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Long term study backs statins for patients with high LDL and no other risk factors

BMJ 2017; 358 doi: (Published 07 September 2017) Cite this as: BMJ 2017;358:j4171
  1. Jacqui Wise
  1. London

Treatment with statins reduced deaths from coronary heart disease by 28% in men with very high levels of low density lipoprotein (LDL) cholesterol but no other risk factors or signs of heart disease, a 15 year follow-up study has reported in the journal Circulation.1

The authors said that the findings provide the first direct randomised trial evidence to confirm current guidance that patients with LDL above 190 mg/dL should be considered for statin treatment regardless of other risk factors.

Kausik Ray, the study leader, from Imperial College London’s School of Public Health, said, “For the first time, we show that statins reduce the risk of death in this specific group of people who appear largely healthy except for very high LDL levels. This legitimises current guidelines, which recommend treating this population with statins.

“The findings also suggest that we should consider prescribing statins more readily for those with elevated cholesterol levels above 155 mg/dL and who also appear otherwise healthy.”

The researchers analysed follow-up data from the West of Scotland Coronary Prevention Study (WOSCOPS)—a five year study in 1995 that provided the first evidence that treating men with high LDL levels with statins significantly reduced the risk of death from heart disease. In that study 6595 men aged 45-64 with raised LDL cholesterol were randomly assigned to receive 40 mg pravastatin a day or placebo, for five years.

The researchers followed 5229 of these men who had no evidence of heart disease for a further 15 years, once they had been released back to the care of their usual physician. Of these, 2560 had LDL cholesterol above 190 mg/dL and 2969 had LDL cholesterol above 155 mg/dL but below 190 mg/dL. The ideal LDL cholesterol level is below 100 mg/dL, but this varies depending on individual risk factors. Five years after the initial trial finished, around one third of the men who were originally assigned pravastatin or placebo were taking statins.

Among all of the men initially allocated to receive pravastatin the study found considerable reductions in the risk of coronary heart disease death (22%), cardiovascular death (17%), and all cause mortality (12%) over the whole 20 years of follow-up. Among the men with LDL cholesterol above 190 mg/dL who were initially assigned statins, the study also showed considerably reduced risk of coronary heart disease death (28%), cardiovascular death (25%), and all cause mortality (18%).

The study was a post-hoc analysis, but the researchers noted that it would currently be unethical to perform a placebo controlled trial of lipid lowering treatment among people with LDL cholesterol above 190 mg/dL.

The analyses were partly funded by a grant from Sanofi to Imperial College London. The original WOSCOPS trial was funded by Bristol-Myers Squibb and Sankyo.


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