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Health
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Title: Studies boost hopes for new class of cholesterol medicines
Source: [None]
URL Source: http://news.yahoo.com/studies-boost ... terol-medicines-174023164.html
Published: Mar 16, 2015
Author: MARILYNN MARCHIONE
Post Date: 2015-03-16 05:53:04 by Tatarewicz
Keywords: None
Views: 66
Comments: 3

Yahoo... SAN DIEGO (AP) — New research boosts hope that a highly anticipated, experimental class of cholesterol drugs can greatly lower the risk for heart attacks, death and other heart-related problems. The government will decide this summer whether to allow two of these drugs on the market.

People taking one of these drugs had half the risk of dying or suffering a heart problem compared to others who were given usual care — typically one of the statin drugs such as Lipitor or Zocor, doctors found. Many people cannot tolerate statins or get enough help from them, so new medicines are badly needed.

The results are "really impressive and very encouraging" for the new drugs, said one independent expert, Dr. Judith Hochman of NYU Langone Medical Center.

The studies were published online Sunday by the New England Journal of Medicine and discussed at an American College of Cardiology conference in San Diego.

They are fresh analyses from older studies designed to look at how much the drugs lower cholesterol, so they can only suggest that the drugs also lower heart problems, not prove that point. Definitive studies will take about two more years, so the federal Food and Drug Administration will be deciding the drugs' fates with only results like this in hand.

The drugs are evolocumab, which Amgen Inc. wants to call Repatha, and alirocumab, which Regeneron Pharmaceuticals Inc. and Sanofi SA have named Praluent.

They lower LDL or bad cholesterol more powerfully and in a different way than existing drugs, by blocking PCSK9, a substance that interferes with the liver's ability to remove cholesterol from the blood.

Side effects remain a question, though, especially on thinking, confusion and memory — problems the FDA has already voiced concern about and asked the companies to track.

The problems affected only 1 or 2 percent of patients and may be temporary, but they were twice as common among people taking one of the new drugs and need to be closely monitored as studies continue, said Dr. Anthony DeMaria, a University of California at San Diego heart specialist and past president of the American College of Cardiology. As a patient facing potential side effects, "the last one I want" is one that affects the brain, he said.

Dr. Eric Topol, a cardiologist at Scripps Clinic in La Jolla, California, said the new results show "an unquestionable signal" of a potential safety issue. More side effects typically turn up once a drug is approved and used in a wider population, he said.

Two other heart experts — Drs. Neil Stone and Daniel Lloyd-Jones of Northwestern University in Chicago — wrote in the medical journal that "it would be premature to endorse these drugs for widespread use" until the definitive studies are done in a couple of years. Other drugs that initially seemed good failed when put to the most rigorous test, they wrote.

Still, the results so far suggest that the drugs "appear to be on track" to be important new medicines, they wrote.

Dr. Clyde Yancy, cardiology chief at Northwestern University in Chicago and a former American Heart Association president, agreed.

"Science has revealed a brand new approach to treating cholesterol," and there is "reasonable enthusiasm" it will be a big boon to patients, he said.

___

Online:

Cholesterol info: http://tinyurl.com/2dtc5vy

Heart facts: http://circ.ahajournals.org/content/127/1/e6

___

Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP 9 Comments

[MrMr]

Any word on how either drug impacts HDL levels? [Westy]

Some studies have shown an increase, usually around 10% or less. That isn;t as dramatic as the 50-60% reduction in LDL. Early days yet.

[spuds]

Yeah,I trust em.NOT.Try researching the approval of statins if you want a REAL eye opener on pharma lying for money.A german guy told me..."Take this whole generation,run em thru the ovens,and apologize later" Thats EXACTLY what they are doing with statins.


Poster Comment:

John Blah, blah, blah...... Red yeast rice cuts your cholesterol in half with zero side effects. Do your own research. -2

richard nothing beat two cloves of garlic a day fresh chapped 4-2

[richard] garlic is numero uno liver detoxifier besides kills warms and parasites in your gut. check YT garlic

From Relaxnews Patients were randomized to either receive evolocumab, made by the pharmaceutical company Amgen, injected under the skin in addition to standard care, or standard care alone, which meant taking the cholesterol-lowering statin drug recommended by their physician. Evolocumab works differently than traditional statins. It is a human monoclonal antibody that blocks a harmful protein in the liver, freeing the organ up to remove LDL cholesterol from the blood. This new class of drug is known as a PCSK9 inhibitor, and three different kinds, including evolocumab, are being studied in large clinical trials. Previous research has shown evolocumab could lower LDL or "bad" cholesterol -- the kind that contributes to plaque buildup in the arteries -- by 61 percent. The drug has yet to be approved by the US Food and Drug Administration, and more years of study are planned to test its longer term outcomes. But after one year, the analysis showed the rate of cardiovascular events -- such as death, heart attack, stroke, hospitalization or surgery to open blocked arteries -- in the evolocumab group was 0.95 percent, compared to 2.18 percent in the traditional statin group, most of whom were taking moderate or high intensity regimens of the cholesterol-lowering drugs. "The reduction in LDL was profound and that may be why we saw a marked reduction in cardiovascular events so quickly," said lead author Marc Sabatine, senior physician in the Division of Cardiovascular Medicine at Brigham and Women's Hospital in Boston. "It suggests that if we can drive a patient's LDL cholesterol down a large amount to a very low level, we may start to see a benefit sooner than would be expected with a more modest intervention."

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#1. To: Tatarewicz (#0)

See the PBS presentation by Dr. Perlmutter, author of "Grain Brain."

Cholesterol is essential for your brain. The more the populace lowers its cholesterol; the higher the rate of dementia. Eating fats (oils/eggs) is essential for a healthy brain. Lose weight by eating more fats (coconut oil, olive oil, eggs).

Forget drugs. Cholesterol has nothing to do with heart health and a lot to do with brain health. The more; the better.

Warning on Lipitor ( may cause memory loss and confusion). It destroyed by father's life (took it 2 years) and harmed my husband. These drugs (and other cholesterol lowering drugs) should not be on the market. They are crippling the nation.

ratcat  posted on  2015-03-16   10:55:21 ET  Reply   Trace   Private Reply  


#2. To: ratcat (#1)

Ideally we could come up with an enzyme which would peel off plaque on artery walls but things don't look good in that regard:

AtheroNova and its Subsidiary File for Chapter 11 Bankruptcy Protection Download PDF

IRVINE, Calif., March 3, 2015 /PRNewswire/ -- AtheroNova Inc. (OTCQB: AHRO) today announced that the Company and its subsidiary, AtheroNova Operations, Inc., filed voluntary petitions under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court, Central District of California, Santa Ana division (the "Bankruptcy Court") on March 2, 2015. The Company's Chapter 11 cases are expected to be jointly administered.

The Company will evaluate all options, including a Bankruptcy Court supervised asset sale process, for all or substantially all of its assets to a party who could potentially be interested in continuing the Company's clinical programs.

During the bankruptcy process, the Company will continue to operate in the ordinary course, including continuing the evaluation of its recently concluded Phase 1b clinical trial in Russia. In addition, the Company intends to request Bankruptcy Court approval of a series of customary motions. Bankruptcy Court documents and additional information are available as indicated below.

Levene, Neale, Bender, Yoo & Brill L.L.P. is serving as the Company's bankruptcy counsel, and Sherwood Partners, LLC is serving as the Company's financial advisor and sales agent in this process.

- - -

AtheroNova Inc. is a biotechnology company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans. Cardiovascular plaque reduction – the holy grail of cardiovascular research1 – is our business. Our lead compound, AHRO-001, has demonstrated remarkable plaque reduction in animals. We have shown a strong safety and tolerability profile for AHRO-001 in a Phase I clinical trial in humans. Our current corporate focus is the preparation and filing of an IND with the US Food & Drug Administration for clinical development in the United States and rest of the world. Atherosclerosis and its complications cost consumers more than $38 billion annually in the United States alone.

http://ir.stockpr.com/atheronova...-11-bankruptcy-protection

Tatarewicz  posted on  2015-03-17   1:48:32 ET  Reply   Trace   Private Reply  


#3. To: ratcat (#1)

These drugs (and other cholesterol lowering drugs) should not be on the market. They are crippling the nation.

^^This^^

 photo 001g.gif
“With the exception of Whites, the rule among the peoples of the world, whether residing in their homelands or settled in Western democracies, is ethnocentrism and moral particularism: they stick together and good means what is good for their ethnic group."
-Alex Kurtagic

X-15  posted on  2015-03-17   2:05:10 ET  Reply   Trace   Private Reply  


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