Caution urged in prescribing statins
January 19, 2011
Nicole Baute
STAFF REPORTER
There is not enough evidence to support the widespread use of cholesterol-fighting drugs for people at low risk for heart disease, a new study says.
The Cochrane Collaboration systematic review released Wednesday looked at data from 14 trials involving more than 34,000 patients, concluding that although statins reduce the risk of heart attack, stroke and high cholesterol in people without cardiovascular disease, the benefits are questionable.
The researchers, based at the London School of Hygiene and Tropical Medicine, say the decision to take statins for primary prevention should be made with caution, leaving patients and their doctors to decide whether or not to commit to drugs such as Lipitor and Crestor, which are usually taken for a lifetime.
According to IMS Brogan, which tracks pharmaceutical marketing, Canadians spent more than $2 billion on more than 30 million statin prescriptions in 2010. Those figures have risen steadily since 2006, when less than 21 million prescriptions were dispensed.
The Cochrane review flagged concerns about potentially biased reporting in the studies, as all but one was sponsored by the pharmaceutical industry. Eight of the 14 trials did not report on adverse effects, two of the trials stopped early, and the subjects were mostly white, middle-aged men, suggesting the results may not be applicable to women and the elderly.
“The implications of this kind of research are huge,” said Alan Cassels, a drug policy researcher affiliated with the University of Victoria. “It’s because probably 20 per cent of Canadians over 45 are taking a statin, so just the sheer volume of drugs people are swallowing every day in the hopes of preventing cardiovascular disease is mind-boggling.”
The billions of dollars spent on statins every year would probably be better spent on other ways to reduce our cardiovascular risk, he said.
“The second thing is that these drugs are not completely benign. They have a range of potential risks that only seems to grow.”
Potential side effects include muscle weakness, liver inflammation, and cognitive impairments.
Dr. Jim Wright, co-managing director of British Columbia’s Therapeutics Initiative, said the most common side effects are subtle, such as sleep disturbance and irritability. “I don’t think we really know how prevalent all those things are,” he said.
Last year, the Therapeutics Initiative released a similar review of studies on statins, Wright said, and recommended that “anybody who hasn’t already got proven occlusive vascular disease should not be taking them.”
But Dr. Dennis Ko, a cardiologist at the Sunnybrook Health Sciences Centre, said the Cochrane review’s findings — that people taking statins had a 17 per cent relative reduction in mortality from all causes and a 30 per cent reduction in fatal and non-fatal heart attacks and strokes — do not in his view match the researchers’ conclusion that taking the drug preventively might not be cost-effective.
While some experts argue there is little benefit to taking statins to further reduce an already-low risk of heart disease, Ko said this is “a matter of perspective” — and that some concerned patients would disagree.
Dr. Gary Newton, division head of cardiology at Mount Sinai Hospital, said the decision to prescribe statins must be made on an individual basis. In selected high-risk patients — for example, smokers with diabetes, high cholesterol and a family history of fatal heart attacks — taking statins as a preventative measure would likely be worthwhile.
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