Updated draft NICE guidance on the management of type 2 diabetes recommends wider use of SGLT2 inhibitors in those with or at high-risk of cardiovascular disease.
The guideline, out for consultation until 14 October, recommends offering an SGLT2 inhibitor in addition to metformin in patients with diabetes who have congestive heart failure or established cardiovascular disease.
And in those at high risk of cardiovascular disease, an SGLT2 inhibitor should be considered alongside first-line treatment with metformin, the recommendations state.
GP experts said this represents a ‘new way of working’ and will affect ‘large numbers of patients with type 2 diabetes’.
This dual therapy should be done sequentially, starting with metformin, to check tolerability to the drugs, the guidelines state.
When metformin is contraindicated or is not tolerated in those with or at high risk of cardiovascular disease, an SGLT2 inhibitor can be given on its own, under the new guidance for 2021.
For anyone with diabetes who cannot take metformin but is not at high risk of cardiovascular disease, doctors should consider a DPP-4 inhibitor, pioglitazone, a sulfonylurea or an SGLT2 inhibitor if it meets criteria previously set out by NICE in its technology appraisal on the drugs.
Before starting an SGLT2 inhibitor, clinicians should check the person is not following a low-carb or ketogenic diet and they are not pregnant or planning a pregnancy.
Patients on the drugs will also need to be monitored for renal function.
Dr Becky Haines, a clinical lead for diabetes at NHS Newcastle Gateshead CCG, told Pulse: ‘The main pharmacological change is the early addition of SGLT2i alongside Metformin if tolerated, for people with congestive heart failure, atherosclerotic CV disease or at high risk of CV disease. And with “high risk” being QRisk2 over 10% I would expect this to be a large number of people with T2DM.
‘Using these two drugs together for first line pharmacological therapy in this way will be a new way of working for most people in primary care, although some specialist GPs and nurses are already following the evidence and using this approach.
‘We need to see what people with T2DM feel about another tablet – bearing in mind they may also be offered a statin and possibly BP lowering medication at the same time – the burden of multiple medications should not be underestimated and may be one of the limiting factors.’
The update comes after an evidence review from NICE on newer drugs licensed for diabetes since the last recommendations in 2015 that have been shown to have cardiovascular benefits on top of blood glucose control.
Committee members also looked at cost-effectiveness data for the newer classes of drugs finding that overall SGLT2 were the only ones with the potential to be cost-effective.
But there was variation between SGLT2 inhibitors and ‘to address the differences in cost-effectiveness, and mindful of future price changes and new treatments entering the market, the committee agreed that wherever an SGLT2s was suitable for people at high [cardiovascular disease] risk, the SGLT2 with the lowest acquisition cost should be used’.
Dr Haines said: ‘I am surprised that the use of GLP-1 mimetic injections is not more prominent, which seems to be due to cost implications.’
The guidelines also include new decision aids on setting individualised HbA1c targets for patients taking into account adverse affects and quality of life.
NICE guidance summary
1.7.4 Assess the person’s cardiovascular status and risk to determine whether they have congestive heart failure or established atherosclerotic cardiovascular disease or are at high risk of developing cardiovascular disease.
See recommendations on using risk scores and QRISK2 to assess cardiovascular disease risk in adults with type 2 diabetes in NICE’s guideline on cardiovascular disease: risk assessment and reduction, including lipid modification. 
1.7.5 Based on the person’s cardiovascular risk assessment:
- If they have congestive heart failure or established atherosclerotic cardiovascular disease, offer an SGLT2 inhibitor in addition to metformin.
- If they are at high risk of developing cardiovascular disease, consider an SGLT2 inhibitor in addition to metformin. 
1.7.9 For first-line drug treatment in adults with type 2 diabetes, if metformin is contraindicated or not tolerated:
- If they have congestive heart failure or established atherosclerotic cardiovascular disease, offer an SGLT2 inhibitor alone.
- If they are at high risk of developing cardiovascular disease, consider an SGLT2 inhibitor alone. 
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