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DO CHOLESTEROL-LOWERING DRUGS BENEFIT WOMEN?
"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."
By Maryann Napoli
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 65 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 is the associate director of the Center for Medical
Consumers in New York City.
"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."
By Maryann Napoli
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 65 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 is the associate director of the Center for Medical
Consumers in New York City.
