Simvastatin
Lowers CV Risk and Mortality Regardless of Levels
This
information could save about 50,000 lives a year — that is, a
thousand each week."
Simvastatin,
but not antioxidants, lowered cardiovascular (CV) risk and mortality
in the Heart Protection Study (HPS), that, according to two reports in
the July 6 issue of The
Lancet. The
benefit of simvastatin was proportional to the CV risk, not to the
baseline cholesterol concentration.
"HPS
shows unequivocally that statins can produce substantial benefit in a
very much wider range of high-risk people than had been previously
thought," investigator Rory Collins, from the University of
Oxford in England, says in a news release. "These new findings
are relevant to the treatment of some hundreds of millions of people
worldwide."
The
HPS randomized 20,536 adults in the United Kingdom to receive daily
placebo, simvastatin 40 mg, or antioxidant supplementation with 600 mg
vitamin E, 250 mg vitamin C, and 20 mg beta-carotene for five years.
Subjects were 40 to 80 years of age and had coronary artery disease,
other occlusive arterial disease, or diabetes.
Death
from all causes was 12.9% for patients given simvastatin, 14.7% for
patients given placebo, and 14.1% for patients given antioxidants (P=.0003
for simvastatin vs. placebo). The reduced mortality for patients
receiving simvastatin was primarily related to an 18% relative
reduction in the coronary death rate from 6.9% (707 deaths) for
patients receiving placebo to 5.7% (587 deaths) to patients receiving
simvastatin (P=.0006).
"If,
as a result [of these findings], an extra 10 million high-risk people
were to go onto statin treatment, this would save about 50,000 lives a
year — that is, a thousand each week," Collins says. "In
addition, this would prevent similar numbers of people from suffering
non-fatal heart attack or stroke."
Relative
reductions in patients receiving simvastatin were about 25% for
nonfatal myocardial infarction or coronary death, for nonfatal or
fatal stroke, and for coronary or noncoronary revascularization.
Simvastatin was well tolerated with no major adverse effects, although
the annual excess risk of myopathy was 0.01%. Its benefits did not
depend on baseline lipid levels and were synergistic with those of
other cardioprotective treatments including aspirin, beta-blockers,
and angiotensin-converting enzyme inhibitors.
Antioxidant
supplementation was not linked to any significant reductions in the
five-year risk of myocardial infarction, stroke, cancer or other major
outcomes.
"These
findings should tear up the rule-book on statin prescribing,"
says Richard Horton, editor of The Lancet. "They are
the most important and far-reaching results for the treatment and
prevention of heart disease and stroke that we have seen in a
generation. They should result in a dramatic change in clinical
practice around the world. Previously there has been concern that
statins have been used too much; after the results of HPS have been
published there should be concern that they may not be used enough in
the future." Merck
& Co. helped support this study. Lancet. 2002;360:7-22, 23-33
FACT:
Statins
may cause peripheral neuropathy?
Researchers
are now suspecting that. But,
keep this in perspective. The risk of neuropathy from a statin is
probably less than the risk of myopathy.
Researchers speculate that statins might cause neuropathy by
inhibiting cholesterol synthesis and affecting nerve cell membranes.
Statins might also affect nerve function by inhibiting
co-enzyme Q10 which plays a role in neuron energy utilization.
You don’t want to let the fear of this potential side effect
scare patients from using a statin.
Statin’s beneficial effects far outweigh the small risk of
neuropathy. The
data suggest that there is a strong association between statin use and
neuropathy. At this point the incidence appears low. It is probably an
under-recognized problem since it is not common, and clinicians may
not look for it. However, it seems prudent to watch for sensory or
motor changes in patients on long-term statins.
When
you see a patient with unexplained neuropathy...pain, tingling,
numbness, etc...check to see if they’re on a statin and explain that
the neuropathy is often reversible when the statin is
discontinued...but it can take 3 to 12 months.
South
Med J 1998;91(7):667-8.
Kristina
Sandstedt,
MS,
Clinical
Exercise
Physiologist,
Diabetes
Educator
New
Drug Restores Eyesight*
