This
is a contribution from a member of THINCS,
The International Network of Cholesterol Skeptics
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Letter to the editor of Lancet submitted on December 7,
2007 by Uffe Ravnskov.
Read also the editor´s answer below and my comments.
The
safety of statins in clinical practice
Dr Armitage claimed that statin treatment is safe and well-tolerated, a
view based mainly on trials sponsored by the drug companies (24 Nov).
However, by various reasons1 the reports from these trials are
overly optimistic. Muscular problems for instance were reported in less
than one percent, but in two independent studies they were observed in 64
% and 73%, respectively.2,3 Weak or painful muscles is a serious problem
because they are an obstacle for exercise, the most important preventive
measure.
Dr. Armitage had no objections against a
more intensive treatment arguing that there is dose-response, which is not
true. Dose-response cannot be determined by comparing mean effects from
trials, but demands analyses based on individual values, and all statin
trial, where this method was used, found absence of dose-response.4
In accordance, mortality was unchanged at best in the trials that tested
high-dose treatment. It is therefore compulsory to weigh the benefit from
non-fatal events with the side effects, and here we are left in ignorance.
It is especially worrying that in the IDEAL trial almost 50 % of the
patients had serious side effects, both in the low-dose and the high-dose
group, and that the character of these side effects were not given,
neither in the report itself or on request.5 The reason for the
frequent side effects might have been that in contrast to most other
statin trials, where all kinds of frailties including statin intolerance
were used as exclusion criteria, few patients were excluded from the IDEAL
trial.
Uffe Ravnskov
- Ravnskov
U, Rosch PJ, Sutter MC, Houston MC. Should we lower cholesterol as
much as possible? BMJ 2006; 332: 1330-2.
- Sinzinger
H, O'Grady J. Professional athletes suffering from familial
hypercholesterolaemia rarely tolerate statin treatment because of
muscular problems. Br J Clin Pharmacol 57: 525-8, 2004.
- Langsjoen
PH, Langsjoen JO, Langsjoen AM, Lucas LA. Treatment of statin adverse
effects with supplemental Coenzyme Q10 and statin drug discontinuation.
Biofactors 2005;25: 147-52.
- Ravnskov
U. Is atherosclerosis caused by high cholesterol? QJM
2002; 95: 397-403
- Pedersen
TR, Faergeman O, Kastelein JJP, Olsson AG, Tikkanen MJ, Holme I,
Larsen ML, Bendiksen FS. High-Dose Statins and the IDEAL Study—Reply.
JAMA 2006; 295: 2478-9.
Here
is the answer from the editor (my comments in bold)
Dear Dr Dr. Ravnskov,
Thank you for submitting your letter. After in-house review, I'm afraid we
have decided not to accept it for publication. We regret that we are
unable to write a personal note for every letter we turn down, but the
following common reasons for rejection may help you with future
submissions: lateness (ie, more than 2 weeks after publication of the
article on which you are commenting) (the letter was sent within 2
weeks), inclusion of
original research (the section is not peer reviewed, so we cannot publish
such work here) (no original work was included in the letter), submission of case reports
(we have
a separate section for these)(it is not a case report), reiteration of points made by another
correspondent (no other correspondent has responded, and inappropriate length (limits are
250 words and 5 references) (the letter has 250 words and 5 references). If none of these apply
to your letter, please be assured that we have nevertheless considered it
carefully and probably had to refuse it because we have simply received
too much good material (No letters commenting Armitage´s review have
been published).
Yours sincerely
Zoë Mullan
Senior Editor
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