Glecaprevir/pibrentasvir (G/P) is a pan-genotypic, interferon-free, direct-acting antiviral regimen approved for chronic hepatitis C (CHC) treatment. While clinical trials have demonstrated its efficacy and safety, real-world data in the Korean population remain limited. This post-marketing surveillance study aimed to evaluate the safety and effectiveness of G/P in Korean patients with CHC in routine clinical practice. A prospective, multicenter observational study was conducted across 56 institutions in Korea from January 2018 to January 2024. Adult and adolescent patients (aged ≥ 12 years) with CHC receiving G/P were enrolled. Safety outcomes evaluated adverse events (AEs), including serious AEs (SAEs), and treatment-related AEs. Effectiveness was assessed by sustained virologic response at 12 weeks post-treatment (SVR12) in evaluable patients. Of 3061 patients enrolled, 51.1
BACKGROUND:The optimal long-term strategy for preventing post-gastrectomy gallstone formation in gastric cancer (GC) remains unclear. This study evaluated the sustained efficacy of a 12-month course of ursodeoxycholic acid (UDCA) after gastrectomy for GC. METHODS:We conducted a randomized, double-blind, placebo-controlled clinical trial at 13 institutions in the Republic of Korea. Patients who underwent total, distal, or proximal gastrectomy for GC were randomized 1:1:1 to receive either 300 mg UDCA, 600 mg UDCA, or placebo daily for 12 months. The primary outcome was the incidence of gallstone formation at least 5 years post-gastrectomy. Secondary outcomes were biliary pain, gallstone complications, and cholecystectomy. RESULTS:A total of 431 participants (300 mg UDCA: n = 141; 600 mg UDCA: n = 150; placebo: n = 140) were analyzed. At 80 months post-gastrectomy, gallstone formation occurred in 10.00% of the 300 mg group, 12.83% of the 600 mg group, and 26.21% of the placebo group. UDCA significantly reduced the hazard of gallstone formation compared to placebo (hazard ratio: 0.33, 95% CI 0.18-0.63, P = 0.0014 for 300 mg; 0.43, 95% CI 0.25-0.75, P = 0.0064 for 600 mg). There were no significant differences among groups in the incidence of biliary pain, gallstone complications, or cholecystectomy. CONCLUSION:Twelve months of UDCA administration was associated with sustained reduction in gallstone formation for up to 80 months after gastrectomy in GC patients.
BACKGRUOUND:Excess intake of added sugars contributes to obesity, type 2 diabetes mellitus (T2DM), cardiovascular disease (CVD), and premature mortality. Sugar-sweetened beverages (SSBs), the main source of added sugars, are consistently linked to adverse outcomes. Artificially sweetened beverages (ASBs) have been suggested as short-term substitutes, but evidence regarding benefits and harms remains inconclusive, and guidance is lacking. METHODS:This consensus statement draws on a structured evidence review combining two approaches: an updated meta-analysis of randomized controlled trials (RCTs) assessing short- to intermediate-term effects of replacing SSBs with ASBs on weight and metabolic outcomes; and an umbrella review of systematic reviews of cohort studies evaluating long-term associations of SSBs and ASBs with major outcomes, including mortality, CVD, and T2DM. RESULTS:In 14 RCTs (3-76 weeks), replacing SSBs with ASBs produced modest reductions in body weight (-0.73 kg) and body fat (-0.72%), with inconsistent effects on glycemic and cardiometabolic markers. Evidence from 20 systematic reviews of cohorts (up to 34 years follow-up) showed that higher intake of both SSBs and ASBs was associated with increased risks of T2DM, CVD, and mortality, with relative risks for ASBs similar to those for SSBs. CONCLUSION:ASBs may serve as a short-term substitution for individuals with high SSB intake, particularly those at elevated metabolic risk. However, regular or long-term use is not recommended due to uncertain safety and potential reinforcement of sweet preference. Public health strategies should emphasize reducing both SSBs and ASBs, prioritizing water and unsweetened beverages as the ultimate goal.
Background/Aims : Zastaprazan (JP-1366) is a novel potassium-competitive acid blocker with a fast onset and prolonged duration. This study aimed to assess the efficacy and safety of zastaprazan versus lansoprazole in patients with gastric ulcers.Methods : A total of 329 subjects with confirmed gastric ulcers participated in a phase 3, multicenter, randomized, double-blind, active-controlled clinical study. Subjects were randomized to receive zastaprazan 20 mg or lansoprazole 30 mg once daily up to 8 weeks. The primary endpoint was the cumulative healing rate of gastric ulcers as confirmed by upper gastrointestinal endoscopy at 8 weeks in patients. Secondary endpoints included ulcer healing rate, symptom recovery, quality of life changes, and safety assessment results.Results : In the per-protocol set, the cumulative healing rate at 8 weeks was 100.00% (146/146) for zastaprazan 20 mg and 97.06% (132/136) for lansoprazole 30 mg, while at week 4, the healing rates were 93.84% (137/146) and 91.91% (125/136), respectively. Zastaprazan was noninferior to lansoprazole in ulcer healing, while the incidence of adverse events was comparable between groups. Gastrin levels increased during the treatment and declined after the treatment in both groups.Conclusions : An 8-week therapy involving zastaprazan 20 mg demonstrated noninferiority to lansoprazole 30 mg in the cumulative rate of healing of gastric ulcers at 8 weeks, and the two demonstrated similar safety profiles. (ClinicalTrials.gov identifier NCT05448001)
Dialyzer-associated anaphylaxis is an uncommon but serious complication of hemodialysis. Although severe anaphylaxis is rare, milder hypersensitivity reactions are likely underrecognized and frequently misattributed to cardiopulmonary or volume-related causes. In clinical practice, the diagnosis is often inferred indirectly from symptom resolution after dialyzer substitution rather than confirmed by immunologic testing. Serum tryptase is widely used as a marker of mast cell activation in anaphylaxis; however, its diagnostic utility is limited in patients with chronic kidney disease (CKD), in whom baseline tryptase levels may be chronically elevated due to reduced renal clearance. A patient with advanced CKD developed acute anaphylaxis with respiratory failure and hypotension during the initial hemodialysis session using a polysulfone-based dialyzer, requiring endotracheal intubation. Reexposure during a subsequent session reproducibly elicited the same reaction, strongly implicating dialyzer-associated anaphylaxis. Given the limitations of serum tryptase and the indirect nature of membrane substitution alone, a membrane-specific immunologic evaluation was pursued. Basophil activation testing (BAT) demonstrated polysulfone-specific basophil activation with upregulation of CD63 and CD203c, confirming immediate hypersensitivity. To our knowledge, this represents the first reported case in Korea of dialyzer-associated anaphylaxis immunologically confirmed by BAT. Using this case as a framework, we review the clinical spectrum and immunologic mechanisms of dialyzer-associated hypersensitivity and highlight the complementary diagnostic role of BAT in enabling definitive diagnosis and safe continuation of hemodialysis.
