P63 A changing of the guard: a single centre experience of adverse events associated with terlipressin administration in patients with type 1 hepatorenal syndrome and comparison to published data

<h3>Introduction</h3> In 2023 the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlined new advice for the use of terlipressin (the most prescribed vasoconstrictor for type 1 hepatorenal syndrome (HRS-1) in the UK.^{1 2} The CONFIRM trial, identified excess respiratory events, sepsis and mortality for patients with high-risk features (advanced renal dysfunction &amp; severe liver disease [ACLF 3 &amp;/or MELD &gt;= 39]).³ This is a single-centre retrospective study evaluating adverse events (AE) during our use of terlipressin and whether our experience mirrors clinical trial results. <h3>Methods</h3> A review of electronic records for de novo prescription of terlipressin in adults admitted to our centre during 2023. Demographic, clinical, and biochemical parameters were analysed. Statistical analyses were performed, Mann-Whitney and Chi-Square T-tests with a p value &lt;0.05 considered statistically significant. <h3>Results</h3> During 2023, 54 discrete episodes of terlipressin use were identified in 51 patients, for indications including variceal bleed (n=34; 63%), HRS-1 (n=13, 24.1%) and others (n=7, 12.9%). The HRS-1 cohort had a mean age of 57; 61.5% male; alcohol aetiology in 54%; mean MELD 29.4 (range 16–40) and mean serum creatinine 223.8 µmol/L (range 81–460 µmol/L). Concomitant albumin was administered in all patients (mean +/- SD; total per person; 292g +/- 264.8g over a median of 5 days). AE within 30 days of stopping terlipressin occurred in 7 patients (53.8%); n=4 (57.1%) developed respiratory failure and intubation was required in one (table 1). The inpatient mortality rate was 46.2% (n=6), with resolution of HRS-1 in n=4 (30.8%). There was no significant difference in MELD (p=0.857), total albumin administration (p=0.912) or starting baseline creatinine (p=0.234) between patients who survived and who died. One patient was transplanted. Four patients initiated on terlipressin would have met the high-risk criteria, and the inpatient mortality rate for this cohort was 50% (with no respiratory failure). There was no significant difference in inpatient mortality between those with high-risk criteria and those without (p=0.317). <h3>Conclusions</h3> The incidence of respiratory failure following terlipressin therapy in our HRS-1 cohort was higher than that published in the CONFIRM trial and in line with MHRA guidance we are reviewing our local policy. HRS-1 remains a significant challenge for clinicians to manage, with limited therapeutic options. However, terlipressin use is not without risk and we highlight the importance of an awareness of the contraindications to, and monitoring of patients on terlipressin. <h3>References</h3> Moore K,<i> et al</i>. Real-world treatment patterns and outcomes using terlipressin in 203 patients with the hepatorenal syndrome. <i>Aliment Pharmacol Ther</i>. 2020. www.gov.uk/drug-safety-update/terlipressin Wong F, <i>et al</i>. Terlipressin plus albumin for the treatment of type 1 hepatorenal syndrome. <i>N Engl J Med</i>. 2021.