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Statins
No benefit in primary prevention trials
From Mr P. D. Burrill, MRPharmS
Hemant Patel is passionate about community pharmacy and developing the
role of community pharmacists. Unfortunately passion can obscure reason
and just because you want something to be true does not necessarily make
it so. Some of Mr Patel’s statements in his letter (PJ, 22 May,
p638) require exploration.
Mr Patel claims that the magnitude of the benefit from statin treatment
appears to be independent of a patient’s low-density lipoprotein
cholesterol level. The randomised clinical trial that provided this information
was the Heart Protection Study.1 Importantly, this was a secondary prevention
study. In primary prevention, the cholesterol level is an essential part
of the equation used to attempt to predict an individual’s risk
of a future vascular event. The participants in the HPS were not at relatively
low risk as Mr Patel claims. The vascular event rate in those receiving
placebo was 25 per cent over five years (equivalent to 50 per cent over
10 years).
The benefit of statin treatment does appear to be dependent on the dose
used. Evidence strongly suggests that moderate to high doses are required,
eg, 20 to 40mg simvastatin daily. A recent Drug Update on statins from
the Regional Drug and Therapeutics Centre at the Wolfson Unit, Newcastle,2 recommends that simvastatin 40mg daily is the statin of choice for both
primary and secondary prevention of coronary heart disease.
The University of British Columbia in its publication, Therapeutics
Letter,
has reviewed the evidence for statins in primary prevention.3 When the
five primary prevention trials are combined, 71 patients with cardiovascular
risk factors have to be treated with a statin for three to five years
to prevent one myocardial infarction or stroke. In other words, 70 patients
take the drug long-term for no benefit, and this is with the doses used
in the trials. No clinical trial has used simvastatin at a dose of 10mg
daily. In the primary prevention trials, a key measure of overall impact,
total mortality, was not reduced by statin therapy. Therapeutics
Letter concludes: “Statins have not been shown to provide an overall health
benefit in primary prevention trials.” Is it likely that low-dose
OTC simvastatin will do what higher doses of statins have failed to achieve
in clinical trials?
A recent Lancet editorial4 refers to OTC statins as “a bad decision
for public health”. The authors comment that those who choose to
buy simvastatin may substitute its use for effective life style modification
such as stopping smoking, losing weight and exercising more. They ask
the pertinent question whether pharmacists will have the time to calculate
an individual’s risk of coronary heart disease. Which risk assessment
tool will pharmacists use? Those derived from the Framingham study have
recently been shown to overestimate significantly the absolute coronary
risk assigned to individuals in the UK.5
For those at sufficiently high risk of a cardiovascular event, simvastatin
40mg daily is available on the NHS. Most primary care trusts are actively
seeking out these people. For those at lower risk, giving a statin at
moderate to high doses has limited benefit and there are several other
potential interventions. I have found no evidence to suggest that simvastatin
10mg daily reduces vascular events and, if it does, it is likely that
hundreds would need to be treated to prevent one event. Would you spend £10
to £15 per month for several years if this was made clear to you?
To optimise health gain with statins, pharmacists could achieve much
by ensuring that prescribed doses are at clinical trial levels.
Peter Burrill
Specialist in Pharmaceutical Public Health
North Derbyshire Public Health Network
References
1. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection
Study of cholesterol lowering with simvastatin in 20,536 high-risk
individuals: a randomised placebo-controlled trial. Lancet 2002;360:7–22.
2. Drug Update. Statins. April 2004. Available as a PDF file
(190K) (accessed 24 May 2004).
3. Do statins have a role in primary prevention? Therapeutics Letter
48. April-May-June 2003. Available as a PDF file
(90K) (accessed 24 May 2004).
4. OTC statins: a bad decision for public health. Lancet 2004;363:1659.
5. Brindle P, Emberson J, Lampe F, Walker M, Whincup P, Fahey T, Ebrahim
S. Predictive accuracy of the Framingham coronary risk score in British
men: a prospective cohort study. BMJ 2003;327:1267–70.
Try sweetened, black tea — it’s cheaper
From Dr G. P. Walsh, MB ChB
Simvastatin, a drug whose expense and benefit has normally to be justified
by NHS patient testing will shortly be on sale at pharmacies to reduce
low-density lipoprotein cholesterol, coronary heart disease and strokes.
Indeed Nicholas Wald and Malcolm Law have proposed a “Polypill” to
include an out of patent (cheaper) statin plus five other drugs, which
could be taken without the need for a medical examination and, used from
age 55, could cut heart and stroke mortality by more than 80 per cent.1
Critics claim no other country puts statins on sale at pharmacies, but
European countries already naturally suffer half Britain’s CHD.
A reason for this might be that the continent has stores of polyphenol
antioxidants, for example the wine grape in the Mediterranean and black
tea in northern countries, such as The Netherlands. But, unlike the Dutch,
the British generally add milk to their tea blocking its precious antioxidant
properties.2,3
As an ex-GP, I have tried in vain to get Britain to copy the Dutch — to
drink black or green tea. Preferably it should be drunk sweetened between
meals to avoid the clash with meal time dairy products and in particular
with the caffeine stimulant on waking and with toast, an olive oil-based
spread and marmalade for breakfast. This may allow a catch up with the
Europeans in much less than 10 years. Of course those living on the continent
do not have to wait until age 55 — they will be “insured” from
youth or when black tea or wine is started.
To patients, therefore, who complain about having to pay for statins,
pharmacists might suggest they change to drinking sweetened black tea.
Geoffrey Walsh
Ripon, North Yorkshire
References
1. Wald NJ, Law MR. A strategy to reduce cardiovascular disease by
more than 80%. BMJ 2003;326:1419–23.
2. Hertog M, Feskens EJ, Kromhout D. Antioxidants flavonols and coronary
heart disease risk. Lancet 1997;349:699.
3. Kromhout D. Diet-heart issues in a pharmacological era. Lancet 1996;348:S20–2. |
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