P104 An emulation trial testing the impact of pharmacist-led carvedilol dose titration in patients with clinically significant portal hypertension

<h3>Introduction</h3> Carvedilol is known to reduce the incidence of decompensation in patients with liver cirrhosis and clinically significant portal hypertension (CSPH). Trials have shown that its benefits are achieved at high doses. In our experience patients can be inadequately dose titrated and therefore risk not experiencing the benefits of therapy. The aim of this emulation trial was to assess whether a pharmacist-led carvedilol titration (PCT) service led to higher daily doses of carvedilol. <h3>Method</h3> We used routinely collected data to emulate the conditions of a randomised trial. At University Hospital Southampton (UK) a pilot PCT service was implemented, involving face to face baseline assessment followed by fortnightly telephone assessment which included blood pressure and pulse monitoring for 8 weeks. Eligible patients had to meet Baveno VII criteria for CSPH. In the pilot phase referral of patients with CSPH to PCT was patchy i.e. some clinicians referred into PCT whereas others continued usual practice. These naturally occurring experimental conditions allowed us to retrospectively compare patients titrated via the PCT service against those managed via usual care (UC). Our primary outcome was total daily dose of carvedilol at 8 weeks from starting therapy. Secondary outcomes include adverse events. Data were analysed with SPSS v26. <h3>Results</h3> 33 patients managed via PCT and 28 patients managed via UC met the inclusion criteria during the study period. The two groups were similar: Male PCT 24 (73%) vs UC 17(60%), mean age PCT 58 years vs UC 62 years, white English ethnicity PCT 28 (84%) vs UC 23 (82%). Most common aetiology MASLD PCT 14 (42.42%) vs UC 15 (53.57%), followed by ALD PCT 11 (33.33%) vs UC 10 (35.71%), The only significant difference between the two groups was liver stiffness (kpa) – PCT 35 vs UC 25 (p&lt;0.01). The distribution of other potentially important confounding variables including a history of hypertension, ischaemic heart disease, prescribed antihypertensives, MELD score and pre-treatment mean arterial blood pressure was balanced between groups. After 8 weeks of treatment the mean daily dose in the PCT group was 16mg (9.37) whereas in the UC group it was 10.53mg (4.35) (p value=0.005) as shown in table 1. Analysis for secondary outcomes including adverse events is ongoing. <h3>Conclusion</h3> A pharmacist led carvedilol titration service led to higher average doses of daily carvedilol than for patients titrated via medical hepatology clinics, highlighting its potential to optimise treatment in patients with CSPH.

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Published
2025-10-01
DOI
https://doi.org/10.1136/gutjnl-2025-basl.118
Primary Topic
Liver Disease and Transplantation
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article
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article

P104 An emulation trial testing the impact of pharmacist-led carvedilol dose titration in patients with clinically significant portal hypertension

Salim I. Khakoo, Kathryn Nash, Ryan Buchanan, Mark Wright et al.
Liver Disease and Transplantation
article

P104 An emulation trial testing the impact of pharmacist-led carvedilol dose titration in patients with clinically significant portal hypertension

Salim I. Khakoo, Kathryn Nash, Ryan Buchanan, Mark Wright, Yoon Jun Kim, Din He Tan
article en

Abstract

<h3>Introduction</h3> Carvedilol is known to reduce the incidence of decompensation in patients with liver cirrhosis and clinically significant portal hypertension (CSPH). Trials have shown that its benefits are achieved at high doses. In our experience patients can be inadequately dose titrated and therefore risk not experiencing the benefits of therapy. The aim of this emulation trial was to assess whether a pharmacist-led carvedilol titration (PCT) service led to higher daily doses of carvedilol. <h3>Method</h3> We used routinely collected data to emulate the conditions of a randomised trial. At University Hospital Southampton (UK) a pilot PCT service was implemented, involving face to face baseline assessment followed by fortnightly telephone assessment which included blood pressure and pulse monitoring for 8 weeks. Eligible patients had to meet Baveno VII criteria for CSPH. In the pilot phase referral of patients with CSPH to PCT was patchy i.e. some clinicians referred into PCT whereas others continued usual practice. These naturally occurring experimental conditions allowed us to retrospectively compare patients titrated via the PCT service against those managed via usual care (UC). Our primary outcome was total daily dose of carvedilol at 8 weeks from starting therapy. Secondary outcomes include adverse events. Data were analysed with SPSS v26. <h3>Results</h3> 33 patients managed via PCT and 28 patients managed via UC met the inclusion criteria during the study period. The two groups were similar: Male PCT 24 (73%) vs UC 17(60%), mean age PCT 58 years vs UC 62 years, white English ethnicity PCT 28 (84%) vs UC 23 (82%). Most common aetiology MASLD PCT 14 (42.42%) vs UC 15 (53.57%), followed by ALD PCT 11 (33.33%) vs UC 10 (35.71%), The only significant difference between the two groups was liver stiffness (kpa) – PCT 35 vs UC 25 (p&lt;0.01). The distribution of other potentially important confounding variables including a history of hypertension, ischaemic heart disease, prescribed antihypertensives, MELD score and pre-treatment mean arterial blood pressure was balanced between groups. After 8 weeks of treatment the mean daily dose in the PCT group was 16mg (9.37) whereas in the UC group it was 10.53mg (4.35) (p value=0.005) as shown in table 1. Analysis for secondary outcomes including adverse events is ongoing. <h3>Conclusion</h3> A pharmacist led carvedilol titration service led to higher average doses of daily carvedilol than for patients titrated via medical hepatology clinics, highlighting its potential to optimise treatment in patients with CSPH.

University Hospital Southampton NHS Foundation Trust (GB), University of Southampton (GB)
Openalex Percentile: Top 62%
Liver Disease and Transplantation
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