School of Health & Wellbeing

The Lancet medical journal currently has an impact factor of 202.7, surpassing that of the New England Journal of Medicine. Between October 8 and November 5, 2022, three trials supported by the Robertson Centre for Biostatistics were published online in the Lancet.

1. The first to be published was ALL-HEART a randomized trial of allopurinol (a drug normally used for the treatment of gout) versus usual care in 5675 patients with ischaemic heart disease (Allopurinol versus usual care in UK patients with ischaemic heart disease (ALL-HEART): a multicentre, prospective, randomised, open-label, blinded-endpoint trial – The Lancet). Despite a previous smaller trial suggesting benefit in patients with angina, this large trial did not show any benefit in reducing the risk of the primary endpoint (non-fatal myocardial infarction, non-fatal stroke or cardiovascular death). Nicola Greenlaw and Ian Ford were Robertson Centre co-authors.
2. The second trial (TIME) compared the strategies of taking blood pressure medication in the evening or the morning (Cardiovascular outcomes in adults with hypertension with evening versus morning dosing of usual antihypertensives in the UK (TIME study): a prospective, randomised, open-label, blinded-endpoint clinical trial – The Lancet). Unlike most clinical trials that recruit participants in health care settings or by face-to-face contact in the community, TIME recruited, consented, randomised and followed up participants remotely via a web-portal and used record linkage to national databases of deaths and hospital discharges to identify potential study endpoints. Two previous Spanish trials had controversially suggested remarkable benefits in reducing cardiovascular events by taking blood pressure treatment in the evening rather than in the morning. TIME, a trial with 21104 participants did not show any such benefit in reducing vascular death or hospitalisation for non-fatal myocardial infarction or non-fatal stroke. Robin Young, Alex McConnachie and Ian Ford were co-authors.
3. The third study was IRONMAN, a randomised trial of intravenous iron infusion versus usual care in 1137 patients with heart failure, reduced ejection fraction and iron deficiency, a common condition in patients with heart failure (Intravenous ferric derisomaltose in patients with heart failure and iron deficiency in the UK (IRONMAN): an investigator-initiated, prospective, randomised, open-label, blinded-endpoint trial – The Lancet). The trial was significantly impacted by the COVID-19 pandemic. Treatment had to be given in a hospital setting and most participants could not or were not willing to attend for hospital appointments during the pandemic. The intention-to treat results of the trial suggested that there were fewer events due to hospitalisation for heart failure or cardiovascular death in the intravenous iron arm, but the difference did not meet achieve statistical significance (p=0.07). However, in a pre-specified COVID-19 sensitivity analysis there was a statistically significant reduction in this endpoint. Lizzie Thomson, Michele Robertson and Ian Ford were co-authors.

Find out more about the Robertson Centre for Biostatistics 

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First published: 1 November 2022