NICE Recommends Empagliflozin (Jardiance) for Chronic Kidney Disease

The National Institute for Health and Care Excellence (NICE) has issued its Final Draft Guidance (FDG) recommending empagliflozin (Jardiance) as an option for the treatment of eligible adults with chronic kidney disease (CKD).  NICE has applied a streamlined process to this assessment of empagliflozin – an approach that is speeding up final recommendations compared with NICE’s usual appraisal process.

“The NICE Final Draft Guidance to recommend empagliflozin for the treatment of eligible patients living with chronic kidney disease is a positive step and will also be welcomed in primary care because we currently have limited treatment options” said Dr Kevin Fernando, GPwSI CVRM and Medical Education. “CKD is a pressing concern for healthcare professionals, therefore it is important that we identify and effectively manage the disease at an early stage to slow the progression and avoid future complications including the need for dialysis or kidney transplantation.”

“We are very pleased to see that the range of SGLT2 inhibitors being recommended for patients with chronic kidney disease is broadening” commented Dr Aisling McMahon, Executive Director of Research and Policy at Kidney Research UK. “In June this year, our report Kidney disease: A public health emergency, warned that growing numbers of patients needing dialysis over the next ten years risked overwhelming the NHS unless urgent action was taken. It recommended this class of medication be made more widely available to CKD patients, as part of a package of measures urgently needed to save patients’ lives and prevent more people descending into kidney failure and requiring dialysis. The NICE recommendation of empagliflozin for patients in England and Wales would be an important step in the right direction.”

The NICE recommendation has the potential to advance the standard of care for the treatment of CKD, and may help relieve the burden on healthcare systems by reducing the risk of CKD hospitalisations, or disease progression which can ultimately lead to a need for dialysis or kidney transplantation.  With existing indications in type 2 diabetes and heart failure, empagliflozin could help manage the risks of cardio-renal-metabolic conditions, which are often interconnected.

Empagliflozin is recommended by NICE as an option for treating CKD in adults if: 

• It is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated, and
• People have an estimated glomerular filtration rate (eGFR) of:

• 20 ml/min/1.73 m² to less than 45 ml/min/1.73 m² or:
• 45 ml/min/1.73 m² to 90 ml/min/1.73 m² and either:

• a urine albumin-to-creatinine ratio (uACR) of 22.6 mg/mmol or more, or
• type 2 diabetes.1

The eGFR is a key indicator of renal function based on blood readings of a patient’s serum creatinine level, age, sex and race. Kidney damage is graded into 5 stages based on an individual's eGFR result. Alongside eGFR, urine albumin-to-creatinine ratio (uACR) is also used to plan the management of CKD by healthcare professionals.

The NICE Final Draft Guidance was based on evidence including the results from EMPA-KIDNEY, the largest dedicated SGLT2 inhibitor trial in CKD that included a broad range of patients, which showed a significant benefit of empagliflozin in reducing the relative risk of kidney disease progression or cardiovascular death by 28 percent vs. placebo in people with CKD (HR 0.72; 95% CI 0.64 to 0.82; P<0.001 [absolute risk reduction 3.6%]). The trial also demonstrated a statistically significant relative risk reduction in first and recurrent hospitalisations for any cause by 14 percent vs. placebo (HR 0.86; 95% CI 0.78 to 0.95; p=0.003 [absolute risk reduction 4.4%]). The overall safety data were generally consistent with previous findings, confirming the well-established safety profile of empagliflozin.