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Entries in Statins (13)

Monday
Jun112012

Statins May Be Linked to Fatigue

Jupiterimages/Thinkstock(PHILADELPHIA) -- Sometimes doctors are also patients. Such was the case with psychiatrist Dr. Bernard Sobel, who has been seeing Dr. Daniel Rader ever since he had a blockage in one of his heart arteries -- requiring surgery -- more than two decades ago.

Since that time, Rader -- director of the Preventive Cardiovascular Program at the University of Pennsylvania in Philadelphia -- had put Sobel on a class of cholesterol busters known as statins in the hopes of reducing future heart problems. However, Sobel has had difficulties tolerating the side effects of statins.

Sobel described the fatigue he experienced when taking the drugs as "kind of feeling lethargic, no energy, feeling 'blah,' lacking interest in things."

"One morning ... I could not get out of bed," he said. "I felt I was drugged."

Anecdotes such as Sobel's suggest that statin use may be related to increased fatigue. Now a new study, published Monday in the journal Archives of Internal Medicine, suggests a formal association between statins, worsening energy levels and exertional fatigue.

These findings may be relevant to the millions of Americans who currently take statins, as well as millions more who may one day start taking the medicines.

In a randomized clinical trial, researchers at the University of California at San Diego evaluated 1,016 patients who received either a low-dose statin or placebo. The patients initially reported their energy level and fatigue on exertion at baseline. Six months after the patients started taking statins, the researchers asked them if there had been any changes from baseline, rating their changes on a 5-point scale ranging from "much less" to "much more."

The researchers found that statins were associated with both decreased energy level and increased fatigue with exertion. Strikingly, women seemed to be disproportionately affected.

"For a lot of people that we treat, there really haven't been a lot of mortality benefits with statins," said Dr. Beatrice Golomb, the study's lead author. Yet now, "a not inconsequential number of patients [on statins] may experience fatigue and exercise intolerance."

I think this is an important study," added Rader. "It will be important for the public."

However, other physicians are more cautious about the findings.

"I am very concerned that this will be over-reacted to," said Dr. Howard Weintraub, clinical director of the NYU Center for the Prevention of Cardiovascular Disease. "Everyone is tired and patients want to blame anything else other than their bad lifestyle, lack of exercise, or sleeping habits."

Dr. Scott Grundy, director for the Center for Human Nutrition at the University of Texas Southwestern Medical Center in Dallas, also noted his skepticism. "I am suspicious that the method of statistical analysis distorts the real tolerance of statins," he said.

But Golomb defended her study. "These are randomized, double blinded, placebo-controlled data," she said. "Here it is clear that ... statin users were significantly more fatigued, and more intolerant to exercise."

In the United States, coronary heart disease is the most common cause of death in both men and women. Risk factors for coronary heart disease include smoking, lack of exercise, high blood pressure -- and elevated cholesterol levels, which statins effectively reduce. Previous studies demonstrate that statins are one of the most efficacious drugs in reducing the risk of having a future heart attack. In addition, statins have been shown to reduce the risk of strokes.

In 2011, simvastatin -- one of the drugs in the current study -- was the second-most prescribed medication in the U.S., accounting for 94.1 million prescriptions. Unfortunately, statins are also associated with a number of side effects, including muscle aches, flu-like symptoms, and liver toxicity. Moreover, the adverse reactions become more severe as the dose of the statin is increased.

And now fatigue and exercise intolerance may be added to the list of side effects.

"Statins have obviously the best track record for reducing heart attack and strokes," said Dr. Carl Lavie, medical director of cardiac rehabilitation and prevention at the University of Queensland School of Medicine in New Orleans. "These benefits have to be weighed against these symptoms [of fatigue and exercise intolerance]... and in most cases prevention of heart attacks, strokes, and deaths should win out."

In the meantime, Sobel is no longer taking any statins. Instead, under Rader's guidance, he has his blood filtered once a month with a procedure that directly removes bad lipids from the bloodstream.

"I couldn't do anything on statins," said Sobel. "I believe Dr. Rader's program has saved my life."

Copyright 2012 ABC News Radio

Wednesday
Mar212012

Study: Experimental Cholesterol-Busting Drug Shows Promise

Zoonar/Thinkstock(CINCINNATI) -- Along with lifestyle changes, a class of medications called statins is first-line therapy for lowering cholesterol. These drugs have been shown to lower levels of bad cholesterol and cut the risk of death for those who take them. But they do not work for all patients. Up to 10 percent of patients experience significant side effects, including muscle pain. An even greater number are unable to get their LDL-C, or "bad cholesterol," down to a range that has been shown to decrease heart disease.

Now, new research suggests that doctors treating at-risk patients may one day have another weapon in the arsenal against high cholesterol. In a study published in the New England Journal of Medicine, researchers looked at a new, experimental class of cholesterol-busting medication -- known for now at least as PCSK9 inhibitors.

In the study, supported by the pharmaceutical companies Regeneron and Sanofi, researchers led by Dr. Evan Stein of the Metabolic and Atherosclerosis Research Center in Cincinnati, found the drug, called REGN727, could decrease bad cholesterol by as much as 65 percent in healthy individuals. More surprisingly, in participants who were already taking the powerful cholesterol-lowering medication atorvastatin -- better known by the trade name Lipitor -- adding this drug further decreased their bad cholesterol by as much as 61 percent. During this preliminary study, there were no side effects that were serious enough to halt the research -- another positive sign.

Stein further noted that the experimental drug may lead to "even greater reductions in LDL-C than the most effective statins."

Dr. Robert Eckel, former president of the American Heart Association, said that if the drug indeed lives up to its promises, it could potentially benefit many patients he sees every day. "Despite the proven benefit of statins in reducing [cardiovascular] risk, additional LDL-C lowering therapies are needed for patients with several genetic disorders that cause high levels of LDL-C and those with statin intolerance." These patients, he added, make up 40 percent of the patients treated at his clinic.

Dr. Dan Rader, a professor of medicine at the University of Pennsylvania who also acts as a consultant for Regeneron and Sanofi, said a new offering for these patients would be a welcome development. "It is worth stating that we really don't have great options for add-on therapy to statins or for statin-intolerant patients.

"Inhibitors of PCSK9 are perhaps the most exciting new approach to LDL-lowering based on very strong human genetics supporting the efficacy and safety of this approach."

And Dr. Christopher Cannon, a professor of medicine at Brigham and Women's Hospital in Boston, called PCSK9 inhibitors a "very important new class of drug. It reduces a major risk factor [for heart disease] by nearly two-thirds."

But some doctors warned that, although promising, the results of this study are just one step in a long process before these drugs can reach the market.

"It is an early study," said Dr. Harlan Krumholz, a professor of medicine at Yale University, said. "It is information that can be used to mount a rationale for further study and investment. But for patients, it is far too early to tell."

Dr. Scott Grundy, at the University of Texas Southwestern Medical Center at Dallas, echoed the sentiment. "PCSK9 inhibitors hold a lot of promise, but there is a long road between their ability to lower LDL and proof that they are practical and reduce risk for [coronary heart disease]."

Copyright 2012 ABC News Radio

Monday
Mar192012

Statins May Lower Pneumonia Risk

iStockphoto/Thinkstock(NEW YORK) -- Statins, the same drugs that help millions of Americans control their cholesterol may also help prevent pneumonia, a new study found.

Blocking cholesterol build-up inside arteries, statin reduces the risk of heart disease. But a clinical trial of Crestor, made by the London-based drug company AstraZeneca, suggests the benefits of statins extend beyond the heart.

“Participants randomly assigned to receive rosuvastatin [Crestor is the brand name] had a modest reduction in the incidence of pneumonia compared with participants assigned to the placebo group,” wrote lead author Dr. Victor Novack of the Soroka University Medical Center. The study was published Monday in the journal CMAJ.

Novack and colleagues analyzed data from more than 17,800 men and women aged 50 and older who had no history of heart disease or diabetes. During a follow-up period of almost two years, 214 people taking statins contracted pneumonia, compared with 257 people taking a placebo — a small, but significant difference that held even when the researchers controlled for pneumonia risk factors, such as age and smoking.

“Although a number of observational studies have suggested a protective effect  of statin use on the incidence of pneumonia and other infections, we are not aware of any evidence from prior randomized trials that specifically evaluated this question,” according to the study.

Previous studies have found that statins have positive effects on inflammation — the hallmark feature of pneumonia, which is triggered by infection. Pneumonia is often a complication of another condition, such as influenza. A study published last year in the Journal of Infectious Diseases linked statins with a decreased risk of death for patients hospitalized for flu.

“They reduce inflammation that may be triggered by the influenza virus,” Dr. Cam Patterson, distinguished professor of cardiovascular medicine at the  University of North Carolina at Chapel Hill, said of the 2011 study. “This may lead to less tissue damage from the virus, making it easier for patients to recover from severe bouts of the flu.”

The proportion of pneumonia cases stemming from flu included in Monday’s study is not known.

Infections other than pneumonia, such as urinary tract infections and sepsis, were diagnosed in 3,760 participants who were taking Crestor, and 3,828 taking a placebo. The infections were classified as serious in 412 patients taking Crestor, and 456 patients taking a placebo.

“These data provide support for ongoing studies such as the Statins for Acutely Injured Lungs from Sepsis, or Sails, trial, and emphasize the need for basic investigators to continue exploring novel mechanisms by which statin therapy appears to reduce the incidence of clinical events,” the authors wrote.

Copyright 2012 ABC News Radio

Wednesday
Feb292012

Patients Question Statins' Safety After FDA's New Label Warnings

iStockphoto/Thinkstock(WASHINGTON) -- A growing number of physicians may find patients questioning the safety of statins following the U.S. Food and Drug Administration's announcement Tuesday that it would require additional safety warnings on the labels of the cholesterol-lowering drugs.

Doctors have said that while the benefits of statins outweigh their potential harm, some patients are alarmed by the new announcement.

"This news will make the care of my patients more difficult and less effective," said Dr. Richard Honaker, a physician with the Family Medicine Associates of Texas in Carrollton.

Honaker said that he has already had a patient who has been reluctantly taking the statin drug Lipitor now tell him he will quit the medication after reading about the new warning labels.

"Some patients are always reading up on their medications on the Internet, and it seems like they only read the negative and not the positive," said Honaker. "It's going to be an uphill battle."

Statins -- more commonly known by the brand names Lipitor, Crestor and Zocor -- inhibit the enzyme that plays a big part in the liver's production of cholesterol.

The FDA now requires that statin labels include warnings about the rare but serious risk of liver damage, memory loss and confusion, and type 2 diabetes. Certain statins, known by the generic name lovastatin, can raise the risk of muscle weakness.

Many experts, including Honaker, said the side effects listed are rare and mild.

"There's gigantic data showing that you'll live longer and healthier," said Honaker.

The decision came following an internal meeting between the FDA's Office of Surveillance and Epidemiology and Office of New Drugs, according to Dr. Amy Egan, the FDA's deputy director of safety in the division of metabolism drug products.

Egan said most of the information reviewed, especially the effect of statins on memory loss, came from a small number anecdotal reports compiled over one year. She added that the warning for memory loss was more for serious cognitive problems than simple forgetfulness.

"We can't establish causality with statin therapy," said Egan, regarding the new warnings.

Also, most of the studies the division evaluated were short-term studies, suggesting that the long-term effects of statin therapy were unclear. Egan also said it had yet to be determined which statins and at what dose could increase the risk of the listed side effects.  

Copyright 2012 ABC News Radio

Wednesday
Feb292012

FDA Announces New Warning Labels for Cholesterol Drug

iStockphoto/Thinkstock(WASHINGTON) -- Federal regulators announced on Tuesday they would add additional safety warnings to the labels on statins, a class of drugs that lower cholesterol.

Statins -- more commonly known by the brand names Lipitor, Crestor and Zocor -- inhibit the enzyme that plays a big part in the liver's production of cholesterol.

The U.S. Food and Drug Administration now requires that statin labels include warnings about the rare, but serious risk of liver damage, memory loss and confusion along with type 2 diabetes.  Certain statins, known by the generic name lovastatin, can raise the risk of muscle weakness.

The decision came following an internal meeting between the FDA's Office of Surveillance and Epidemiology and Office of New Drugs, according to Dr. Amy Egan, the FDA's deputy director of safety in the division of metabolism drug products.

Egan said most of the information reviewed, especially the effect of statins on memory loss, came from a small number anecdotal reports compiled over one year.  She added that the warning for memory loss was more for serious cognitive problems than simple forgetfulness.

"We can't establish causality with statin therapy," said Egan, regarding the new warnings.

Most of the studies the division evaluated were short-term studies, suggesting that the long-term effects of statin therapy were unclear.  Egan also said it had yet to be determined which statins and at what dose could increase the risk of the listed side effects.

Many experts said the added labels should not deter patients from statins.  Instead, they should report any side effects they experience to their physician.

Consumers will be able to see the label changes on their medications within the next 30 days, Egan said. 

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Copyright 2012 ABC News radio

Monday
Jan302012

Statins Just as Effective for Women as Men, Study Finds

John Foxx/Thinkstock(WASHINGTON) -- Whether to prescribe statins for women without heart disease, or whether they can even benefit, is a common quandary among many physicians. It's partly because many studies have yet to enroll enough women. But a new review of studies now suggests that women may reap as much benefit from statins as men do.

The study, whose results were published Monday in the Journal of the American College of Cardiology, reviewed 18 randomized controlled trials that included more than 140,000 patients, and found that statins decreased the risk of heart disease, stroke and death in both men and women equally.

"It seems that, with respect to statin therapy, what is good for the gander is good for the goose," the authors wrote. While the researchers did not find a significant difference between men and women in the way statins work, they still cautioned that not enough data had yet been collected from women to mark a clear distinction. Twice as many studies were initially excluded from review because the researchers said they lacked information on the sex of the patients studied.

"This study just screams for the need for sex-specific reporting," said Dr. Sharonne Hayes, director of Mayo Clinic's Women's Heart Clinic in Rochester, Minn., who was not involved in the study.

While some experts said they prescribed statins to both men and women equally, others said not enough attention was paid to preventing heart disease in women, because they were often perceived to be at lower risk for the disease.

Women are more likely to develop the disease over their lifetime, often at a later age than men.

Still, women are less likely than men to receive statins, even if they exhibit symptoms of heart disease, according to a study published in the January 2009 issue of the journal Heart.

According to Hayes, the result of the current study may not do much to change the minds of those who are reluctant to prescribe statins to women.

It's not clear how the side effects of the drug compare between men and women, according to the findings. Most of the studies analyzed did not record the sex of the patients who experienced side effects.

It's hard to know if other women who don't have clear symptoms, or those considered at low-risk for heart disease, will benefit from statins.

The study does little to address that part of the debate, Dr, Lori Mosca, director of preventive cardiology at Columbia University Medical Center wrote in an accompanying editorial published in the Journal of the American College of Cardiology.

Until more studies track the side effects, the risk of death, to get a better sense of when and how statins should be used for women, "medicine is still an art," Mosca wrote.

Copyright 2012 ABC News Radio

Wednesday
Dec142011

Statins May Reduce Risk of Dying from Flu, Study Finds

iStockphoto/Thinkstock(PORTLAND, Ore.) -- Statins may reduce the risk of death for patients who have been hospitalized for influenza, according to a new study published in the Journal of Infectious Diseases.

Researchers from the Oregon Public Health Division analyzed data from the Centers for Disease Control and Prevention's Emerging Infections Program. The data came from more than 3,000 adult patients who were hospitalized with influenza between 2007 and 2008. One-third of the patients were either already on statins or given statins in the hospitals.

After adjusting for confounding factors, including age, race and heart and lung disease, researchers found that patients who did not take statins were twice as likely to die from influenza than those who received statins.

"Statins are a promising area for further research since the association showed statins decreased odds of dying," said Meredith Vandermeer, a research analyst with Kaiser Permanente Center for Health Research.

Flu treatments are limited to immunization and antiviral medications, but researchers said statins might be one more tool in the arsenal to treat the virus that affects about 10 percent of the U.S. population each flu season.

While past studies have found a similar link between statins, flu and death, Vandermeer said this is the first observation study to analyze medical administrative records that had better disease endpoints, and in turn, to collect data at a better level.

"The most likely explanation is that the healthier and more health-conscious patients were more likely on statins and that this was an association and not causal," said Dr. Carl Lavie, a professor of medicine at Ochsner Clinical School in New Orleans. "I doubt that many will start treating the flu with statins. I hope that maybe some that should have been on statins for definite indications maybe would get started due to the press about this topic, but I see no reason to start statins for the flu if the lipids are already good and CV risk is low."

But Cam Patterson, distinguished professor of cardiovascular medicine at University of North Carolina at Chapel Hill, said that in theory, statins may help the viral process, because they do a lot more than just lower cholesterol levels.

"They reduce inflammation that may be triggered by the influenza virus," said Patterson. "This may lead to less tissue damage from the virus, making it easier for patients to recover from severe bouts of the flu."

Copyright 2011 ABC News Radio

Thursday
Aug182011

Calcium Scores the Best Predictor of Heart Attack Risk

Comstock/Thinkstock(CORAL GABLES, Fla.) -- Joanne Leahy, 59, of Fort Lauderdale, Fla., followed her cardiologist's recommendation and had a computer tomography, or CT, scan to check her heart attack risk because of her family history of heart disease.

The procedure, called coronary artery calcium scoring -- or CAC -- checks for calcium buildup in the arteries. It rates heart attack risk and gauges the benefit of certain heart treatments, such as statins.

"It's quick, painless and an indicator of heart attack," Leahy said Dr. William O'Neill, her cardiologist and chief medical officer at the University of Miami Health System, told her at the time.

Doctors generally use a blood test to check for high levels of C-reactive protein, which can signal artery inflammation and is a potential predictor of a heart attack.

But Leahy's doctor went straight to the CAC scan as his first line of defense.

A study published Thursday in the Lancet now throws some data on O'Neill's confidence. The study suggests that screening for calcium buildup in coronary arteries, called atherosclerosis, may be a better method than a C-reactive protein test, which measures the amount of C-reactive protein in the blood, for not only predicting heart attack risk but whether a patient might benefit from statin therapy.

Researchers looked at 950 patients with no symptoms of heart disease and found that patients with the presence of calcium -- even those with low cholesterol levels -- had twice the risk for heart attack or stroke and four times the risk for heart disease than those with a calcium score of zero.

Statins, cholesterol-lowering medications, are prescribed to prevent or treat plaque buildup that could cause heart attacks. But many are prescribed statins because of such risk factors as age, high cholesterol, diabetes or a family history of heart attacks.

O'Neill said that given the study findings, "You have to ask if they [those with no calcium] should be treated with statins."

While calcium scanning is helpful in seeing whether atherosclerosis has started, for many, calcium presence in the arteries does not necessarily indicate heart disease or even a looming heart attack. Studies have yet to show that calcium scans have reduced the risk of heart attack or death from heart disease.

Some experts do not support calcium scanning, saying that a patient may be exposed to high levels of radiation at extra out-of-pocket expense.

Some experts said that since recommended heart attack prevention methods such as taking statins, losing weight or controlling blood pressure don't treat the calcium buildup, the test could lead to potentially unnecessary procedures.

CAC may benefit adults who could be at an immediate risk of a heart attack within the next 10 years, according to American Heart Association guidelines. Those risk factors include obesity, prediabetes or a family history of heart disease.

Future guidelines for primary heart disease prevention should even include CAC for high-risk patients with normal cholesterol levels, said the association.

The Lancet study was actually a substudy of a previous trial by the researchers, who looked at C-reactive protein levels in asymptomatic patients.

In an accompanying editorial, German doctors said the case made for testing CAC over C-reactive protein was so strong that they now use CAC for treatment in their clinic.

The University of Miami hospital, where Leahy works, offers CAC scans to all of its employees over the age of 50. Still, some experts said that even if a calcium score could help some patients get on such preventive therapies as statins, it's premature to suggest that all would benefit from the findings of the test.

"For a call that everyone should have one, I think we need a randomized trial to show that it is beneficial to screen and then treat differently before it could be recommended for the public," said Dr. Christopher Cannon, a cardiologist at Boston's Brigham and Women's Hospital.

Copyright 2011 ABC News Radio

Tuesday
Jun212011

Study: Higher Dose Statins Raise Risk Of Developing Diabetes

Jeffrey Hamilton/Thinkstock(GLASGOW, Scotland) -- Although cholesterol-lowering statin drugs are a backbone of current heart disease treatment and heart attack prevention, a study published last year found that long-term use of statins can increase the risk of diabetes.  Now a study conducted at the University of Glasgow complicates things a bit further by comparing the effects of moderate versus intensive doses of statins on risk of diabetes as well as heart attacks and strokes.
 
By analyzing five already published studies involving over 30,000 patients, the authors found that intense-dose statin therapy did indeed increase the risk of diabetes over a period of five years compared to moderate-dose therapy -- by 12 percent.  But at the same time, the intense-dose therapy lowered the risk of heart attacks and strokes by 16 percent compared to moderate-dose therapy.  So on one hand there is a greater risk of diabetes, but on the other, a lower risk of major cardiovascular events.  

Faced with this conundrum, the authors write in the report, published in the Journal of the American Medical Association, that physicians “should be vigilant for the development of diabetes in patients receiving intensive statin therapy.”

Copyright 2011 ABC News Radio

Friday
May272011

Combination Cholesterol Drugs Show No Added Heart Benefits

Jupiterimages/Thinkstock(BETHESDA, Md.) -- The combination of statins and niacin, both cholesterol modifying medications, doesn't reduce the chances of having a heart attack, according to findings by the AIM-HIGH trial conducted by the National Heart Lung and Blood Institute, an arm of the National Institutes of Health.

The findings prompted the NHLBI to stop their trial a year and a half early.

The AIM-HIGH study looked at patients who had lowered their LDL, or so-called bad cholesterol, with the help of statins and tried to see if raising HDL, or good cholesterol, by adding niacin to their therapy would additionally reduce the risk of having a heart attack. But the combined therapy of extended release niacin taken with statins showed no benefit in the patients tested.

Previous studies showed that low HDL cholesterol increases the risk of cardiovascular events in men and women, regardless of LDL cholesterol.

"We have had great clinical data that low HDL levels are bad for decades, but there is no evidence that raising HDL levels does anything to reduce the risk," said Dr. Cam Patterson, chief of the division of cardiology at the University Carolina at Chapel Hill.

Still, many cardiologists believe raising HDL reduces the chance of having a heart attack. In fact, the Framingham Cardiac Risk Score, a risk assessment tool used by cardiologists, looks mainly at the HDL score to assess a patient's risk of heart disease. It's unclear which HDL-raising treatments can reduce the risk of heart disease.

Niacin, found over-the-counter and frequently recommended to be taken two to three times daily, blocks the breakdown of HDL while preventing fat cells from releasing LDL. But niacin, also known as vitamin B3, has also been shown to increase the risk of stroke in some patients.

While many experts said they were surprised by the AIM-HIGH findings, some said they wouldn't abandon their longstanding belief in targeting HDL just yet.

In fact, some patients in the control group of the randomized trial may have had a longstanding history of niacin use before they started the study. The entire group of patients studied also had well-controlled LDL levels, which could indicate that their risk of heart disease or heart attack already may be lower compared to those with uncontrolled cholesterol.

Still, many doctors may be too focused on raising HDL without clear evidence of its benefits, according to Dr. Dean Ornish, founder and president of the preventative medicine research institute at the University of California San Francisco.

"There should be less emphasis on raising HDL and more on lowering LDL via diet and lifestyle, and focus on lipid lowering drugs in combination with diet and lifestyle changes to lower LDL, not raise HDL," said Ornish.

Many experts say patients should not stop taking cholesterol-lowering drugs like niacin or statins without talking to their doctor.

Copyright 2011 ABC News Radio







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