RT Journal Article
SR Electronic
T1 Are patients in heart failure trials representative of primary care populations? A systematic review
JF BJGP Open
JO BJGP Open
FD Royal College of General Practitioners
SP bjgpopen18X101337
DO 10.3399/bjgpopen18X101337
VO 2
IS 1
A1 Nicholas D Gollop
A1 John Ford
A1 Pieter Mackeith
A1 Caroline Thurlow
A1 Rachel Wakelin
A1 Nicholas Steel
A1 Robert Fleetcroft
YR 2018
UL http://bjgpopen.org/content/2/1/bjgpopen18X101337.abstract
AB Background Guidelines recommend drug treatment for patients with heart failure with a reduced ejection fraction (HFrEF), however the evidence for benefit in patients with mild disease, such as most in primary care, is uncertain. Importantly, drugs commonly used in heart failure account for one in seven of emergency admissions for adverse drug reactions.Aim To determine to what extent patients included in studies of heart failure treatment with beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and aldosterone antagonists were representative of a typical primary care population with HFrEF in England.Design & setting Systematic review of randomised controlled trials (RCTs) of drug treatment in patients with HFrEF.Method MEDLINE, MEDLINE In-Process, EMBASE, and CENTRAL were searched from inception to March 2015. The characteristics of the patient’s New York Heart Association (NYHA) classification were compared with a primary care reference population with HFrEF.Results Of the 30 studies included, two had incomplete data. None had a close match (defined as ≤10% 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. In general, pre-existing cardiovascular conditions, risk factors, and comorbidities were representative of the reference population.Conclusion Patients recruited to studies typically had more severe heart failure than the reference primary care 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 overtreatment. More evidence is needed on the effectiveness of treatment of heart failure in asymptomatic patients with NYHA class I.