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Heart failure treatment based on ‘unrepresentative’ patients

Studies recruit sicker patients, boosting risk of over treatment and casting doubt on true value of certain drugs for milder disease

Caroline White

Friday, 26 January 2018

Heart failure treatment recommendations are based on studies that typically recruit the sickest patients, who are not representative of those seen in primary care with milder forms of the disease, finds a review of the available evidence*, published in BJGP Open.

This casts doubt on the actual benefits of certain treatments. And it boosts the risk of over treatment, conclude the researchers, particularly as the drugs often used to treat heart failure account for one in seven emergency admissions associated with unwanted side effects.

Heart failure carries a high risk of ill health and death that is associated with the degree of failure. The drugs used to treat it have all been shown to curb these risks, but they also carry a significant risk of major side effects.

To gauge just how representative of primary care patients studies of heart failure treatment are, the researchers trawled research databases for relevant randomised controlled trials involving treatment with beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and aldosterone antagonists, and published up to March 2015.

The characteristics of the patient’s New York Heart Association (NYHA) classification were compared with a primary care reference population with heart failure with a reduced ejection fraction (HFrEF).

Patients recruited to studies typically had more severe heart failure than the reference primary care population, the findings showed.

Of the 30 included studies, two had incomplete data. None had a close match defined as less or equal to 10 per cent deviation from reference study for NYHA class I disease; 5/28 were a close match for NYHA class II; 5/28 for NYHA class III; and 18/28 for NYHA class IV.

Patients with pre-existing cardiovascular conditions, risk factors, and underlying conditions were generally representative of the reference population.

“When evidence from sicker patients is generalised to less sick people, there is increased uncertainty about benefit and also a risk of harm from over-treatment,” conclude the researchers.

More evidence is needed for the effectiveness of these treatments in populations typical of primary care, they say.


*Nicholas D Gollop ND, Ford J, Mackeith P, et al. Are patients in heart failure trials representative of primary care populations? A systematic review. BJGP Open 23 January 2018; bjgpopen18X101337. DOI: 10.3399/bjgpopen18X101337

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