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Pfizer Australia Statement: Media Report on Statins and Transient Memory Loss
Tuesday November 16, 2004
A media report on Australian TV program Today Tonight recently claimed there
was a link between statin (anti-cholesterol medicine) usage and transient memory
loss. As the maker of the country’s most prescribed statin, Lipitor,
Pfizer Australia’s response is as follows:
- Reports of memory changes associated with any statin treatment occur very
rarely. A causal relationship between statins and these cases has not been
established.
- The risk of adverse reactions with statins must be weighed against their
considerable medical benefits. There is a proven public health benefit to
the use of statins in the prevention and treatment of cardiovascular disease,
which remains the leading cause of death in Australia and;
- Lipitor has a safety profile, supported by vast clinical and real-world
experience from 75 million patient years of treatment.
Several studies have indicated that taking a statin may actually reduce dementia
risk. Preliminary data from a clinical trial1,
reported last week, showed that more Alzheimer's Disease patients had their
condition stabilised when Lipitor was added to their treatment, than when placebo
was added. Longer-term data are needed and statins are NOT indicated for the
treatment or prevention of dementia.
If patients have any concerns or questions about statins and memory loss,
they should continue their medication and speak to their doctor as soon as
possible.
Lipitor® (atorvastatin) is indicated as an adjunct to diet for the treatment
of patients with hypercholesterolaemia. Lipitor is also indicated in hypertensive
patients with risk factors for heart disease to reduce the risk of non-fatal
myocardial infarction and non-fatal stroke.
Lipitor is contraindicated in patients with active liver disease, or unexplained
persistent elevations in liver enzymes, and in patients who are pregnant or
breast feeding. Lipitor should be withheld or temporarily discontinued in patients
with uncontrolled seizures, severe acute infection, low blood pressure, major
surgery, trauma or injury and severe metabolic, endocrine and electrolyte disorders.
Lipitor should be discontinued if myopathy (muscle-related disorders) are diagnosed.
Lipitor should be used with caution in patients who consume substantial quantities
of alcohol and/or have a history of liver disease. Patients should promptly
report unexplained muscle pain, tenderness or weakness, particularly if accompanied
by malaise or fever. Lipitor should be used with caution in combination with
certain medications.
The most frequent adverse effects of Lipitor are constipation, flatulence
dyspepsia, abdominal pain, headache, asthenia, nausea, diarrhoea, insomnia
and myalgia. Liver function tests should be preformed in all patients before
the start of treatment and periodically thereafter.
Lipitor is listed on the PBS as a restricted benefit for patients meeting
criteria set out in the Schedule of Pharmaceutical Benefits. The full text
of the Consumer Medicine Information can be viewed here.
Please note that the list of benefits and side effects in the CMI not exhaustive,
and patients should consult their doctors if they have any concerns about the
information listed above or require further information.