1 Recommendations

1 Recommendations

1.1 Empagliflozin is recommended as an option for treating symptomatic chronic heart failure with reduced ejection fraction in adults, only if it is used as an add-on to optimised standard care with:

  • an angiotensin-converting enzyme (ACE) inhibitor or angiotensin 2 receptor blocker (ARB), with a beta blocker and, if tolerated, a mineralocorticoid receptor antagonist (MRA), or

  • sacubitril valsartan with a beta blocker and, if tolerated, an MRA.

1.2 Start empagliflozin for treating symptomatic heart failure with reduced ejection fraction on the advice of a heart failure specialist. Monitoring should be done by the most appropriate healthcare professional.

1.3 This recommendation is not intended to affect treatment with empagliflozin that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

People with heart failure with reduced ejection fraction may have symptoms that are not controlled well enough despite being on the most appropriate (optimised) standard care. Standard care includes an ACE inhibitor or an ARB, with a beta blocker and, if tolerated, an MRA. Then, if symptoms continue on this, people may be offered sacubitril valsartan with a beta blocker and, if tolerated, an MRA.

Evidence from a clinical trial shows that empagliflozin plus standard care reduces the risk of dying from cardiovascular causes compared with placebo plus standard care. It also shows that it reduces the likelihood of hospitalisation for heart failure. There are no trials directly comparing empagliflozin with the most appropriate comparator, dapagliflozin. However, an indirect comparison suggests that empagliflozin is likely to be similar to dapagliflozin in reducing the risk of dying and the likelihood of hospitalisations for heart failure.

The cost-effectiveness estimates for empagliflozin are within what NICE normally considers an acceptable use of NHS resources. So empagliflozin is recommended.

Increased monitoring or changes to other medicines being taken may be needed for treating heart failure with empagliflozin. So, it should only be started on advice from a heart failure specialist.

  • National Institute for Health and Care Excellence (NICE)