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Should Statins be Available for Everyone?

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They lower cholesterol and heart attack risk and may hold promise against other diseases, including cancer. Doctors consider broadening their use.
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Should statin drugs be put in the water, or what? ¶ More than 13 million Americans are taking these medications to lower their cholesterol and hopefully stave off heart disease — a job the drugs appear to excel at. Statins can lower “bad” LDL cholesterol by 20% to 60%. Over time, this can lower the risk of having a heart attack by about the same amount. ¶ For many years, it was believed that statins worked solely by reducing blood cholesterol, which can build up in sticky plaques in the arteries that supply blood to the heart, potentially blocking blood flow and causing heart attacks. But evidence is mounting that the drugs reduce heart disease risk through more than just their cholesterol-lowering effects. New research suggests they may be beneficial even for people with cholesterol in the normal range. ¶ This has doctors and medical researchers debating whether many more people should be on statins than currently fall under treatment guidelines. Some drug companies and doctors have even argued that low doses of the drugs should be available over the counter, as they are in the United Kingdom.

At the same time, other studies are reporting that statins might help prevent or treat a number of noncardiovascular conditions — including multiple sclerosis, cancer and Alzheimer’s disease. With all this news, many may be wondering, “Should I take a statin, just in case?”

Experts, for the most part, will say only, “Maybe.”

Most of the people at high risk of cardiovascular disease “are going to be safer and live longer if they’re on a statin than if they’re not,” says Nathan Wong, director of the UC Irvine Heart Disease Prevention Program. But that doesn’t hold for people whose risk for heart attacks is very low to begin with, he adds. “I’m not saying that everyone is going to be better on a statin. They need to be used with discretion.”

All six statins available today — atorvastatin (Lipitor), rosuvastatin (Crestor), simvastatin (Zocor), lovastatin (Mevacor), pravastatin (Pravachol) and fluvastatin (Lescol) — work by blocking an enzyme called HMG-CoA reductase.

In the liver, blocking this enzyme shuts down cholesterol production and increases the amount of cholesterol the liver takes out of the bloodstream.

But statins also block HMG-CoA reductase in the cells lining blood vessels, where, among other things, they can reduce inflammation.

Dramatic results
The anti-inflammatory effect of statins has been on many heart experts’ minds since the Nov. 9 announcement of the results of a clinical trial called JUPITER. The trial showed that statin treatment can reduce the risk of heart disease in people with normal cholesterol levels but high levels of inflammation as measured by blood levels of a marker called C-reactive protein (CRP).

A team led by Dr. Paul Ridker of Brigham and Women’s Hospital in Boston and Harvard Medical School found that in 8,901 people with high blood CRP levels, rosuvastatin (Crestor) reduced the risk of a heart attack by 54% and the need for bypass surgery or angioplasty by 46% compared with an equal number of people taking a placebo.

There were 68 heart attacks and 131 bypass surgeries/angioplasties in the placebo group, but only 31 and 71, respectively, in the group taking the statin. There were 48% fewer strokes — 64 versus 33. These effects were so dramatic that regulators stopped the trial, slated to go for four years, after less than two. AstraZeneca, the company that makes Crestor, funded the JUPITER trial.

The results raise an obvious question: Are the cholesterol-lowering effects or the inflammation-reducing effects of statins more important?

Dr. Christopher Cannon, a cardiologist at Brigham and Women’s, says they both play a part: “You have to have some cholesterol get into the arteries [and cause damage]. And if you have inflammation that damages the lining of the arteries, the cholesterol gets in more easily.”

Inflammation can also encourage plaques to rupture, causing clots that block blood flow. “Both [cholesterol buildup and inflammation] are happening simultaneously, and both are inhibited simultaneously with statins,” Cannon says.

Currently, more than 13 million people take statin drugs for elevated LDL cholesterol, and at least 47 million more have cholesterol levels high enough to make them eligible by current National Heart, Lung, and Blood Institute cholesterol guidelines.

Ridker estimates an additional 4 million to 6 million people would be added to the mix if everyone who would have qualified for the JUPITER trial (men over 50, women over 60, LDL cholesterol below 130 mg/dL and CRP above 2 mg/L) started taking a statin.

Anti-inflammatory:

Statins may be good for more than just fighting heart disease.

Very preliminary studies suggest that the anti-inflammatory effects of statins could help treat autoimmune diseases. A small, nine-month study of 36 patients with multiple sclerosis published in April in the journal PLoS One showed that statin treatment, either alone or combined with standard MS treatment, reduced the number of brain lesions characteristic of the disease by 24% and reduced their size by about 12%.

Another pilot study of just seven people, published in September 2007 in the Journal of the American Academy of Dermatology, showed that a statin reduced the severity of the skin disease psoriasis

A combined analysis of 19 studies, published in August in the International Journal of Cancer, found that statin use reduced the risk of advanced prostate cancer by 23%.

And a study published in November in the Journal of the National Cancer Institute showed that men prescribed statins had a 4.1% decline in their blood levels of prostate-specific antigen (PSA), a marker of prostate cancer.

There is some evidence that statins can lower the risk of developing Alzheimer’s disease. An October study of almost 7,000 people in Rotterdam, Netherlands, found that people taking a statin had about a 50% lower risk of Alzheimer’s compared with those who had never used cholesterol-lowering medication. Other studies, however, have failed to find an effect of statins on the risk for dementia or Alzheimer’s disease.

As the benefits of these drugs are experienced by more people, the risks will be too. Though statins are generally considered safe, they do have side effects.

Drugs’ side effects:-
The most commonly reported adverse event associated with statins is muscle pain. A 2006 analysis of seven clinical trials published in Medscape General Medicine found that 2.5% to 6% of patients taking statins reported aches and pains related to their drugs.

Rhabdomyolysis, a breakdown of skeletal muscle that can lead to kidney failure and sometimes death, has also been linked to statins. According to the 2006 Medscape report, less than 0.1% of patients taking statins reported rhabdomyolysis. There was only 0.15 death from rhabdomyolysis per 1 million prescriptions.

Liver effects are also seen in some patients taking statins. In less than 1% of patients taking moderate doses of statins, and in about 2% to 3% of those taking high doses, liver enzyme levels are abnormally high. But the enzyme changes usually subside after discontinuing statin use or switching to a different statin, says Dr. Antonio Gotto, dean of Weill Cornell Medical College in New York.

In 2007, the Food and Drug Administration conducted an investigation into whether statins increase the risk of the fatal neurodegenerative disease amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease, when the agency received a higher than expected number of reports of the disease in people taking statins. Although an analysis of 41 long-term controlled clinical trials reported in September detected no such link, the FDA has said it plans to continue studying the issue.

Dr. Scott Grundy, a professor of internal medicine and director of the Center for Human Nutrition at the University of Texas Southwestern Medical Center at Dallas, says he thinks the drugs, on balance, are safe. But he adds that caution is still warranted, especially when it comes to considering a broad expansion of their use or prescribing them earlier in people’s lives.

Statins have been in use only since the late 1980s, he notes, and so there hasn’t been enough time yet to learn what might happen if someone were to be on the drugs for 30 or 40 years. “It is possible that some of these rare side effects might turn out to be quite important if [statins are] started early in life and continued for years and years,” he says.

Whether statin use is substantially expanded may depend on how the results of the JUPITER trial and other recent research are incorporated into new cholesterol guidelines slated to be released next year by the National Heart, Lung and Blood Institute.

If CRP testing becomes part of the standard battery of tests that guide risk assessment and statin treatment decisions, millions more Americans could find themselves filling a prescription.

Currently, most doctors use CRP testing as a sort of tie-breaker when they are on the fence as to whether a patient is at high enough risk of heart disease to warrant statin therapy. Patients might, for example, have intermediate cholesterol levels but a family history of heart attacks or some other risk factor.

Dr. Mary Malloy, co-director of the adult lipid clinic and director of the pediatric lipid clinic at the UCSF Medical Center, does not think this should change, even though she characterizes the JUPITER results as “very impressive.”

“I am personally not ready to corral everyone over 35 and do CRP testing,” she says.

Wong says it’s important that people take into account a person’s absolute risk when judging whether or not a patient needs a statin.

Of the JUPITER trial, he says, “There was a 44% reduction in cardiovascular events. This sounds very dramatic, and it is.” But the risk of heart attack in those patients was pretty tiny to begin with — 2.8%. The 44% drop took it down to 1.6%.

The bottom line is that monetary cost as well as potential side effects of statins must be weighed against the potential benefits.

Wong’s biggest concern is that people will get the idea that statins are a cure-all — and they’ll stop bothering about habits that could affect their heart health just as much.

“People think statins are magic pills,” he says. “You can’t forget about other risk factors like smoking, diabetes and blood pressure. . . . you have to make sure all these things are adequately controlled.”

Sources: Los Angles Times

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6 Ways to Reduce Inflammation — Without a Statin Drug

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Experts predict that as a result of the so-called JUPITER study, which seemed to show that the statin drug Crestor lowers the risk of heart attacks and strokes in those with high levels of inflammation, will lead to millions of people being put on statin drugs.

But the benefits were actually tiny — about 0.72 percent of the statin takers in the trial had a heart attack or stroke, compared with 1.5 percent of those taking placebos.

Instead of a statin drug that comes with dangerous side effects, try these six measures instead:

    1. Stop smoking. Smoking hardens the arteries and increase inflammation. But research shows you can reverse all the damaging effects to your arteries within 10 years of quitting.
    2. Exercise  daily :  Exercise  keep you fit,  mobile  & improve  immune system.
    3. Think olive oil, fish, and nuts. People who stick with a Mediterranean-style diet based on fruits, vegetables, nuts, and olive oil can lower their levels of inflammation. It works by increasing the amount of foods you eat that are rich in omega-3 fats, which fight inflammation.
    4. Get active. Exercise a great way to lower inflammation without any of the side effects associated with medications.
    5. Shrink your waist size. If you’re a woman with a waist measurement of over 35 inches or a man with a waist of over 40 inches, you probably have high inflammation. Whittling a few inches off the waist by reducing your portions and increasing activity can go a long way toward solving that problem.
    6. Get enough sleep. A new study shows that elderly people with high blood pressure who sleep less than 7.5 hours a night have dramatically elevated chances of having a stroke or heart attack. Other research has shown that both too little and too much sleep increases inflammation. The American Academy of Sleep Medicine says most adults need between seven and eight hours of sleep each night.
    7. Reduce stress. High levels of stress hormones can lead to the release of excess inflammatory chemicals.
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Healthy People May Benefit From Statins Too

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In results from an eagerly anticipated study that could dramatically change the treatment of cardiovascular disease, researchers have found that statin drugs — now given to millions of people with high cholesterol — can halve the risk of heart attacks and stroke in seemingly healthy patients as well.

The drugs, currently given to people with high cholesterol, could also reduce risk of heart attacks and strokes for those with normal levels, researchers say. Costs and side effects would have to be w

.
The study of nearly 18,000 people with normal cholesterol found that the drugs, already among the most widely prescribed in the country, also lowered the risk of death from heart disease by 20%, suggesting that millions more people should be put on a daily regimen.

The effects were so beneficial that the planned four-year study was halted after less than two years, researchers said today at a New Orleans meeting of the American Heart Assn.

“These are very, very dramatic findings,” said Dr. Elizabeth G. Nabel, director of the National Heart, Lung and Blood Institute.

Nabel, who was not involved in the research, noted that the institute already had an expert panel revising guidelines for treatment and prevention of heart disease and that the new results were likely to be included in their recommendations.

The revision would most likely call for testing a wide range of healthy people with a simple blood test for above-normal levels of a compound called C-reactive protein, which indicates increased arterial inflammation that can be treated with statins.

The new study focused on a specific drug — rosuvastatin, sold as Crestor by drug maker AstraZeneca, which funded the research.

But Dr. Tim Gardner of the Christiana Care Health System in Wilmington, Del., and president of the American Heart Assn., said, “This is likely to be a class effect, not a specific drug effect. This is a win for all statins, I would say.”

The new treatment could prevent 50,000 heart attacks, strokes and deaths each year if it were widely adopted, experts said.

The findings “really change what we are going to do in the future,” said Dr. W. Douglas Weaver of Henry Ford Hospital in Detroit, president of the American College of Cardiology. “This targets a patient group that normally would not be screened or treated to prevent cardiovascular disease.”

Critics, however, charged that such wide use would cost the U.S. healthcare system more than $9 billion a year at a time when healthcare costs are climbing dramatically and could expose large numbers of people to potential side effects. Crestor is one of the most expensive statins, costing about $3.45 a day, but generic statins typically sell for less than $1.

About 120 people would have to take the drugs for two years to prevent one heart attack, stroke or death, Dr. Mark Hlatky of Stanford University wrote in an editorial accompanying the report, which was published online today by the New England Journal of Medicine.

Nonetheless, the findings will most likely be widely adopted soon, Gardner said. “It will be incorporated into practice guidelines after all the nuances are sorted out,” he said.

Statins, first introduced in 1987, block the production of cholesterol in the liver. High cholesterol is a major risk factor for heart attacks and stroke because it contributes to the buildup of plaque that blocks arteries, preventing oxygenated blood from reaching the heart and brain.

An estimated 450,000 Americans die of heart disease each year and an additional 150,000 from strokes.

More than 13 million Americans take statins regularly, and worldwide sales total more than $22 billion a year, the bulk of that in the United States.

But doctors have long been mystified by the fact that about half of heart attacks occur in patients with normal cholesterol levels and researchers have been looking for other important risk factors.

Three years ago, Dr. Paul Ridker of Brigham and Women’s Hospital in Boston and his colleagues studied results from clinical trials in which statins had been used to treat high cholesterol levels and concluded that, in addition to their cholesterol-lowering ability, the drugs also reduced arterial inflammation, which can lead to the buildup of plaque.

The finding was part of a series of studies that showed statins have a number of beneficial effects beyond their ability to reduce cholesterol. Several reports have shown that they also help prevent glaucoma and cataracts and inhibit dementia. Others suggest that they also moderate the symptoms of multiple sclerosis and increase bone density. These benefits may be related to their ability to reduce inflammation.

C-reactive protein, or CRP, has long been associated with inflammation. Very high levels of CRP are associated with arthritis and other autoimmune diseases. But slightly elevated levels — about a hundredth of the levels seen in arthritis — have been linked to inflammation in the arteries that causes cardiovascular diseases.

In the new trial, called Jupiter, Ridker and his colleagues studied 17,802 patients with normal cholesterol levels and elevated CRP, as measured by a test called high-sensitivity CRP, which Ridker and his hospital hold the patent on.

Men in the study were over 50, women were over 60. About 7,000 of the patients were women and 5,000 were minorities — both groups that have not received much attention in previous statin trials.

Half of the patients received 20 milligrams of rosuvastatin and half a placebo. “We specifically chose rosuvastatin because it is the most potent of the statins,” said Ridker, who has worked as a consultant to AstraZeneca and other pharmaceutical companies. “We got very large effects on both [cholesterol] and CRP.”

Low-density lipoproteins, the so-called bad cholesterol, were reduced by 50%, and CRP was reduced by 37%.

Patients receiving rosuvastatin had a 54% lower risk of a heart attack, a 48% lower risk of stroke and a 46% lower risk of requiring either angioplasty or bypass surgery, Ridker said.

There were 136 heart-related problems a year for every 10,000 people taking the placebo compared with 77 for those taking rosuvastatin. “This is very good news for these populations,” Ridker said.

The primary side effect was a slight increase in newly diagnosed diabetes among those taking the drug, an increase that has also been noted in previous trials of statins.

“This will become an important part of the armamentarium of the primary care doctor,” Weaver said. “I see this as being part of that panel of preventions that they will be applying in men over 50 and women over 60.”

The CRP test costs about $80.

Dr. James Stein and Dr. Jon Keevil of the University of Wisconsin, Madison, estimate that about 4% of the adult U.S. population, about 7.4 million people, fit the criteria to receive the test.

Sources: Los Angles Times

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Fish Oil is Better Than Drugs for Preventing Heart Failure

A typical fish oil softgel
Image via Wikipedia

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Fish oil supplements appear to work better than a popular cholesterol-reducing drug to help patients with chronic heart failure, according to recently released research.

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Researchers gave nearly 3,500 patients a daily omega-3 pill derived from fish oils. Roughly the same number of patients were given placebo pills. Over a four-year period, fewer patients in the group taking the fish oil pills died of heart failure or were admitted to the hospital with the problem.

In a parallel study, the researchers gave nearly 2,300 patients the cholesterol-lowering drug Crestor and another group of close to 2,300 patients placebo pills. After four years, there was little difference in heart failure rates between the groups, but when the two studies were compared they found that fish oil is slightly more effective than Crestor because the oil performed better against a placebo than the drug did.

Chronic heart failure is a condition that occurs when the heart becomes enlarged and cannot pump blood efficiently around the body. Omega-3 fats have long been proven to offer health benefits such as protecting the heart and brain.

Sources:
Time August 31, 2008
The Lancet August 31, 2008
The Lancet August 31, 2008

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