Importance of low cholesterol in very-high-risk patients and risks associated with Cox-2 inhibitor use rank among most important 2004 stories
Two cardiology topics were in the top 10
health stories of 2004, according to the Harvard Health Letter:
an increased emphasis on lowering cholesterol levels among patients
with high cardiovascular risk and documentation of cardiovascular
risks associated with use of Cox-2 inhibitors.
The importance of aggressive interventions for patients at greatest
risk for cardiovascular disease was highlighted by revised U.S.
guidelines that defined a new group, very-high-risk patients, and
set a new goal value for low-density lipoprotein cholesterol in
these patients of 70 mg/dL or less.
In September 2004, Vioxx (rofecoxib), a selective cyclooxygenase-2
(Cox-2) inhibitor, was voluntarily withdrawn from the world market
after study findings showed that risk for myocardial infarction
doubled in patients who used the drug for longer than 18 months.
In December, analysis of data from two trials of Celebrex (celecoxib),
another Cox-2 inhibitor, raised the question of its impact on cardiovascular
risk. The National Institutes of Health suspended a cancer chemoprevention
trial with high-dose celecoxib, the Adenoma Prevention with Celecoxib
(APC) trial, because analysis by an independent safety and monitoring
board showed a 2.5-fold increased risk of major fatal and non-fatal
cardiovascular events for drug use compared with placebo. Findings
from a second trial, which involved lower-dose therapy, were unclear
regarding an increase in cardiovascular risk.
Celebrex’s manufacturer pointed out that the typical dose of the
anti-inflammatory drug for patients with osteoarthritis or rheumatoid
arthritis, the original target population, is 100 to 200 mg daily
and 200 to 400 mg daily, respectively, compared with doses of 400
or 800 mg daily in the cancer chemoprevention trials.
The full list of Harvard Health Letter’s top 10 health stories
for 2004 are:
1. Cholesterol, high-dose statins. Revised government guidelines
defined a new “very-high-risk” category and set a super-low standard
of 70 mg/dL or less of “bad” LDL cholesterol for people in this
new category.
2. Cloning for stem cells. Two controversial research paths crossed
this year when South Korean scientists announced that they had created
30 cloned human embryos and harvested embryonic stem cells from
one of them. If this “therapeutic” cloning becomes acceptable and
practical, this breakthrough would make a steady supply of stem
cells available. Not only that, but the stem cells could contain
the patient’s own genes, reducing the risk that they would be rejected
by the immune system.
3. The rise and fall of Vioxx. In September, Merck pulled it’s
the Cox-2 inhibitor, Vioxx off the market after a study showed that
it doubled heart attack and stroke risk in people who took it longer
than 18 months.
4. “Smart” drugs. The latest generation of cancer drugs focuses
on abnormalities particular to tumor cells, as opposed to traditional
cancer drugs, which attack all dividing cells.
5. Bad news about drugs to be reported. A new solution has been
proposed to make sure that the findings of drug trials get reported.
Researchers would have to post information about trials in a public
database before they embarked on them to make sure the media and
the public know what trials are taking place, and when they should
look for results.
6. Walking improves cognitive activity. Taking regular walks may
also be good for your mind according to recent studies. Results
from Harvard’s Nurses’ Health Study suggest that regular physical
activity, including walking, lowers the risk for cognitive impairment
by 20% for women in their 70s. Results from another study also found
that walking seemed to afford some protection against dementia.
7. Increasing PSA velocity. Judging by the declining mortality
statistics for prostate cancer, most experts agree that PSA screening
for the disease does more good than harm. But there are other important
factors to consider besides the PSA number, including how fast PSA
levels have increased ? often called “PSA velocity.” One study found
that patients whose PSA levels had increased by more than 2.0 in
the year before a diagnosis of prostate cancer had a much higher
mortality rate than those with slower rates of increase.
8. Health care cost shifting. For the third year in a row, private
health insurers in the United States have tried to rein in double-digit
premium increases by shifting costs to their customers. One way
they do it is by increasing copayments for doctor and hospital visits.
Many insurers have tiered their drug coverage: low copayments for
generic drugs, more for brand-name medications on a “preferred”
list (a formulary), and much more for brand-name drugs that aren’t
on the formulary. Some companies are applying the same approach
to hospital care.
9. Controversy over coronary calcium scanning. Scanning coronary
arteries for signs of calcium is a high-tech way to uncover atherosclerosis
early. However skeptics believe that this test adds more cost than
benefit. Even people with minimal atherosclerosis (and almost all
Americans have some) may have a “positive” scan that leads to unnecessary
further tests and even treatment. After a press report said the
American Heart Association was getting ready to endorse the scans,
the organization decided against publishing a new statement and
reemphasized the position it took in 2000: The scans are best used
as tie-breakers when some criteria indicate increased risk and others
do not.
10. The flu vaccine shortage. The flu vaccine shortage this winter
shows that the American system for immunizing people may be a disaster
waiting to happen. Part of the problem is economic-because vaccines
aren’t big money-makers, American companies shy away from them.
Proposals to realign economic incentives to lure American companies
back into vaccine manufacturing may help, as would new advances
in the flu vaccine itself.
|