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Intensified lipid-lowering treatment with alirocumab in patients with coronary heart disease
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  • Published on:
    Treatment with PCSK9-inhibitors - a questionable measure
    • Uffe Ravnskov, MD, PhD, independent researcher Not affiiated to any institution
    • Other Contributors:
      • Michel de Lorgeril, cardiologist and researcher
      • Malcolm Kendrick, General practitioner
      • David M. Diamond, Professor

    According to Steffens et al.,1 patients with cardiovascular disease (CVD) whose cholesterol is too high despite ongoing cholesterol-lowering treatment should be treated with the PCSK9-inhibitor alirocumab. They base their conclusion on twelve weeks of treating 244 middle-aged and elderly patients (half of whom had familial hypercholesterolemia), where the LDL-cholesterol (LDL-C) was lowered by around 50% without any serious side effects. A relevant question is whether or not such treatment provide clinic benefit.
    The optimal way to demonstrate the benefits of any drug is through the use of double-blinded placebo-controlled trials. More than 30 PCSK9-inhibitor-trials have now been published,2,3 and none of them has demonstrated a reduction in overall or CV mortality. Only three, which included 73 936 patients with CVD, were performed correctly.2 Although LDL-cholesterol was lowered by more than 50%, none of them achieved a statistically significant reduction in either total or CVD mortality. In the longest trial (the 2.8 year long ODYSSEY-trial), which included almost 19,000 statin-treated patients, total mortality was a little lower in the alirocumab-group (3.5% vs 4.1%),2 which means that to save one life per year, it is necessary to treat more than 550 patients at a cost of more than five million US dollars.
    That such a strong cholesterol-lowering is ineffective is not unexpected, because there is much evidence that CVD is not caused by elevated...

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    Conflict of Interest:
    None declared.