Background/Aims: Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing. Methods: In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs). Results: In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively. Conclusions Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.

Purpose: Although upper eyelid retraction is commonly associated with thyroid eye disease, its etiology remains unclear. This study evaluated the clinical features and treatment outcomes of patients with upper eyelid retraction caused by idiopathic orbital myositis (IOM). Methods: We conducted a retrospective analysis of the medical records of patients who presented with unilateral upper eyelid retraction. IOM was diagnosed based on normal thyroid function tests (TFT), including thyroid-stimulating immunoglobulin (TSI). Orbital imaging demonstrated contrast-enhanced enlargement of the superior rectus-levator palpebrae superioris complex (SR-LC). Pre- and post-systemic steroid treatment, margin-reflex distance 1 (MRD1), MRD1 difference between affected and unaffected eyes, exophthalmos, and diplopia were assessed. Results: In total, five patients (male: 4, female: 1) with a median age of 36.4 years were diagnosed with IOM. Three patients presented with diplopia on upgaze and supraduction limitation. Orbital imaging revealed levator palpebrae superioris muscle enlargement with distinct borders and homogeneous contrast enhancement. All cases with superior rectus enlargement demonstrated tendon involvement. The median duration from symptom onset to treatment initiation was 2.2 months. Four patients received oral prednisolone, whereas one received intravenous methylprednisolone. Although no significant improvements were observed in MRD1, MRD1 difference, or exophthalmos post-treatment, diplopia resolved in all three patients. Conclusions IOM can present with upper eyelid retraction, emphasizing the importance of differentiating it from thyroid eye disease. TFT, including TSIs, and orbital imaging are essential diagnostic tools. These findings indicate that systemic corticosteroids can effectively manage diplopia associated with IOM, emphasizing the potential benefit of early and aggressive treatment.

Background/Aims: Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing. Methods: In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs). Results: In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively. Conclusions Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.

Purpose: Although upper eyelid retraction is commonly associated with thyroid eye disease, its etiology remains unclear. This study evaluated the clinical features and treatment outcomes of patients with upper eyelid retraction caused by idiopathic orbital myositis (IOM). Methods: We conducted a retrospective analysis of the medical records of patients who presented with unilateral upper eyelid retraction. IOM was diagnosed based on normal thyroid function tests (TFT), including thyroid-stimulating immunoglobulin (TSI). Orbital imaging demonstrated contrast-enhanced enlargement of the superior rectus-levator palpebrae superioris complex (SR-LC). Pre- and post-systemic steroid treatment, margin-reflex distance 1 (MRD1), MRD1 difference between affected and unaffected eyes, exophthalmos, and diplopia were assessed. Results: In total, five patients (male: 4, female: 1) with a median age of 36.4 years were diagnosed with IOM. Three patients presented with diplopia on upgaze and supraduction limitation. Orbital imaging revealed levator palpebrae superioris muscle enlargement with distinct borders and homogeneous contrast enhancement. All cases with superior rectus enlargement demonstrated tendon involvement. The median duration from symptom onset to treatment initiation was 2.2 months. Four patients received oral prednisolone, whereas one received intravenous methylprednisolone. Although no significant improvements were observed in MRD1, MRD1 difference, or exophthalmos post-treatment, diplopia resolved in all three patients. Conclusions IOM can present with upper eyelid retraction, emphasizing the importance of differentiating it from thyroid eye disease. TFT, including TSIs, and orbital imaging are essential diagnostic tools. These findings indicate that systemic corticosteroids can effectively manage diplopia associated with IOM, emphasizing the potential benefit of early and aggressive treatment.

Background/Aims: Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing. Methods: In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs). Results: In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively. Conclusions Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.

Purpose: Although upper eyelid retraction is commonly associated with thyroid eye disease, its etiology remains unclear. This study evaluated the clinical features and treatment outcomes of patients with upper eyelid retraction caused by idiopathic orbital myositis (IOM). Methods: We conducted a retrospective analysis of the medical records of patients who presented with unilateral upper eyelid retraction. IOM was diagnosed based on normal thyroid function tests (TFT), including thyroid-stimulating immunoglobulin (TSI). Orbital imaging demonstrated contrast-enhanced enlargement of the superior rectus-levator palpebrae superioris complex (SR-LC). Pre- and post-systemic steroid treatment, margin-reflex distance 1 (MRD1), MRD1 difference between affected and unaffected eyes, exophthalmos, and diplopia were assessed. Results: In total, five patients (male: 4, female: 1) with a median age of 36.4 years were diagnosed with IOM. Three patients presented with diplopia on upgaze and supraduction limitation. Orbital imaging revealed levator palpebrae superioris muscle enlargement with distinct borders and homogeneous contrast enhancement. All cases with superior rectus enlargement demonstrated tendon involvement. The median duration from symptom onset to treatment initiation was 2.2 months. Four patients received oral prednisolone, whereas one received intravenous methylprednisolone. Although no significant improvements were observed in MRD1, MRD1 difference, or exophthalmos post-treatment, diplopia resolved in all three patients. Conclusions IOM can present with upper eyelid retraction, emphasizing the importance of differentiating it from thyroid eye disease. TFT, including TSIs, and orbital imaging are essential diagnostic tools. These findings indicate that systemic corticosteroids can effectively manage diplopia associated with IOM, emphasizing the potential benefit of early and aggressive treatment.

Purpose: In men with metastatic castration-resistant prostate cancer (mCRPC), new bone lesions are sometimes not properly categorized through a confirmatory bone scan, and clinical significance of the test itself remains unclear. This study aimed to demonstrate the performance rate of confirmatory bone scans in a real-world setting and their prognostic impact in enzalutamide-treated mCRPC. Materials and Methods: Patients who received oral enzalutamide for mCRPC during 2014-2017 at 14 tertiary centers in Korea were included. Patients lacking imaging assessment data or insufficient drug exposure were excluded. The primary outcome was overall survival (OS). Secondary outcomes included performance rate of confirmatory bone scans in a real-world setting. Kaplan-Meier analysis and multivariate Cox regression analysis were performed. Results: Overall, 520 patients with mCRPC were enrolled (240 [26.2%] chemotherapy-naïve and 280 [53.2%] after chemotherapy). Among 352 responders, 92 patients (26.1%) showed new bone lesions in their early bone scan. Confirmatory bone scan was performed in 41 patients (44.6%), and it was associated with prolonged OS in the entire population (median, 30.9 vs. 19.7 months; p < 0.001), as well as in the chemotherapy-naïve (median, 47.2 vs. 20.5 months; p=0.011) and post-chemotherapy sub-groups (median, 25.5 vs. 18.0 months; p=0.006). Multivariate Cox regression showed that confirmatory bone scan performance was an independent prognostic factor for OS (hazard ratio 0.35, 95% confidence interval, 0.18 to 0.69; p=0.002). Conclusion Confirmatory bone scan performance was associated with prolonged OS. Thus, the premature discontinuation of enzalutamide without confirmatory bone scans should be discouraged.