Regulatory Focus™ > News Articles > UK NICE Gives Green Light to Servier's Procoralan for Chronic Heart Failure

UK NICE Gives Green Light to Servier's Procoralan for Chronic Heart Failure

Posted 08 August 2012 | By Louise Zornoza

The UK's National Institute for Health and Clinical Excellence (NICE) on 7 August issued draft guidance recommending French drugmaker Servier Laboratories' cardiovascular drug Procoralan (ivabradine) be used by the National Health Service (NHS).

In clinical trials, ivabradine has been shown to reduce mortality and improve quality of life in patients with certain forms of chronic heart failure. The draft guidance recommends ivabradine as an option for the treatment of chronic heart failure (NYHA class II to IV with systolic dysfunction, in people in sinus rhythm and whose heart rate is 75 beats per minute or more) in combination with standard therapy, including beta-blocker therapy, or when beta-blocker therapy is contraindicated or not tolerated.

The draft guidance also recommends that therapies used routinely for managing heart failure (ACE inhibitors, beta-blockers and aldosterone antagonists) should be optimized before treatment with ivabradine is initiated by a heart failure specialist with access to a multi-disciplinary heart failure team, and after a stabilization period on these therapies of 4 weeks. The NICE clinical guideline for chronic heart failure (CG108) recommends that all patients be considered for first-line treatment with beta-blockers and an angiotensin-converting enzyme (ACE) inhibitor unless contraindicated or not tolerated.

A Disease with Co-morbidities

The most common cause of heart failure in the UK is coronary artery disease, with many patients having suffered a myocardial infarction (heart attack) in the past. It affects about 900,000 people in the UK, and that number is increasing as a result of improved prognosis of coronary artery disease, aging of the population and better treatments.

"Although the prognosis for people with heart failure has been improving over recent years, largely as a result of better treatments, heart failure can have a significant detrimental impact on quality of life, particularly in terms of affecting a person's ability to perform everyday tasks," said Carole Longson, NICE Health Technology Evaluation Centre Director.

"Because heart failure is predominantly a disease of the elderly, co-morbidities increase the impact of the disease and usually require lifestyle changes," Longson continued. "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."

Consultation on the draft guidance will end 29 August 2012. 

Read more:

NICE - NICE draft guidance recommends new treatment for people with chronic heart failure

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