Effectiveness and efficiency of different guidelines on statin treatment for preventing deaths from coronary heart disease: modelling study
BMJ 2006; 332 doi: https://doi.org/10.1136/bmj.38849.487546.DE (Published 15 June 2006) Cite this as: BMJ 2006;332:1419All rapid responses
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As a member of two subgroups (women and everyone over 65), I don’t
see how treatment guidelines, even those from New Zealand, can help
doctors and, in turn, individuals make an informed decision about lifelong
statin therapy. How evidence-based are any of these guidelines, for
example, when only nine of the 20 lipid-lowering drug trials that included
women have published their results by gender? 1
Dr. Manuel and colleagues suggest that treatment recommendations be
focused on people at the highest risk of heart disease, but the trend in
the U.S. is to label everyone high risk if he or she is over 65 and has
high cholesterol. Unless treatment guidelines take into consideration the
number needed to harm, especially overall deaths, they are misleading to
doctors and to the general public.
The public purportedly should not know how its laws and sausage are
made. I would suggest treatment guidelines be added to the list.
--
1 Diagnosis and treatment of coronary heart disease in women:
systematic reviews of evidence on selected topics. U.S. Agency for
Healthcare Research & Quality publication No. 03-0037, May 2003.
Competing interests:
None declared
Competing interests: No competing interests
Though Manuel DG et al have shown that guidelines on statin treatment
should focus on people with the highest risk of coronary heart disease 1,
we agree with their conclusions.
However, the concerns about the optimal choice of statins are still
remain. A recent meta-analysis (n=71,108) of randomized controlled trials
have shown that the occurrence of myalgia is less frequent with
fluvastatin, pravastatin and simvastatin than atrovastatin (OR= 0.28; 95%
CI: 0.18-0.44, OR=0.43; 95% CI: 0.36-0.51, OR= 0.23; 95% CI: 0.19-0.28,
respectively) 2. This observation could also be supported by Japanese post
-marketing surveys for both atorvastatin and pitavastatin 3, 4. For
example, atorvastatin had an increased risk of musculoskeletal adverse
events including the elevations of serum creatine phosphokinase (CK) as an
important indicator of rhabdomyolysis compared with pitavastatin in
Japanese common clinical practice (atorvastatin: 144/4805, pitavastatin:
154/7930, risk ratio, 1.54; 95% CI: 1.23-1.93; p=0.0001 by using Mann-
Whitneys U test) 3, 4. This difference was shown between atorvastatin and
pitavastatin, though pitavastatin at 1, 2, 4 mg appears to be as
efficacious as atrovastatin at 10, 20, 40 mg in the rate of LDL (low-
density lipoprotein)-C (cholesterol) reduction 5. Thus, the rate of muscle
-related adverse events differs among statins 2. The common shared belief
is that the cause of myotoxity with statins is dose-dependent 5.
Therefore, we think that lower doses of statin can be tolerated without
the risk of muscle-related adverse events.
Considering the same efficacy for the rate of LDL-C reduction are
shown in atrovastatin at 20 mg, 40 mg, pitavastatin at 2 mg, 4 mg,
rosuvastatin at 2.5 mg, 10 mg and simvastatin at 40 mg, 80 mg,
respectively 2, 5, lower doses of statins should be chosen in terms of
optimal disease management.
References:
1 Manuel DG, Kwong K, Tanuseputro P, Lim J, Mustard CA, Anderson GM,
et al. Effectiveness and efficiency of different guidelines on statin
treatment for preventing deaths from coronary heart disease: modelling
study. BMJ 2006;332: 1419-22.
2 Silva MA, Swanson AC, Gandhi PJ, Tataronis GR. Statin-related
adverse events: a meta-analysis. Clin Ther 2006;28: 26-35.
3 Kurihara Y, Douzono S, Fujita S, Kakuda T, Nachi S, Uematsu H.
Interim Report, 8083 Patients on the Drug Use Investigation of
Pitavastatin (LIVALO Tablet), Jpn Pharmacol Ther 2006;34: 317-26. (in
Japanese)
4 Komano N, Masaki M, Kawai H, Kubota Y, Kajiura T. The safety and
efficacy in post-marketing surveys of atorvastatin. Prog. Med 2005;25: 131
-42. (in Japanese)
5 Mukhtar RY, Reid J, Reckless JP. Pitavastatin. Int J Clin Pract
2005;59: 239-52.
Competing interests:
None declared
Competing interests: No competing interests
In 2005 the Joint British Societies published updated guidelines (1).
Many people would be very interested to see how well the new guidelines
perform in relation to the old (and other national guidelines). E.g., what
is the NNT? And, what are the effectiveness and efficiency gaps? Please
publish an update to Figure 2 in the paper? Thanks very much. Michael
Power.
(1) British Cardiac Society, British Hypertension Society, Diabetes
UK, HEART UK, Primary Care
Cardiovascular Society, The Stroke Association. JBS 2: Joint British
Societies' guidelines on prevention of cardiovascular disease in clinical
practice. Heart 2005;91(Suppl V):v1–v52. doi: 10.1136/hrt.2005.079988
Competing interests:
None declared
Competing interests: No competing interests
New Zealand Guidelines are Unworkable in Real Life
The authors' enthusiasm for the New Zealand Guidelines on
Cardiovascular Risk Assessment and management is misplaced. They are
unworkable in real life and hence little used by most New Zealand general
practitioners. The reason for this is simple: They rely on absolute risk
assessment. Absolute risk for cardiovascular disease inevitably rises as
one ages and in the elderly is uniformly high. If one uses the guidelines
one would recommend the use of statins and antihypertensives to veirtually
all elderly patients. This is nonsensical as the benefits accrued to a
healthy 80 year old put onto these drugs is minute (if present at all!)
The perils of polypharmacy in the elderly seem to have been forgotten by
enthusiasts for these guidelines.
A far more logical approach and one most working general
practitioners use is to ask what benefit in terms of adding years of life
will using these medications bring to a particular patient. This approach
has been modelled by Ulrich et al in the BMJ, 2000;320:1134-40 article
"What is the optimal age for starting lipid lowering treatment: A
mathematical model. This model clearly shows that use of guidelines based
on absolute risk is not effective as it invariable leads to overtreatment
of the elderly with little benefit and undertreatment of younger patients.
Competing interests:
None declared
Competing interests: No competing interests