NICE backs lowering of threshold for statin use to prevent cardiovascular disease

The National Institute for Health and Care Excellence issued an update Friday to its guidelines on lipid modification, recommending that the threshold for starting preventative treatment for cardiovascular disease (CVD) be halved from a 20-percent risk over 10 years, to a 10-percent risk. The agency suggested that the move, which could see as many as 4.5 million people eligible for statins, "could help to prevent up to 28 000 heart attacks and 16 000 strokes each year."

According to NICE's guidance, doctors should start statin treatment for the primary prevention of CVD with Pfizer's Lipitor (atorvastatin), which is also available generically, at a 20-mg dose. Meanwhile, patients with established CVD, type 1 or type 2 diabetes, should be offered an 80-mg dose of atorvastatin. The agency, which first proposed the changes in February, noted that not everyone with at least a 10-percent risk of CVD within 10 years will require statin therapy, and that preventative lifestyle measures should be adopted first.

NICE recommended that people be evaluated for CVD risk using the QRISK2 assessment tool, which takes into account risk factors such as smoking status, cholesterol levels, hypertension and body mass index. The calculator then provides a percentage risk of developing CVD in the next 10 years.

Mark Baker, director of the agency's Centre for Clinical Practice, said "doctors have been giving statins to 'well people' since NICE first produced guidance on this in 2006. We are now recommending the threshold is reduced further." He also noted that "the effectiveness of these medicines is now well proven and their cost has fallen."

Anthony Wierzbicki, chair of the guideline development group, commented that "we've got the best evidence base, huge numbers and the biggest set of clinical trials ever done. Other areas of medicine would give their teeth for this evidence, it's that good." Wierzbicki added that "statins work, they are very cheap, and are becoming considerably cheaper as they come off patent, which in a cost-limited health service, is a big consideration."

NICE faced criticism following the release of the draft guidance, including a suggestion that it relied too heavily on data from company-sponsored trials, which some said may downplay the risk of side effects caused by statin use. The agency has since responded to the objections, saying "the evidence clearly shows there is no credible argument" against the safety and effectiveness of statins for use as proposed by the latest recommendations.

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