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This website is intended for UK Healthcare Professionals only. Other UK residents please visit astrazeneca.co.uk
The presence of T2D and a lack of appropriate management can cause a physiological cascade, potentially affecting the renal and cardiovascular systems.5
Dapagliflozin is a sodium-glucose co-transporter-2 inhibitor (SGLT2i) recommended by NICE and indicated for the treatment of insufficiently controlled T2D, symptomatic chronic heart failure (HF) and chronic kidney disease (CKD).1,6-8
There is an increased risk of CV complications and death in T2D, with the presence of CKD or HF10-13
Diabetes is one of the most common risk factors of CKD, with 40% of T2D patients developing CKD
Increasingly higher healthcare costs are incurred at each CKD stage in patients with T2D15
Diabetes is one of many risk factors and comorbidities associated with CV disease16
~24% of HF patients and ~40% of patients with hospitalisations for heart failure (hHF) have diabetes mellitus17
Approximately 93%* of T2D patients in a UK study had a QRISK®2† score greater than 10% or had established HF or ASCVD.18 The NICE guidelines recommend considering SGLT2i treatment, such as with dapagliflozin, as first-line treatment alongside metformin in patients with T2D at high risk of CVD.8,19‡
However, on average, only 18.8%§ of eligible patients in Great Britain are prescribed an SGLT2i.20
*Estimates are derived from a UK cohort of people with T2D (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).19
†QRISK®2 is a tool used to assess whether people are at high risk of developing CVD. Adults over 40 with T2D and a QRISK®2 score more than 10% are at high risk of developing CVD.8
‡First-line treatment with SGLT2i alongside metformin (as soon as metformin tolerability is confirmed) in eligible patients at high risk of CVD. High risk is defined as a QRISK®2 score of 10% or higher, or an elevated lifetime risk (defined as the presence of 1 or more cardiovascular risk factors in someone under 40).8
§The analysis used to create this SGLT2i data is based on a series of assumptions and estimates made by AstraZeneca and is only intended to act as a guide to the proportion of patients receiving treatment with an SGLT2i.20
The latest guidelines recommend dapagliflozin for the treatment of type 2 diabetes (T2D) in appropriate patients
The NICE guidelines recommend considering SGLT2i treatment, such as with dapagliflozin, as first-line treatment alongside metformin in patients with T2D at high risk of CVD.8*
The NICE guidelines for T2D include a focus on manging long-term cardiorenal risk, signalling a shift from focusing solely on HbA1c.8
For adults with T2D and CKD, an SGLT-2i should be offered with an angiotensin receptor blocker (ARB) or angiotension-converting enzyme inhibitor (ACEi), if:8
All rights reserved. Subject to notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this material.
*First-line treatment with SGLT2i alongside metformin (as soon as metformin tolerability is confirmed) in patients at high risk of CVD. High risk is defined as a QRISK®2 score of 10% or higher, or an elevated lifetime risk (defined as the presence of 1 or more cardiovascular risk factors in someone under 40).8
**For cardiorenal protection, FORXIGA can be initiated in patients with eGFR ≥15 mL/min/1.73m2.1 However, there is limited experience with initiating treatment with FORXIGA in patients with eGFR <25 mL/min/1.73m2. Glycaemic efficacy of FORXIGA is reduced at an eGFR <45 mL/min/1.73m2, consider additional glucose treatment in these patients with T2D for glycaemic efficacy.1
The SMC has accepted the use of FORXIGA (dapagliflozin) for restricted use within National Health Service (NHS) Scotland in adults ≥18 years with T2D to improve glycaemic control as add-on combination therapy with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control22
The DECLARE trial was a large pivotal study that assessed cardiovascular outcomes with dapagliflozin in more than 17,000 patients1,24
The use of other glucose-lowering agents (other than an open-label sodium-glucose co-transporter-2 inhibitor (SGLT-2i), pioglitazone or rosiglitazone) was at the discretion of the treating physician.24
This was the largest CV outcomes trial (CVOT) with an SGLT-2i to study hospitalisation for heart failure (hHF) risk reduction in both high risk primary and secondary prevention patients1,24
The DECLARE trial was a pivotal study providing results in the largest patient population within SGLT-2i CVOTs to date1,241,24
For further information please refer to the Summary of Product Characteristics (SmPC)
*Ischaemic heart disease, peripheral artery disease or cerebrovascular disease24
** ≥55-year-old males and ≥60-year-old females plus at least one of the following: dyslipidaemia, hypertension or current smoking24
Primary endpoint: Dapagliflozin demonstrated non-inferiority vs placebo for the composite of major cardiovascular events (MACE p=0.005). There was a numerical reduction in MACE in patients taking dapagliflozin vs placebo but this did not reach statistical significance for superiority (p=0.17). Therefore, all individual components are considered nominally significant.1,24
Adapted from Wiviott SD, et al. 2019.24
Dapagliflozin 10 mg daily demonstrated superiority versus placebo in preventing the composite of hospitalisation for heart failure or cardiovascular death. The difference in treatment effect was driven by hospitalisation for heart failure, with no difference in cardiovascular death.
in hHF*24
(2.5% vs. 3.3%) hazard ratio (HR) 0.73; 95% confidence interval (CI), 0.61, 0.88 nominal significance
in progression to nephropathy**24
(1.5% vs. 2.8%) HR 0.53; 95% CI, 0.43, 0.66 nominal significance
*hHF alone was a separate, nominally significant exploratory endpoint in DECLARE; the primary endpoint composite of CV death/hHF was driven by hHF24
**Nominally significant, prespecified exploratory renal composite outcome of a sustained decrease of ≥40% in estimated glomerular filtration rate (eGFR) to <60/min/1.73 m2 of body surface area, new end-stage kidney disease (ESKD), or death from renal or cardiovascular causes24
Understand key safety considerations about the use of dapagliflozin.
ACEi, angiotensin-converting enzyme; ACR, albumin to creatinine ratio; ARB, angiotensin receptor blocker; ARR, absolute risk reduction; ASCVD, atherosclerotic cardiovascular disease; CI, confidence interval; CKD, chronic kidney disease; CV, cardiovascular; CVD, cardiovascular disease; CVOT, cardiovascular outcomes trial; DKA, diabetic ketoacidosis; DKD, diabetic kidney disease; DPP-4i, dipeptidyl-peptidase 4 inhibitor; eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease; GLP-1, glucagon-like peptide 1; HbA1c, glycated haemoglobin; HF, heart failure; hHF, hospitalisation for heart failure; HR, hazard ratio; MACE, major adverse cardiovascular events; NHS, National Health Service; NICE, National Institute for Health and Care Excellence; PCDS, Primary Care Diabetes Society; RRR, relative risk reduction; SGLT2i, sodium-glucose co-transporter-2 inhibitor; SMC, Scottish Medicines Consortium; TZD, thiazolidinediones; T2D, type 2 diabetes.
GB-70104 | DOP: September 2025
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com/ or by calling 0800 783 0033.
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