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WORLD HOSPITAL DIRECTORY
Addiction Medical Alcohol and Alcoholism - current issue
<span class="paragraphSection"><div class="boxTitle">Abstract</div><div class="boxTitle">Aims</div>We evaluated the safety, efficacy, and patient adherence to oral ANS-6637, a selective, reversible inhibitor of aldehyde dehydrogenase 2 (ALDH2), for treating alcohol use disorder (AUD).<div class="boxTitle">Methods</div>A 3-arm, double-blind, randomized, proof-of-concept human laboratory study embedded in a 5-week multisite clinical trial tested 200 mg and 600 mg daily doses of ANS-6637 compared to placebo in treatment-seeking adults with AUD. After 1 week of medication, participants completed an alcohol cue reactivity session. Drinking and safety assessments were measured during treatment; other exploratory outcomes were measured 1 week after treatment ended.<div class="boxTitle">Results</div>The study was terminated following enrollment of 43 of 81 planned participants due to clinically significant, reversible increases in liver enzymes in three women. Adverse events consistent with ALDH2 inhibition in the presence of alcohol (heart rate/palpitations, flushing, nausea) were dose dependent. Group differences in cue-elicited craving were not significant; effect sizes (Cohen’s d) comparing the 200 mg and 600 mg doses to placebo were .71 and .06, respectively. Secondary endpoints did not differ significantly between groups; Cohen’s d ranged from .31 to .57 for the 600 mg dose compared to placebo for continuous drinking outcomes.<div class="boxTitle">Conclusions</div>Findings of liver toxicity with ANS-6637 led to early termination and reduced power to test hypotheses. Effect size estimates are consistent with the hypothesis that selective ALDH2 inhibition may reduce craving and drinking, however these estimates may be unreliable due to the small sample size. Additional research with non-hepatotoxic selective and reversible ALDH2 inhibitors is needed to evaluate this approach to AUD pharmacotherapy.</span>
<span class="paragraphSection"><div class="boxTitle">Abstract</div><div class="boxTitle">Background and aims</div>Alcohol-associated hepatitis (AH) frequently triggers acute decompensation (AD) in cirrhosis, with severe AH linked to high short-term mortality, especially in acute-on-chronic liver failure. Current corticosteroid treatments have limited efficacy, highlighting the need for new therapies. We hypothesized that severe AH outcomes are influenced by early specialized care; thus, we examined the impact of time-to-tertiary care (TTTc).<div class="boxTitle">Methods</div>Adults with cirrhosis or advanced chronic liver disease were enrolled (RH7, NCT04767945). AH was diagnosed using National Institute on Alcohol Abuse and Alcoholism criteria. Primary admission site, TTTc, and adverse outcomes (death or liver transplantation) were analyzed. Patients admitted directly to tertiary care were assigned a TTTc of zero.<div class="boxTitle">Results</div>Of 221 AD-AH patients, 107 were transferred from secondary care to tertiary care (TTTc >0) and 114 were admitted directly (TTTc = 0). TTTc >0 patients were younger (48.3 vs. 52 years, <span style="font-style:italic;">P</span> = .008) and had more severe disease, as shown by model for end-stage liver disease scores (25.5 vs. 20.8, <span style="font-style:italic;">P</span> < .001) and Maddrey’s discriminant function (59.3 vs. 40.6, <span style="font-style:italic;">P</span> < .001). Propensity-score matching yielded 49 case pairs. The Cox model showed that transfer from secondary care was not associated with increased risk, but delayed transfer (days, hazard ratio = 1.03, 95% confidence interval 1.01–1.05) independently predicted adverse outcomes.<div class="boxTitle">Conclusions</div>Delayed initiation of specialized care adversely impacts outcomes in AD-AH. If validated, timely care bundles could improve AH survival, similar to sepsis or vascular syndromes.<div class="boxTitle">Highlights</div><ul><li class="bullet">AD-AH is a common syndrome associated with high short-term mortality.</li><li class="bullet">There is an unmet need for new prognosis-modifying therapies for AH.</li><li class="bullet">Currently, in real-life hepatology, refining the existing bundle of care is the only practical option to improve the prognosis of AD-AH.</li><li class="bullet">Past experience with acute coronary syndromes, stroke, and sepsis, emphasizing symptoms-to-intervention duration, combined with the recent COVID-19 lockdown finding of increased mortality due to skewed access to specialized liver care indicates that focusing on timely specialized care might be key to improved outcome in certain liver conditions.</li><li class="bullet">In this line, we set out to track the number of days elapsing between admission to SC and referral to TC, coining this interval as “time-to-tertiary care” (TTTc). We examined TTTc as a potential compound surrogate that might influence the prognosis in AD-AH.</li><li class="bullet">After correcting for important baseline differences, we conclude that the delay of transfer to the tertiary care hospital was independently associated with a worse prognosis with each additional day in TTTc increasing adverse outcomes by nearly 3%.</li></ul></span>
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