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A study in high-risk, maximally pretreated patients to determine the potential use of PCSK9 inhibitors at various thresholds of total and LDL cholesterol levels
  1. Carl Groves1,
  2. Chandrashekar Shetty2,
  3. Richard C Strange3,
  4. Julian Waldron4,
  5. Sudarshan Ramachandran1,4,5
  1. 1Department of Clinical Biochemistry, Heart of England Foundation NHS Trust, Sutton Coldfield, UK
  2. 2Department of Clinical Biochemistry, Worcestershire Acute Hospitals NHS Trust, Worcester, Worcestershire, UK
  3. 3Institute for Science and Technology in Medicine, Keele University Medical School, Stoke-on-Trent, Staffordshire, UK
  4. 4Department of Clinical Biochemistry, University Hospitals of North Midlands, Stoke-on-Trent, Staffordshire, UK
  5. 5Faculty of Health Sciences, Staffordshire University, Stoke-on-Trent, Staffordshire, UK
  1. Correspondence to Professor Sudarshan Ramachandran, Department of Biochemistry, Good Hope Hospital, Heart of England Foundation NHS Trust, Rectory Road, Sutton Coldfield B75 7RR, UK; sud.ramachandran{at}heartofengland.nhs.uk

Abstract

Purpose of the study Statins and ezetimibe reduce low-density lipoprotein cholesterol (LDL-c) and cardiovascular disease (CVD) risk. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors lower LDL-c by 50%–70% and might be useful in refractory patients. The National Institute for Health and Care Excellence (NICE) technology appraisal guidance (TAG) recommends use of these drugs in secondary prevention and familial hypercholesterolaemia (FH) at differing LDL-c thresholds. We have estimated the proportion of patients in whom this third-line drug might be useful.

Study design We used data from a lipid-lowering audit programme to study 72 with FH and/or CVD of 271 patients referred over 12 months who failed to achieve target total cholesterol (TC) and LDL-c levels. All 72 patients were treated with ezetimibe, and 69 cases also received statins. We used LDL-c thresholds 1.5–5.5 mmol/L to estimate how many of these refractory patients could benefit from PCSK9 inhibitors.

Results In 72 patients, TC and LDL-c targets were not met by 64 and 53 patients, respectively. We judged using the NICE TAG that only one patient (1.4% ezetimibe requiring and 0.4% total referrals) required a PCSK9 inhibitor.

Conclusions We determined that the proportion of patients eligible for a PCSK9 inhibitor at various TC and LDL-c levels is modest. This may reflect the use of all available statins in UK lipid clinics often at non-daily frequency. We suggest that cost-effective use of PCSK9 inhibitors requires prescribing being restricted to clinicians working in specialised lipid clinics.

  • PCSK9 inhibitors
  • Statins
  • Ezetimibe
  • Dyslipidaemia targets
  • PREVENTIVE MEDICINE

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