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Red Yeast Rice Supplements: Not a Safe Alternative to Statins

Posted by medconsumers on July 1, 2009

Many people who cannot tolerate any of the cholesterol-lowering drugs called statins (e.g., Lipitor, Pravachol, Zocor) turn to an herbal supplement called red yeast rice, which lowers the low-density lipoprotein (LDL) cholesterol. Statin intolerance is most often chalked up to muscle pain (myalgia). A rare side effect of all statins is the potentially fatal disease called rhabdomyolysis, which causes destruction of the skeletal muscles.

A new trial, with only 62 statin-intolerant participants, randomly assigned them to take either red yeast rice supplements (1800 mg) or a placebo twice daily for six months. All took part in a 12-week program of education, diet, exercise, and relaxation sponsored by a local cardiology practice.

Both groups lost weight but the people taking the supplements showed greater reductions in LDL than the people on placebos. And the supplement group did not suffer more muscle pain. Yet despite these promising findings, the editorial that accompanied this study, published recently in Annals of Internal Medicine, advised doctors not to recommend the red yeast rice supplement. Reason: it is “an unapproved, unstandardized form of lovastatin labeled as a nutraceutical.”

The basis for this charge is a 2008 test of ten different brands of red yeast rice supplements by ConsumerLab.com. This independent testing group revealed that all ten supplements contained naturally occurring statin compounds in varying doses—some as high as that of prescription statins. This explains why the supplement used in the new study contained lovastatin (sold under the brand name: Mevacor).

There are other reasons why the new trial failed to show that supplements are better than statins. It lasted only six months and thus could not rule out the possibility that red yeast supplements taken longer would cause muscle pain. Unlike statins, the supplements have not been proven to reduce the risk of heart attack and stroke. The new study was primarily funded by the Commonwealth of Pennsylvania.

For information on the risks and small benefits of statin drugs, read this. And if you are taking Zetia or Vytorin, read this. And if you want to know more about statin drugs vs. the Mediterranean diet, read this.

Maryann Napoli, Center for Medical Consumers©

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Take a Closer Look at Statin’s Benefit

Posted by medconsumers on December 1, 2008

Going on Statin’s? Take a New Look at the Size of the Benefit

The current practice of advising healthy adults to go on prolonged drug therapy just got a big boost from a large international trial. It found that people with normal cholesterol can halve their risk for heart attack and stroke by taking the cholesterol-lowering statin drug Crestor (generic name: rosuvastatin). Although at low risk for heart disease, all the participants had high blood levels of C-reactive protein, or CRP, which indicates the presence of inflammation within the artery walls.

This trial, which is expected to greatly expand the market for Crestor, was funded by its maker, AstraZeneca. And it is the brainchild of the lead author Paul M. Ridker, MD, who co-owns the patent on the CRP test. The 17,802 participants—men 50 or older and women 60 or older—were randomly assigned to take either 20 mg Crestor or a placebo each day. Results were so definitively in favor of Crestor that the trial was stopped three years ahead of its five-year schedule. Millions more healthy Americans are now candidates for Crestor, and there is talk of including a CRP screening with the routine blood test for cholesterol.

The findings from this trial called JUPITER were first presented early last month at a meeting of the American Heart Association. The next day, they became freely accessible at the Web site of The New England Journal of Medicine days before the intended publication date—a move that signals the importance of new trial results.

Crestor’s 50% reduction in cardiac events was widely reported in the media, but few reporters explained that this statistic is actually far more modest than meets the eye. JUPITER’s finding is, in fact, no different from the results of other trials designed to test whether a drug can prevent a disease in healthy people—only a tiny minority will benefit from years of drug therapy.

If the small chance of benefit is important to you, so too is this critical look at JUPITER.

50% reduction explained:

JUPITER defined cardiac events as heart attack, stroke or confirmed death from cardiovascular causes. According to the editorial that accompanied JUPITER, at least one of these cardiac events occurred in 1.8% of the participants in the placebo group (157 of 8,901 participants) and 0.9% of those taking Crestor (83 of the 8901 participants). In short, over the nearly two-year duration of the trial, few of these low-risk people had a cardiac event whether they were taking Crestor or not. To single out cardiovascular deaths, there were 37 deaths in those taking placebos and 31 deaths in those on Crestor.

What it means to you:

If you fit the profile of the people who participated in JUPITER, your chance of benefiting from Crestor is also explained in the editorial that accompanied JUPITER: For every 120 people who take Crestor for nearly two years, one cardiac event will be avoided. Or, put another way: Out of every 120 people who take Crestor, 119 will receive no benefit.


Profile of the participants:

JUPITER excluded people with diabetes, high LDL cholesterol, uncontrolled hypertension, cancer diagnosed in the past five years, or inflammatory ailments, such as severe arthritis, lupus or inflammatory bowel disease—among other conditions too numerous to mention in this space.


Stopping JUPITER early:

All major trials have a Data and Safety Monitoring Board. For ethical reasons, JUPITER’s DSMB stopped the trial as a majority of participants neared the two-year mark when those on the placebo had nearly 1% more cardiac events than those on Crestor. The early stopping of trials, an increasingly common practice, has been criticized by researchers and consumer groups. It favors the drug company’s interest since more adverse effects are likely to be reported if the trial is allowed to continue. On the other hand, the benefit may also increase. Some of the JUPITER participants were tracked for nearly five years. The difference in favor of Crestor continued a steady increase as these participants neared the five-year point.


Adverse events:

There was a small increase in the diagnosis of type 2 diabetes in people taking Crestor. This increase comes close to the nearly1% benefit shown for Crestor. Newly diagnosed diabetes was reported in 3.0% of people on Crestor and 2.4% of people on placebos. The rate of any serious adverse event was the same whether participants were taking Crestor or a placebo. However, JUPITER followed participants for a median of 1.9 years, and people take statins for the rest of their lives.


Other long-term statin info:

Since 1995, nine primary prevention trials, comparing a statin drug with a placebo, have been published. They followed participants for about five years. Although all the trials collected serious adverse events, all have failed to make the complete data available to researchers. Thus, the safety of statins is unknown.

Interesting statistic:

25% of the participants in JUPITER who were assigned to take Crestor had stopped taking the drug when the trial was stopped at 1.9 years.

Noteworthy aspects of JUPITER:

This is the first trial to have a representative proportion of female, Hispanic, and African-American participants. Findings were separated out according to subgroups which showed that the reductions in cardiac events were roughly the same for all—50%.

Noteworthy previous research:

JUPITER is not the first trial to show that a statin drug can benefit people with no history of heart disease or high LDL cholesterol. Other statins—e.g., lovastatin (Mevacor), pravastatin (Pravachol)—produced similar, though slightly smaller, reductions in cardiac events. These studies, which date back to 1999, provided the first hints that the benefit of statins may be unrelated to their cholesterol-lowering effect (they are far better at lowering cholesterol than they are at lowering the risk for stroke, heart attack and death).


Cost:

Crestor is still under patent and is therefore not available generically. A month’s supply of Crestor is $105. The cost of statins, including generic versions, can vary considerably, according to Consumer Reports. A month’s supply of another statin, sold generically as simvastatin, can cost $30 at some retail pharmacies and as little as $6 at Costco.

Inflammation and heart disease:

The role of CRP and inflammation in heart disease is hotly debated, according to The New York Times, which quoted Paul M. Ridker, MD, the lead author of JUPITER, saying that he believes inflammation plays an important role, probably by causing plaque in the arteries to rupture. Dr. Ridker went on to say, “Screening for cholesterol alone is like having two passengers in a car but only one air bag. If we’re not screening for CRP, we don’t have the opportunity to save that person’s life.” Dr. Ridker, a cardiologist at Harvard Medical School, co-owns the patent on the test that measures CRP. He is expected to earn millions of dollars once it becomes part of the routine blood test for all adults.


Other conflicts of interests:

Dr. Ridker and most of his 13 JUPITER co-authors have received grants, lecture and consulting fees, and other funding from AstraZeneca and other drug companies, many of which make statin drugs. The list at the end of the JUPITER paper in The New England Journal of Medicine was so extensive that it took up six inches of tiny type.


Should you be tested?

Some say JUPITER calls into question the prevailing hypothesis that high cholesterol is a major risk factor for heart disease. This position is bolstered by the long-known, but oft-forgotten, fact that half of all heart attacks occur in people with normal cholesterol levels. Many assume that CRP testing will soon become routine.

In one of their excellent podcasts recorded at the University of British Columbia, Vancouver, (www.ti.ubc.ca), James McCormack, Pharm.D, and Michael Allan, MD, dismissed the obsession among some researchers who are trying to tease out whether statins work by lowering cholesterol, or reducing inflammation or some other mechanism. McCormack and Allan say that statins clearly reduce the risk for cardiac events, and this was shown to be 1% in low-risk people like the JUPITER participants. Other trials show the benefit is higher in high-risk people, e.g., the 2% benefit for those who have had a heart attack or stroke. If these benefit rates sound good to you, say McCormack and Allan, then just take the statin and forget about having your CRP or cholesterol measured—they add nothing to the decision.


For more information:

To read the JUPITER trial findings, click here. Physicians from all over the world have answered the journal’s survey, asking whether JUPITER will change their practice. Their comments can also be read at the Web site.

Maryann Napoli, Center for Medical Consumers ©

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Why is Anyone Taking Zetia or Vytorin?

Posted by medconsumers on October 1, 2008

Vytorin and Zetia Continue to be Prescribed Despite Hints of Harms and No Proof of Benefit

There is no proof that Zetia can do anything beyond lowering cholesterol—no evidence that it can reduce heart attacks or cardiovascular disease, which, of course, is the ultimate goal. Once again, this blockbuster drug sold alone or as a combination medicine has produced negative clinical trial results. This time it failed to provide any benefit to people with heart-valve disease. Worse, there were more cancers and cancer deaths among the drug-treated participants than in those taking a placebo, though these findings are described as “due to chance.”

Release of preliminary results of this trial had generated so much interest in the media last summer that The New England Journal of Medicine allowed the final results to be available on its Web site in early September—well in advance of the planned publication date.

Zetia is a relatively new cholesterol-lowering drug that can be prescribed alone. Vytorin combines Zetia with the 22-year-old statin drug, called simvastatin (brand name Zocor), into a single pill. Last year this expensive, heavily promoted combination drug became what only can be described as a drug maker’s worst nightmare. Study results showed that Vytorin was no better at reducing atherosclerosis of the carotid (neck) arteries than the older, cheaper simvastatin alone. There was also a hint that Vytorin might actually worsen artery disease.

And if that’s not bad enough, Merck and Schering-Plough Corp., which jointly market Vytorin, had withheld these unfavorable study results for nearly two years. It was, of course, in the financial interest of both companies to do so because Vytorin and Zetia are among the top-selling drugs worldwide. Four years after both drugs went on the market, backed by an aggressive ad campaign that featured a “food and family” cholesterol theme, yearly sales reached $5.2 billion.

On its Web site last month, The New England Journal of Medicine also published an editorial and an analysis that addressed Vytorin’s possible cancer-causing effect. The analysis was based on all the people diagnosed during the new heart-valve study and two other, much larger ongoing Vytorin trials. It was conducted by an Oxford University, U.K, research team, which found no increase in cancer incidence, but did find an increase in cancer deaths among those taking Vytorin. This finding was described as due “entirely to the play of chance rather than to a true increase in cancer mortality.”

The New England Journal of Medicine editors, however, are not so sure. In an editorial, they described a plausible mechanism for a cancer-causing effect, “[Zetia] interferes with the gastrointestinal absorption not only of cholesterol, but also other molecular entities that could conceivably affect the growth of cancer cells.” Once the cancer concerns were made public again last month, the FDA announced that its own analysis is in the works.

What makes this Vytorin/Zetia story so appalling is the fact that Zetia’s only advantage over the older statin drugs is a 17% greater reduction in LDL cholesterol. Incredibly, Merck and Schering-Plough were able to sell doctors and the public on the idea that this is more important than proof that this drug can cut the risk of heart attack (which has been proven for statins prescribed to high-risk men and people with heart disease). Zetia was studied for only 12 weeks before it went on the market.

Despite their uncertain safety records, Zetia and Vytorin continue to be prescribed to people with high LDL cholesterol. After the initial bad publicity, sales of Vytorin and Zetia dropped 40% in the first six months of 2008. That’s encouraging. But the question remains: Why is anyone still taking these drugs?

Maryann Napoli, Center for Medical Consumers ©
October 2008

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Failed Vytorin Study Raises Questions About Cholesterol

Posted by medconsumers on February 1, 2008

A firestorm of bad publicity erupted over cholesterol drugs last month when an expensive combination drug proved to be no better than an older drug alone. This finding was suppressed for 20 months by Merck and Schering-Plough, the two companies that make Vytorin, which is a one-pill combination of Zetia and Zocor. Their two-year trial failed to prove that Vytorin is better than Zocor alone for slowing plaque accumulation; instead atherosclerosis worsened in those taking Vytorin.

But the study results were not revealed until the two drug companies were pressured into doing so by an article in The New York Times and a Congressional inquiry. Worldwide, about one million prescriptions for Vytorin and Zetia are written each week, and they generated about $5 billion in sales last year. Zocor can be purchased under its generic name simvastatin for less than $6 for a month’s supply; whereas an equivalent amount of Vytorin costs about $100. It was obviously in the two companies’ interest to withhold the negative results for as long as they could get away with it.

When Vytorin came on the market two years ago, it was impossible not to be cynical about its purpose. Merck’s patent for Zocor was running out, and its blockbuster status would soon be diminished with generic competition. The company joined forces with Schering-Plough, maker of Zetia, and sought FDA approval for Vytorin. Their FDA-required trials showed a 17% greater reduction in LDL, the so-called bad cholesterol, than Zocor alone.

Making this 17% reduction in LDL look like an amazing achievement was not much of a stretch. Merck and the makers of other statin drugs like Lipitor and Pravachol had already paved with way. Their respective marketing machines had long ago misled most of us (doctors included) into thinking that cholesterol reductions equal heart attack reductions. One consistently overlooked fact about statins: They are far better at lowering cholesterol than preventing heart attacks or strokes. And those small reductions in heart attacks and strokes shown in clinical trials are largely confined to high-risk middle-aged men and those with heart disease or diabetes. Vytorin, on the other hand, has not been proven to reduce heart attacks or strokes in anyone.

LDL Reduction Irrelevant

Though doctors tend to focus their statin-taking patients on the size of their LDL reductions, heart disease researchers have long ago noted that this is likely irrelevant. Statin trials often show that the size of the cholesterol reductions are not consistent with reductions in heart attacks. Such observations led researchers to suspect that the ability of statins to reduce heart attacks and strokes has less to do with cholesterol reduction and more to do with other biological effects like plaque stability and anti-inflammatory effects. Another important but overlooked observation: “Elevated LDL identify less than one half of individuals who will die from coronary heart disease” (Rosenson et al. Antithrombotic Properties of Statins, JAMA, May 27, 1998).

The fall-out from the Vytorin debacle continues to reverberate. At this writing, Merck and Schering-Plough are running full-page ads daily in the Times and Wall Street Journal, warning people not to be confused by a single study and to continue taking Vytorin. The advice was backed by the American Heart Association, which appeared to be an independent source until The Times reported that the AHA receives nearly $2 million a year from Merck/Schering-Plough Pharmaceuticals.

One of the unintended consequences of two drug companies withholding their negative trial results is that it led some in the media, notably Alex Berenson, an investigative reporter for the Times, to look back at another important failed cholesterol drug trial and question the very foundation of heart disease prevention. In his heretically titled article “Cholesterol as a Danger Has Skeptics,” Berenson cites Pfizer’s trial of its much-anticipated drug torcetrapib that raised HDL, the good cholesterol, and lowered LDL. The trial had to be stopped in 2006 because the drug caused heart attacks and strokes. (Sound familiar? Postmenopausal hormones were widely prescribed because they were so good at improving cholesterol levels but they also increased the risk of heart attack, stroke and blood clots.) “Torcetrapib’s failure shows that lowering cholesterol does not prove a drug will benefit patients,” said a skeptical Walter Reed cardiologist quoted in Berenson’s article.

Many researchers, physicians and scientists around the world have long questioned the import of high cholesterol for anyone other than middle-aged men. In fact there is an International Network of Cholesterol Skeptics (disclosure: we belong), but the skeptics have been marginalized over the years. Now some mainstream media like Business Week and the cardiology Web site, TheHeart.org are willing to give them voice.

Could the house of cards be falling? Would the house of cards be allowed to fall when a worldwide $40 billion-a-year industry is at stake?

For More Information

The International Network of Cholesterol Skeptics www.thincs.org

Business Week magazine (www.businessweek.com) click into past issues, January 17, 2008 Lipitor cover story: “Do Cholesterol Drugs do any Good?”

TheHeart.org from Web MD www.theheart.org, see video blog of Eric J. Topol, MD, who questions the import of LDL reduction in “Temple of the LDL Cholesterol.”

Maryann Napoli, Center for Medical Consumers ©
February 2008

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Statins and Mediterranean Diet

Posted by medconsumers on February 1, 2007

One might reasonably expect the U.S. government’s cholesterol-treatment guidelines to be firmly based on scientific evidence. Certainly, that was the claim of the National Cholesterol Education Program when it issued an updated report in 2004. What alarmed some researchers and consumer advocates at the time was the expansion of statin use to include people who do not have heart disease but are supposedly at “moderately elevated risk” for developing it.

The updated guidelines would put an additional 23 million Americans on statins for the rest of their lives. A cloud of doubt hung over the entire issue once it became known that the majority of physicians who established the guidelines had financial ties to companies that make statin drugs.

Statins, the top-selling class of drugs in history, are cholesterol-lowering drugs that include atorvastatin (Lipitor), lovastatin (Mevacor), pravastatin (Pravachol), fluvastatin (Lescol), simvastatin (Zocor) and rosuvastatin (Crestor). Their benefit to people with heart disease is proven, but there is a controversy regarding the use of these drugs by everyone else. Three-quarters of all Americans now on long-term statin therapy do not have heart disease.

In a recent issue of the medical journal, Lancet, John Abramson, MD, Harvard Medical School, and James Wright, MD, University of British Columbia, Vancouver, co-authored a commentary entitled, “Are Lipid-Lowering Guidelines Evidence-Based?” They conducted an analysis of all the major trials in which participants were randomly assigned to take either a statin or a placebo. The seven trials that included adults between 30 and 80 years old who already have heart disease clearly showed that statins lower the risk of a cardiac death as well as a death from any cause.

However, their analysis of the other trials that included healthy but high-risk people without heart disease showed that statins should not be prescribed to women of any age who do not have heart disease or diabetes, or to men older than 69 years who do not have heart disease or diabetes because no benefit was shown for them.

There is a modest benefit for men aged 30-69 years who are at high risk of developing heart disease. Out of 50 high-risk men taking a statin every day for five years, only one avoids a “cardiac event” —that is, a heart attack or heart-related death. Put another way, out of every 50 men who stay on statins for five years, 49 risk an adverse drug reaction for no benefit. “In our experience,” wrote Drs. Abramson and Wright, “many men presented with this evidence do not choose to take a statin, especially when informed of the potential benefits of lifestyle modification on cardiovascular risk and overall benefit health.”

*****

What follows is an interview with the lead author of this analysis, John Abramson, MD, who is also the author of the 2004 book entitled, “Overdosed America” and serves as an expert consultant to plaintiffs’ attorneys in litigation involving the drug industry including Pfizer and Lipitor. He is interviewed by Maryann Napoli.

MN: Whenever I write about statins, I get calls from readers that indicate many are misled about their level of risk. Typical is the healthy woman over the age of 65 pressured to take statins by her doctor who says that she is at high risk for a heart attack solely because of age and high cholesterol.

JA: 1) The evidence shows that the higher her cholesterol, the longer she will live; 2) no trial shows that statin therapy will benefit her; 3) people over 65 who exercise routinely, eat a Mediterranean-style diet, don’t smoke, drink moderately, will have a 60% lower rate of death than the people who don’t do these things.

MN: That one trial with people over 70, called PROSPER (PROspective Study of Pravastatin in Elderly at Risk), is often misrepresented.

JA: This trial clearly showed the limited benefit of statins in the elderly. For those who already have cardiovascular disease, taking a statin reduces the risk of heart attack or cardiac death. But it also showed that people in this age range who are at increased risk of, but do not have, cardiovascular disease do not benefit from taking a statin. Importantly, the study also found that at four years, there was one extra new cancer for every 70 people taking a statin. No reduced risk of stroke and no benefit for people without cardiovascular disease and an increased risk of cancer, yet millions of elderly Americans without heart disease or diabetes are taking these drugs because they and their doctors are misled into believing that clinical trials have shown that statins are beneficial.

MN: And people who have had a heart attack?

JA: Statins are definitely helpful for people who have already had a heart attack. Still, the Lyon Diet Heart Study shows how much more effective a healthy diet is in reducing the risk of heart attack for these folks. The participants were randomly assigned to receive counseling about a Mediterranean-style diet (see end of article) or a standard post-heart attack diet. Those who went on the Mediterranean-style diet developed 72% less heart disease than those in the control group. There was also a 56% lower death rate and 61% less cancer than the people in the control group. Simply eating a Mediterranean-style diet is nearly three times more effective at preventing recurrent heart disease and death in post-heart attack patients than is taking a statin. Even more surprising, those on the Mediterranean-style diet did not have lower cholesterol than those eating the standard post-heart attack diet. So when your doctor tells you to get your cholesterol down…keep that in mind.

MN: Lifestyle changes aren’t given much attention.

JA: The vast majority of communication about heart disease is influenced by the drug companies. They focus on cholesterol, rather than diet, exercise, and not smoking because their primary responsibility is to maximize the financial return to their investors, and that’s where the money is. All but one of the major statin trials was funded by a company that makes statins.

MN: That should make us all wary—studies show that the majority of drug company-funded studies produce results favorable to their product.

JA: The ALLHAT [Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial] was the only one of the 14 major statin trials included in the most recent review [published in the Lancet in October 2005] not funded by a drug company. It included a good mix of people: men and women with and without heart disease and/or diabetes. Half of the participants were randomly assigned to be treated with a statin and half to go to their regular doctor and do whatever he or she thought was right. By the end of the study, 26% of the people assigned to “usual care” had been put on a statin by their doctors and 77% of those in the statin group were still taking the statin (the others discontinued because of side effects, other medical conditions, etc.). But the results showed that there was no less heart disease or death in the group with three times as many people taking statins.

MN: These results seem to be widely misperceived.

JA: One of the reasons is a misleading editorial that accompanied the publication of ALLHAT in the Journal of the American Medical Association. It stated: “Physicians might be tempted to conclude that this large study demonstrates that statins do not work; however, it is well known that they do.” That’s not quite what I think of as evidence-based medicine. The editorialist actually had the chutzpah to suggest that statins may be less effective when they are prescribed by primary care physicians, as they were in the ALLHAT, than by cardiologists. At the time of the editorial, the writer had financial relationships with at least seven drug companies. He is now employed by Merck, which makes Zocor.

MN: All but two of the statin trials failed to report their serious adverse events, defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, requires prolongation of hospitalization, or results in significant disability.

JA: The statin trials that report only the drug’s effects on heart disease are not presenting what we all really need to know. The most important question is: What is the overall effect of taking the drug? In other words, if a statin decreases the risk of heart disease but does not reduce the overall risk of serious illness or death unrelated to heart disease, is it worth taking? And the difficulty of answering this question ought to lead people to wonder if there are alternative ways to reduce the risk of heart disease.

MN: Why do journals allow drug companies to publish only heart-related results of their trials?

JA: Medical journals are not fulfilling their responsibilities when they publish trial results and omit all serious adverse events and deaths from all causes.

MN: Any parting thoughts?

JA: People ask, “Why can’t I just take a pill, eat what I want and forget about going to the gym?” And I say to them: If the pill worked, that would be a good question, but there just isn’t any evidence from clinical trials showing that statins are beneficial for women or older men who don’t already have heart disease or diabetes. Healthy lifestyle changes are a more effective, less expensive, and safer way to reduce your risk of heart disease and improve your chances of staying healthy overall.

For information on the Mediterranean-style diet: go to www.americanheart.org and type into the search box: Lyon Diet Heart Study.

Maryann Napoli, Center for Medical Consumers ©

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Statins: Low Odds of Benefit

Posted by medconsumers on July 1, 2006

Statin-Treatment Guidelines: 198 to 1 odds that the drug won’t help

Would you go on long-term statin drug therapy if you knew that the odds are one in 23,000 that the drug will save you from a cardiac death? How about one in 198? And are you prepared to stay on that drug for the rest of your life, though the full story on the drug’s harms is yet to be known? That is what the experts who put together the U.S. and Canadian statin-treatment guidelines expect of the public, according to an analysis published last month in the British Medical Journal.

So much of medical decision-making boils down to probabilities. What is my chance of having a heart attack? And how will this drug reduce the risk? Cholesterol drug ads, for example, proclaim a 25% reduction in heart attack. But that means nothing unless you know your personal odds of a heart attack. Always ask: 25% of what?

If, for example, you are a healthy middle-aged woman with high cholesterol but a tiny chance of having a heart attack in the next five years, then the drug offers a 25% reduction in those already miniscule odds. But, if you are a middle-aged male smoker who has already had a heart attack, then the 25% reduction offers a large benefit.

Researchers who study drug trials have another way of determining odds called number needed to treat. They frame the research question this way: How many people must take this drug every day for five years to save one person from a cardiac death? That formula is the basis of the new analysis of international guidelines for prescribing the cholesterol-lowering statin drugs that include Lipitor, Mevacor, Zocor, Pravachol, Crestor, and Lescol. It highlights some major deficiencies in the information intended to guide physician prescribing practices. And in turn, deficiencies in the information consumers need to make informed decisions.

The statin-treatment guidelines from five countries—Australia, Canada, New Zealand, the U.K., the U.S.—and several European medical societies were assessed by a team of Canadian researchers led by Douglas G. Manuel, MD, of the Institute for Clinical Evaluative Sciences in Toronto. The number needed to treat was determined by applying each set of guidelines to the same population of 6,760 Canadian men and women, aged 20 to 74 years.

The “winners” are the Australian and British guidelines because they are the most effective in potentially avoiding the most deaths. However, the New Zealand guidelines were deemed the most efficient because they potentially avoided almost as many deaths while recommending statin drugs to the fewest people. Based on the New Zealand guidelines, the number needed to treat is 108, or for every cardiac death prevented, 108 people must take statins for five years. (By comparison, the number needed to treat is 198 and 154, for the U.S. and Canada, respectively.)

What is most troubling about the results of this new analysis is not just that the U.S. and Canadian guidelines identify a larger pool of people as candidates for statin therapy in order to prevent one cardiac death. But it is also the fact that the crucial topic of drug-related harm was ignored by those who established the guidelines. “Treatment guidelines don’t discuss harms. I don’t know why,” said Douglas G. Manuel, MD, the lead author of the analysis, in a telephone interview.

“Harms are idiosyncratic, meaning everyone has more or less the same chance of harm. I say that with lots of caveats,” explained Dr. Manuel, a scientist and primary care physician. “But this is not so where it concerns benefits. If a person is at high risk because he has had a heart attack, then the benefit [of statin therapy] will be large. But as a person’s risk of heart disease gets lower, then I am more uncomfortable [about prescribing statins].”

The harm question was put to David Atkins, MD, medical officer at the U.S. Agency for Healthcare Research and Quality, the lead federal agency charged with improving the quality, safety, efficiency, and effectiveness of health care for all Americans. “Many guidelines about drugs skirt around the issue of harms,” he said in a telephone interview. “With anti-hypertension drugs, for example, side effects include sexual dysfunction and dry mouth, but they affect a small number of people—2-5%.” They are not addressed, Dr. Atkins explained, because it “complicates the message too much.” What’s more, he said, “Doctors tend to regard the issue of side effects as trivial in light of a heart attack.”

All of the statin-treatment guidelines are purportedly evidence based, meaning they are drawn from the same published results from clinical trials in which participants have been randomly assigned to take a statin or a placebo and followed for about five years. However, a healthy skepticism is in order where it concerns women without heart disease. A 2003 government report, Diagnosis and Treatment of Coronary Heart Disease in Women: Systematic Reviews of Evidence on Selected Topics, concluded, “There is insufficient evidence to determine whether lipid lowering [i.e., with drugs, diet or other lifestyle changes] reduces risk for any clinical outcome [e.g., heart attack, stroke].” The main reasons for the “insufficient evidence” are: women are underrepresented in statin trials and most of the trials pool the results of men and women together.

Informed decision-making about statin therapy is hampered further by another problem with medicine’s gold standard evidence—the randomized clinical trial, according to Dr. Manuel. “My expectation to get good information about harms from a randomized clinical trial is somewhat low because we are missing key parts of the information about adverse events from drugs in general, not just statins. What we need is better postmarketing surveillance,” he said, referring to mandatory reporting of adverse drug reactions after a new drug goes on the market. (Currently, reporting is voluntary and captures less than 10% of all serious adverse drug reactions.)

The FDA-required clinical trials conducted prior to approval usually have a few thousand participants at best. Only when hundreds of thousands of people begin taking a drug for years do the rare or uncommon serious adverse reactions come to light. Cardiologists are often quoted in the media saying that statins are safer than aspirin, but they are likely unaware that drug trials frequently fail to report all serious adverse reactions. (To see how common it is for drug companies to withhold information about adverse reactions suffered by clinical trial participants, see “Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.”)

Statin trials are a case in point. James Wright, MD, and colleagues at the University of British Columbia conducted a 2003 review of all five statin primary prevention trials and found that the serious adverse events* went unreported in three of these published trials. When Dr. Wright was asked for an update, he explained by e-mail that the serious adverse events were collected in all 12 major statin trials. However, ten of these trials have failed to report these important results (i.e., make them publicly available). Worse, the authors of these trials refused the UBC reviewers’ repeated requests for the harms data.

Treatment guidelines may be aimed at physicians, but the brunt of their deficiencies will be borne by the people who unquestioningly follow their doctors’ recommendations, especially those who are at low risk of developing heart disease. Understanding the probabilities that relate to the drug as well as your own personal risk is crucial to informed decision-making.

If your doctor says that statin therapy will reduce your odds of having a heart attack by 25% but cannot answer the question—25% of what?—here is how to do it yourself. Go to the National Heart, Lung and Blood Institute Web site for the less than perfect 10-year risk calculator. If, for example, you have a 2% chance of having a heart attack in the next ten years (two out of 100 people with exactly your risks), then the 25% reduction from statin therapy will bring your odds down to 1.5%. Predictably, the quiz, or anything else on this Web site, won’t help you understand the odds of harm or benefit from statin drugs. It is easy to see why pharmaceutical companies like to convey benefit in terms of a 25% reduction in their ads without explaining what that means or how it relates to a person’s baseline risk of having a heart attack. It is much harder to understand why information gathered and disseminated by a government agency funded with taxpayers’ money would not be more forthcoming.

Bottom Line: The new analysis of international guidelines shows a wide variation in the number needed to treat, though all are based on the same clinical trials. Harms are not addressed, possibly because there is a consensus among cardiologists that statins are safe and that serious side effects are rare. But there is also a consensus among people who study the FDA’s postmarketing surveillance system that less than 10% of all serious adverse drug reactions are reported to the agency. Inefficient guideline like those from Canada and the U.S. will send many people to statin therapy who have only a low risk for heart disease. Using the Canadian guidelines, Dr. Manuel and colleagues estimated that at least 23,000 low-risk people would have to take statins for five years to prevent one death from heart disease.

* Defined as “any untoward medical occurrence that results in death, is life-threatening, requires hospitalizations, requires prolongation of hospitalization, or results in persistent or significant disability.”

Maryann Napoli, Center for Medical Consumers ©

Controversy over U.S. Cholesterol-Treatment Guidelines

On July 12, 2004, the U.S. National Cholesterol Education Program updated its statin-treatment guidelines, greatly expanding the pool of candidates for statin drugs. They include men and women without heart disease but who have a moderately high risk of developing it, plus low-density lipoprotein (LDL) levels between 100 and 129 mg/dL; and those with heart disease and LDL levels between 70 and 100 mg/dL. The new recommendations are applied to men and women regardless of age. Overnight, millions more Americans became eligible for life-long statin therapy.

Within days of the announcement, two reporters at Newsday revealed that eight of the nine physicians on the committee that established the new guidelines had strong financial ties to companies that make statin drugs.

Two months later an open letter went to the media and the heads of the National Institutes of Health (NIH) and its division, the National Cholesterol Education Program, calling for the creation of an independent review panel free of conflicts of interest to conduct another review of all the new data from the five studies that led to the updated recommendations. The letter was written by Merrill Goozner of the Center for Science in the Public Interest and signed by 36 physicians, researchers, scientists, and politicians.

The letter charged that the expanded guidelines do not reflect the evidence. Among the objections: the evidence does not support the broad use of statins in women (including those at “moderately high risk”) and people over 70 without heart disease. And there is conflicting evidence about the value of statins to people with diabetes. Additionally, the letter asked whether the lower levels of LDL are justified by the scientific evidence.

A point-by-point response came in a letter from Barbara Alving, MD, NIH acting director, which is also available on the NCEP Web site. A new panel will be formed when results of the ongoing trials are available and the guidelines require another update, wrote Dr.Alving, and future guidelines will be posted in draft form on the National Heart, Lung, and Blood Institute Web site, along with “financial disclosure information.”

Maryann Napoli, Center for Medical Consumers ©

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Vytorin: Yet Another Cholesterol Drug

Posted by medconsumers on February 1, 2006

Vytorin Ads Aimed at Keeping Profits High

“Pay no attention to direct-to-consumer ads for prescription drugs. These are meant to sell drugs, not educate consumers, and they only add to the prices you pay.” Even if you follow this wise advice offered by Marcia Angell, MD, in her acclaimed 2004 book, The Truth About Drug Companies, chances are you will have one of the following drugs prescribed by a physician. They are currently advertised heavily to doctors as well as the general public. Not surprisingly, the most aggressively promoted drugs wind up to be the most frequently prescribed…and the most frequently given out as free samples. In many cases, there are lower cost alternatives.

Vytorin to Lower Cholesterol

When a blockbuster drug is due to lose its patent protection—and blockbuster is usually defined as sales over a billion dollars a year—the drug company must find creative ways to keep the profits high. Vytorin illustrates one path commonly taken by drug companies. This drug is the creation of the pharmaceutical giant Merck, which will soon face competition from cost-cutting generic drug companies when its blockbuster cholesterol-lowering drug, Zocor, goes off patent this year.

Working with another drug company, Schering-Plough, Merck has come up with Vytorin.  Sometimes referred to as the newest statin, the top-selling class of cholesterol-lowering drugs in the world, Vytorin combines an older statin, Zocor (generic name: simvastatin), with a newer cholesterol-blocking drug called Zetia, made by Schering-Plough. To allow plenty of time to sell doctors the idea that they should prescribe a newer, more expensive drug, Vytorin came on the market in 2004—well before Zocor’s patent runs out. Its sales have risen steadily ever since.

How Long Did the Vytorin Studies Last?

People are usually on cholesterol therapy for life; yet the two FDA-required clinical trials lasted only 12 and 23 weeks, respectively. In both trials, participants were randomly assigned to take either Vytorin, a placebo (sugar pill), Zocor, or Zetia. The study participants taking Vytorin showed greater reductions in the so-called “bad cholesterol,” or low-density lipoproteins. Whether Vytorin is better than any other single-ingredient statin drug at reducing the risk of a heart attack or stroke has not been studied.

Cautions:

Statins are great at lowering cholesterol; but they are much less impressive at lowering the risk of heart attack and stroke in people without heart disease. Media reports usually refer to statins as safe or well tolerated. Rarely is it mentioned that virtually all the clinical trials involving statins were conducted by the drug’s manufacturer. And many of these drug trials have failed to release all the data involving adverse reactions. [See the review of primary prevention trials www.ti.ubc.ca, Letter #48.] Therefore, the safety of long-term statin use remains unknown. Even less is known about the safety of the other drug in Vytorin, called Zetia, which works by partially blocking the absorption of cholesterol in the small intestine. Zetia was approved by the FDA in 2002 based on its cholesterol-lowering ability, shown in two trials that lasted only two and eight weeks, respectively.

Alternatives:

Two statins, Zocor and Pravachol, will become available generically this year, and only one, lovastatin (brand name: Mevacor), is already available generically for $1.00 to $1.88 a day, compared with $4.00 a day for the top-selling statin, Lipitor. If you are taking an expensive statin, ask your doctor whether you can switch to generic lovastatin. No long-term head-to-head comparison trial of all six statin drugs has been conducted to determine whether Lipitor is superior to the others in reducing the risk of heart attack or stroke.

Maryann Napoli, Center for Medical Consumers ©
February 2006

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Do Cholesterol-Lowering Drugs Benefit Women?

Posted by medconsumers on June 1, 2004

Many doctors have come to believe that the cholesterol-lowering drugs called statins (Lipitor, Zocor, Pravachol, Mevacor, Crestor) are safer than low-dose daily aspirin. That becomes apparent whenever statins are featured in the media as a wonder drug for the prevention of heart disease. In fact, there’s a growing consensus among cardiologists that all adults should take a statin whether or not they are at high risk.

Yet women have been underrepresented in the major clinical trials in which people with and without heart disease were randomly assigned to take a statin or a placebo (dummy pill) every day for several years. Women made up less than one-third of all the study participants. Put that together with the fact that women under the age of 75 years have a low rate of heart attack and stroke. Add this disturbing bit of news from University of British Columbia researchers who conducted a thorough review of the five prevention clinical trials: only two of the five trials released their data regarding the serious adverse effects* suffered by the study participants who were taking statins. Working with what they had, that is, the data from only two of the statin trials, the researchers found that statins did not prolong life for men or women. Worse, the benefit of taking statins (a reduced rate of non-fatal heart attacks and stroke) was offset by an increase in the serious adverse events. Until all the statin trials release their serious adverse effects data, the public will not know whether these drugs are safer than low-dose aspirin.

The sparse information that people receive about cholesterol treatment was unintentionally but aptly illustrated recently by one of the country’s top medical journals. The Journal of the American Medical Association, or JAMA, regularly publishes a “patient page,” which amounts to a layman’s translation of one of the more important papers published in each issue.

The May 12, 2004 issue of JAMA contained a review of all trials in which women with high cholesterol had been randomly assigned to take a drug or a placebo. (Most of the trials involved a statin.) Judith M.E. Walsh, MD, MPH, and Michael Pignone , MD, MPH conducted the review. Their conclusion: For women without heart disease, drugs did not prolong life or reduce the odds of dying of heart disease. The drug may reduce non-fatal cardiac events (heart attack, stroke, etc.), but “current evidence is insufficient to determine this conclusively.” For women with heart disease, drugs do not affect mortality but will reduce non-fatal events.

Turn to the patient page in the same issue of JAMA, and none of this important information can be found. Instead, six sentences are devoted to statins explaining how they work; the need for regular lab tests to check for statin-induced liver damage; the possibility of muscle damage, etc. The reader will find nothing about the drugs’ effectiveness (or ineffectiveness) in preventing or treating heart disease. The rest of the page was given over to the usual information about exercise and smoking cessation. Worse, it has outdated information about the importance of a low-fat diet; despite the fact that a review of all relevant studies found that it has little effect on heart disease prevention (see below). The patient page is intended for physicians to photocopy and give to their patients.

And what about the unreported serious adverse effects of statin drugs? Not a mention in the patient page, of course, but there it was in the “comments” section of the JAMA article. At the end of their review, Drs. Walsh and Pignone discuss possible explanations for why statins do not prolong life for women with heart disease. The drugs reduce the odds of dying of heart disease, but that benefit is canceled by a higher rate of death from other causes.

“Possible explanations include chance, the limitation that not all studies reported both heart disease and total mortality… Another potential explanation might be an increase in a competing cause of mortality, for example, an increase in hemorrhagic stroke with cholesterol-lowering therapy. However, information on the causes of non-heart disease mortality is not available for all the trials, so this possibility cannot be proven. [emphasis added] Publication of cause-specific mortality for many of the larger trials could help to clarify the association between cholesterol-lowering therapy and total mortality.”

There you have it, the full story is not yet available on the safety of cholesterol-lowering drugs, though these trials were published years ago. Traditionally, researchers design trials to answer specific questions. In this case: Does this drug reduce the rate of heart attacks and strokes or the rate of cardiovascular death? But the drug itself might cause deaths from other causes, and as Drs. Walsh and Pignone wrote, not all studies reported deaths from other causes. These concerns are relevant to men, as well.

As for the doctors who say that statins are safer than aspirin, they might one day be proven correct. But it took more than 100 years to get the full story on aspirin. (In fact, there might be more to learn.) Gastrointestinal bleeding and rarely, hemorrhagic stroke are both potentially fatal side effects of chronic use of aspirin, even at low doses. And the dangers of giving aspirin to children who have flu or chicken pox have only been known to be associated with the rare risk of Reye’s syndrome for less than 30 years.

For More Information:

- Go to the Web site, sponsored by the above-mentioned University of British Columbia researchers (www.ti.ubc.ca). In the archives, locate Therapeutics Letter No. 48 “Do statins have a role in primary prevention?

- Go to the archives of the British Medical Journal at www.bmj.com for the review of all studies assessing the heart disease prevention benefit of reduced dietary fat intake. Find the March 31, 2001 issue featuring “Dietary fat intake and prevention of cardiovascular disease: systematic review” by Lee Hooper et al.

*Serious adverse effects are any untoward medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, or results in persistent or significant liability.

Maryann Napoli, Center for Medical Consumers (C)
June 2004

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Cardiologists Poised to Give Everyone Lipitor

Posted by medconsumers on April 1, 2004

The findings were considered to be so important that The New England Journal of Medicine made the study freely available on its Web site one month earlier than the April 8 publication date. Two cholesterol-lowering statin drugs—Lipitor (atorvastatin) and Pravachol (pravastatin)—were compared in a clinical trial that involved 4,162 people who had been hospitalized for a sudden attack of chest pain due to heart disease. Lipitor proved to be more effective at reducing the rate of deaths from heart disease, heart-related problems and the need for procedures, such as bypass surgery and angioplasty. Once the news caught media attention, the reporting made the benefit appear larger than it is.

Some of the participants, all of whom had heart disease and low levels of LDL, the so-called bad cholesterol, benefited from even further reductions in their LDL with Lipitor. The finding is widely expected to lead to a lowering of what constitutes the ideal level of LDL. Currently, people are told to keep their LDL below 100 mg.

The participants had been randomly assigned to take either a higher than normal dose of Lipitor (80 mg) or the standard 40 mg dose of Pravachol each day. Because of the high stakes, drug companies rarely pit their drug against a competitor in a clinical trial. Bristol-Myers Squibb, maker of Pravachol, lost big time by sponsoring this trial. It was designed to prove that Pravachol, which had been losing market share, is just as good as the more costly high dose Lipitor.

At the time this trial was planned, Pravachol’s highest dose was 40 mg. The study is known by the catchy name of Prove It, or Pravastatin or Atorvastatin Evaluation and Infection Therapy.

Here are the differences in outcomes in the Prove It trial: After two years, the people on Pravachol had a combined rate of heart attack, bypass surgery, angioplasty, stroke and death of 26.3% compared with 22.4% for people on Lipitor. The death rate from heart disease was 1.1% for the Lipitor group compared to 1.4% for the Pravachol group. The rate of death from any cause was 2.2% for people on Lipitor and 3.2% for people on Pravachol.

These 1- 3% differences in favor of Lipitor have cardiologists across the country quite excited and ready to raise the statin dose and lower the threshold for safe LDL levels. The Prove It results would be exciting if we had the full picture on high-dose Lipitor. As is often the case, the serious adverse effects experienced by the study participants taking Lipitor were not reported.

Christopher P. Cannon, MD, who led the Prove It trial, was asked about this information gap. “We do plan a separate full publication of all the safety data soon…the journal only allows a certain amount of space for only one paper,” he responded by e-mail. “There were more liver function test abnormalities with Lipitor at 80 mg, but these were all transient and were resolved when the dose was stopped or reduced.” Still, adverse reactions caused nearly one out of every three participants to stop the drug. 3% more people in the Lipitor group stopped taking the drug. Besides liver failure, muscle pain is a known consequence of high-dose statin therapy.

Dr. Cannon said that his study found Lipitor to be better than Pravachol for both men and women, though women represented only 22% of the participants (911). The above-quoted statistics apply to all participants, and the researcher did not break things down to show how large the benefits are to women, or whether they have a higher rate of serious adverse reactions.

90% of participants were white and the rest were not specified. This leaves an information gap for everyone else. Earlier studies have shown that Asians, for example, are at a higher risk for severe muscle damage if they take any statin at daily doses of 80 mg. For unknown reasons, the drug tends to remain in the body longer in Asians, which raises their odds of this and other adverse effects. Dr. Cannon and colleagues suggest that their findings point to the need for 62 mg as the new LDL threshold for people with “established coronary heart disease.”

Judging from the media reports of Prove It trial, many cardiologists seem poised to extend its results to people without heart disease. None of the physicians quoted in the media warned that this would amount to a dangerous experiment. In all the previous clinical trials that involved people without heart disease, statin drugs were administered in doses no higher than 40 mg. Only one prevention trial involved people taking Lipitor. None lasted more than seven years.

Interestingly, the new results have revived an old controversy about whether the benefits of statins are due to their cholesterol lowering, anti-inflammatory or some other effects. “Unfortunately, we do not know the precise mechanism of action responsible for atorvastatin’s [Lipitor's] superiority,” wrote Eric J. Topol, MD, of the Cleveland Clinic in an accompanying editorial. Dr. Topol believes that “only a fraction of the patients who should be treated with a statin are actually receiving such therapy.” He sees cost as the biggest stumbling block. Lipitor, at the recommended starting dose of 10 mg, is about $900 per year. At the 80-mg dose used in the Prove It trial, Lipitor costs about $1,400 per year.

What you can do
Here are several non-drug ways to reduce your odds of having a heart attack.

  • Cut trans fatty acids from your diet because they have long been known to be damaging to the heart. Trans fatty acids are formed during the hydrogenation of either vegetable or fish oils. They are used extensively in processed foods to ensure a longer shelf life. Certain foods like donuts, potato chips and other snack foods are particularly high in trans fatty acids. Look for the words “partially hydrogenated oil” or “shortening” on the ingredients list.
  • Take niacin supplements. The Coronary Drug Project followed 3,908 men taking a placebo or niacin therapy for nine years. The niacin group had a lower rate of non-fatal heart attacks and an 11% lower rate of all-cause mortality than the men in the placebo group. A recent survey of the various types of niacin on the market found that immediate-release niacin is the least expensive and safest version to purchase (and the no-flush niacin products are useless, see HealthFacts January 2004).
  • Add heart healthy foods with omega-3 fatty acids and folic acid to your diet. Omega-3 fats can be found in fish, omega-3-enriched eggs, walnuts and flax seeds. Folic acid is in green vegetables, beans, wheat germ and certain fruits and vegetables.

Maryann Napoli, April 2004

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Niacin Supplements for Cholestrol-Reduction: Not All Brands are Equal… and Some are Dangerous

Posted by medconsumers on January 1, 2004

by Maryann Napoli

Many people take over-the-counter niacin as a replacement for, or complement to, cholesterol-lowering drugs. A new survey shows that these products do not always contain the amount of niacin, or nicotinic acid (vitamin B 3 ) described on the label. The survey found broad variations in the products, ranging from no available niacin to toxic levels of niacin. The inconsistencies are attributed to the fact that niacin is classified by the FDA as a dietary supplement. This means that the product is entirely unregulated; therefore, the manufacturers do not have to prove quality, safety, or efficacy.

The survey of niacin products was conducted by C. Daniel Meyers, MD, Veterans Affairs Medical Center, Long Beach, CA, and colleagues, who acknowledged that niacin is one of the first agents found to raise the level of good cholesterol (HDL) and lower the level of bad cholesterol (LDL) and triglycerides when taken in daily doses of 1,000-4,000 mg. The worst side effect is “niacin flushing,” that is, redness, itching, burning, which starts within 10-15 minutes after swallowing the tablet and can last up to an hour.

Dr. Meyers and colleagues looked at 29 commonly used over-the-counter niacin products (500-mg tablets or capsules) from three categories: Immediate-release, sustained-release, and “no-flush.” They calculated the monthly cost for each product purchased in pharmacies, health-food stores or over the Internet. Ironically, the no-flush preparations, the most expensive ($21.70) of all, do not contain free* nicotinic acid. Some brands of the sustained-release preparations contain amounts of niacin so high as to be toxic to the liver.

In yet another ironic twist, the best products are the least expensive ($7.10). They are the immediate-release preparations, which contain, according to Dr. Meyers and colleagues, “the full amount of free nicotinic acid used safely for more than 40 years” and “shown to prevent cardiovascular disease and death.” The cheapest brands in this category are Rugby, Bartell’s, Natural Factors—all are under $5.19 for a one-month supply (Annals of Internal Medicine, 12/16/03). In most people, the niacin flushing becomes less pronounced with time, according to Dr. Meyers and colleagues, who wrote, “Both the frequency and severity of flushing episodes decrease with repeated doses…Some trials, however, show that 40% of the people stopped taking niacin because of this side effect.”

The biggest irony of all regarding niacin is the likelihood that it is safer and just as effective as statin drugs—for men, that is. In the introduction to this survey, Dr. Meyers and colleagues cite the Coronary Drug Project, which followed 3,908 men taking a placebo or niacin therapy. After nine years of follow-up, the men in the latter group had not only a lower rate of non-fatal heart attacks but also an 11% lower rate of all-cause mortality than the men in the placebo group. Statin drugs lower cholesterol and reduce the rate of non-fatal heart attacks in men, but they do not reduce the rate of cardiovascular or overall death (See Statin Drugs: How Safe? How Effective?).

*The full amount, as designated on the label.

January 2004

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