Conclusions from the heart protection study were premature
Conclusions from the heart protection study were premature
EDITOR
With
reference to the news item by Kmietowicz, in their press
release the directors of the heart protection study did
not mention that their results were substantially
worse than in the previous Scandinavian
simvastatin survival study (4S) (table).
1 2
3
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The way the results were presented exaggerates the
benefit for the individual patient. The most interesting
figure is survival because most myocardial
infarctions heal with minimal cardiac
dysfunction, if any. Tell a patient that his chance not
to die in five years without statin treatment
is 85.4% and that simvastatin treatment can
increase this to 87.1 %. With these figures in hand
I doubt that anyone should accept a treatment whose
long term effects are unknown. For example, it
was claimed that the study presented uniquely
reliable evidence that simvastatin is not carcinogenic.
But the study went on for about five years only,
just like other statin trials. It is not
possible to say anything about the risk of
cancer because it takes decades to disclose chemical
carcinogenesis in human beings. Heavy smoking,
for example, does not induce lung cancer in
five years. All the statins and also the fibrates have
proved carcinogenic in rodents, and it scares me
that, if the new American guidelines for
cholesterol treatment are followed strictly,
half of mankind may take statins in a few years and
for the rest of their lives.4
Low cholesterol concentrations have been related to depression, cognitive impairment, and suppression of the immune system. Does a reduction of 1.7 % in mortality balance these risks? As in the previous trials, the effect of simvastatin was independent of the initial cholesterol concentration; patients with low concentrations benefited just as much (or just as little) as patients with high concentrations. The best results were seen in patients older than 75 years, an age group in which the lowest quartile of cholesterol concentration had the highest total and cardiovascular mortality.5
That statin treatment works in patient and age groups
in whom a high cholesterol concentration is not a risk
factor for cardiovascular disease shows that
the benefit is not the result of cholesterol
lowering. High or low cholesterol concentrations are
markers for other, more important disease
factors; they are not causal factors
themselves.
| 1. | Medical Research Council/British Heart Foundation Heart Protection Study. Press release. Life-saver: World's largest cholesterol-lowering trial reveals massive benefits for high-risk patients. Available at www.ctsu.ox.ac.uk/~hps/pr.shtml (accessed 19 March 2002). |
| 2. | Kmietowicz Z. Statins are the new
aspirin, Oxford researchers say. BMJ 2001;
323: 1145 |
| 3. | Scandinavian Simvastatin Survival
Study Group. Randomised trial of cholesterol lowering
in 4444 patients with coronary heart disease: the
Scandinavian simvastatin survival study (4S).
Lancet 1994; 344: 1383-1389 |
| 4. | Newman TB, Hulley SB.
Carcinogenicity of lipid-lowering drugs. JAMA
1996; 275: 55-60 |
| 5. | Schatz IJ, Masaki K, Yano K, Chen R,
Rodriguez BL, Curb JD. Cholesterol and all-cause
mortality in elderly people from the Honolulu heart
program: a cohort study. Lancet 2001; 358:
351-355 |
National Institute for Clinical Excellence should assess statins
EDITORAlthough
the heart protection study is good news, it is premature
to say that statins are the new aspirin.1
An aspirin tablet a day costs just over 1p
whereas simvastatin costs £1.06 at the doses
used, and it would cost the NHS almost £400m each
year to treat 1 million people. Also, although the
trial was large, it would only detect adverse
reactions that occur more often than about one
in 3000 patients and rare, serious reactions that may
occur when a large population is exposed to the
drug will have been undetectable.2
Cerivastatin was voluntarily withdrawn by Bayer in
2000 after reports of 31 deaths from rhabdomyolysis in
the United States. This disorder has also
occurred with other statins. It sounds as if
the National Institute for Clinical Excellence needs to
weigh up the risks, benefits, and costs of using
statins.
| 1. | Kmietowicz Z. Statins are the new
aspirin, Oxford researchers say. BMJ 2001;
323: 1145 |
| 2. | Eypasch E, Lefering R, Kum CK,
Troidl H. Probability of adverse events that have not
yet occurred: a statistical reminder. BMJ
1995; 311: 619-620 |
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