Inclisiran: UK to roll out new cholesterol lowering drug from next yearBMJ 2020; 368 doi: https://doi.org/10.1136/bmj.m139 (Published 13 January 2020) Cite this as: BMJ 2020;368:m139
All rapid responses
The Health Department’s announcement, with Novartis and Oxford University, of an immediate large trial and likely NHS-wide roll-out of inclisiran (e.g. New heart disease drug to be made available to patients through ground-breaking collaboration. BMJ 18 Jan) was surprising, since there is no published evidence that this novel cholesterol-lowering treatment reduces cardiovascular morbidity or mortality. I was especially startled, as I have just been enrolled into the ORION-4 trial. This 5-year double-blind study of people with a history of heart attacks or strokes aims to tell us, by 2024, whether adding this novel drug to our standard cholesterol-lowering medication will give us any increased protection.
The claim in the Health Department’s and Matt Hancock’s press release that inclisiran “has the potential of saving 30,000 lives in the next 10 years” therefore seems over-hyped. However optimistically we interpret ‘has the potential’, this is a remarkable claim for an untested drug that is yet to be approved by any regulatory authority. The press release also anticipated “introduction of Inclisiran into the NHS” (in 2021), but then went on to say that this “yet to be approved” drug “will be put through NICE’s approval programme at the earliest opportunity possible” – seemingly with some confidence that this is just a formality? It also quotes Oxford’s Prof Landray as referring to the “successful ORION-4 trial” – but this is a trial that is just starting and won’t end until 2024?
The same “30,000 lives could be saved” claim opens the description of this Novartis/Government/Oxford initiative on the website of the Oxford clinical trials unit that runs the ongoing ORION-4 trial and will run the new, much larger, trial. Again, it all depends how you interpret “could”.
The BMJ’s News report covered much the same ground, but added a cautionary comment about a need for “longer term safety data” and included gentle reminders that “the absolute benefits these drugs provide for individual patients is more questionable” and that inclisiran might add to the burden of treatment for these patients.
So what was missing? None of these reports, not even the BMJ’s, told readers that inclisiran is a treatment that is yet to show any clinical benefit in any group of patients. The trials that have been completed so far have not even asked this question, and the ORION-4 trial that has just started will do this for an acknowledged at-risk group. Inclisiran is a treatment that dramatically decreases elevated blood cholesterol levels of LDL-C, which strongly suggests that it might be protective against cardiovascular disease. No doubt this is why Novartis paid $9.7 billion to buy The Medicines Company, its inventors. But hope, even Matt Hancock’s hope, is not evidence, and readers should be told the whole story.
3 K Dyrbus, M Gaslor, P Penson, K K Ray & M Banach (2019) Inclisiran – new hope in the management of lipid disorders. J. Clin. Lipidol, in press. doi: 10.1016/j.jacl.2019.11.001.
Competing interests: No competing interests