Archive for the ‘pfizer’ Category

Do Kids Need Cholesterol Checks?

Tuesday, February 5th, 2008

While routine screening of children for high cholesterol isn’t necessary, you may want to consider it under certain circumstances.

Children should be screened if their parents, grandparents, aunts or uncles have high cholesterol or cardiovascular disease before age 55 for men and 65 for women.

Higher-than-normal blood cholesterol among children does not always predict high levels in adulthood. But for children from high-risk families, check with your doctor and work with a registered dietitian to bring cholesterol levels down.

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Lowering Cholesterol Drastic Diet

Tuesday, February 5th, 2008

Lowering cholesterol drastic diet you cannot really talk about of some cholesterol-lowering diet as the best of than to very much of the metabolism to the patient it’s depend.

Lowering cholesterol drastic diet also on the response of certain treatment, there is some of simple may get together daily with exercise will do the risk, and amount natural supplement or cholesterol lowering

Person who do not answer to the steps on diet, the two diets you don’t have to take cholesterol-lowering drugs, you have to try some very –fats diet.

After eliminates these diets you most eat meats and fats, and dairy product include twenty-eight to twenty-six percent of calories from fats contain.

Having high cholesterol in your blood means leave with a greater risk enough of heart attacks, a drastic diet can help you.

The amount of every on percent high in it, in the average peoples bloods. Three is about two percent high in the risk of the heart attack.

Heart study have found is the best for decreasing cholesterol level, plant food getting no cholesterol, whereas, meats, dairy production get large amount of cholesterol saturated fats.

Even if ignored you’ve been with the atherosclerosis, you can still hope it without drugs a doctors has demonstrated that disease may be reversed, and has dangerous side effect some time.

Diet in vegetables with less than ten percent fats and some moderated exercise within a year, Starting a dissolve plaque that have been growing in their heart with decade.

By the way every body knows there is two type of cholesterol, the good cholesterol hdl, high density lipoproteins and bad one ldl low-density lipoproteins.

The first one present in the body hdl protect the heart, and the walls of the arteries against the artery disease.

You can lower it by exercising will help you to decrease your risk of heart attack.

And maintains the healthy body weigh in an amount of trans fats can be minimized by replace these with the dietary, fibre with saturated fats.

There some goods reason to get check your cholesterol, for do not lead you problems, pay intention to not have too much cholesterol in your bloods.

It is very necessary to reduce in your blood bad cholesterol, and fat without side effect, by lowering cholesterol drastic diet.

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Cholesterol Confusion

Tuesday, February 5th, 2008

Do you have high choresterol?  Taking statins?  Thinking of taking statins?

On January 17 the NYTs business section — that is right, the  business section not the health section — wrote about mounting  evidence that while statins reduce bad cholesterol there is no proof they reduce heart attacks and strokes.

For decades, the theory that lowering cholesterol is always beneficial has been a core principle of cardiology. It has been accepted by doctors and used by drug makers to win quick approval for new medicines to reduce cholesterol.

But now some prominent cardiologists say the results of two recent clinical trials have raised serious questions about that theory — and the value of two widely used cholesterol-lowering medicines, Zetia and its sister drug, Vytorin. Other new cholesterol-fighting drugs, including one that Merck hopes to begin selling this year, may also require closer scrutiny, they say.

“The idea that you’re just going to lower LDL and people are going to get better, that’s too simplistic, much too simplistic,” said Dr. Eric J. Topol, a cardiologist and director of the Scripps Translational Science Institute in La Jolla, Calif. LDL, or low-density lipoprotein, is the so-called bad cholesterol, in contrast to high-density lipoprotein, or HDL.

For patients and drug companies, the stakes are enormous. Led by best sellers like Lipitor from Pfizer, cholesterol-lowering medicines, taken by tens of millions of patients daily, are the largest drug category worldwide, with annual sales of $40 billion.  That is why this piece was in the business section.

Doctors generally believe that the amount by which cholesterol is lowered, not the method of lowering it, is what matters.

The revelation that statin cholesterol drugs may be of little benefit, as revealed in a lengthy cover story in January 28 issue of Business Week (BW) magazine continues the expose.

How can anyone question the benefits of such a drug, asks BW, when they are “thought to be so essential that, according to the official government guidelines from the National Cholesterol Education Program (NCEP), 40 million Americans should be taking them. Some researchers have even suggested – half-jokingly – that the medications should be put in the water supply, like fluoride for teeth. And it’s almost impossible to avoid reminders from the industry that the drugs are vital. A current TV and newspaper campaign for one statin drug, as endorsed by Dr. Robert Jarvik, artificial heart inventor, proclaims that this drug ‘reduces the risk of heart attack by 36%…in patients with multiple risk factors for heart disease.”

Jarvik’s claim is incorrect.   The Business Week report says statin drugs benefit only 1 in 100 users, but they claim to reduce the risk of a non-mortal heart attack by 36%. But that figure is a relative number, not a hard one. About 3% of patients taking an inactive placebo pill will experience a heart attack compared to 2% taking a statin drug, which produces the so-called 30-plus percent risk reduction. But in hard numbers, this is only a 1% reduced risk.

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Cholesterol Diet

Monday, February 4th, 2008

It is important to follow the recommendations of healthcare professionals. High Blood Cholesterol is a high risk factor for coronary artery disease and the number one killer in the United States of America because it clogs the pipes. Cholesterol is a waxy substance found in all animal tissue, including humans, and is found in all foods that come from animal sources. Bad and good cholesterol There are two primary forms of cholesterol; low-density lipoproteins (LDLs) and high-density lipoproteins (HDLs). LDL cholesterol is considered as bad cholesterol because it tends to drop off along the way, clogging arteries and blood vessels, and contributing to plaque formation.

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Cholesterol is NOT the Critical Cause of Heart Disease

Monday, February 4th, 2008

Cholesterol is not the major culprit in heart disease or any disease. If it becomes oxidized it can irritate/inflame tissues in which it is lodged in, such as the endothelium (lining of the arteries). This would be one of numerous causes of chronic inflammation that can injure the lining of arteries. However, many good fats are easily oxidized such as omega-3 fatty acids, but it does not mean that you should avoid it at all costs.

Common sense would indicate that we should avoid the oxidation (rancidity) of cholesterol and fatty acids and not get rid of important life-giving molecules. Using the same conventional medical thinking that is being used for cholesterol would lead one to believe that doctors should reduce the risk of Alzheimer’s disease by taking out everybody’s brain.

In fact, cholesterol is being transported to tissues as part of an inflammatory response that is there to repair damage.

The fixation on cholesterol as a major cause of heart disease defies the last 15 years of science and deflects from real causes such as the damage (via glycation) that sugars such as glucose and fructose inflict on tissues, including the lining of arteries, causing chronic inflammation and resultant plaque.

Insulin & Leptin Resistance

Hundreds of excellent scientific articles have linked insulin resistance and more recently leptin resistance to cardiovascular disease much more strongly than cholesterol, and they are in fact at least partially responsible for cholesterol abnormalities. For instance, insulin and leptin resistance result in “small dense” LDL particles and a greater number of particles.

This is much more important than the total cholesterol number. Because of particle size shift to small and dense, the total LDL cholesterol could still be low even though the number of particles and the density of the particles is greater. Small, dense LDL particles can squeeze between the cells lining the inside of the arteries, the “gap junction” of the endothelium, where they can get struck and potentially oxidize, turn rancid, and cause inflammation of the lining of the arteries and plaque formation.

Importantly, many solid scientific studies have shown a mechanistic, causal effect of elevated insulin and leptin on heart and vascular disease, whereas almost all studies with cholesterol misleadingly only show an association. Association does not imply cause. For instance, something else may be causing lipid abnormalities such as elevated cholesterol and triglycerides, and also causing heart disease.

This “something else” is improper insulin and leptin signaling. Similarly, sugar does not cause diabetes; sugar is just listening to orders. Improper insulin and leptin signaling is the cause of diabetes. Likewise, cholesterol does not cause heart disease, but improper metabolic signals including improper signals to cholesterol (causing it to oxidize) and perhaps to the liver that manufactures the cholesterol, will cause heart and vascular disease and hypertension.

Removing cholesterol will do nothing to improve the underlying problems, the real roots of chronic disease, which will always have to do with improper communication, and the generals of metabolic communication are insulin and leptin. They are really what must be treated to reverse heart disease, diabetes, osteoporosis, obesity, and to some extent aging itself.

Cholesterol; Wrongly Accused?

Before we can begin to talk about the real cause and effective treatment for heart and blood vessel disease, we must first look at what is known, or I should say what we think we know. The first thing that comes to mind when one hears about heart disease is almost always cholesterol. Cholesterol and heart disease has been almost synonymous for the last half-century. Cholesterol has been portrayed as the Darth Vader to our arteries and our heart.

The latest recommendation given by a so-called panel of “experts” recommends that a person’s cholesterol be as low as possible, in fact to a level so low they say it cannot be achieved by diet, exercise, or any known lifestyle modification. Therefore, they say cholesterol-lowering drugs; particularly the so-called “statins” need to be given to anyone at high risk of heart disease. Since heart disease is the number one killer in this country that would include most adults and even many children. The fact that this might add to the $26 billion in sales of statin drugs last year I’m sure played no role in their recommendations.

Or did it?

Expert Conflict of Interests

Major consumer groups think so. They found out that eight of the nine “experts” that made the recommendations were on the payroll of pharmaceutical companies that manufacture those drugs. Major scientific organizations have chastised medical journals for allowing the pharmaceutical industry to publish misleading results and half-truths. There is a major push under way to force the pharmaceutical industry (and others) to publish results of all of their studies, and not just the ones that appear positive. The studies that showed negative results would be forced to be published also.

It could be that lowering cholesterol might not be as healthy as we are being told. More and more studies are coming out showing just how unhealthy lowering cholesterol might be, particularly by the use of statin drugs. In particular, statin drugs have been shown to be harmful to muscles causing considerable damage. A common symptom of this damage is muscular aches and pains that many patients experience on cholesterol-lowering drugs, however most do not realize that these drugs are to blame.

Hmm…isn’t the heart a muscle?

Statin Drugs Actually Increase Heart Disease

Indeed, low cholesterol levels have been shown to worsen patients with congestive heart failure, a life-threatening condition where the heart becomes too weak to effectively pump blood. Statin drugs have been shown to also cause nerve damage and to greatly impair memory. One reason that statin drugs have these various serious side effects is that they work by inhibiting a vital enzyme that manufactures cholesterol in the liver. However, the same enzyme is used to manufacture coenzyme Q10, which is a biochemical needed to transfer energy from food to our cells to be used for the work of staying alive and healthy.

Statin drugs are known to inhibit our very important production of coenzyme Q10. Importantly, while many cardiologists insist that lowering cholesterol is correlated with a reduction in the risk of heart attacks; few can say that there is a reduction in the risk of mortality (death). That has been much harder to show. In other words it has never been conclusively shown that lowering cholesterol saves lives. In fact, several large studies have shown that lowering cholesterol into the range currently recommended is correlated with an increased risk of dying, especially of cancer.

No Such Thing as Good and Bad Cholesterol

Because the correlation of total cholesterol with heart disease is so weak, many years ago a stronger correlation was sought. It was found that there is so-called “good cholesterol” called HDL, and that the so-called “bad cholesterol” was LDL. HDL stands for high-density lipoprotein, and LDL stands for low-density lipoprotein. Notice please that LDL and HDL are lipoproteins — fats combined with proteins. There is only one cholesterol. There is no such thing as a good or a bad cholesterol. Cholesterol is just cholesterol. It combines with other fats and proteins to be carried through the bloodstream, since fat and our watery blood do not mix very well.

Fatty substances therefore must be shuttled to and from our tissues and cells using proteins. LDL and HDL are forms of proteins and are far from being just cholesterol. In fact we now know there are many types of these fat and protein particles. LDL particles come in many sizes and large LDL particles are not a problem. Only the so-called small dense LDL particles can potentially be a problem, because they can squeeze through the lining of the arteries and if they oxidize, otherwise known as turning rancid, they can cause damage and inflammation. Thus, you might say that there is “good LDL” and “bad LDL.” Also, some HDL particles are better than others. Knowing just your total cholesterol tells you very little. Even knowing your LDL and HDL levels do not tell you very much.

A mistake that is rarely made in the hard-core sciences such as physics seems to be frequently made in medicine. This is confusing correlation with cause. There may be a weak correlation of elevated cholesterol with heart attacks, however this does not mean it is the cholesterol that caused the heart attack. Certainly gray hair is correlated with getting older; however one could hardly say that the gray hair caused one to get old. Using hair dye to reduce the gray hair would not really make you any younger. Neither it appears would just lowering your cholesterol.

Perhaps something else is causing both the gray hair and aging. Even if elevated cholesterol were significant and heart disease (which I question) perhaps something else is causing the elevated cholesterol and also causing the heart disease.

Let’s look little more at cholesterol or, as Paul Harvey was fond of saying, “the rest of the story.” First and foremost, cholesterol is a vital component of every cell membrane on Earth. In other words, there is no life on Earth they can live without cholesterol. That will automatically tell you that, in of itself, it cannot be evil. In fact it is one of our best friends. We would not be here without it. No wonder lowering cholesterol too much increases one’s risk of dying. Cholesterol also is a precursor to all of the steroid hormones. You cannot make estrogen, testosterone, cortisone, and a host of other vital hormones without cholesterol.

Cholesterol Is The Hero, Not The Villain.

It was determined many years ago that the majority of cholesterol in your bloodstream comes from what your liver is manufacturing and distributing. The amount of cholesterol that one eats plays little role in determining your cholesterol levels. It is also known that HDL shuttles cholesterol away from tissues, and away from your arteries, back to your liver. That is why HDL is called the “good cholesterol;” because it is supposedly taking cholesterol away from your arteries. But let’s think about that.

* Why does your liver make sure that you have plenty of cholesterol?
* Why is HDL taking cholesterol back to your liver?
* Why not take it right to your kidneys, or your intestines to get rid of it?

It is taking it back to your liver so that your liver can recycle it; put it back into other particles to be taken to tissues and cells that need it. Your body is trying to make and conserve the cholesterol for the precise reason that it is so important, indeed vital, for health.

One function of cholesterol is to keep your cell membranes from falling apart. As such, you might consider cholesterol your cells “superglue.” It is a necessary ingredient in any sort of cellular repair. The coronary disease associated with heart attacks is now known to be caused from damage to the lining of those arteries. That damage causes inflammation. The coronary disease that causes heart attacks is now considered to be caused mostly from chronic inflammation.

What Is Inflammation?

Think of what happens if you were to cut your hand. Within a fraction of a second, chemicals are released by the damaged tissue to initiate the process known as inflammation. Inflammation will allow that little cut to heal, and indeed to keep you from dying. The cut blood vessels constrict to keep you from bleeding too much. Blood becomes “thicker” so that it can clot. Cells and chemicals from the immune system are alerted to come to the area to keep intruders such as viruses and bacteria from invading the cut. Other cells are told to multiply to repair the damage so that you can heal. When the repair is completed, you have lived to be careless another day, though you may have a small scar to show for your troubles.

We now know that similar events take place within the lining of our arteries. When damage occurs to the lining of our arteries (or even elsewhere) chemicals are released to initiate the process of inflammation. Arteries constrict, blood becomes more prone to clot, white blood cells are called to the area to gobble up damaged debris, and cells adjacent to those damaged are told to multiply. Ultimately, scars form, however inside our arteries we call it plaque. And the constriction of our arteries and the “thickening” of our blood further predisposes us to high blood pressure and heart attacks.

So Where Might Cholesterol Fit Into All Of This?

When damage is occurring and inflammation is being initiated, chemicals are being released so that that damage can be repaired. One could speculate that to replace damaged, old and worn-out cells the liver needs to be notified to either recycle or manufacture cholesterol since no cell, human or otherwise, can be made without it. In this case, cholesterol is being manufactured and distributed in your bloodstream to help you repair damaged tissue and in fact to keep you alive.

If excessive damage is occurring such that it is necessary to distribute extra cholesterol through the bloodstream, it would not seem very wise to merely lower the cholesterol and forget about why it is there in the first place. It would seem much smarter to reduce the extra need for the cholesterol — the excessive damage that is occurring, the reason for the chronic inflammation.

So Why Take Cholesterol-Lowering Drugs?

The pharmaceutical companies thought that you might think that. They went back to the drawing board. They did more “research” and found (coincidentally) that statin drugs had anti-inflammatory effects. Therefore we’re currently being told to stay on our cholesterol-lowering drugs because now they work by reducing inflammation and perhaps not even by reducing cholesterol, and in fact perhaps in spite of it. Aspirin reduces inflammation for a lot less money. So does vitamin E, and fish oil, and dietary changes without the dangers of drugs and having many other benefits instead.

What About Triglycerides?

Triglycerides are just medical terminology for fat. A person with high triglycerides has a lot of fat in the bloodstream. Triglycerides are generally measured when a person has fasted overnight. High fasting triglycerides are either from manufacturing too much, or using (burning) too little. In other words, what high triglycerides are telling you is that you are making too much fat and you are unable to burn it. This indeed is a major problem. The inability to burn fat underlies virtually all of the chronic diseases of aging, and in fact may contribute to the rate of aging itself.

As such, one might think that the control all fat burning and storage might be very important in heart disease, and the other diseases of aging such as diabetes, obesity, osteoporosis, and even cancer. Indeed, this appears to very much be the case. The two hormones that to a major extent control our ability to burn and store fat, insulin and leptin, appear to play a major role in all of the chronic diseases of aging. I would call them the most important hormones, indeed chemicals in the entire body. But that is a story for next time.

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What to Eat to Lower Your Cholesterol?

Monday, February 4th, 2008

High cholesterol levels are slowly killing off the population. The increasing prevalence and risk of hypertension and heart disease in Americans are ringing the alarm bells in the country’s health sector.

Health officials are desperately trying to find ways to combat the rise and make people aware of the eating lifestyle and exercise lifestyle that they are imbibing.

The truth about cholesterol Although cholesterol is mainly the culprit in the increase in high blood pressure in the body, not all cholesterol that we take in is essentially bad.
In fact, small amounts of cholesterol is being used by the body in the production of bile salts and in the transformation of Vitamin D. Cholesterol also plays a role in the balancing of hormones especially in women.

There are two kinds of cholesterol, the good and the bad as the lay people will like to clal them. The bad cholesterol or the LDL is the kind that is often found in saturated fats and trans fatty acids.

These are taken into the body through foods that are pre-packed and prepared such as potato chips, canned goods, etc. LDL cholesterol adheres to the walls of the arteries. High levels of LDL can form plaques in the arterial walls that may eventually cause clogging in the passageway of the blood.

This slows down the blood flow, which in turn makes it hard for the heart to pump. This scenario describes the initial stages of hypertension and coronary heart problems.

What to eat The good cholesterol HDL on the other hand lower the levels of LDL in the body by helping transport the LDL to the liver where it is excreted.

HDL cholesterol can be found in fishes as well as in nuts. Other foods that can lower the cholesterol levels are fruits and vegetables. These foods do not contain that much cholesterol so whatever you have, you will not be adding to its levels.

Another great thing about veggies and fruits is the fact that they are great sources of fibers that the body also need to combat the increase in LDL cholesterol. Berries, fruits that are citrus and carrots are just some of the fruits that you can count on.

Another food that can dramatically reduce the levels of cholesterol in the body is the soya. Fiber-rich food, soya as well as almonds and plant sterols figure in a landmark study conducted by University of Toronto that reduced the cholesterol levels of the participants by as much as 20 percent.

Eating oats, olive oil and barley are also great ways to lower LDL. Another great source of cholesterol are foods that are really oily.

To lower one’s LDL, one must consciously avoid foods that are deep-fried. If you have to eat fried foods, make sure that the oil that you use is made out of vegetable. Never use butter as this is rich in saturated fats. Instead, use margarine as a substitute. Try to also steam, braise, boil or bake your food.

You will find that they are tastier and healthier. Not just the foodThere are many factors that contribute to the rise of cholesterol levels in the body.

In addition to one’s eating lifestyle, there is the age, the gender, the family history and of course the amount of physical activity that the person does.

Exercise is fairly important in keeping LDL cholesterol at bay.
What is more, it strengthens the body’s resistance as well as improves blood circulation.

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Lipitor

Sunday, February 3rd, 2008

Two and a half years ago, I had some health issues and went to a Dr. My cholesterol was near 400. This is not considered good. My first appointment I had to fill out a health history. 3 people read it back to me, 2 nurses and the Dr, and 3 people looked at the computer portion. I was completely honest with this history. Many people are not. I put that I smoked a pack of day. I smoked pot regularly. I drank nearly a quart a day of alcohol. I was 40 lbs overweight. These are not things I am proud of, but they were fact, and it was my health history. This is what my diagnosis and treatment were based on. If I wanted to get better, I thought honesty was important.

Not 1 person questioned these facts. The Dr did not recommend I change anything. He prescribed 3 medications. One of them was Lipitor. To begin taking it I had to have 2 blood liver tests. I went home and read the small print that came with it. I took them for 1 week and threw them away. From what I read, I did not fit any criteria to take it, and it would most likely harm me.

This week the cover of BusinessWeek is on Lipitor.  Go to Google. Type in Lipitor. Search the news. Congress is investigating it this week. By Pfizer’s own studies, Lipitor shows zero benefit for women and harm to 10-15%. Why is this the most prescribed drug in America???? Fear. And laziness. We don’t want to change the way we live, we want to take magic pills and make it all go away.

For myself, I chose not to go the pill route. I also had high blood pressure. It runs in my family. I studied the causes of it… extra weight, alcohol, smoking….  even with the pills, I was still committing suicide. I decided to change my habits. I lost 35 lbs, I started walking, I quit drinking alcohol and stopped drugs. Three months after that I stopped smoking. My blood pressure plummeted.  I wasn’t taking any meds and had not felt so good in all my life. Almost 2 years later, I could still lose 15 lbs, but I’m a lot like Oprah. I would just yo-yo. I have maintained this weight for over a year. I haven’t had any alcohol and 18 months since any cigarettes.

We are so conditioned to do everything a Dr tells us to.  I wish my Dr had to be to quit abusing myself. I think more Drs should try ti and quit writing so many prescriptions. But then we would have to take responsibility.

Get off this page, go to google or some search engine. Check out these medications. The results will astound you. Congress is investigating these drugs this week. What the Hell was the FDA doing years ago??? If we quit feeding these huge drug companies, maybe we could start getting true health care for more Americans.

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Adding Lipitor Early Provided a Significant Reduction in Heart Attacks

Sunday, February 3rd, 2008

The early addition of Lipitor(R) (atorvastatin calcium) Tablets to effective blood pressure lowering treatment maintained a significant 36 per cent reduction in the relative risk of fatal or non-fatal heart attacks over five years, according to a new analysis.

This was a post-hoc analysis (designed and completed following theclosure of the trial) of the lipid-lowering arm of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT-LLA) follow-up period. A majority of patients who were treated with Lipitor or placebo during a three-year study went on to receive Lipitor during two years of post-study follow up. At the start of the study, patients had high blood pressure and additional cardiovascular risk factors but no coronary heart disease.

ASCOT-LLA is one of the first studies to explore the benefit of controlling more than one cardiovascular risk factor at a time.
“These important results show that starting early initiation of Lipitor with an effective blood pressure lowering drug regimen may have significant clinical implications for reducing the risk of heart attacks,” said Professor Peter Sever, study principal investigator, professor of clinical pharmacology and therapeutics, International Center for Circulatory Health at London’s Imperial College. “It is vital that physicians use the right combination of treatments from the start to maximize the reduction in the risk of heart attacks and coronary heart disease death.”

The results were published online in the European Heart Journal: “Patients with high blood pressure and other risk factors for cardiovascular disease are usually treated with blood pressure lowering medications first,” said Professor Bryan Williams, professor of medicine, University Hospitals NHS Trust, Leicester, United Kingdom, and chairman of the British Hypertension Society Guidelines working party.

“It is important to note, however, that many people with high bloodpressure are also at sufficient risk of cardiovascular disease to benefit from statin therapy,” he said. “Even if patients are prescribed statins in this context, they are generally only treated with statins after lifestyle modifications have failed.”

“This study highlights the importance of initiating medical treatment for both blood pressure and cholesterol as soon as possible, and raises questions about medical guidelines that do not focus on early intensive treatment of multiple risk factors, notably blood pressure and cholesterol, in patients with moderate cardiac risk,” he said.

Pfizer offers physicians and patients the option of Lipitor or a combination medication known as Caduet(R) (amlodipine besylate/atorvastatin calcium) that includes Lipitor and Norvasc(R) (amlodipine besylate).

ABOUT THE STUDY

The ASCOT study was one of the largest hypertension trials ever conducted with 19,342 patients in Europe. It compared the calcium channel blocker anti-hypertensive Norvasc based regimen versus a beta-blocker based regimen in reducing cardiac events in patients with high blood pressure and additional cardiovascular risk factors but without coronary heart disease.

Patients in ASCOT-LLA had normal to mildly elevated cholesterol levels (n=10,000), were not candidates for lipid-lowering treatment at the time of the study initiation, and received Lipitor 10 mg or placebo at the outset of the trial.

The ASCOT-LLA part of the trial was expected to last five years, but was stopped early after three years due to a highly significant 36 per cent lower risk of death from heart disease and non-fatal heart attack in patients treated with Lipitor versus patients taking placebo.

At the end of the follow-up period, LDL-C levels were similar in both groups as a result of Lipitor treatment and the average blood pressure level was significantly reduced from 164/95 mmHg to 137/78 mmHg with the blood pressure lowering therapy.

Funded by Pfizer, ASCOT was an investigator-led trial coordinated by an independent steering committee.

ABOUT LIPITOR

Lipitor is the most extensively studied and most prescribed cholesterol-lowering therapy in the world, with nearly 144 million patient-years of experience. Lipitor is supported by an extensive clinical trial program involving more than 400 ongoing and completed trials with more than 80,000 patients.

Lipitor is a prescription drug indicated to lower LDL cholesterol and other fats in the blood (such as triglycerides) when response to diet and other lifestyle measures alone have been inadequate, in both adults and pediatric patients (boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia). Lipitor is also indicated to reduce the risk of myocardial infarction in adult hypertensive patients without clinically evident coronary heart disease, but with at least three additional risk factors (such as 55 years and older, smoking and type 2 diabetes) for coronary heart disease.

Lipitor is also indicated to reduce the risk of myocardial infarction and stroke in adult patients with type 2 diabetes mellitus and hypertension without clinically evident coronary heart disease, but with other risk factors such as age (55 years and older) retinopathy, albuminuria or smoking.

In addition, Lipitor is indicated to reduce the risk of myocardial infarction in patients with clinically evident coronary heart disease.

Lipitor is generally well-tolerated. Adverse reactions have usually been mild and transient. The most common adverse events were gastrointestinal complaints, headache, pain, muscle pain and fatigue.

ABOUT CADUET

Caduet is a prescription drug that combines two medicines, Lipitor (atorvastatin calcium) and Norvasc (amlodipine besylate), which have been extensively studied in clinical trials. It is a single-pill therapy that reduces global cardiovascular risk in hypertensive patients with risk factors for cardiovascular disease such as smoking, physical inactivity, being overweight, high blood pressure and diabetes.

Norvasc is a prescription drug indicated in the treatment of mild to moderate essential hypertension. Norvasc is also indicated for the management of chronic stable angina (effort-associated angina) in patients who remain symptomatic despite adequate dose of beta blockers and/or organic nitrates or who cannot tolerate those agents.

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Cholesterol Agent Now FDA Approved in Treatment of Diabetes Mellitus

Friday, February 1st, 2008

Other cholesterol-lowering agents have been trying for a while now, but one now has lobbied for and earned the FDA indication for the adjunctive treatment of diabetes mellitus II. The focus on the treatment of this now-epidemic disorder has long abandoned the prime need to just keep fasting blood sugars (surrogate markers in the diagnosis of diabetes mellitus) down; the interplay in the diabetic patient among other risk factors like cholesterol abnormalities represents the latest stratagem in the full scope of treatment for this disorder.

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New Questions on Treating Cholesterol

Friday, February 1st, 2008

Correction Appended

For decades, the theory that lowering cholesterol is always beneficial has been a core principle of cardiology. It has been accepted by doctors and used by drug makers to win quick approval for new medicines to reduce cholesterol.

But now some prominent cardiologists say the results of two recent clinical trials have raised serious questions about that theory — and the value of two widely used cholesterol-lowering medicines, Zetia and its sister drug, Vytorin. Other new cholesterol-fighting drugs, including one that Merck hopes to begin selling this year, may also require closer scrutiny, they say.

“The idea that you’re just going to lower LDL and people are going to get better, that’s too simplistic, much too simplistic,” said Dr. Eric J. Topol, a cardiologist and director of the Scripps Translational Science Institute in La Jolla, Calif. LDL, or low-density lipoprotein, is the so-called bad cholesterol, in contrast to high-density lipoprotein, or HDL.

For patients and drug companies, the stakes are enormous. Led by best sellers like Lipitor from Pfizer, cholesterol-lowering medicines, taken by tens of millions of patients daily, are the largest drug category worldwide, with annual sales of $40 billion.

Despite widespread use of the drugs, though, heart disease remains the biggest killer in the United States and other industrialized nations, and many people still have cholesterol levels far higher than doctors recommend.

As a result, drug companies are investing billions of dollars in experimental new cholesterol-lowering medicines that may eventually be used alongside the existing drugs. If the new questions result in slower approvals, it would be yet another handicap for the drug industry.

Because the link between excessive LDL cholesterol and cardiovascular disease has been so widely accepted, the Food and Drug Administration generally has not required drug companies to prove that cholesterol medicines actually reduce heart attacks before approval.

They have not had to conduct so-called outcome or events trials beforehand, which are expensive studies that involve thousands of patients and track whether episodes like heart attacks are reduced.

So far, proof that a drug lowers LDL cholesterol has generally been enough to lead to approval. Only then does the drug’s maker begin an events trial. And until the results of that trial are available, a process that can take several years, doctors and patients must accept the medicine’s benefits largely on faith.

“You’ve got a huge chasm between F.D.A. licensure and a clinical events trial,” said Dr. Allen J. Taylor, the chief of cardiology at Walter Reed Army Medical Center.

Nonetheless, the multistep process has worked well for several cholesterol drugs — including Lipitor and Zocor, which are in a class of drugs known as statins. In those cases, the postapproval trials confirmed that the drugs reduce heart attacks and strokes, adding to confidence about the link between cholesterol and heart disease.

Doctors generally believe that the amount by which cholesterol is lowered, not the method of lowering it, is what matters.

That continues to be the assumption of Dr. Scott M. Grundy, a professor of medicine at the University of Texas Southwestern Medical Center who was the chairman of a panel in 2001 that set national guidelines for cholesterol treatment.

“LDL lowering, however it occurs, delays development of coronary atherosclerosis and reduces risk for heart attack,” Dr. Grundy said this week. In atherosclerosis, plaque builds up in the arteries, eventually leading to blood clots and other problems that cause heart attacks and strokes.

In the last 13 months, however, the failures of two important clinical trials have thrown that hypothesis into question.

First, Pfizer stopped development of its experimental cholesterol drug torcetrapib in December 2006, when a trial involving 15,000 patients showed that the medicine caused heart attacks and strokes. That trial — somewhat unusual in that it was conducted before Pfizer sought F.D.A. approval — also showed that torcetrapib lowered LDL cholesterol while raising HDL, or good cholesterol.

Torcetrapib’s failure, Dr. Taylor said, shows that lowering cholesterol alone does not prove a drug will benefit patients.

Then, on Monday, Merck and Schering-Plough announced that Vytorin, which combines Zetia with Zocor, had failed to reduce the growth of fatty arterial plaque in a trial of 720 patients. In fact, patients taking Vytorin actually had more plaque growth than those who took Zocor alone.

Despite those drawbacks, that trial, called Enhance, also showed that patients on Vytorin had lower LDL levels than those on Zocor alone. For the second time in just over a year, a clinical trial found that LDL reduction did not translate into measurable medical benefits.

The Enhance trial was not an events trial and was not intended to study whether Zetia or Vytorin were effective at reducing heart attacks. But the growth of fatty plaque is closely correlated with heart attacks and strokes.

Without data from events trials for Zetia and Vytorin, no one can be certain if the drugs help or hurt patients. But Merck and Schering did not begin an events trial for the drugs until 2006, nearly four years after the F.D.A. approved Zetia. That trial will not be completed until 2011.

Dr. Robert M. Califf, the vice chancellor for clinical research at Duke University, and a co-lead investigator on the Zetia trial still under way, said companies should have started the trials more quickly. “Outcome trials ought to start when you know you’re going to get on the market,” he said.

On January, the American Heart Association called for the Zetia outcome trial to be completed as quickly as possible.

Merck has asked the F.D.A. to approve its drug Cordaptive, which raises HDL cholesterol and lowers LDL, without waiting for the results of an events trial. Merck has begun an events trial for Cordaptive, but data will not be available until 2013.

Merck has submitted the application for Cordaptive and has said it expects an answer from the F.D.A. before July. Doctors, patients and the drug industry will be waiting to see whether regulators are still willing to accept the theory that lower cholesterol is always a good thing.

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