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NICE risks making itself a ‘laughing stock’ over guidance on metformin alternatives, say experts



Primary care experts are urging NICE to overhaul draft guidelines on type 2 diabetes, claiming recommendations to use the drug repaglinide are ‘bonkers’ and risk setting care back a decade, Pulse has learned.

The experts said the recommended treatment algorithm for glycaemic control was ‘nonsensical’, drawing particular attention to the promotion of the insulin secretagogue repaglinide – which primary care has ‘little understanding of’ because it is rarely prescribed.

The draft guidelines still recommend metformin as first-line initial therapy, but have demoted sulfonylureas from their position as a second-line or alternative option to metformin over concerns about their associated risks of hypoglycaemia.

They now propose repaglinide as an alternative first-line therapy in people who cannot tolerate metformin. But Professor Roger Gadsby, GPSI in diabetes and principle teaching fellow at the University of Warwick, told Pulse the treatment algorithm was considered ‘bonkers’ by diabetes experts.

Professor Gadsby said: ‘Many experts in diabetes have labelled part of this draft guidance as “bonkers”… A particular area of concern is the recommendation that in the 15% or so who cannot tolerate metformin as initial monotherapy for glycaemic control the drug repaglinide should be used.’

He continued: ‘It is a drug that was launched in the 90s but never caught on. There are very few people taking it today so there is no real understanding in general practice of how to use the drug, what dose should be given, and what dose escalation is appropriate.’

Professor Gadsby also pointed out that repaglinide has to be taken three times a day, its adverse events have been poorly documented and that as it is not licensed for use with anything other than metformin, patients who were unable to get to target glucose levels with repaglinide would have to be taken off it and start again on a new therapy.

Dr Andrew Brewster, a GPSI in obesity and type 2 diabetes and research fellow at Reading University, said he also had concerns about the treatment algorithm and repaglinide in particular – and warned the recommendations would ‘make a laughing stock’ of NICE.

Dr Brewster said: ‘I think the guidelines are nonsensical because a) they are not tailoring treatment and b) the treatment is a bit bizarre – especially for repaglinide.’

He added: ‘There is no mention of modified-release metformin, yet we know metformin reduces all-cause mortality so if someone can’t tolerate standard metformin they should be given the opportunity to have modified release metformin.

‘I’m against using sulfonylureas because they do cause hypoglycaemia and there’s concern about increasing mortality, but I think we need to tackle what is the most fundamental problem for most patients, which is insulin resistance – and repaglinide does nothing for that.

‘I think it’s a cheap algorithm but it’s not necessarily a sensible one. This makes a laughing stock of NICE – this is not clinical excellence.’

The concerns voiced by Professor Gadsby and Dr Brewster echoed criticisms outlined in an editorial written by UK specialists in diabetes and published online in the British Journal of Diabetes and Vascular Disease

Led by Dr Paul O’Hare, from the division of metabolic and vascular health at University of Warwick Medical School, said the recommendations on glucose-lowering appeared to be ‘driven by an imperative on costs and failing to appreciate the “value” of the options’.

They added: ‘In our opinion, the draft proposals are so out of kilter with current recommendations for “best practice” that, if enacted, they will reduce quality of care and patient safety and will set back modern diabetes management by decades.

‘At best, it is our belief that most clinicians will ignore the recommendations or “pay lip service” to them, thus undermining the valuable role NICE can play in giving clear, credible and cost-effective advice.’                                                                                                                                                                                              

NICE declined to respond to the specific criticisms while the public consultation is still underway, but said views would be ‘fully considered’ to ‘help inform the final guideline’.

A spokesperson said: ‘The public consultation on the NICE guideline for type 2 diabetes will run until Wednesday 4 March. As is the usual NICE process we are now actively seeking feedback from healthcare professionals and stakeholder organisations.

‘We encourage anyone with a relevant interest to submit their views via our website so they can be fully considered by the guideline development group and help inform the final guideline. All documents and details on how to comments are available on our website.’