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PCSK9 Inhibitors as Add on to Statins Evidence Base for Current Clinical Utility

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Prof Dr PC Manoria, Bhopal    06 January 2018

  1. The landmark secondary prevention FOURIER trial with evolocumab released in 2017 has passed on three unprecedented big messages: It has evoked a new concept of super low LDL i.e., 25 mg/dL never heard before; evolocumab has incredible safety; evolocumab showed incremental benefit on top of statins.
  2. There was an incremental 15% reduction in the primary efficacy endpoint of CV death, MI, stroke and hospitalization for UA or coronary revascularization and a 20% reduction in secondary efficacy endpoint of CV death and MI stroke. All subsets of patients benefited. The curves were divergent so that NNT at 1 year was 74 and at 2 years it dropped to 50. It seems that if the trial was followed for a longer period of time the benefit would have increased further.
  3. PCSK9 monoclonal antibodies have emerged as a new star on the horizon of lipid management. They are indicated in three subsets of patients: Patients with ASCVD not achieving LDL-C goals, familial hypercholesterolemia, statin intolerance.
  4. As per WHO, dyslipidemia accounts for 50% of all CV events. We know from CTT meta-analysis that high-intensity statin therapy decreases LDL-C by 1 mmol and this translates into reduction of CV events by 20-24%. PCSK9 inhibitors decrease LDL-C by additional 1 mmol and they will decrease CV events by another 20%. Thus, when used together they will decrease CV events by 40-45% and we will able to minimize lipid atherogenicity to very great extent. Thus, after witnessing the statin era for last 30 years, we are now heading for another revolution after statin therapy.

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