperparathyroidism. J
Clin Endocrinol Metab.
2005;90:135-141.
This was a well conducted study, and like other smaller studies (yep,
even fewer patients), it shows that Sensipar will decrease the blood
calcium in about 3/4 of patients. However, since the PTH doesn't go down
in most people, it seems that the patient's bones are still exposed to
excess PTH.
Our Experience With Sensipar and Primary
Hyperparathyroidism.
We've put people on Sensipar who were sent to us after a failed
operation somewhere else and we couldn't find their tumor (so we elected
to not operate on them for a year). We have also had many patients sent to
us for surgery after their doctor tried Sensipar and it made them sick, or
they just continued to get worse. In June 2008 we will be presenting our
data on patients with PRIMARY hyperparathyroidism who have had Sensipar
for at least 1 year, some as long as 3 years. Our experience with Sensipar
and primary hyperparathyroidism shows that Sensipar 1) makes a lot of
people feel bad (nausea) so they can't take it, 2) in patients that can
take this drug, it doesn't usually make them feel better--they still feel
tired and have all the symptoms of primary hyperparathyroidism, 3) their
calcium does come down, some more than others, but all are intermittent,
4) most people have a WORSENING of their osteoporosis. Our experiences
with this drug are very poor, and we have written the FDA and Amgen to
make them aware of our findings... the abstract of our findings which will
be presented at the biggest endocrine meeting of the year is here:
Sensipar and Primary Hyperparathyroidism... What is the
Bottom Line?
The bottom line is this: primary hyperparathyroidism is caused by a
tumor of one (or uncommonly, two) parathyroid glands. Taking a pill every
day will not remove the tumor. Taking a pill every day may actually accelerate
the formation of osteoporosis--thus this drug does not appear to be a way
to "avoid" parathyroid surgery. If your doctor thinks you can
"avoid" parathyroid surgery, or "delay" parathyroid
surgery by taking a pill every day... then print this and take it to
him/her. There is NO medical evidence ANYWHERE that suggests taking
Sensipar will help you avoid surgery. In fact, all of the evidence is that
1/3 of you can't tolerate the drug because it will make you sick, and most
of you will get a dramatic worsening of your bones. And THEN, you will get
surgery to get the tumor out.
This drug will cost you between $620 and $1250 per month in the US. Most insurances will
not pay it... and they should not. It is in your best interest to find an
excellent parathyroid surgeon and get the parathyroid tumor removed. It
can be done in less than 20 minutes by some experts... then get on with
your
life.
Sensipar, Sensipar-HCL. Cinicalcet,
Sensipar-Cinicalcet, Cinacalcet, Cinacalcet-Sensipar, Cinacalcet-HCL,
Cinicalcet-HCL.
