Attention all you sinners New Drugs coming!

William Wagner · medicine forum Guru Joined: 29 Apr 2005 Posts: 809

http://www.theledger.com/apps/pbcs.dll/article?AID=/20050621/NEWS/5062103
01/1021

I recommend looking at the above URL. Dave 73 frowned . Perhaps i read
too much into that.

"A recently developed medication has raised hopes of even more effective
treatment of HDL levels. Pfizer, the maker of Lipitor, is testing a drug
called torcetrapib, designed to boost HDL, especially when used in
conjunction with other statins. A small, preliminary study found that
the drug doubled HDL levels for some patients."

Bill

...................

SCOTT WHEELER/THE LEDGER
Dave Riddle, 73, of Winter Haven takes Lipitor to help control his
cholesterol. He says his doctor put him on the drug about three years
ago to control his levels of "bad" cholesterol. The drug also seems to
have boosted his "good" cholesterol.

Published Tuesday, June 21, 2005
The Good Cholesterol
More Emphasis Put on Boosting HDL Levels

By Gary White
The Ledger

Dave Riddle, like most of us, pays enough attention to medical news to
be familiar with the phrase "good cholesterol." The Winter Haven
resident knows he could use more of it; he just wishes it were as easy
to acquire as the bad kind.

In the not so distant past, cholesterol was regarded much like the
villain in a simplistic Western movie, one-dimensional and having no
redeeming qualities.

Medical advances, however, have brought greater complexity to our
understanding of cholesterol. Rather than a single, unequivocally bad
entity, cholesterol is more like Dr. Jekyll and Mr. Hyde -- a complex
agent capable of both positive and negative effects.

Doctors in recent years have put increasing emphasis on the positive,
encouraging patients to increase their levels of high-density
lipoprotein (HDL), commonly called "good cholesterol." Its counterpart
is low-density lipoprotein (LDL), or "bad cholesterol."

Dr. Christopher Simek, a Lakeland cardiologist, says studies have
suggested high levels of HDL can mitigate the damaging effects of LDL,
which combines with other substances circulating through the bloodstream
to form artery-clogging plaque, the cause of myriad medical problems
that make heart disease the top cause of death among Americans.

When it comes to HDL, Simek says the current medical consensus says the
higher the better.

"HDL is a very important risk factor," says Simek, who practices at
Watson Clinic. "We think that for every milligram you can raise HDL,
there's a further 2 (percent) to 3 percent reduction in cardiovascular
events, irrespective of what the LDL is."

All forms of cholesterol are measured as milligrams per deciliter in the
blood. The American Heart Association reports men have average HDL
levels between 40 and 50 and women between 50 and 60. The group sets 40
as the minimum healthy HDL level for adults.

Simek says public understanding of cholesterol is highly muddled, with
patients and some doctors still preoccupied with total cholesterol
figures rather than the more important individual LDL and HDL numbers.

The National Institutes of Health recommends a goal of 100 or below for
LDL levels, and Simek notes that a federal panel recently suggested
those with diabetes or other risk factors fare best at 70 or below.

The cardiologist also warns against too much emphasis on the ratio
between total cholesterol and HDL l evels. Though the American Heart
Association describes a 4-to-1 ratio as healthy, Simek notes a patient
could have a dangerously high LDL reading yet still achieve that ratio.

Simek says certain steps are generally believed to boost HDL levels --
exercising regularly, achieving a healthy weight, avoiding smoking and
decreasing the intake of saturated fats.

Medications have proven better at affecting LDL than HDL. But Simek says
statins (such as Lipitor and Zocor), intended to lower LDL levels, also
tend to boost HDL. Nicotinic acid or niacin in high-dosage form -- as
opposed to the level found in multivitamins -- has proven effective in
raising HDL levels.

Simek says researchers have experimented with the injection of HDL
particles directly into the bloodstream.

A recently developed medication has raised hopes of even more effective
treatment of HDL levels. Pfizer, the maker of Lipitor, is testing a drug
called torcetrapib, designed to boost HDL, especially when used in
conjunction with other statins. A small, preliminary study found that
the drug doubled HDL levels for some patients.

Watson Clinic is one of many medical centers across the country involved
in the five-year combined trial of the drug, which began about a year
and a half ago. Simek says the trials involve participants with varying
levels of HDL, not those in the low range.

Riddle has been paying attention to his cholesterol for several years.
Riddle, 73, says his doctor put him on Lipitor about three years ago to
control his LDL levels, and the drug seems to have boosted his HDL
numbers a bit.

Riddle, a semi-retired mortgage banker, has also followed his doctor's
advice to exercise (he walks regularly) and modify his diet.

"I try to kind of stay clear of pork because it has a pretty high fat
content, I think," Riddle says. "With beef you have to be careful in
trimming fat off the piece of meat. . . . Trimming portions and eating
smaller portions of red meat has probably been the biggest factor."

Lauren Hemedinger of Auburndale recently had blood work done, and the
results showed his HDL level at 34 -well below the recommended minimum
of 40. His LDL measured at 98, in the range the American Heart
Association considers optimal (though the National Institutes of Health
recently set 70 as the target level for adults).

Hemedinger, 70, takes the prescription drug Zocor. He says the
medication has lowered his bad cholesterol, but his figures remain
outside the 4-to-1 ratio between total cholesterol and HDL that is
considered healthy.

Following his doctor's advice, Hemedinger has cut down on sugars and
added more whole grains to his diet.

"Exercise is a real catalyst for bringing up your (good) cholesterol,"
Hemedinger says. "But when you're getting into your later years, you
don't have the yearning to go out there and hit the exercise trail.
Winter time is fine, but as the temperature goes up the ladder it's
harder."

Ellis Hirsch of Lakeland has a family history of unhealthy cholesterol
readings. Hirsch, 64, says his overall cholesterol has been as high as
280, while his measure of HDL was less than 40. His doctor prescribed
Lipitor.

"They tried to explain to me, with HDL the higher you are the better it
is for you," he says. "That good (cholesterol) eats your bad, so even if
you're high it's working for you. . . . I'd love to get it up in the 50s
and 60s."

Hirsch's condition is complicated by diagnoses of prostate cancer and
diabetes. But the advice his doctor has given him applies to anyone with
concerns about cholesterol.

"Exercise, exercise, exercise," Hirsch says, echoing the emphasis of his
doctor. "I'm swimming now. I joined the (YMCA), so I'm hoping exercise
will take some weight off and help not only my diabetes but this
cholesterol thing."

Gary White can be reached at gary.white@theledger.com or at 863-802-7518.

--
Garden Shade Zone 5 in a Japanese Jungle manner.
FAIR USE NOTICE: This may contain copyrighted (© ) material the use of
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material is distributed without profit.

Robert · medicine forum Guru Joined: 28 Apr 2005 Posts: 1700

"William Wagner" <b2wagner@snip.net> wrote in message
news:b2wagner-CADC16.11412321062005@news.snip.net...

Robert · medicine forum Guru Joined: 28 Apr 2005 Posts: 1700

<James216440@yahoo.com> wrote in message
news:1119394659.567780.91930@z14g2000cwz.googlegroups.com...

GaryG wrote:

William Wagner · medicine forum Guru Joined: 29 Apr 2005 Posts: 809

http://biz.yahoo.com/prnews/050622/nyw077.html?.v=16

......................................

Press Release
Source: Pfizer Inc
Pfizer Begins Production at Torcetrapib/Atorvastatin Manufacturing
Facility; Major Milestone for Potential Cardiovascular Medicine
Wednesday June 22, 8:39 am ET

First Batch Produced at New $90 Million Plant Expansion in Loughbeg,
Ireland

NEW YORK, June 22 /PRNewswire-FirstCall/ -- More than 15 years after
Pfizer researchers set out to design a novel medicine that could
significantly reduce the risk of heart disease, the company has begun
production at a $90 million plant expansion in Ireland.
The facility will manufacture torcetrapib, which Pfizer is combining
with Lipitor (atorvastatin calcium) in a new medicine. Torcetrapib was
discovered as part of its research efforts to raise HDL, or "good"
cholesterol. Researchers believe HDL plays an important role in heart
disease.
Pfizer believes torcetrapib/atorvastatin will build on the proven
efficacy and safety of Lipitor, the world's most-prescribed medicine to
lower LDL, or "bad" cholesterol. Numerous studies with statins have
established the critical importance in LDL-lowering for reducing the
risk of cardiovascular disease, the world's leading killer of men and
women. Pfizer's scientists are testing the hypothesis that
simultaneously raising HDL and lowering LDL could provide an even
greater reduction in the risk of cardiovascular disease.
The production of the first batch of torcetrapib at Pfizer's Loughbeg,
Ireland, facility is the latest in a series of torcetrapib/atorvastatin
milestones.
Pfizer has undertaken the largest and most comprehensive clinical trial
development program ever. Torcetrapib/atorvastatin's clinical program
will involve 25,000 patients at hundreds of medical centers worldwide at
a cost of about $800 million.
"If we prove our hypothesis, torcetrapib/atorvastatin has the potential
to benefit millions of lives around the world," said Dr. John L.
LaMattina, president of Pfizer Global Research and Development. "Nothing
is certain except our huge investment. Even if this fails as a new
medicine, we will have advanced scientific understanding in this area."
Pfizer researchers began the torcetrapib/atorvastatin program more than
15 years ago, basing their HDL-raising approach on inhibiting CETP, a
protein in the liver that transfers cholesterol. In 1990, The New
England Journal of Medicine reported that a group of Japanese patients
who were lacking the CETP protein had high HDL levels and a low
incidence of coronary artery disease.
Pfizer chemists spent years trying to find a compound that could inhibit
CETP. Preliminary work led them to their most promising compound -- CP-
529,414, now known as torcetrapib. Other Pfizer researchers then spent
several more years improving the compound's physical properties and
understanding how torcetrapib worked before it could be administered to
people in 1999.
While torcetrapib alone was inadequate in lowering LDL -- with some
patients even experiencing slight increases in LDL levels --
consultation with external experts confirmed that the compound should be
used with atorvastatin, which has been widely studied and shown to be
highly effective at reducing LDL levels.
Pfizer also developed a new dosage form technology called spray-dried
dispersion (SDD) in collaboration with Bend Research, which is being
used at Loughbeg. The plant in County Cork will use this new technology
to manufacture the SDD component that ultimately is combined with
Lipitor to formulate the torcetrapib/atorvastatin combination used in
the clinical development program.
When the facility expansion is fully operational, it will require 40
employees, said Pfizer Global Manufacturing President Nat Ricciardi.
"This is the type of major financial commitment Pfizer is willing to
make on an entirely new and yet-to-be-approved medicine because it has
potential to improve lives of people around the world," he said. "Having
the operation up and running before our regulatory filings should
facilitate the review process," Ricciardi said.
In addition to the SDD technology, the Loughbeg facility has the latest
in process analytical technology, on-line sensing instruments, and a
wide range of novel manufacturing technologies.
An official opening ceremony will be held at the facility on Friday,
June 24. The event will be hosted by Nat Ricciardi and Michael Martin,
Ireland's minister for enterprise, trade and employment.

Key torceptrapib/atorvastatin milestones:
1990 Scientific paper includes hypothesis about the benefits of
HDL elevation
1993 Pfizer identifies a promising compound that might have
relevant medicinal qualities
1994 Pfizer modifies chemical, now known as CP-529, 414, to
improve its activity
1995 Pfizer demonstrates its compound's activity in vivo (cell
cultures and animal models)
1996 Pfizer further modifies compound to improve in vivo activity
1999 First human trials demonstrate how CP-529,414 (torcetrapib)
works in the body
2000 Larger-scale, Phase II trials begin to further test safety
and efficacy
2003 $800 million Phase III trials begin to test the prospective
medicine's activity against disease
2004 Begin enrollment of the ILLUMINATE, morbidity/mortality
clinical trial

PFIZER DISCLOSURE NOTICE: The information contained in this release is
as of June 22, 2005. Pfizer assumes no obligation to update any
forward-looking statements contained in this release as the result of
new information or future events or developments.
This release contains forward-looking information about a product
candidate that involves substantial risks and uncertainties. Such risks
and uncertainties include, among other things, the uncertainties
inherent in research and development; decisions by regulatory
authorities regarding whether and when to approve any drug applications
that may be filed for the product candidate as well as their decisions
regarding labeling and other matters that could affect its commercial
potential; and competitive developments.
A further list and description of risks and uncertainties can be found
in Pfizer's Annual Report on Form 10-K for the fiscal year ended
December 31, 2004 and in its reports on Form 10-Q and Form 8-K.

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--
Garden Shade Zone 5 in a Japanese Jungle manner.
FAIR USE NOTICE: This may contain copyrighted (© ) material the use of
which has not always been specifically authorized by the copyright
owner. Such material is made available for educational purposes, to
advance understanding of human rights, democracy, scientific, moral,
ethical, and social justice issues, etc. It is believed that this
constitutes a 'fair use' of any such copyrighted material as provided
for in Title 17 U.S.C. section 107 of the US Copyright Law. This
material is distributed without profit.

Jim Chinnis · medicine forum Guru Joined: 30 Apr 2005 Posts: 1030

"Bill" <xxx@yy.zz> wrote in part:

William Wagner · medicine forum Guru Joined: 29 Apr 2005 Posts: 809

In article <b2wagner-FABF31.10243022062005@news.snip.net>,
William Wagner <b2wagner@snip.net> wrote:

outrider · medicine forum Guru Joined: 28 Apr 2005 Posts: 1155

Jim Chinnis wrote:

William Wagner · medicine forum Guru Joined: 29 Apr 2005 Posts: 809

In article <1119476074.918295.80700@g43g2000cwa.googlegroups.com>,
"zee" <outrider@despammed.com> wrote:

Google