Next month, Penelope Wilde plans
to make the long trip to her physician to see if she's
a candidate for a cholesterol-lowering drug. Her father
died of a heart attack at 52 and now that she's turned
50, she's concerned about her own risk. She recently learnt
of an interesting piece of news. In the UK, simvastatin
(Zocor) will soon be available over the counter (OTC).
Penelope couldn't help but wish that the same option would
be available to her. After all, wouldn't many more people
like her benefit from this change?
The British Department of
Health announced that starting this July, the UK will
be the first country to make a statin available over
the counter. Simvastatin (10mg) tablets will be available
for individuals who have a moderate (10-14%) risk of
developing CHD in the next 10 years, as reported in
the May 22 issue of the British Medical Journal.
People at moderate risk for a coronary event include
men older than 54 or aged 45 to 54 and women over 55
who are either smokers, overweight, South Asian or have
a family history of CHD.
Canadian cardiologists weigh in on different sides of
this issue. "I think it's a wonderful idea. It's
a very safe medication. Individuals can be actively
involved in their health.... Less than 20% of people
are at target lipid cholesterol values," says Dr
Gregory P Curnew, assistant clinical professor at McMaster
University and former director of the Coronary Care
Unit at the Hamilton General. He was quick to add: "This
does not prevent physicians from working with their
patients in lowering vascular risk. However, this allows
individuals especially those with no access to MDs to
try a different path in prevention. I'm open to new
ideas and hopefully this process can be studied to determine
who can be helped or harmed with this approach."
Dr George Fodor, head of research in Preventive Cardiology
at the University of Ottawa Heart Institute and one
of the authors of "Recommendations for the management
of dyslipidemia and the prevention of cardiovascular
disease," agrees that simvastatin is as safe as
aspirin, but voices two concerns. "First, it seems
far-fetched to expect busy pharmacists to have time
to perform this evaluation. Second, the Canadian guidelines
consider as 'very high risk' anyone with more than a
20% risk. This suggests that a very large group of UK
patients who should receive the drug will now have to
pay for it."
In the UK, pharmacists' groups and the British Heart
Foundation back the move, but others are skeptical.
Dr John Chisholm, Chairman of the British Medical Association's
General Practitioner committee warns that patients would
not receive a thorough risk assessment, consequently
their statin dose might be too low. Presently 1.8 million
people in the UK take government-paid statins. The low-dose
statin would target an additional 8 million people.
A critical editorial in the May 22 issue of The Lancet
points to the lack of OTC statin trials and compliance
data. The editors ask "Will those who buy simvastatin
also stop smoking, lose weight and do more exercise
or will they substitute drug use for lifestyle modification?
Will pharmacists have the time to determine the individual's
risk of coronary heart disease before selling the drug
and also give lifestyle advice?" Interestingly,
although UK data analysis showed that therapy with 10mg
simvastatin is associated with a 27% decrease in LDL
cholesterol, an appraisal of higher dose statins by
the University of British Columbia did not find a link
with decreased mortality. In the US, Merck is planning
to apply to the FDA next year to switch lovastatin to
an OTC drug. The proposal was rejected in 2000 but the
UK 'experiment' could cause a change of heart.
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