Researchers Claim Statins Heart Benefits Outweigh Diabetes Risks
Febuary 17, 2010
Reuters
By Ben Hirschler
People on cholesterol-lowering statins are 9 percent more likely to develop diabetes, but this small absolute risk is outweighed by the drugs’ heart-protecting properties, researchers said on Wednesday.
The finding is unlikely to dent the use of best-selling pills like Pfizer Inc’s Lipitor and AstraZeneca Plc’s Crestor by the majority of patients.
It could, however, prompt a rethink among those with low cardiovascular risk factors who are tempted to take statins to prevent future heart disease.
Statins are among the most successful drugs of all time and have been credited with preventing millions of heart attacks and strokes. They generally have few adverse side effects.
Experts said the latest finding, published in the Lancet medical journal, should not stop patients at moderate or high heart risk from taking statins. But it could deter a headlong rush to use them even more widely.
“It will stop us putting statins in the water, as it were, and mean we give them when appropriate for the right reasons,” lead researcher Naveed Sattar of the Glasgow Cardiovascular Research Center at the University of Glasgow told Reuters.
Past trials of statins have produced conflicting results, with some — including an influential study of Crestor in 2008 — suggesting they may cause type 2 diabetes, but others pointing to an actual reduction in risk.
LIVE-SAVING DRUGS
To resolve the issue, Sattar and colleagues carried out what is known as a meta-analysis, reviewing data from 13 large randomised controlled trials of statins between 1994 and 2009, involving more than 91,000 patients.
The result showed a clear statin-diabetes link, which researchers said was unlikely to be a chance finding. But the effect was slight and treating 255 patients with statins for four years would result in only one extra case of diabetes.
For comparison, the researchers estimated that giving statins to the same group would avoid 5.4 deaths or heart attacks over four years, and nearly the same number of strokes or artery-opening procedures would also be avoided.
“Whilst a new risk of statins has been identified, the risk seems small and far outweighed by the benefits of this life-saving class of drugs,” Christopher Cannon of Boston’s Brigham and Women’s Hospital and Harvard Medical School said in an accompanying commentary.
Sattar said the effect appeared to be common to all drugs in the statin class, although whether some may be more detrimental than others required further research.
The diabetes finding contrasts with that of cancer, where another meta-analysis two years ago concluded statins neither caused nor prevented the disease.
Just why statins should be linked to diabetes risk is unclear and cannot be explained by the fact that people on the drugs live slightly longer.
Sattar said the fact that statins cut bad cholesterol, improved blood vessel function and dampened inflammation made the link surprising. But he noted they also affected the liver and muscles, which seemed to tip the balance.
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Pfizer Triples Profits to $767 Million
February 3, 2010
Raw Story
By AFP
Pharmaceutical giant Pfizer said Wednesday fourth-quarter net income nearly tripled from a year ago to 767 million dollars, boosted by the acquisition of rival drugmaker Wyeth.
Pfizer, the maker of blockbuster cholesterol treatment Lipitor and Viagra for erectile dysfunction, said the results pushed its yearly profit for 2009 up seven percent to 8.6 billion dollars.
Revenues for the world’s biggest drugmaker rose 16 percent in the October-December period to 16.5 billion dollars, and for the year were up four percent to 50 billion dollars.
“During the fourth quarter, we closed the Wyeth acquisition and immediately began the integration of our operations, advancing the transformation of the company,” Pfizer chairman and chief executive Jeff Kindler said in a statement.
“We are pleased with the rapid pace of the integration and our ability to quickly realize the benefits of our combined organization. We remain excited about our more diverse in-line product and pipeline portfolio, which we expect will result in improved opportunities for the company in 2010 and beyond.”
The fourth quarter results amounted to a profit of 49 cents a share excluding special items, a penny below Wall Street forecasts. Revenues meanwhile were better than expected.
The jump in profits in the quarter also reflected the prior year’s charges due to litigation over its pain medications Bextra and Celebrex, and from cost cutting. Another factor was the divestment of biotech unit Vicuron required under the Wyeth tie-up.
The company’s 2010 outlook was below forecasts calling for per-share profit in a range of 2.10 to 2.20 dollars instead of 2.27 dollars expected. But its revenue outlook was better than anticipated, a range of 67 to 69 billion dollars.
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Women Weighing Breast Cancer Screening Benefits/Risks
December 23, 2009
DailyMail.co.uk
By Nigel Hawkes
Here’s a little test. Breast cancer screening reduces deaths by 25 per cent. If we assume that 1,000 women dutifully turn up to all their screening appointments, how many lives will be saved?
Remarkably, the answer is one. Not 250, or 100, or even 25 - the figures picked by a substantial proportion of gynaecologists who were asked this question.
As a recent study showed, if 1,000 women began screening at the age of 50, and had a mammogram every year, only one would have her life saved through early detection and treatment of cancer by the time screening stops at the age of 70.
Without screening, four women would have died from breast cancer. With it, three would have done so.
But in the same group, between two and ten women would also be treated needlessly - possibly with surgery, radiotherapy and chemotherapy.
And between 100 and 500 would have a false alarm, suffer worry, and need further tests before getting the all-clear. About half would undergo an unnecessary biopsy.
Here’s another example. The drug giant Pfizer claims, on the basis of a clinical trial, that its statin drug Lipitor reduces the risk of heart attacks in people with multiple risk factors - high blood pressure, high cholesterol or angina - by 36 per cent.
Assume 100 people take Lipitor for three-and-a-half years. How many heart attacks will be prevented?
The answer, once again, is one.
Without Lipitor, there would have been three heart attacks. With it, there were two.
More…
* Thousands of women still waiting months for breast cancer diagnosis despite Labour pledge
This is, indeed, close to the 36 per cent reduction claimed: Pfizer is not lying. But the bottom line is that 100 high-risk people had to take Lipitor for more than three years to prevent one of them having a heart attack. The other 99 got no benefit.
Benefits are easy to exaggerate when they are expressed in this way - and medicine is riddled with examples of inflated benefits and understated risks, misleading the unwell into unrealistic expectations and causing healthy people to worry needlessly.
The problem is called mismatched framing. Benefits are framed in one way; side-effects in another.
Expressing benefits as a relative risk - 25 per cent fewer breast cancer deaths, 36 per cent fewer heart attacks - produces a nice big number that looks impressive. But unless we know what the real underlying risk is, a percentage reduction is meaningless.
Let’s suppose that the risk to women of dangerous blood clots from a contraceptive pill is one in 7,000. A new pill is introduced and the risk doubles. Letters are sent to GPs across the country saying that the risks of the new pill are 100 per cent greater, and panic ensues.
Women give up the new pill in droves, abortions rise, and so does the risk of blood clots, since pregnancy carries a greater risk of thrombosis than the new pill.
This, of course, actually happened in 1995. If women had been told not that the risk had doubled, but it had increased by one in 7,000, would the same panic have occurred? Almost certainly not. One in 7,000 is an absolute risk increase; 100 per cent is a relative risk increase.
In medical journals, it is commonplace for benefits to be expressed in relative terms, while side-effects are given in absolute terms.
One recent study of the BMJ, the Journal of the American Medical Association and The Lancet found that a third of papers that included both benefits and harms failed to express them in the same metric.
The Academy of Medical Sciences has postponed a report on the issue until later in 2010.
In February, misleading leaflets urging women to get screened for breast cancer were withdrawn by the NHS because they failed to mention risks - false positives, invasive tests, misleading results, unnecessary operations and anxiety - and did not express benefits straightforwardly.
Public health specialists are in a bind over this. Their job is to get as many participants as possible screened, or vaccinated against flu, or whatever the latest wheeze is. So they focus on big numbers in order to make <em>not </em>participating seem like a dereliction of duty.
But what matters to the individual making a decision about whether to participate is not how it affects national statistics, but what it means to him or her.
The best way to express that is as a ‘number needed to treat’ (NNT) - that is, how many people have to take the treatment to save one event. In the case of the statin trial, the NNT would be 100. With breast cancer screening, it is 1,000.
So the chances that an individual will personally benefit are quite small: one in 100 for statins, one in 1,000 for mammography.
Some doctors argue that any treatment with an NNT of over 50 is no better than buying a lottery ticket. If women were told this, some would decide to get screened anyway. Others may prefer to opt out.
Screening is not worthless, but nor is it quite as wonderful as women have been led to believe.
Can public health doctors afford to be honest about risks and benefits? I wouldn’t bet on it. If drug companies, journals, public health campaigners and journalists are allowed to exaggerate without actually lying, who’s to stop them?
Meanwhile, the public struggle to understand what’s really best for them. Much greater transparency is needed, and fast.
Click here for the full report.
FDA Now Recommending Drugs for Healthy People
December 16, 2009
ABC News
By Peggy Peck
The joke in the world of heart disease is that “they should put statins in the water,” but to a U.S. Food and Drug Administration advisory panel that has recommended giving statins to “healthy” people, it’s no joke.
The panel voted 12 to four with one abstention to recommend that the potent statin Crestor (rosuvastatin) be approved to prevent heart attacks in people who have no history of heart disease and don’t fit the traditional profile of an “at risk” population.
The FDA is not obligated to follow the advisors recommendations, but it often does. If it did so this time, it would mark a first — a drug normally used to lower dangerously high LDL (bad) cholesterol in people with a history of heart disease or risk factors to develop heart attacks or strokes would be approved for the prevention of heart attacks in healthy people.
The new label as recommended by the advisors would state that the drug should be given to men age 50 or older and women age 60 or older who have LDL cholesterol of less that 130 mg/L and triglycerides of less than 500 mg/L if — and this too is a first — the patient also had an elevated blood level of C-reactive protein, a marker for inflammation.
The committee’s vote was immediately seized upon by cardiologists who characterized using terms ranging from “great news” to “courageous.”
“If the FDA accepts this recommendation, it will expand the number of Americans eligible for statin therapy by millions,” said Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic.
Dr. James Stein of the University of Wisconsin School of Medicine and Public Health called the vote “very significant,” adding that if approved, “it will also, have the (possibly) unintended consequence of increasing highly sensitive CRP testing in the U.S.”
Dr. Cam Patterson, a professor at the University of North Carolina School of Medicine, agreed with Stein. “It’s been difficult to find a compelling reason to order CRP levels on patients,” Patterson said. “This is some guidance from the FDA about how to take high CRP levels into account, and that is good news.”
And Patterson predicts that clinicians will see this as a signal to use other statins for this population as well. Although the panel vote dealt only with the Crestor label, Patterson said pointed out that another popular statin — Lipitor — will be available as a generic in 18 months. “It will be tough to justify paying a premium price for Crestor when another high potency statin is available at a much cheaper price.”
The basis for the new indication was the JUPITER study of almost 18,000 men and women, average age 66. All patients in the study had no history of heart disease, but did have an elevated level of the marker called CRP.
Patients in the study took 20 mg of Crestor or a sugar pill placebo for 1.9 years. At the end of that time, the patients taking Crestor had an average LDL cholesterol of 55 mg/dL– down from 109 mg/dL when they started the study.
And compared with patients who took the placebo, the Crestor patients had a 44 percent reduction in heart attacks, stroke, need for surgery or stenting to open clogged arteries, or death from heart disease.
For every 25 people treated with Crestor, a heart attack, stroke, or death was prevented.
Those results, according to Dr. Melvyn Rubenfire of the University of Michigan, were a “home run for JUPITER” but it is not clear if the results would be same with another statin.
Noting that the panel’s vote was a “somewhat courageous decision”, Rubenfire said the “issue now is how the FDA, physicians, and insurers approach the results. That is, ‘are all statins the same?’ The robustness of the results are unique to Crestor.”
But there were some risks associated with Crestor, including 13 deaths due to gastrointestinal disorders in study subjects taking rosuvastatin, and 18 patients reported a “confused state” while taking the drug.
The most troubling adverse event, however, was an uptick in investigator reported new onset diabetes mellitus in the treatment arm, 2.8 percent versus 2.5 percent, or an increased risk of 27 percent.
Although the advisory committee agreed that the benefit of rosuvastatin outweighed the risk, it said that patients should be carefully monitored for diabetes and they admonished the manufacturer to “carefully define the target population in marketing materials.”
Click here for the full report.
Drug Companies and Doctors Make Billions on Swine Flu
October 14, 2009
ABC News
By Dalia Fahmy
Americans are still debating whether to roll up their sleeves for a swine flu shot, but companies have already figured it out: vaccines are good for business.
Drug companies have sold $1.5 billion worth of swine flu shots, in addition to the $1 billion for seasonal flu they booked earlier this year. These inoculations are part of a much wider and rapidly growing $20 billion global vaccine market.
“The vaccine market is booming,” says Bruce Carlson, spokesperson at market research firm Kalorama, which publishes an annual survey of the vaccine industry. “It’s an enormous growth area for pharmaceuticals at a time when other areas are not doing so well,” he says, noting that the pipeline for more traditional blockbuster drugs such as Lipitor and Nexium has thinned.
As always with pandemic flus, taxpayers are footing the $1.5 billion check for the 250 million swine flu vaccines that the government has ordered so far and will be distributing free to doctors, pharmacies and schools. In addition, Congress has set aside more than $10 billion this year to research flu viruses, monitor H1N1’s progress and educate the public about prevention.
Drugmakers pocket most of the revenues from flu sales, with Sanofi-Pasteur, Glaxo Smith Kline and Novartis cornering most of the market.
But some say it’s not just drugmakers who stand to benefit. Doctors collect copayments for special office visits to inject shots, and there have been assertions that these doctors actually profit handsomely from these vaccinations.
It is a notion that Dr. Lori Heim, president of the American Academy of Family Practitioners, says is simply not true.
“According to most of the physicians I have talked to, the administration of these vaccines is done for the community’s benefit as opposed to anything that helps profit,” she says. Heim adds that even though doctors will not have to shell out for the H1N1 vaccine, they will bear the usual costs associated with storage and administering the shots.
“There is an administration fee, for the costs that you can’t get reimbursed through Medicare or Medicaid,” she says. “This is usually less than, or right at the break-even point.”
Still, pharmacies also charge co-payments or full price of about $25 to those without insurance and often make more money if patients end up shopping for other goods.
“Flu shots present a good opportunity to bring new customers into our stores,” says Cassie Richardson, spokesperson for SUPERVALU, one of the country’s largest supermarket chains. Drawing customers to the back of a store, where pharmacies are often located, offers retailers a chance to pitch products that might otherwise go unnoticed.
Even companies outside of the medical industry are benefiting: the UPS division that delivers vaccines in specially designed containers, for example, has seen a bump in business.
New Entrants in Flu Shot Business
The intensifying competition has irked some doctors.
“Retailers and other non-medical professionals have siphoned off the passive income that once helped to cover medical overhead,” says Dr. Caroline Abruzese, an internist in Atlanta. “The larger retail chains can invest up front in large volumes of vaccine at low prices, and market to customers already in their stores.”
The promise of profits has attracted new players into the business. Some of the world’s largest drugmakers, who in the past avoided the vaccine market because of its limited scope — its not easy to convince healthy adults to get a shot for measles — are now jumping into the fray.
Last month alone saw three large vaccine deals. Abbott Labs bought a Belgian drug business, along with its flu vaccine facilities, for $6.6 billion. Johnson & Johnson invested $444 million in a Dutch biotech firm that makes and develops flu vaccines. Merck, which already makes vaccines for shingles and other diseases, struck a deal to distribute flu shots made by Australian CSL.
Smaller biotechs are also angling for a slice of the action, making vaccines one of the fastest-growing areas of research in the biotech industry.
Large and small drugmakers are drawn to the business largely because of scientific advances that promise to radically expand the range of health problems that vaccines can address. In addition to preventing childhood diseases such as measles and polio, vaccines can now also ward off cervical cancer, and researchers are working on vaccines for HIV and tuberculosis.
Scientists believe they can create therapeutic vaccines than treat diseases such as Alzheimers and diabetes after they have set in. (At least one company is betting on a vaccine that helps cigarette smokers quit.)
“These innovations broaden the market potential for vaccine makers and partly explained the renewed interest by drugmakers,” says Anthony Cox, a professor at Indiana University’s Kelley School of Business who specializes in the marketing of medical products.
But Mark Grayson, a spokesperson for the Pharmaceutical Research and Manufacturers of America, which represents the country’s leading pharmaceutical research and biotechnology companies, says that drugmakers are also compelled by the government to join efforts to ensure that there is enough vaccine to go around.
“Because of national security implications, the government felt that they needed to encourage and ask [vaccine manufacturers] to move much quicker,” he says. Grayson adds that vaccine manufacturers also face significant costs; aside from the expense of fitting a new vaccine into a tight production schedule, drugmakers GlaxoSmithKline and Sanofi Pasteur were forced to acquire new vaccine production facilities in recent years to keep up with demand.
Alternatives to Vaccines Are Few
While this promise of new treatments for painful diseases brings hope to many, vaccines continue to attract critics. The National Vaccine Information Center, a non-profit advocacy group, is at the forefront of a movement demanding that vaccines be tested more thoroughly before hitting the market. Although there has been little evidence to support their claim, detractors — including the comedian Jim Carrey — believe that vaccines are at least partly to blame for the sharp rise in autism in recent decades.
The swine flu vaccine has also attracted its share of critics. Frank Lipman, a New York-based doctor who specializes in a mix of Western and alternative medicine, points out that the swine flu is rarely fatal and that it’s too early to tell if it’s safe because it hasn’t been widely tested.
Others argue that Americans have little choice. The cost of a widespread pandemic, similar to Spanish Flu outbreak in 1918, which killed 675,000 Americans (and 50 million worldwide), would be devastating. The Trust for America’s Health, a Washington-based non-profit organization, estimates that a severe pandemic could push down GDP by more than 5 percent and cost Americans $683 billion.
“We’re not seeing a pandemic that’s this severe,” says Jeff Levi, director of Trust for Americas Health. “We’ve dodged a lot of bullets.”
Click here for the full report
Misbranding drugs leads to Pfizer paying $1.3 billion in criminal fines
October 19, 2009
Natural News
By Mike Adams
In the largest criminal fine ever levied against any drug company in the world, a unit of U.S.-based Pfizer, Inc. was sentenced to pay $1.3 billion in criminal fines and revenue forfeiture. It’s all part of a $2.3 billion settlement announced by the Justice Department. The case centers around Pfizer’s criminal “off-label marketing” of four drugs, including the painkiller Bextra. After whistleblowers filed lawsuits in three states, the U.S. Justice Department took an interest in the case and prosecuted Pfizer for criminal acts.
In the settlement, Pfizer admitted to a felony crime and agreed to pay $2.3 billion in fines and other fees. The investigation of Pfizer reportedly turned up evidence that Pfizer engaged in kickback payments to doctors for nine drugs, including Viagra and Lipitor.
Part of the reason the penalty against Pfizer was so large is because the company was considered a “repeat offender” in promoting drugs for unapproved uses (which is a violation of federal law).
Off-label marketing makes a mockery of modern medicine
So-called “off-label” marketing of drugs is rampant in the pharmaceutical industry. Although the FDA, drug companies and many conventional doctors claim the drug industry is guided by a “gold standard” of scientific scrutiny, the truth is that pharmaceuticals are routinely marketed and prescribed for health conditions for which they have never even been studied… much less actually approved by the FDA. The fact that this continues today makes a mockery of any “scientific credibility” the pharmaceutical industry claims to possess.
Drug companies take advantage of this gaping hole in regulatory oversight by getting their drugs approved by the FDA for one health condition, then heavily promoting it for numerous unrelated conditions. A drug approved for high blood pressure, for example, could be openly marketed for diabetes or Alzheimer’s disease even though there is no evidence whatsoever showing the drug to be either safe or effective for such conditions.
The same is true with the intended demographics of pharmaceuticals: Drug companies often get their drugs approved for adults, then they market those drugs to children even though the drugs have never been tested with children.
The result is a pharmaceutical industry that appears to be highly regulated, but isn’t. Virtually any drug can be pushed for any disease for almost any reason — all with virtually no oversight by the FDA. In fact, in this Pfizer case, even with the Justice Department filing criminal charges against Pfizer, the FDA has stood by and done absolutely nothing to prevent such actions from being repeated in the future by Pfizer or another drug company.
Click here for full report from Natural News
Statins Cause Serious Structural Muscle Damage
August 27, 2009
Natural News
By S.L. Baker
If there is a super star in Big Pharma’s list of money making drugs, it may well be the group of medications known as statins. The New York Times reported last year that statins are, in fact, the biggest selling drugs in the world. Their names, like Lipitor and Crestor, are familiar from countless television and magazine ads and almost everyone knows someone taking a statin. Promoted widely as safe, they are actually known to cause a litany of potential side effects. For example, the National Institutes of Health web site notes that about one in 1,000 of those taking statins suffer from muscle pain. Usually, these aches go away. But not always. And now new research shows that in some people statins cause serious structural damage to muscles.
The study, just published in CMAJ (the Canadian Medical Association Journal) suggests that patients who are taking statins and who complain to their doctors about muscle tenderness or pain could well be describing severe muscle problems due to the drugs. Although muscle damage is usually associated with elevated levels of an enzyme called creatine phosphokinase, the CMAJ research shows that’s not always the case. And it may take muscle biopsies to show that underlying structural injury has occurred.
The study was conducted by scientists from the University of Bern, Switzerland and the Tufts-New England Medical Center in Boston, Massachusetts. The research team investigated muscle biopsies from 83 patients. Twenty of these had never taken statins. The results showed significant muscle injury only in people who had taken statin drugs. Perhaps what was most surprising is that several people who were no longer taking statins were found to still have significant structural muscle damage.
“Although in clinical practice, the majority of patients with muscle symptoms improve rapidly after cessation of therapy, our findings support that a subgroup of patients appears to be more susceptible to statin-associated myotoxicity, suffering persistent structural injury,” Dr. Annette Draeger from the University of Bern and her coauthors wrote in the CMAJ article.
The study did not address whether statins might cause other significant body-wide damage. However, it is interesting to note that the very organ statins are supposed to protect, the heart, is a muscle. And that raises troublesome questions about possible long term, not-yet-known side effects statin drugs may have on the heart itself.
The researchers did note in a statement to the media that there is “a need to evaluate alternative treatment strategies for patients with significant muscle symptoms.” As Natural News readers are well aware, there are already well-known natural health strategies that lower cholesterol levels safely, without any possibility of muscle damage. For example, previous research has shown certain foods, including tofu, almonds, cereal fiber and plant sterols, can lower total cholesterol and LDL, the “bad” cholesterol, better than statins. Weight loss, increased intake of Omega-3 fatty acids and exercise are also drug-free strategies that lower cholesterol safely.
Click here for the full report from Natural News
Statins May Cause Muscle Damage in Some Patients
July 6, 2009
Forbes
Statins, medications widely used to lower cholesterol, may cause structural damage to the muscles of people experiencing muscle aches and weakness, a new study has found.
The damage may occur even when tests for a protein thought to signal injury are normal, and may persist even after statin use is halted, according to the study in the July 7 issue of the Canadian Medical Association Journal.
The researchers stressed that people not experiencing significant pain had no cause for alarm and should continue taking the medicine.
About 10 to 15 percent of people taking statins report myalgia, or minor muscle aches and weakness, according to the study authors. A smaller number have stronger, persistent pain, called myopathy.
In the study, researchers biopsied leg muscle tissue from 83 patients: 44 were taking statins and had serious and persistent muscle pain; 19 were taking statins and had no myopathy, and 20 had never taken statins or suffered myopathy.
Of the 44 with myopathy, 29 were still taking a statin at the time of the biopsy, while 15 had discontinued their use for at least three weeks.
Biopsies showed that 25 of the 44 with myopathy had muscle damage, defined as injury to 2 percent or more of the muscle fibers.
Yet only one patient showed elevated levels of creatine phosphokinase (CPK), an enzyme expressed inside skeletal muscle cells, said study co-author Dr. Richard Karas, director of preventive cardiology at Tufts Medical Center in Boston.
Elevated levels of CPK in the blood can mean the enzyme is leaking out of the muscle cells, indicating muscle damage.
“This paper is challenging the dogma that if the CPK level is low, it rules out the possibility of muscle damage,” Karas said. “You can have microscopic muscle damage and the level of CPK can still be normal.”
The researchers also found that most participants showed signs of muscle injury even after they’d stopped taking statins.
“Although in clinical practice, the majority of patients with muscle symptoms improve rapidly after cessation of therapy, our findings support that a subgroup of patients appears to be more susceptible to statin-associated myotoxicity, suffering persistent structural injury,” said senior study author Dr. Annette Draeger of the University of Bern, Switzerland.
A study presented in September at the American Physiological Society meeting found that statins may hinder the body’s ability to repair muscles. Muscle cells exposed to increasing doses of simvastatin (Zocor) showed less ability to multiply and, therefore, heal and regenerate.
Over the past decade, statins have become the best-selling drug in America, accounting for $14.5 billion in sales in 2008. The drugs, which work in the liver to prevent the formation of cholesterol, are used in the prevention of coronary artery disease.
In the new study, 41 percent of those experiencing myopathy were taking simvastatin (Zocor); 31 percent were taking pravastatin (Pravachol); 17 percent were taking atorvastatin (Lipitor); 7 percent were taking fluvastatin (Lescol), and 3 percent were taking rosuvastatin (Crestor).
The study participants were experiencing pain severe enough to interfere with daily tasks and exercise.
The authors note that the sample size was too small to determine if one drug was associated with increased complaints of muscle pain or damage.
American Heart Association spokesman Dr. Roger Blumenthal said studies such as this may help doctors learn why some people develop statin-related side effects while others don’t.
In the study, the researchers noted that expression of ryanodine receptor 3 was heightened in those with structural muscle damage, offering a clue to the genetic underpinnings for those who suffer statin-related side effects.
“It’s a very interesting study,” said Blumenthal, director of the Johns Hopkins Ciccarone Preventive Cardiology Center in Baltimore. “This whole issue of why about one in 50 people on statins gets recurrent or severe muscle pain is very frustrating for physicians.”
Known risk factors for muscle pain include old age, high doses of statins, exercising vigorously while on statins and certain medications, including warfarin (Coumadin), cancer drugs, oral medications for fungal disorders and certain antibiotics, which interfere with the removal of statins from the body.
In 2001, cerivastatin (Baycol) was withdrawn from the market because of a high incidence in rhabdomyolysis, a widespread breakdown of skeletal muscle tissue.
Click here for the full report from Forbes.com
