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Hidden side-effects data to be analysed to allay fears over 10% statin threshold



Researchers whose work underpinned NICE’s controversial decision to recommend millions more take statins for primary prevention have launched a major analysis of all unpublished safety data.

The analysis will see the Cholesterol Treatment Triallists (CTT) group requesting all available information on side effects from trials of statins – including so far unreported data from other trial investigators.

Last year’s new NICE guideline recommending lowering the 10-year risk threshold for primary prevention with statins from 20% to 10% was met with heavy critique, with some arguing that underpinning research data was ‘of serious concern’.

Professor Rory Collins, leader of the CTT and a professor at the University of Oxford, said he doubted the new analysis would change NICE guidance but he hoped it would lay concerns over statin side effects to rest.

He told Pulse: ‘This is work we have been planning since early in 2013, that in the light of anxieties that had been raised, we felt it would be useful to get hold of all of the adverse event data from clinical trials.

‘We know already from the individual trials and what has been published that there are no big adverse effects. So we know the claims of, for example 10-20% of people having side effects of statins are not correct, because the individual trials that have looked at all of this were big enough and recorded the data in enough detail to demonstrate that this was not the case.’

He added: ‘It may be that this identifies either some small beneficial or adverse effect of treatment, but it wouldn’t change the balance of benefits to risks materially.’

The new statin guidance has been met by widespread opposition from leading GPs and other medics because of concerns about ‘over-medicalisation’ of the healthy population, in particular because of worries that the risks of certain side effects – including muscle pains and weakness in particular – may outweigh any benefit people at low risk can expect to gain.

GPC member Dr Simon Poole, who was behind a motion that was carried unanimously at last year’s LMCs conference urging NICE to hold back on implementing the lower threshold until it had access to all the data, said: ‘I would welcome any review of the data but I think it is very important that all the data are available to all independent reviewers and that this information is fully available in the public domain.

‘I also think it’s regrettable that while NICE may be supporting the review by a specific group of unpublished data, in their submission to the new QOF menu of indicators they include the 10% threshold which the profession has expressed a clear lack of confidence in, in the absence of the fully published, publicly available data.’

A Pulse survey of over 500 GPs carried out in February last year showed that a clear majority – 57% – did not support the new NICE guideline and a follow-up survey in September showed two-thirds of GPs are disregarding the advice.

NICE has already moved to allay fears over its guideline. In November it told Pulse it had written to MPs to say it hoped to ‘soon have additional informaiton’ on unpublished data.

The letter, to Health Committee chair Dr Sarah Wollaston MP, said: ‘Whilst most observers acknowledge that these data are unlikely to impact significantly on our conclusions, we will of course review the impact of such data on our guidance as soon as it becomes available.’