EU approval for heart drug ivabradine

Heart and lungs

A pill costing £1.40 a day “could save the lives of thousands of heart disease patients”, according to the Daily Mail. Several other newspapers have reported on the drug ivabradine, a.k.a. Procoralan...

A pill costing £1.40 a day “could save the lives of thousands of heart disease patients”, according to the Daily Mail.

Several other newspapers have reported on the drug ivabradine, known by the brand name Procoralan, as European drug regulators have today approved it for the treatment of chronic heart failure. In heart failure, the heart is unable to pump sufficient blood to the limbs and organs, causing a range of unpleasant symptoms such as weakness and breathlessness.

The drug is already used to treat some patients with a form of heart-related chest pain called angina. After an examination of evidence by the European Medicines Agency (EMA), ivabradine has also been granted a “marketing licence” for the treatment of chronic heart failure. This will allow ivabradine’s manufacturer to make the medicine available to patients and healthcare professionals in all EU countries. However, before it is available on the NHS, its treatment effects and cost effectiveness will need to be assessed by the National Institute for Health and Clinical Excellence (NICE).

Despite all the positive news coverage, prescribers will need to consider both the effectiveness and cost of ivabradine compared to other treatments for heart failure. It’s possible that other drugs could perform as well or better for less cost.

What is ivabradine used for?

Despite what some news reports suggest, ivabradine is not a new drug. It is already used to treat the symptoms of long-term stable angina. It is not the first choice for treating stable angina, and NICE guidelines recommend that it is only prescribed to people who cannot take beta-blockers or calcium channel blockers, which are generally preferred to treat angina.

The drug has made the papers because it has now been granted a licence for the treatment of some types of chronic heart failure. Although it has previously been approved for treating stable angina, drugs must be licensed for each of their specific uses. In August 2010, Behind the Headlines reported on a randomised controlled trial that looked at ivabradine for heart failure.

What is heart failure?

Contrary to what the term implies, heart failure does not mean that somebody’s heart has stopped beating or misses beats. Instead, it refers to a chronic condition where the heart can no longer pump sufficient blood around the body.

During each heartbeat, blood enters the heart and is pumped out towards the organs and limbs. In heart failure, the heart cannot cope with pumping the normal amount of blood in each heartbeat. This can be due to the lower chambers of the heart (the ventricles) not contracting properly so that blood is not completely pumped out of the heart (systolic heart failure) or because the ventricles do not fill up with enough blood between each heartbeat (diastolic heart failure). It can be a combination of the two. It may affect the left or right side of the heart, or both sides. It can cause a range of symptoms, including breathlessness, tiredness, weakness, dizziness, nausea, swollen ankles and legs, enlargement of the liver, constipation and loss of appetite.

Risk factors or causes of heart failure include:

  • ischaemic heart disease (coronary heart disease)
  • diseases of the heart muscle or heart valves
  • abnormal heart rhythms
  • high blood pressure (hypertension)

Around 68,000 new cases of heart failure are diagnosed in the UK each year.

How does ivabradine work?

Ivabradine slows the heat rate. This may have a protective effect on the heart, and allow the heart to pump more efficiently at a slower rate.

Is it suitable for everyone?

The European Medicines Agency (EMA), which is responsible for issuing the authorisation, says that ivabradine is medically suitable for people with:

  • long-term heart failure with symptoms (a severity of symptoms called NYHA II to IV)
  • the form of the illness involving systolic dysfunction (where blood is not completely pumped out of the heart) 
  • a regular rhythm and a heart rate of 75 beats a minute or more

The EMA says that when treating heart failure, ivabradine can be given either in combination with standard therapies, including beta-blockers, or on its own when beta-blocker therapy is not suitable or not tolerated.

The EMA also states that ivabradine should not be used for patients who have:

  • unstable or acute heart failure, also known as “new onset” heart failure
  • a heart rate imposed exclusively by a pacemaker

Ivabradine is also unsuitable for people who:

  • react to any of the components of the tablets
  • have a heart rate below 60 beats a minute before treatment
  • have very low blood pressure
  • have various types of heart disorder (cardiogenic shock, a history of acute heart attack, rhythm disorders or unstable or acute heart failure) or have unstable angina or a pacemaker
  • have liver problems
  • are taking certain other drugs
  • are pregnant or breastfeeding

Are there any side effects?

The most common side effect of ivabradine is a temporary brightness in the field of vision. Other common side effects (affecting 1 in 100 people or more) include:

  • blurred vision
  • headaches
  • changes in electrical activity of the heart
  • heart or circulation problems
  • dizziness, tiredness, weakness, lowered blood pressure, general feeling of being unwell, fainting or brief losses of consciousness

Is ivabradine available now?

Ivabradine is available now for the treatment of long-term stable angina, having been approved for this use several years ago. It is in the news because it has now been granted “marketing authorisation” by the EMA as a treatment for heart failure. This allows the manufacturer of ivabradine to make the medicine available to patients and healthcare professionals in all EU countries. However, before it is available on the NHS, it will need to be approved by NICE.

What kind of things will NICE have to consider?

NICE will consider the cost effectiveness of ivabradine treatment (how its medical effectiveness relates to the cost of the drug). It should not be assumed that ivabradine will become the standard treatment for heart failure. Other drugs may be more effective or less likely to cause side effects, and therefore better options.

While several newspapers have reported that the drug is cheap at just £1.40 a day, this is higher than many beta-blocker drugs currently in use, which may cost just a few pounds a month. If these existing drugs can provide similar or better results to ivabradine for a lower price, then it is likely they will remain the default option for prescribers.

Article Metadata Date Published: Mon, 21 Aug 2017
Author: Zana Technologies GmbH
NHS Choices