Lipitor

Pfizer has announced that Lipitor 80mg reduced the risk of heart attack and stroke by 32% in patients who have heart disease and chronic kidney disease compared with patients taking the 10mg dose of Lipitor.

The primary endpoint of the Treating to New Targets (TNT) study was the reduction of major cardiovascular events, including death from heart disease, non-fatal heart attacks, resuscitated cardiac arrest, and fatal or non-fatal strokes. This sub-analysis studied 3,107 patients with moderate to severe chronic kidney disease, as defined using a standard measure of kidney function.

The efficacy results in this analysis were primarily driven by reductions in heart attack and stroke. Both doses of Lipitor (80mg and 10mg) were well tolerated. Lipitor 80mg is not a starting dose. The safety of Lipitor 80 mg in patients with chronic kidney disease was similar to that reported for the overall TNT population, with no unexpected safety concerns identified.

Halit Bander, senior director of Pfizer’s global cardiovascular metabolic medical team, said: “The results of this analysis complement the large body of evidence from multiple clinical trials demonstrating the cardiovascular benefits of Lipitor.”

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Cholesterol is a lipid, a type of fat found in the body. Having high “bad” cholesterol means you have too much LDL in your blood. LDL is low-density lipoprotein, or “bad” cholesterol.

Too much cholesterol in the blood, or high cholesterol, can be serious. People with high cholesterol are at risk of getting heart disease. This can lead to a heart attack or stroke.

Only about 20% of cholesterol comes from the foods you eat. The other 80% is made by your body. Things such as age and family health history affect how much cholesterol your body makes.

Cholesterol levels tend to rise as you get older. Unfortunately, there are usually no signs that you have high cholesterol. But it can be detected with a blood test. These tests can also help your doctor predict what your risk for heart disease may be.

Total Cholesterol

Your blood test report will show your cholesterol levels in milligrams per deciliter of blood (mg/dL). The total number is based on:

* LDL (”bad” cholesterol)
* HDL (”good” cholesterol)
* Triglyceride (a type of fat found in your blood) levels

Total Cholesterol Levels / What It Means

Less than 200 mg/dL / Desirable
200-239 mg/dL / Borderline high risk for heart disease
240 mg/dL and above / High risk for heart disease

The 2 Types of Cholesterol: LDL and HDL

Bad cholesterol: Low-density lipoprotein (LDL)

Too much LDL in your blood can clog arteries. This can increase the risk of heart attack and stroke.

Good cholesterol: High-density lipoprotein (HDL)

High levels of HDL can help protect you from a heart attack or stroke. HDL carries cholesterol from the body’s tissues to the liver. So, low levels of HDL can increase the risk of heart disease.

If you’re worried about high cholesterol and heart disease, make an appointment to speak with your doctor. LIPITOR is clinically proven to lower bad cholesterol 39-60%, when diet and exercise are not enough (average effect depending on dose).

LIPITOR is a prescription drug. It is used in patients with multiple risk factors for heart disease such as family history, high blood pressure, age, low HDL (”good” cholesterol) or smoking to reduce the risk of heart attack and stroke. When diet and exercise alone are not enough, LIPITOR is used along with a low-fat diet and exercise to lower cholesterol.

LIPITOR is also used in patients with type 2 diabetes and at least one other risk factor for heart disease such as high blood pressure, smoking or complications of diabetes, including eye disease and protein in urine, to reduce the risk of heart attack and stroke.

LIPITOR is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, pregnant or may become pregnant.

If you take LIPITOR, tell your doctor if you feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects. Tell your doctor about all medications you take. This may help avoid serious drug interactions. Your doctor should do blood tests to check your liver function before and during treatment and may adjust your dose. The most common side effects are gas, constipation, stomach pain and heartburn. They tend to be mild and often go away.

When diet and exercise alone are not enough, adding LIPITOR can help. LIPITOR is one of many cholesterol-lowering treatment options that you and your doctor can consider.

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Drugs that are commonly used to lower cholesterol can block the proliferation and promote the destruction of esophageal cancer cells in the laboratory, according to a report in the American Journal of Gastroenterology by UK researchers.

The esophagus is the tube that carries food, liquids and saliva from the mouth to the stomach - and adenocarcinoma is the most common type of cancer in this organ.

Statins, a type of popular cholesterol-lowering agents, which include drugs such as Lipitor, achieve this effect by inhibiting the signaling pathways that lead to the formation of the cancer cells, co-authors Dr. Olorunseun O. Ogunwobi, from Norfolk and Norwich University Hospital, and Dr. Ian L. P. Beales, from the University of East Anglia in Norwich, note.

A rapid rise in the number of esophageal cancers and deaths has been seen worldwide, leading many researchers to look for drugs that can prevent this cancer from occurring, report indicates.

Prior research has shown that statins, which have a good safety record, can reduce the availability of various biosynthetic intermediate molecules that are critical for cancer cell signaling. Whether this might translate into a beneficial anti-cancer effect, however, was unclear.

Using laboratory cultures of esophageal cancer cells, the researchers found that adding simvastatin, lovastatin, and pravastatin reduced the number of esophageal cancer cells and inhibited their growth. The higher the dose of the statin, the greater was the destruction of the cancer cells.

“As yet, it is not possible to extrapolate from our laboratory studies to clinical scenarios, but the current data do suggest that any effects of statins taken by patients with esophageal cancer and Barrett’s esophagus are possibly beneficial,” the investigators note.

Further examination of statins or other agents that inhibit the same signaling pathways that lead to the formation of esophageal cancer cells — in experimental models or in clinical trials with patients — should continue so researchers can “better define whether this class of drugs has a definite role in prevention or treatment of esophageal cancer,” the authors conclude.

SOURCE: American Journal of Gastroenterology, April 2008.

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Pfizer Inc announced today that Lipitor® (atorvastatin calcium) 80 mg reduced the risk of heart attack and stroke by 32 percent in patients who have heart disease and chronic kidney disease compared with patients taking the 10 mg dose of Lipitor. This analysis, designed and completed following the closure of the five-year Treating to New Targets (TNT) study, was published in the “Journal of the American College of Cardiology.”

“People with chronic kidney disease are more likely to die from heart disease than to develop kidney failure,” said Dr. James Shepherd, a member of the TNT steering committee and clinical academic consultant, department of pathological biochemistry, University of Glasgow Medical School. “It is critical for us to find new ways to reduce cardiovascular burden in these patients. Intensive statin therapy seems to be at least part of the solution.”

The primary endpoint of the TNT study was the reduction of major cardiovascular events, including death from heart disease, non-fatal heart attacks, resuscitated cardiac arrest, and fatal or non-fatal strokes. This sub-analysis studied 3,107 patients with moderate to severe chronic kidney disease, as defined using a standard measure of kidney function. The efficacy results in this analysis were primarily driven by reductions in heart attack and stroke. Both doses of Lipitor (80 mg and 10 mg) were well tolerated. Lipitor 80 mg is not a starting dose. The safety of Lipitor 80 mg in patients with chronic kidney disease was similar to that reported for the overall TNT population, with no unexpected safety concerns identified.

“The results of this analysis complement the large body of evidence from multiple clinical trials demonstrating the cardiovascular benefits of Lipitor,” said Halit Bander, Ph.D. senior director of Pfizer’s global cardiovascular metabolic medical team.

About Chronic Kidney Disease

An estimated 26 million Americans and 50 million people worldwide have chronic kidney disease, or permanent kidney damage due to injury or disease. Patients with chronic kidney disease do not effectively filter toxins from the blood. When chronic kidney disease progresses to kidney failure, either dialysis or a kidney transplant is needed. Chronic kidney disease recently has been recognized as an important risk factor for cardiovascular disease, the leading cause of death and illness in patients with kidney disease.

About the TNT Study

The TNT study was a landmark investigator-led trial coordinated by an independent steering committee and funded by Pfizer. It was the largest study to date evaluating the efficacy and safety of Lipitor 80 mg. The study enrolled 10,001 men and women with coronary heart disease aged 35 years to 75 years in 14 countries and followed them for an average of five years. The safety of Lipitor 80 mg in patients with chronic kidney disease was similar to that reported for the overall TNT population, with no unexpected safety concerns identified.

About Lipitor

Lipitor is the only statin proven to provide a combination of impressive average LDL (“bad” cholesterol) lowering of 39 percent to 60 percent, significant and proven cardiovascular event reductions, and a well-established safety profile across a broad range of patients.

It is the most prescribed cholesterol-lowering therapy in the world, with nearly 151 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.

Important U.S. Prescribing Information

Lipitor is a prescription medication. It is used in patients with multiple risk factors for heart disease such as family history, high blood pressure, age, low HDL (“good” cholesterol) or smoking to reduce the risk of a heart attack, stroke, certain types of heart surgery and chest pain.

Lipitor is also used in patients with type 2 diabetes and at least one other risk factor for heart disease such as high blood pressure, smoking or complications of diabetes, including eye disease and protein in urine, to reduce the risk of heart attack and stroke.

Lipitor is used in patients with existing coronary heart disease to reduce the risk of heart attack, stroke, certain kinds of heart surgery, hospitalization for heart failure, and chest pain.

When diet and exercise alone are not enough, Lipitor is used along with a low-fat diet and exercise to lower cholesterol.

Lipitor is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, pregnant or may become pregnant.

Patients taking Lipitor should tell their doctors if they feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects. Patients should tell their doctors about all medications they take. This may help avoid serious drug interactions. Doctors should do blood tests to check liver function before and during treatment and may adjust the dose. The most common side effects are gas, constipation, stomach pain and heartburn. They tend to be mild and often go away.

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There’s more to managing cholesterol than just lowering your LDL. According to the American Heart Association, an estimated 80 million American adults have high LDL (bad) cholesterol, and more than 44 million Americans, or one in six, have low levels of HDL, the good cholesterol the body uses like a broom to sweep the bad cholesterol from the blood.

“Managing cholesterol involves many things, not just lowering LDL,” according to Dr. Christie Ballantyne of the Methodist DeBakey Heart and Vascular Center. “There is a serious need for medicines that both raise good cholesterol and lower the bad components of cholesterol.”

The Food and Drug Administration recently approved Abbott’s SIMCOR, a combination of two widely prescribed cholesterol therapies – Niaspan (Abbott’s proprietary niacin extended-release) and simvastatin – in a single pill. When used along with diet, SIMCOR treats bad cholesterol (LDL) and good cholesterol (HDL) when treatment with Niaspan or simvastatin monotherapies is considered inadequate.

“SIMCOR represents a new option to help patients reach their treatment goals and target all their cholesterol levels,” says Ballantyne.

More than 105 million Americans have total blood cholesterol levels at or above 200 mg/dL, which is considered high. Statin therapy, which has primarily been used to lower bad cholesterol, is an important treatment option, but many patients might need additional lipid treatments to help them reach their goals. In order to manage all of your cholesterol levels, you need to learn your numbers first.

This is why it’s important to know all of your cholesterol levels and talk with your doctor about how to manage them. Start by getting your cholesterol checked today.

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To understand high blood cholesterol (ko-LES-ter-ol), it is important to know more about cholesterol.

* Cholesterol is a waxy, fat-like substance that is found in all cells of the body. Your body needs some cholesterol to work the right way. Your body makes all the cholesterol it needs.
* Cholesterol is also found in some of the foods you eat.
* Your body uses cholesterol to make hormones, vitamin D, and substances that help you digest foods.

Blood is watery, and cholesterol is fatty. Just like oil and water, the two do not mix. To travel in the bloodstream, cholesterol is carried in small packages called lipoproteins (lip-o-PRO-teens). The small packages are made of fat (lipid) on the inside and proteins on the outside. Two kinds of lipoproteins carry cholesterol throughout your body. It is important to have healthy levels of both:

* Low-density lipoprotein (LDL) cholesterol is sometimes called bad cholesterol.
o High LDL cholesterol leads to a buildup of cholesterol in arteries. The higher the LDL level in your blood, the greater chance you have of getting heart disease.
* High-density lipoprotein (HDL) cholesterol is sometimes called good cholesterol.
o HDL carries cholesterol from other parts of your body back to your liver. The liver removes the cholesterol from your body. The higher your HDL cholesterol level, the lower your chance of getting heart disease.

What Is High Blood Cholesterol?

Too much cholesterol in the blood, or high blood cholesterol, can be serious. People with high blood cholesterol have a greater chance of getting heart disease. High blood cholesterol on its own does not cause symptoms, so many people are unaware that their cholesterol level is too high.

Cholesterol can build up on the walls of your arteries (blood vessels that carry blood from the heart to other parts of the body). This buildup of cholesterol is called plaque (plak). Over time, plaque can cause narrowing of the arteries. This is called atherosclerosis (ath-er-o-skler-O-sis), or hardening of the arteries.

Special arteries, called coronary arteries, bring blood to the heart. Narrowing of your coronary arteries due to plaque can stop or slow down the flow of blood to your heart. When the arteries narrow, the amount of oxygen-rich blood is decreased. This is called coronary artery disease (CAD). Large plaque areas can lead to chest pain called angina (an-JI-nuh or AN-juh-nuh). Angina happens when the heart does not receive enough oxygen-rich blood. Angina is a common symptom of CAD.

Some plaques have a thin covering and burst (rupture), releasing fat and cholesterol into the bloodstream. The release of fat and cholesterol may cause your blood to clot. A clot can block the flow of blood. This blockage can cause angina or a heart attack.

Lowering your cholesterol level decreases your chance for having a plaque burst and cause a heart attack. Lowering cholesterol may also slow down, reduce, or even stop plaque from building up. Plaque and resulting health problems can also occur in arteries elsewhere in the body.

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Cholesterol is a lipid or a fat-like substance that the body needs for several processes. The absence or excess of it can cause an imbalance in the body.

The Importance of Cholesterol in the Body

Cholesterol is responsible for several functions in the body. Here are some of them:

1. It is used to make vitamin D. Vitamin D is synthesized using sunlight and cholesterol. This process takes place under the human skin.
2. It absorbs the fat and fatty acids from the human intestines.
3. The body produces steroid hormones using cholesterol.
There are two kinds of cholesterol that exists in the body. These are the LDL, and the HDL forms of cholesterol. LDL is used by the body to perform the above-mentioned functions. HDL, on the other hand, is used by the body to clean up the excess cholesterol in the bloodstream and tissues so that it can be disposed of.

You might wonder now, if cholesterol is actually an important part of the body, why is it linked to heart complications and disease? In the Quaker Oats commercial, it is touted to contribute to a healthy heart by removing the cholesterol in our bloodstream so it will not clog and cause heart diseases. Why is there a need to do so when cholesterol is actually needed for some bodily functions?

Causes of High LDL

In reality, LDL does not directly contribute to heart disease as we are sometimes led to believe because of misleading advertisements. The problem can only arise if the LDL levels in our blood go way beyond the norm. An excess of LDL can cause a condition known as atherosclerosis, in which cholesterol as well as other dangerous substances in the body start to build up inside the arteries. When this happens, you are mostly likely going to suffer a heart attack or a stroke.

LDL build-up in the blood can be caused by a high saturated fat diet. This happens when you consume too much butter, cream, cheese and other full-fat dairy products. Some meats and many baked, fried and snack foods also high amounts of saturated fat. It can also be found from palm or coconut oil, so it is important to note that having vegetable oil as one of the ingredients in a product does not necessarily mean it is a low fat product.

High LDL levels can also be hereditary, which means you inherit it from your family. There is nothing you can do about this, except to watch your saturated fat diet so the LDL in your body does not have to rise higher than it already is.

Ways to Lower or Maintain a Low LDL in the Blood

Obviously, we have to lower our saturated fat diet in order to maintain a low or optimal level of LDL in the body. How can we do this?

First, it would be helpful to switch to reduced-fat or low-fat diets rather than full-fat dairy foods. You should also replace solid cooking fats with unsaturated cooking oils like sunflower, soybean or olive. When eating snacks, avoid as much as possible biscuits, cakes, pastries and fried snack foods.

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The combination of anti-inflammatory and cholesterol-lowering drugs may be able to stop the progression of prostate cancer, according to new research so far carried out only in mice.

“The two drugs work through different mechanisms of action, but there is a synergistic effect that inhibits the growth of prostate cancer cells,” said Xi Cheng, assistant research professor at Rutgers, the State University of New Jersey, who conducted the study.

His team administered a combination of Celebrex, a non-steroidal anti-inflammatory drug used to treat arthritis and other pain, and Lipitor, a cholesterol lowering statin, to cultured mice tumors in order to measure the transition of early prostate cancer to its more aggressive and potentially fatal stage.

Both drugs are sold by Pfizer Inc, but the company played no role in the National Institutes of Health-funded study, Zheng said.

The researcher said both drugs have been shown in earlier studies to have some impact on cancer growth when used alone.

The Rutgers team found that the combination of low doses of Lipitor and Celebrex had a more potent impact on tumor growth than a higher dose of either agent when used separately.

Prostate cancer is the second-leading cause of cancer death in men in the United States, with more than a quarter-million new cases appearing each year, according to the American Cancer Society.

In the early stage of the disease, prostate cancer cells depend on androgen hormones, such as testosterone, to grow. Treatment involves either decreasing the production of the hormone or blocking its action.

“Anti-androgen therapy slows the prostate cancer but eventually the cancer becomes androgen-independent, the therapy becomes ineffective and the cancer cells become more aggressive,” said Zheng.

“Treatments available for the later stage cancers are not very good,” Allan Conney, director of cancer research at Rutgers, said in a statement. “Oncologists employ classical chemotherapy drugs which are very toxic and don’t work all that well.”

The objective of the Rutgers study was to indefinitely delay the transition to androgen-independence, prolonging the time during which the cancer would be responsive to low-toxicity, anti-hormone therapy.

Zheng said it appears that a cell signaling pathway for tumor cell growth is inhibited by the combination of the two compounds.

He said human clinical trials are being planned.

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New findings from a landmark trial reaffirms that patients with evidence of coronary artery disease undergoing aggressive rosuvastatin therapy could experience reverse plaque buildup in the arteries.

The therapy involved using a 40 milligrams once-a-day dosage of Lipitor for two years.

The findings are significant considering that this is the first time a statin—chiefly used for lowering cholesterol—has shown regression of coronary atherosclerosis in a major clinical study.

Coronary atherosclerosis is the major cause of heart attacks as well as sudden unexpected death among otherwise healthy adults in the prime of their lives.

Regression proven

Proponents of the landmark trial Asteroid, short for A Study To Evaluate the effect of Rosuvastatin On Intravascular ultrasound-Derived coronary atheroma burden, were able to prove the regression using two imaging techniques called intravascular ultrasound and quantitative coronary angiography on which the new report is based.

Furthermore, this is the first time that QCA was used to demonstrate regression of atherosclerosis as a result of statin monotherapy.

The trial showed positive result: those who have taken rosuvastatin for two years were able to exhibit significant decrease in percent diameter stenosis (abnormal narrowing in a blood vessel) as well as significant increase in minimum lumen diameter (referring to the channel that makes up the inside of the blood vessel).

Cholesterol levels

Furthermore, the report also noted a 53.3 percent reduction in LDL-cholesterol (the “bad” cholesterol) level as well as a 13.8 percent increase in HDL-cholesterol (the “good” cholesterol) level in patients who underwent the resuvastatin regimen.

Asteroid treated 507 coronary disease patients with rosuvastatin 40 mg a day for two years. The result of which was presented at the recent 57th annual scientific session of the American College of Cardiology.

Asteroid is part of AstraZeneca’s (makers of Crestor) series of clinical trials—called Galaxy—designed to address important unanswered questions in statin research.

The Galaxy program has already enrolled more than 64,000 patients recruited from 55 countries worldwide.

Furthermore, these studies seek to validate the approach of targeting bad cholesterol and good cholesterol levels in order to attack the buildup of arterial plaque, the fundamental cause of heart disease.

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High doses of Pfizer Inc’s Lipitor was more effective than low doses of the cholesterol fighter in reducing arterial inflammation in patients with carotid artery disease, according to a small, 12-week study.

Inflammation in arteries has been associated with an increased risk of stroke.

Inflammation and emboli, or small blood clots, were significantly reduced in patients treated with 80 milligrams of Lipitor compared with those who received 10 mg of the drug each day for 12 weeks, said researchers, who presented the data at the American College of Cardiology scientific meeting on Monday.

The study divided 40 patients with diseased carotid arteries into the two groups. The artery was examined for changes in inflammation at six weeks and 12 weeks using a unique contrast agent with high-resolution magnetic resonance imaging (MRI).

While the 80 mg Lipitor, known generically as atorvastatin, reduced inflammation, researchers appeared even more enthusiastic about the technique used to measure the results.

The arteries were viewed using Ultra Small Particles of Iron Oxide, or USPIO-enhanced, high-resolution MRI.

“The real star of this study is this new way of imaging, which allows you to zero in on what is actually going on in these arteries,” said Dr Jonathan Gillard, one of the study’s lead researchers.

The study demonstrates that if you treat patients who have inflammation of the carotid artery with “a high dose of atorvastatin, you substantially reduce the amount of inflammation and risk of stroke, whereas low dose atorvastatin does not reduce risk,” Gillard said.

“Thanks to this imaging technique, we can now figure out which patients need the aggressive treatment before we begin our therapy,” he added.

Lipitor, which lowers levels of LDL, or bad, cholesterol in the blood, is the world’s top-selling prescription medicine with some $12 billion in annual sales.

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