National Institute for Health and Care Excellence (NICE) draft guidance recommends dapagliflozin (Forxiga, AstraZeneca) as an add-on option to optimised standard care for patients who have heart failure with reduced ejection fraction (HFrEF).
The regulator cites DAPA-HF clinical trial evidence that adding dapagliflozin to standard ACE inhibitor, ARB, or sacubitril valsartan treatment reduced mortality and hospitalisation risk compared with standard care alone.
An indirect comparison has also shown dapagliflozin is likely to be as effective as sacubitril valsartan at reducing the risk of death from heart disease.
The annual treatment list price before any NHS discounts is £476.98. NICE estimates that around 260,000 people could be eligible for dapagliflozin treatment.
Dapagliflozin should only be started on the advice of a heart failure specialist, and should be monitored once commenced.
Dapagliflozin is approved separately for glucose management in type 1 and type 2 diabetes, but it is not suitable for patients with type 1 diabetes at the dose used for HFrEF.
Reaction: Does Not Go Far Enough
Mamas Mamas, professor of cardiology, Keele University who comments on cardiology issues for Medscape UK told us: "The NICE draft guidance around the recommendation of adding dapagliflozin to medically optimised chronic heart failure patients with the SGLT-2 is a step in the right direction for utilising this new class of drugs in patients with heart failure. Nevertheless, I believe that the guideline does not go far enough in its recommendations.
"There are two large randomised controlled trials that have shown the benefits of this class of drugs in symptomatic patients with chronic heart failure and reduced LV function - DAPA-HF and EMPEROR Reduced
- using dapagliflozin and
empagliflozin. It is therefore surprising that the draft guidelines only focus on dapagliflozin rather than both agents as a class.
"Secondly, patients with HF have significant event rates, and in the real world achieving optimal HF medical treatment takes time. I cannot see any pathophysiological reason why the guidelines recommend waiting until patients with HF are on optimal HF therapies before starting dapagliflozin given that in the real world, optimising patients on triple therapy often takes many months.
"In my view, the guidelines should have advocated a more state-of-the-art approach of rapid initiation/uptitration of quarternary therapy within a month, to reduce the risk of HF events, rather than the more conservative approach that was practised a decade ago.
"Nevertheless, challenges to overcome in the implementation of these guidelines will be around a workforce not used to prescribing/using these drugs that have been the remit of diabetologists to date." By Nicky Broyd, UK Medical News