Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Ivabradine in Heart Failure?

The Lancet has published the results of the SHIFT study which aimed to assess the effect of heart rate reduction using ivabradine (Procoralan®) in patients with heart failure. The results of this study have been reported in the general media (BBC).

The study recruited and treated 6,505 participants in symptomatic heart failure (NYHA II-IV) with an ejection fraction of 35% or less. They were all in sinus rhythm with a pulse rate of at least 70 beats per minute. Participants were on stable background treatment which included a beta-blocker, if tolerated. Treatment was randomly assigned to ivabradine titrated to a maximum of 7·5 mg twice daily or matching placebo.

The primary outcome of the study was a composite of cardiovascular death or hospital admission for worsening heart failure. Mean follow up was 22.9 months.

793/3,241 (24%) patients in the ivabradine group and 937/3,264 (29%) of those taking placebo had a primary endpoint event (HR 0·82, 95% CI 0·75-0·90, p<0·0001, NNT ~24). The difference was mainly driven by a reductions in the rate of hospital admission for heart failure (21% with placebo versus 16% with ivabradine, HR 0·74, 0·66-0·83; p<0·0001, NNT ~21) and death due to heart failure (5% with placebo versus 3% with ivabradine, HR 0·74, 0·58-0·94, p=0·014, NNT ~88). A greater number of patients treated with ivabradine reported bradycardia (5% versus 1%) and visual disturbances (3% versus 1%).

The authors of the study conclude that, "our results support the importance of heart-rate reduction with ivabradine for improvement of clinical outcomes in heart failure ". However, an editorial in the same issue of the Lancet and the British Heart Foundation both call for further research to assess the place in therapy for ivabradine.

It should be noted that ivabradine is not currently licensed for use in heart failure and that at the current cost of £39.00 for 28 days of treatment it would cost approximately £84,000 to treat 88 patient in order to prevent one death due to heart failure.

Action: Clinicians should be aware of this study. Pending additional research it would be wise to use the recently updated the Heart Failure Clinical Guideline produced by the National Institute for Health and Clinical Excellence.

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NICE Guidance - August 2010

The National Institute of Health and Clinical Excellence has published new guidance for the month of August 2010. This month there are three clinical guidelines that impact upon primary care.

The Chronic Heart Failure guideline (QRG) is an update to the 2003 guideline. It covers the care and treatment of people with chronic heart failure and includes updates on diagnosis, pharmacological treatment, monitoring and rehabilitation.

The Hypertension in Pregnancy guideline (QRG) covers the care and treatment of women who have or are at risk of developing hypertension in pregnancy. It contains pre-conceptual advice and advice on the diagnosis and management during pregnancy, birth and the postnatal period.

The Transient Loss of Consciousness in Adults guideline (QRG) covers the assessment, diagnosis and specialist referral of adults and young people (aged 16 and older) who have experienced transient loss of consciousness.

Action: Clinicians should be aware of these guidelines. They will be a useful resource for clinicians who see patients with heart failure, women of child-bearing age and in cases of transient loss of consciousness.

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Additional CKS Update - August 2010

Clinical Knowledge Summaries (CKS) has been further updated in August 2010 for the following clinical areas:

Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.

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MeReC Extra 46

The National Prescribing Centre has published MeReC Extra 46 (PDF) which discusses the place in therapy for simvastatin 80mg daily and the increased risk of cancer observed with angiotensin receptor blockers (ARBs).

The first section notes that earlier this year regulatory authorities drew attention to the increased risk of myopathy with simvastatin at a daily dose of 80mg. This advice is then placed into context with a review of the current Lipid Modification guidance issued by the National Institute for Health and Clinical Excellence (NICE). Statin doses and lipid targets (or the lack of them) are detailed for primary prevention, secondary prevention and acute coronary syndrome (ACS). Clinicians are also reminded that when treatment appears ineffective it is worthwhile checking how concordant the patient is in taking their treatment.

The second section discusses the results of a recent meta-analysis that identified an increased rate of new cancer diagnoses in patients taking ARBs in randomised controlled trials. Although the absolute risk increase is small (1.2% over 4 years) the large number of patients potentially involved means that this information deserves some consideration. Clinicians are advised to review prescribing of ARBs on an individual patient basis. Angiotensin converting enzyme (ACE) inhibitors have more robust efficacy and safety data and may be a suitable alternative.

Action: Clinicians who prescribe statins or ARBs will find this information useful and informative.

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CKS Update - August 2010

Clinical Knowledge Summaries (CKS) has been updated in August 2010 for the following clinical areas:

Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.

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