Dapagliflozin

NICE (National Institute of Clinical Excellence) have recommended Dapagliflozin as an option for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), only if it is used as an add-on to optimised standard care

 Standard care would be:

  • Angiotensin converting enzyme inhibitor (ACE inhibitor) or Angiotensin receptor antagonist (ARB) with a beta blocker and a mineralocorticoid receptor antagonist ( MRA)  if tolerated or
  • Sacubitril valsartan, with beta blockers, and, if tolerated, MRAs.

Heart failure with reduced ejection fraction is a chronic condition which can affect length and quality of life. The patient experts highlighted the psychological effects of a diagnosis and explained that breathlessness, extreme fatigue and fluid accumulation in particular can be debilitating (NICE 2020).

DAPA-HF was a double-blind randomised clinical trial comparing Dapagliflozin (a sodium-glucose cotransporter-2 inhibitor) plus standard care with placebo plus standard care. Standard care was defined by pharmaceutical company AstraZeneca as:

“ACE inhibitors or ARBs, beta blockers and, if tolerated, MRAs (referred to in this guidance as standard care based on ACE inhibitors or ARBs), or Sacubitril valsartan, plus beta blockers, and, if tolerated, MRAs (referred to in this guidance as standard care based on sacubitril valsartan).”

People in the trial had HFrEF defined by an ejection fraction of 40% or less who despite being 'optimally treated with pharmacological and/or device therapy' remain symptomatic. Symptomatic HFrEF was defined as New York Heart Association (NYHA) functional class 2 to 4 present for at least 2 months.

The DAPA-HF trial demonstrated that Dapaglilozin in addition to standard of care, reduced the risk of worsening heart failure hospitalisation versus placebo by 26%.

Dapagliflozin is an oral, once daily SGLT2 inhibitor given to adults for the treatment of poorly controlled type 2 diabetes as both a single medication or as part of combination therapy in addition to diet and exercise to improve glycaemic control, with the additional benefits of weight loss and blood pressure reduction.

Dapagliflozin is currently being studied in patients with heart failure in the DELIVER (heart failure with preserved ejection fraction HFpEF) which is recruiting participants due to complete in November 2021  (Read more on ClinicalTrials.gov) and DETERMINE (heart failure with reduced ejection fraction and preserved ejection fraction) which closed in March 2020 (Read more here)

Dapagliflozin has been studied in multiple clinical trials in more than 35,000 patients. It is promising news for people with heart failure,  as they will now be able to receive a new treatment for their condition, which, when added to existing medication can improve symptoms, reduce the likelihood of hospital admission and extend life expectancy.

Usual Adult Dose for Heart Failure with Reduced Ejection Fraction:

  • 10 mg orally once a day
  • You may take Dapagliflozin with or without food.

Potential side effects

Side effects may include frequent urination, dizziness or light-headedness may occur. To reduce the risk of dizziness and light-headedness you would be advised to get up slowly when rising from a sitting or lying position.

You would be advised to tell your GP if you have any serious side effects, including: signs of a urinary tract infection (such as burning/painful/frequent/urgent urination, pink/bloody urine), signs of kidney problems (such as change in the amount of urine, swelling legs/feet).

Also, tell your GP if you have any signs of dehydration, such as urinating less than usual, unusual dry mouth/thirst, fast heartbeat, or dizziness/light-headedness/fainting.