459. vonoprazan versus lansoprazole for healing erosive esophagitis in patients with systemic sclerosis (heal-SSC): a preliminary report of randomized placebo-controlled trial
Abstract
Abstract Background Systemic sclerosis (SSc) is a complex autoimmune disorder characterized by fibrosis and vasculopathy, with GI involvement observed over 90% of patients. GERD, particularly erosive esophagitis, is highly prevalent in SSc patients. Currently proton pump inhibitors (PPIs) are the standard treatment for erosive esophagitis in SSc patients; however fewer than 50% of patients experience sufficient symptom relief. In current study, has demonstrated that potassium-competitive acid blocker (PCAB) non-inferior acid suppression and promising efficacy in refractory GERD. This study proposed a randomized controlled trial to compare the therapeutic efficacy of PCABs versus PPIs in the healing EE among patients with systemic sclerosis. Methods This randomized, placebo-controlled trial was approved by the Khon Kaen University Ethics Committee for Human Research (approval number HE671104). The inclusion criteria were patients with SSc, aged older than 18 years, and diagnosed with refractory GERD based on the Thailand GERD guideline 2020. Eligible participants were enrolled and randomly assigned a 1:1 ratio to received either vonoprazan 20 mg/day with a lansoprazole placebo, or lansoprazole 30 mg/day with a vonoprazan placebo. The participants underwent history-taking, assessment of GERD symptoms at baseline, 2nd week, 4th week, and 8th week. The EGD was performed at baseline and 8th week. Results Between June 2024 and March 2025, 74 patients with refractory GERD underwent…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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