Intended for healthcare professionals


UK deal over inclisiran

BMJ 2020; 368 doi: (Published 18 February 2020) Cite this as: BMJ 2020;368:m579
  1. Paula Byrne, research affiliate1,
  2. John Cullinan, senior lecturer1,
  3. Barbara Mintzes, associate professor2,
  4. Susan M Smith, professor of primary care medicine3
  1. 1J E Cairnes School of Business and Economics, National University of Ireland Galway, Galway, Ireland
  2. 2School of Pharmacy and Charles Perkins Centre, Faculty of Medicine and Health, University of Sydney, Sydney, Australia
  3. 3HRB Centre for Primary Care Research and Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland
  1. Correspondence to: P Byrne p.byrne13{at}

Government’s public enthusiasm looks premature given the lack of available data

The UK government recently announced an “innovative and ground-breaking collaboration” with the drug company Novartis to launch a clinical trial of inclisiran, a new cholesterol lowering drug.1 In addition, health officials said that they would provide the “cutting edge new cholesterol treatment” to patients once it was approved by regulators and the National Institute for Health and Care Excellence.2 They also stated that early results suggest that if 300 000 patients are treated each year, 55 000 heart attacks and strokes could be prevented and 30 000 lives saved over 10 years.1

This collaboration comes in the context of increasing uncertainty about the use of statins,3 and the newer PCSK9 inhibitors, which are expensive,2 and may not have lived up to expectations in terms of reductions in cardiovascular deaths or all-cause mortality.4 Inclisiran is not yet approved by any regulatory body worldwide, and there is currently no reliable publicly available evidence on its effect on cardiovascular disease or long term safety and cost effectiveness.

Inaccessible results

Inclisiran is …

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