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NICE backs Servier’s chronic heart failure treatment Procoralan

Draft recommendation is for combination use with standard therapies

The UK’s National Institute for Health and Clinical Excellence (NICE) has recommended Servier Laboratories’ Procoralan (ivabradine) as an option for the treatment of chronic heart failure. 

In draft guidance NICE backed Procoralan’s use as a treatment option for mild to severe (NYHA II to IV class) chronic heart failure in patients with systolic dysfunction and in sinus rhythm and whose heart rate is above 75 bpm.

But it would have to be given combination with standard therapy including beta-blocker therapy or used when beta-blocker therapy is contraindicated or can’t be not tolerated.

The draft guidance also recommends that standard therapies for managing heart failure (ACE inhibitors, beta-blockers and aldosterone antagonists) should be assessed and optimised before introducing treatment with Procoralan.

Professor Carole Longson, NICE Health Technology Evaluation Centre 

director, said: “In clinical trials ivabradine has been shown to have a beneficial effect in reducing mortality and improving quality of life in people with some types of chronic heart failure.

“The Committee was mindful that there is robust evidence for the effectiveness of ACE inhibitors, beta-blockers and aldosterone antagonists that are used routinely in managing heart failure.

“They concluded that ivabradine should be initiated only after optimal treatment with these drugs has been achieved, when patients are still symptomatic after receiving optimised initial therapies, or when beta-blockers are contraindicated as specified in the marketing authorisation or not tolerated by the patients.”

Heart failure is a complex clinical syndrome of symptoms - such as breathlessness and fatigue - and signs - such as fluid retention - that suggest the efficiency of the heart is impaired.

The most common cause of heart failure in the UK is coronary artery disease, which causes many patients to suffer a heart attack and affects about 900,000 people in the UK.

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