High Doses of Statins Carry Dangers, Swedish Report Says

[Guest guest]

High Doses of Statins Carry Dangers, Swedish Report Says

http://www.kasa.com/Global/story.asp?S=4978481 & nav=9E5B

By Reinberg

HealthDay Reporter

THURSDAY, June 1 (HealthDay News) -- A Swedish warning on the

potential risks of using statins in high doses has triggered strong

criticism from some of the top U.S. cardiologists.

The timing of the debate is apt: Recently revised recommendations in

the United States call for lowering cholesterol more than ever before

as a way of reducing the risk of heart disease, and that translates

into more people taking statins, and in higher doses.

That trend is troubling, claims a report in the June 3 issue of the

British Medical Journal, because the side effects of taking these

cholesterol-lowering medications in higher doses could be potentially

dangerous.

However, U.S. experts said this is not the case and that the authors

of this article ignored the findings of many large clinical trials

that show the benefits and safety of statins, even in large doses.

The American National Cholesterol Education Program said last year

that people at high risk of heart disease should be treated more

aggressively. Aggressively lowering cholesterol means that LDL

cholesterol should be lowered to less than 1.81 millimoles per liter

of blood (mmol/l) in high-risk individuals. Current guidelines

generally recommend 2.56 mmol/l.

According to Uffe Ravnskov, an independent researcher from Lund,

Sweden, achieving this new goal would mean that most of the western

world's adult population would be on statins, and doses would have to

be more than eight times higher than currently used.

Doses this high would increase both the number and seriousness of

side effects, Ravnskov's team contended. Side effects could include

heart failure, myalgia and rhabdomyolysis (which destroys muscle

tissue), neurological problems and cancers.

In addition, the researchers claimed that clinical trials suggest

that higher doses of statins do not lower overall mortality, and side

effects are generally under-reported.

" In the paper we have argued in detail why we distrust the reporting

of side effects in the statin trials. There are many indications that

they are under-reported. It is a question of confidence, " Ravnskov

said.

And any reduction in nonfatal events from the use of high doses of

statins may be outweighed by more numerous and more severe side

effects, Ravnskov's group concluded.

However, one expert thinks Ravnskov's group is entirely wrong.

" Ravnskov's arguments are not compelling, " said Dr. E. Nissen,

interim chairman of the department of cardiovascular medicine at the

Cleveland Clinic, and president of the American College of

Cardiology. " High doses [of statins] are safe. "

Nissen noted that many studies have shown these drugs are

safe. " There are side effects, " he said. " But most people tolerate

these drugs very well. There is no data on heart failure, there is no

good data on neurological symptoms, and there is certainly no

compelling data on cancer. "

Nissen believes that the benefits of these drugs outweigh the

risks. " Ravnskov is understating the benefits, which have been shown

in dozens of clinical trails across large populations, " he said.

Statins are not for everyone, Nissen noted. In terms of how low

cholesterol should be, Nissen said it depends on who you are. " If you

have existing coronary disease, probably as low as possible, " he said.

" When you examine Ravnskov's arguments, which have been around for

longer than I have, they just don't cut it, " Nissen said.

Another U.S. expert agreed with Nissen.

" The authors in this article are stating that occasional side effects

that are entirely reversible should be given greater consideration in

therapeutic decision-making than significant reductions in the risk

of myocardial infarction and stroke, " said Dr. Gregg C. Fonarow, a

professor of cardiology at the University of California, Los Angeles.

" There are countless well-controlled trials demonstrating [that] the

benefits of statin therapy greatly outweigh the potential risks, even

at high doses, " he said.

The study authors overlooked data from multiple randomized clinical

trials that disprove their statements, Fonarow added. " They

selectively cite studies only if it supports their viewpoint, even if

the totality of evidence negates their view. "

" For example, they state that statins may cause heart failure, but

seem to be unaware of the studies showing that statins lower the risk

of heart failure compared to placebo, " Fonarow said.

" The views expressed in this article are not consistent with other

very careful and scientifically rigorous analyses on this subject, "

Fonarow said. " Nor are they consistent with peer-reviewed statements

from the American Heart Association, American College of Cardiology,

nor the National Heart, Lung, and Blood Institute. "

However, one of the authors of the article disagreed with the idea

that statins carry no dangers. " If you look at the data, that's not

really true, " said Dr. Morley C. Sutter, an emeritus professor of

pharmacology at the University of British Columbia.

" They upset the liver, they upset muscle function, and it is possible

that they alter brain function, " he said. " The fact that they have as

little undesirable effects as they do is quite miraculous. "

The reason this information isn't taken into account is due to the

large commercial interest in statins, Sutter claimed. " It's the

biggest-selling drug in the world -- billions of dollars, " he said.

As far as taking a statin to prevent a heart attack, Sutter said he's

against it. " Certainly, unless I had a heart attack, I would not take

a statin, " he said. " If I were a woman, I would not take a statin

because there is no evidence that they help women. "

The American Heart Association can tell you more about statins

(www.americanheart.org target =_new) and other cholesterol-lowering

drugs.

SOURCES: E. Nissen, M.D., interim chairman, department of

cardiovascular medicine, Cleveland Clinic, and president, American

College of Cardiology; Gregg C. Fonarow, M.D., professor, cardiology,

University of California, Los Angeles; Uffe Ravnskov, independent

researcher, Lund, Sweden; Morley C. Sutter, M.D., emeritus professor,

pharmacology, University of British Columbia, Vancouver; June 3,

2006, British Medical Journal