Recent UK type 2 diabetes treatment guidance represents a near whole population indication for SGLT2-inhibitor therapy

Abstract

Recent type 2 diabetes guidance from the UK's National Institute for Health and Care Excellence (NICE) proposes offering SGLT2-inhibitor therapy to people with established atherosclerotic cardiovascular disease (ASCVD) or heart failure, and considering SGLT2-inhibitor therapy for those at high-risk of cardiovascular disease defined as a 10-year cardiovascular risk of > 10% using the QRISK2 algorithm. We used a contemporary population-representative UK cohort of people with type 2 diabetes to assess the implications of this guidance. 93.1% of people currently on anti-hyperglycaemic treatment are now recommended or considered for SGLT2-inhibitor therapy under the new guidance, with the majority (59.6%) eligible on the basis of QRISK2 rather than established ASCVD or heart failure (33.6%). Applying these results to the approximately 2.20 million people in England currently on anti-hyperglycaemic medication suggests 1.75 million people will now be considered for additional SGLT2-inhibitor therapy, taking the total cost of SGLT2-inhibitor therapy in England to over £1 billion per year. Given that older people, those of non-white ethnic groups, and those at lower cardiovascular disease risk were underrepresented in the clinical trials which were used to inform this guidance, careful evaluation of the impact and safety of increased SGLT2-inhibitor prescribing across different populations is urgently required. Evidence of benefit should be weighed against the major cost implications for the UK National Health Service.

Keywords: Cardiovascular disease; Diabetes mellitus type 2; SGLT2-inhibitors.

Fig. 1

SGLT2-inhibitor recommendations for type 2 diabetes currently treated with anti-hyperglycaemic medication in UK primary care. Estimates are derived from a UK cohort of people with type 2 diabetes (Clinical Practice Research Datalink, n = 568,524 actively registered with a GP practice in February 2020). People with chronic kidney disease stage 4–5 were excluded (n = 18,594) as this group represents a specific population with different criteria for SGLT2-inhibitor initiation. Remaining individuals were classified as either currently receiving anti-hyperglycaemic treatment (73.0%, n = 415,267) or currently untreated (27.0%, n = 153,257). NICE criteria was then used to classify individuals by cardiovascular disease status as (1) having established atherosclerotic cardiovascular disease or heart failure [Offer SGLT2-inhibitor]; (2) at high-risk of cardiovascular disease as defined by a 10-year risk of cardiovascular disease > 10% applying the QRISK2 algorithm [Consider SGLT2-inhibitor]; (3) not at high-risk of cardiovascular disease (QRISK2 < 10%) [SGLT2-inhibitor not indicated]. Amongst the 27.0% currently untreated individuals, the majority of whom will eventually require treatment, 93.3% are recommended or considered for SGLT2-inhibitor therapy, with the majority (57.6%) eligible on the basis of QRISK2 rather than established ASCVD (35.7%) [data not shown]