VYTORIN & ZETIA? Study Says They're NOT EFFECTIVE As Advertised On TV! Be Warned!
spicpussy
"Merck defends medications, says research is limited"
By Lyndsey Layton
Washington Post Staff Writer
Monday, November 16, 2009
A WIDELY PRESCRIBED AND EXPENSIVE CHOLESTEROL DRUG is not as effective
as niacin, a cheap vitamin, in helping to unclog coronary arteries in
people already taking statins, the standard medicines used to lower
cholesterol, according to a new study.
The research, which appears Monday in the New England Journal of
Medicine, is sending rumbles through the medical community because it
is the third recent study to raise questions about the effectiveness
of Zetia and its sister drug, Vytorin, highly profitable
pharmaceuticals made by Merck & Co.
"This is the third strike," said Steven Nissen, chairman of
cardiovascular medicine at the Cleveland Clinic. "The studies are
telling us that it doesn't appear to produce benefits. This is a drug
used by millions of Americans, a very big seller, in a health-care
system where costs are a major issue. And the question has to be, is
this the right approach?"
Vytorin and Zetia are among the most popular prescription drugs. Last
year, physicians in the United States wrote a total of more than 29
million prescriptions for them, and worldwide sales totaled $4.56
billion, according to Merck.
Although the drugs have been shown to reduce cholesterol, there is no
evidence that they prevent heart attacks, strokes and other
cardiovascular problems.
Top Merck executives are vigorously defending their drugs and have
dismissed the new research as limited.
"I don't think a clinician or a doctor or a patient should use this as
the basis for any decision-making whatsoever," said Richard Pasternak,
vice president of Merck research laboratories. "I worry that people
might unnecessarily come off a drug that is approved and accepted."
He and other critics said the study appearing Monday involved just 200
patients, was ended early, and examined what is known as a surrogate
marker -- the amount of plaque on artery walls -- rather than
evaluating the rate of heart attacks and stroke.
Because plaque can clog arteries and restrict blood flow to the heart
and brain, cardiologists view plaque as a good indication for the risk
of heart attack and stroke.
The study has been highly anticipated by the medical community and
financial analysts, and is the buzz at the annual meeting of the
American Heart Association, which began Sunday in Orlando.
Introduced in 2002 and 2004 amid heavy direct-to-consumer marketing,
Zetia and Vytorin became blockbusters for Merck and Schering-Plough,
which had collaborated on their development. The companies recently
merged.
But new research has placed the drugs under greater scrutiny and the
number of written prescriptions has been slipping, although together
they still represent big business for Merck.
Last year, a study released by Merck showed that Zetia did not reduce
plaque in arteries compared with patients taking only statins, which
are much less expensive and available in generic form. Although
released in January, the study had been completed in 2006, prompting a
class-action lawsuit alleging that Merck intentionally withheld
unfavorable results of a clinical trial. The company paid $41.5
million in August to settle the claims.
Another study published last year showed a potential increase in
cancer among patients taking Zetia and Vytorin, compared with those
taking only statins.
Taken as a whole, the new research is unnerving, said Harlan Krumholz,
a Yale University cardiologist. "The accumulating evidence isn't
giving you any confidence," he said. "This is a very expensive drug
being used without any strong evidence that it's benefiting patients."
Zetia and Vytorin should be "drugs of last resort, if used at all,"
Krumholz said. "And anyone who uses it should make sure patients are
informed that they're taking a gamble."
Statins, such as Lipitor, have long been used to lower cholesterol and
reduce cardiovascular disease. They inhibit the production of LDL, or
low-density lipoprotein, often called "bad" cholesterol, which can
lead to plaque buildup in arteries.
Zetia, the brand name for ezetimibe, uses a different mechanism. It
blocks the absorption of cholesterol from food in the intestines. It
has been shown by Merck to lower LDL by 18 percent on average. It is
designed for patients who cannot tolerate statins, or for whom high-
dose statins are not working.
Vytorin is Zetia combined with a statin, simvastatin, in one pill.
The study released Monday followed about 200 patients who were already
taking statins. Some were also given Niaspan, a modified form of
Vitamin B, or niacin. The rest took Zetia. Researchers took images of
the artery leading to the brain to measure the thickness of the artery
walls over 14 months.
The patients who took Niaspan had less plaque in their arteries and
also had higher levels of high-density lipoprotein or HDL. Known as
"good" cholesterol, HDL is believed to remove cholesterol from the
arteries and carry it back to the liver, where it is passes from the
body.
The patients who took Zetia had more plaque in their arteries but
lower levels of LDL. They also had more heart attacks, strokes and
other cardiovascular problems than the patients taking niacin. Merck
President Peter Kim said the fact that Zetia lowers LDL cholesterol
makes it valuable. "It's very well established that lowering LDL saves
lives," he said.
Roger S. Blumenthal, a cardiologist at Johns Hopkins, criticized the
new study in an editorial also published Monday in the New England
Journal of Medicine. Blumenthal, who has been a paid speaker for
Merck, noted that the new study was halted early, which meant results
from 40 percent of the participants were not included in the final
analysis.
The study's author, Allen J. Taylor of Walter Reed Army Medical Center
and Washington Hospital Center, said the trial ended early because the
results were quickly apparent. "It couldn't be more clear," Taylor
said. "It would have been unreasonable to continue the experiment
because the trial had met its objective -- niacin is superior to
ezetimibe."
Kim said any conclusions about Zetia and Vytorin should wait until
Merck completes a large-scale clinical trial. It involves 15,000
patients and is not expected to yield results until at least 2012.
http://www.washingtonpost.com/wp-dyn/content/article/2009/11/15/AR2009111502848.html
GLOBALIST
Gregory Hall
news:43ce06f3-6cdf-4f2b...@k9g2000vbl.googlegroups.com...
> "New study questions effectiveness of popular cholesterol drugs"
>
> "Merck defends medications, says research is limited"
>
> By Lyndsey Layton
> Washington Post Staff Writer
> Monday, November 16, 2009
>
>
>
> A WIDELY PRESCRIBED AND EXPENSIVE CHOLESTEROL DRUG is not as effective
> as niacin, a cheap vitamin, in helping to unclog coronary arteries in
> people already taking statins, the standard medicines used to lower
> cholesterol, according to a new study.
Niacin is some good stuff.
I take Rosuvastatin (5mg) to reduce my cholesterol. I supplement this with
niacin(100mg) and fish oil (1000mg) vitamin e (400mg), and Co-enzyme Q-10 at
(200mg). Statins work but they tend to deplete co-enzyme Q-10 so anybody
taking statins should also take Co Q-10.
5mg of Rosuvastatin reduced my cholesterol from over 300 to around 220. The
doc wanted up up my dose to 10mg but I balked knowing statins are powerful
drugs that can damage muscles and the liver in the higher doses. Taking the
above supplements along with the statin caused my cholesterol to drop to 180
or so and my good cholesterol is nice and high (70-80) and my bad
cholesterol is in the low range now. If course I also supplement with 2-3
hours a day of strenuous physical activity - cycling. And my BMI is in the
mid-normal range.
--
Gregory Hall
Kofi
> reduce cardiovascular disease. They inhibit the production of LDL, or
> low-density lipoprotein, often called "bad" cholesterol, which can
> lead to plaque buildup in arteries.
>
> Zetia, the brand name for ezetimibe, uses a different mechanism. It
> blocks the absorption of cholesterol from food in the intestines. It
> has been shown by Merck to lower LDL by 18 percent on average. It is
> designed for patients who cannot tolerate statins, or for whom high-
> dose statins are not working.
This route also blocks the absorption of fat-soluble vitamins - like
vitamin D3.
>
> Vytorin is Zetia combined with a statin, simvastatin, in one pill.
>
> The study released Monday followed about 200 patients who were already
> taking statins. Some were also given Niaspan, a modified form of
> Vitamin B, or niacin. The rest took Zetia. Researchers took images of
> the artery leading to the brain to measure the thickness of the artery
> walls over 14 months.
>
> The patients who took Niaspan had less plaque in their arteries and
> also had higher levels of high-density lipoprotein or HDL. Known as
> "good" cholesterol, HDL is believed to remove cholesterol from the
> arteries and carry it back to the liver, where it is passes from the
> body.
>
> The patients who took Zetia had more plaque in their arteries but
> lower levels of LDL. They also had more heart attacks, strokes and
> other cardiovascular problems than the patients taking niacin.
J Am Coll Cardiol. 2009 Nov 3;54(19):1787-94
�
Comment on:
* J Am Coll Cardiol. 2009 Nov 3;54(19):1795-6.
Effects of high-dose modified-release nicotinic acid on atherosclerosis
and vascular function: a randomized, placebo-controlled, magnetic
resonance imaging study.
Lee JM, Robson MD, Yu LM, Shirodaria CC, Cunnington C, Kylintireas I,
Digby JE, Bannister T, Handa A, Wiesmann F, Durrington PN, Channon KM,
Neubauer S, Choudhury RP.
Department of Cardiovascular Medicine, University of Oxford and Oxford
Centre for Clinical Magnetic Resonance Research (OCMR), Oxford, United
Kingdom.
OBJECTIVES: Our aim was to determine the effects of high-dose (2 g)
nicotinic acid (NA) on progression of atherosclerosis and measures of
vascular function. BACKGROUND: NA raises high-density lipoprotein
cholesterol (HDL-C) and reduces low-density lipoprotein cholesterol and
is widely used as an adjunct to statin therapy in patients with coronary
artery disease. Although changes in plasma lipoproteins suggest
potential benefit, there is limited evidence of the effects of NA on
disease progression when added to contemporary statin treatment.
METHODS: We performed a double-blind, randomized, placebo-controlled
study of 2 g daily modified-release NA added to statin therapy in 71
patients with low HDL-C (<40 mg/dl) and either: 1) type 2 diabetes with
coronary heart disease; or 2) carotid/peripheral atherosclerosis. The
primary end point was the change in carotid artery wall area, quantified
by magnetic resonance imaging, after 1 year. RESULTS: NA increased HDL-C
by 23% and decreased low-density lipoprotein cholesterol by 19%. At 12
months, NA significantly reduced carotid wall area compared with placebo
(adjusted treatment difference: -1.64 mm(2) [95% confidence interval:
-3.12 to -0.16]; p = 0.03). Mean change in carotid wall area was -1.1
+/- 2.6 mm(2) for NA versus +1.2 +/- 3.0 mm(2) for placebo. In both the
treatment and placebo groups, larger plaques were more prone to changes
in size (r = 0.4, p = 0.04 for placebo, and r = -0.5, p = 0.02 for NA).
CONCLUSIONS: In statin-treated patients with low HDL-C, high-dose
modified-release NA, compared with placebo, significantly reduces
carotid atherosclerosis within 12 months. (Oxford Niaspan Study: Effects
of Niaspan on Atherosclerosis and Endothelial Function; NCT00232531).
Publication Types:
* Comment
* Randomized Controlled Trial
* Research Support, Non-U.S. Gov't
PMID: 19874992
clams_casino
>"New study questions effectiveness of popular cholesterol drugs"
>
>"Merck defends medications, says research is limited"
>
>By Lyndsey Layton
>Washington Post Staff Writer
>Monday, November 16, 2009
>
>
>
>A WIDELY PRESCRIBED AND EXPENSIVE CHOLESTEROL DRUG is not as effective
>as niacin, a cheap vitamin, in helping to unclog coronary arteries in
>people already taking statins, the standard medicines used to lower
>cholesterol, according to a new study.
>
>
>
I initially went on Lipitor with a significant drop in cholesterol and
triglycerides (low 200's down to about 140 on both). After two years,
I switched to simvistatin (generic Zocar) in an attempt to save
money. After about a year, I began having significant muscle problems
(inflammation, swelling / stiffness throughout my arms. Within a few
months thereafter, I could barely move my wrists. The cholesterol
numbers went up to 184 & triglycerices to 215 when tested after 16
months. I then stopped taking the simvisatin. Without a statin, my
doctor strongly advised losing 20-30 pounds (6 ft / 215 lbs). It's been
six months and with physical therapy, I've regained perhaps 90% of my
arm & wrist motion. I've lost 15 lbs (increased protein / significantly
reduced carbs) . My triglycerides & cholesterol are now lower than when
I was taking the simvastatin, although admittedly not as low as with the
lipitor, but below the 200 threshold. And for the record, the "simple"
blood test did NOT clearly predict the liver problems caused by the
simvisatin. In my case, the problem was severe, but the increased ALT,
AST values only went from middle range to slightly above the upper limit
of normal. The CPK value remained on the low end of normal.
The crap was slowly killing me. Furthermore, any savings with the
generic quickly disappeared considering the cost of doctor appointments,
extra blood tests & therapy.
1) Do consider losing weight before taking a statin.
2) Be wary of the generics.
3) Be very aware if you experience any muscle problems (in my case, it
was not strength, but a significant stiffening of the arms & wrist
muscles - not what I was picturing when they talked about potential
muscle problems.).
Joan F (MI)
supposedly a good thing though I think the whole cholesterol scare is a scam
to sell drugs.
Joan F (MI)
Don
wrote:
Joan,
This is news that is over a year old. I was on both, for a short
time, had side effects and went off of them without telling the Doctor
until I saw her again. She was not sure why I went off but she found
out a few weeks later when this news broke. If you don't need
statins, don't take them. If you need them take them. It might just
help you live a while longer. I've been on them since 1996 and before
that I only had a diet to use. It didn't work and I paid for it later
with clogged arteries. Had the statins been available I may have
averted surgery which I can tell you is no fun day at the office.
Don
Don Klipstein
I want to add personal experiences of myself and of a close friend.
<SNIP previously quited material>
Experience of a close friend of mine, who is among the 15-20% of the
population having a genetic deficiency in cholesterol regulation:
1. It is fairly well known that dietary cholesterol intake has a
significant effect on such people. Such people should eat animal
products in general only in moderation, and should eat only sparingly egg
yolks, organ meats, and most shellfish (since most include organ meats).
2. This close friend of mine, after his early age heart attack following
total cholesterol in the mid-upper 200's with a bad ratio of LDL/HDL,
started taking statins as well as taking on a major change in diet and a
major uptick in exercise. The combination has achieved total cholesterol
around 140 with ratio of LDL/HDL becoming marginally good, and
triglycerides taking some time to decrease greatly from a bad level to a
good level.
His dietary change was reduction of calories, mostly greatly reducing
fat calories and distant 2nd place after that calories from alcohol. His
carb intake is close to unchanged or slightly increased and his protein
intake slightly decreased.
He changed his exercise lifestyle from sedentary to about 8 hours a week
of hiking and taking brisk walks.
The change in diet and exercise got his weight down by about 30 pounds,
from "pudgy with a bit of beer belly" to normal for his height and frame.
My experience:
I have good genes, deliver food by bicycle for my "day job", and commute
mostly by bike.
I used to eat the "see-food" diet, but in recent years reduced my
consumption of things in/near "empty calorie" class, with the only item I
started consuming less of with carb/fat ratio greater than in the "food
pyramid" being sugary fountain soda. I did greatly reduce my intake of
fat-rich items such as potato chips, cakes and pastries (often rich in
"bad fats"), breaded deep-fat-fried products, and mayo (usual mayo has
more calories per ounce than pure sugar has, and almost entirely fat).
I try to get my fat intake "at least somewhat limited" to sunflower
seeds and oily fish (sardines, mackerel and salmon).
I increased my intake of veggies, both other-than and including ones
disfavored by "anti-carbers" such as beans and carrots.
The dietary change has gotten my weight down from mid 170's to low
160's. If I cave in less for my weekness for beer, I will probably get
to the mid-150's appropriate for my frame.
I do tank up on B-vitamins, as in either the "B-50" or the "B-100",
usually to extent of taking in on average at least 100 mg of niacin daily.
My latest cholesterol reading was 166, with HDL of 100 and LDL of 66.
- Don Klipstein (d...@misty.com)
Samatha Hill -- take out TRASH to reply
> "New study questions effectiveness of popular cholesterol drugs"
This news is well over a year old, right? At least, I know I heard it
well over a year ago.
trigonometry1972@gmail.com |
I remember talking to someone about the health
risks of statins in the year 2000. And there risks
per muscle damage was fairly well known to some
even then. Albeit not to the local Docs of the late 90's.