Bang et al found that lower LDL-cholesterol levels with or without statin treatment were strongly and
independently related to a higher risk of symptomatic hemorrhagic
transformation after recanalization therapy. [1] These findings, added to
those of the industry-driven SPARCL trial, [2] should place into question the
widely-held assumption of beneficial effects of statin therapy in the
prevention of stroke.
In the SPARCL trial, [2] it was reported
that, as compared with placebo, the use of high-dose statin in patients
who had a stroke or TIA reduced the risk of nonfatal stroke from 11.8% to
10.4% over a period of 5 years, but it did so without improving survival
(five more deaths in the statin arm), and with 66% increase in the
relative risk of hemorrhagic stroke among the patients receiving high-dose
atorvastatin. To the best of our knowledge, no statin trial has
demonstrated a net reduction in all-cause mortality when studying primary
or secondary prevention of stroke. What is the point of decreasing the
number of events without decreasing overall mortality, when considering
that statin therapy might increase the risk of hemorrhagic infarction, and
when the harm caused by the side effects of statins is considered?
It is very possible that the numbers of side effects are much
larger in clinical practice where the drugs may be given to most patients
usually excluded in randomized trials, in which ingenious criteria used
for selecting the test individuals and generous limits for what is
considered as normal laboratory results are usually used. [3]
Furthermore, in the accompanying editorial, [4] Goldstein (from the
Steering Committee for the SPARCL study) highlighting the beneficial
effects of statins in reducing vascular events, discussed the global
beneficial action of statins in the prevention of stroke. However, he did
not mention any other statin-related side effects. We don’t share
Goldstein’s optimism and think that concerns about efficacy and safety of
statins remain.
References
1. Bang OY, Saver JL, Liebeskind DS, et al. Cholesterol level and
symptomatic hemorrhagic transformation after ischemic stroke thrombolysis.
Neurology 2007; 68: 737-742.
2. Amarenco P, Bogousslavsky J, Callahan A 3rd, et al.; Stroke
Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL)
Investigators. High-dose atorvastatin after stroke or transient ischemic
attack. N Engl J Med 2006; 355: 549-559.
3. Mascitelli L, Pezzetta F. Statins for primary prevention of coronary artery disease. Lancet 2007; 369: 1078-1079.
4. Goldstein LB. Low LDL cholesterol, statins, and brain hemorrhage:
should we worry? Neurology. 2007; 68: 719-720.
Disclosure: The authors report no conflicts of interest.