Medications in the "statin" (HMG-CoA reductase inhibitors) class are
used by millions of patients and their benefits for reducing cholesterol
and preventing heart attacks are well known. Statins are prescribed for
individuals with high cholesterol as well as patients with mildly
elevated cholesterol and have other risk factors for heart attacks such
as diabetes, hypertension, previous stroke, or previous heart attack.
Statins have been available in the U.S. for over 20 years. Therefore,
the recent announcement from the U.S. Food and Drug Administration (FDA)
that the package insert for these popular drugs will include
information about post-marketing reports of reversible memory loss,
forgetfulness, and confusion alarmed many patients and healthcare
providers. This not the first time that the effect of statins on brain
function has been evaluated. Earlier small statin studies suggested that
statins may actually improve brain function but more robust scientific
studies did not support this theory.
The FDA reviewed
post-marketing adverse events reports, published case reports,
observational studies, and clinical studies to decide whether statins
cause memory loss. Post-marketing adverse events cases of memory loss
included people over 50 years of age with memory loss or impairment with
onset from one day to years after starting a statin, and duration of a
few weeks (median 3 weeks) after stopping the statin. Age, type or dose
of statin, or other medications used did not correlate with the
occurrence of memory loss. Available observational and clinical studies
suggest that statins do not have significant effect on brain function.
The
available evidence does not show that statins affect brain function.
The FDA's goal was to tell the public that there are post-marketing
reports of memory loss or confusion associated with statin use.
Post-marketing reports are not evidence of cause and effect because
there are other possible explanations for the memory loss. Patients
should not panic because statins have been used for many years and
available data does not show that statins cause memory loss or
confusion. Moreover, there are many drugs that are proven to affect
brain function but are still used because their benefits are greater
than their risk. The benefits of statins on preventing stroke, heart
attack, or death far outweigh the very small risk, if any, of reversible
effects on cognitive brain function. Patients should report adverse
effects, including confusion and persistent change in memory, to their
healthcare provider.
Drugs in the statin class:
- Lipitor (atorvastatin)
- Crestor (rosuvastatin)
- Livalo (pitavastatin)
- Pravachol (pravastatin)
- Zocor (simvastatin)
- Lescol (fluvastatin)
- Mevacor (lovastatin)
- Altoprev (lovastatin extended-release)
- Vytorin (simvastatin/ezetimibe)
- Advicor (lovastatin/niacin extended-release)
- Simcor (simvastatin/niacin extended-release
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