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    Role of Tegoprazan in Eradication Therapy. Gut and liver 10.5009/gnl220272
    Efficacy of Seven-Day Potassium-Competitive Acid Blocker-Based First-Line Eradication Therapy Administered with Bismuth. Kim Ji Yeon,Lee Sun Young,Kim Hyobin,Kim Jeong Hwan,Sung In Kyung,Park Hyung Seok Yonsei medical journal PURPOSE:To determine the efficacy of a potassium-competitive acid blocker (P-CAB)-based first-line eradication therapy with bismuth compared with that of proton pump inhibitor-based first-line therapy with bismuth. MATERIALS AND METHODS:Eradication-naive -infected patients were consecutively enrolled from January to November 2020. Before approval of the P-CAB-based eradication therapy, twice daily administration of a regimen containing lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and bismuth potassium citrate 300 mg was prescribed for 7 days. After approval, lansoprazole was replaced with tegoprazan (50 mg). Clarithromycin resistance was examined in patients who underwent gastroscopic biopsy at our center. Efficacy was assessed via the C-urea breath test. RESULTS:Of the 381 eradication-naive patients, eradication was successful in 88.3% (151/171) treated with tegoprazan and 82.8% (140/169) treated with lansoprazole in per-protocol analysis (=0.151). In intention-to-treat analysis, eradication rates were 78.8% (152/193) in the tegoprazan and 74.5% (140/188) in the lansoprazole group (=0.323). Clarithromycin resistance was observed in 30 (20.1%) of the 148 patients (74 from each group), and only four of the 16 clarithromycin-resistant patients in the tegoprazan group achieved successful eradication. Clarithromycin resistance [odds ratio (OR)=42.1, 95% confidence intervals (CIs)=12.6-141.0] and poor patient compliance (OR=17.1, 95% CIs=1.6-189.1) were independent risk factors for eradication failure. CONCLUSION:In eradication-naive patients, eradication success rates for 7-day first-line triple therapy regimen exceeded 82% with bismuth administration. In clarithromycin-resistant patients, neither tegoprazan 50 mg nor lansoprazole 30 mg achieved acceptable eradication rates when administered twice daily for 7 days. 10.3349/ymj.2021.62.8.708
    Pharmacokinetics and Pharmacodynamics of Tegoprazan Coadministered With Amoxicillin and Clarithromycin in Healthy Subjects. Ghim Jong-Lyul,Chin May Chien,Jung Jinah,Lee Jiwon,Kim Seokuee,Kim Bongtae,Song Geun Seog,Choi Young-Kyung,Shin Jae-Gook Journal of clinical pharmacology This clinical trial was conducted to evaluate the pharmacokinetics and pharmacodynamics of tegoprazan when coadministered with amoxicillin/clarithromycin in healthy subjects. Cohort 1 was an open-label, randomized multiple-dose study to evaluate the mutual interaction of tegoprazan and amoxicillin/clarithromycin on the disposition of 3 tested drugs including tegoprazan M1 metabolite and 14-hydroxyclarithromycin (14-OH-clarithromycin). Cohort 2 was an open-label, randomized, active-controlled, parallel multiple-dose study to compare the intragastric pH profile after multiple oral doses of 50 or 100 mg tegoprazan coadministered with amoxicillin/clarithromycin 1000/500 mg for 7 days and pantoprazole-based triple therapy as the comparator arm. The coadministration of tegoprazan with amoxicillin/clarithromycin increased C (2.2-fold) and AUC (2.7-fold) of tegoprazan and M1 (2.1- and 2.2-fold for C and AUC , respectively) compared with administration of tegoprazan alone. The C and AUC of 14-OH-clarithromycin increased by 1.7- and 1.8-fold, respectively; the disposition of amoxicillin and clarithromycin were not significantly changed. On days 1 and 7 of treatment, tegoprazan-based therapies (both 50- and 100-mg therapies) maintained pH above 6 for more than 88% of the 24-hour period, which was significantly longer compared with pantoprazole-based therapy. Tegoprazan either alone or in combination with amoxicillin/clarithromycin was well tolerated in healthy subjects. In conclusion, the exposure of tegoprazan was increased after coadministration of amoxicillin/clarithromycin, which led to increase pharmacodynamic response measured by intragastric pH compared with tegoprazan alone. Therefore, tegoprazan-based triple therapy would be effective therapeutic regimen to manage intragastric pH in terms of gastric or duodenal ulcers healing, treatment of gastroesophageal reflux disease, and Helicobacter pylori eradication. 10.1002/jcph.1805
    7-day versus 14-day tegoprazan-based triple therapy to treat Helicobacter pylori infection: Real-world evidence. Journal of gastroenterology and hepatology BACKGROUND AND AIM:Potassium-competitive acid blockers (P-CABs) can be used to eradicate Helicobacter pylori infection. We aimed to evaluate the impact of treatment duration (7 vs 14 days) on successful H. pylori eradication with P-CAB-based triple therapy in Korea, where clarithromycin resistance rate is high. METHODS:We retrospectively reviewed the data of patients who received first-line treatment for H. pylori infection with tegoprazan-based triple therapy (50 mg tegoprazan + 1000 mg amoxicillin + 500 mg clarithromycin twice daily for 1 or 2 weeks). The primary endpoint was the eradication rate in intention-to-treat (ITT) analysis. RESULTS:Of the 948 patients included in the study, 435 and 513 received 7-day and 14-day tegoprazan-based triple therapy, respectively. The eradication rate was higher in the 14-day therapy group than in the 7-day therapy group (ITT, 63.9%; 95% confidence interval [CI], 59.3-68.3%] vs 78.6% [95% CI, 74.9-81.9%], respectively, P < 0.001; per-protocol, 70.5% [95% CI, 65.8-74.8%] vs 85.1% [81.7-88.1%], respectively, P < 0.001). Overall adverse event rates did not differ between the two groups. Although six patients in the 14-day treatment group discontinued the prescribed medications due to adverse events, four of them (67%) discontinued the medication within 4 days. CONCLUSIONS:The 14-day tegoprazan-based triple therapy showed a superior eradication rate and acceptable adverse events compared with the 7-day tegoprazan-based triple therapy. A 14-day treatment regimen may be required when H. pylori infection is treated with tegoprazan-based triple therapy in regions with high clarithromycin resistance. 10.1111/jgh.15939
    Randomised clinical trial: tegoprazan, a novel potassium-competitive acid blocker, or lansoprazole in the treatment of gastric ulcer. Cho Yu Kyung,Choi Myung-Gyu,Choi Suck Chei,Lee Kee Myung,Kim Tae Oh,Park Soo-Heon,Moon Jeong Seop,Lim Yun Jeong,Kang Dae Hwan,Cheon Gab Jin,Baik Gwang Ho,Kim Kyoung Oh,Cho Kwang Bum,Jang Jin Seok,Park Jong-Jae,Son Byoung Kwan,Jung Hye-Kyung,Kim Byung-Wook,Kim Sung Kuk,Lee Soo Teik,Cha Jae Myung,Kim Ah Rong,Kim Eun Ji,Park Hyun Wook,Song Geun Seog Alimentary pharmacology & therapeutics BACKGROUND:Tegoprazan is a novel potassium-competitive acid blocker for the treatment of acid-related disorders. AIMS:To assess whether tegoprazan is non-inferior to lansoprazole in terms of efficacy and safety in patients with gastric ulcers. METHODS:In this phase 3, double-blind, active control, multicentre study, 306 gastric ulcer patients were randomised to one of three treatment groups: tegoprazan 50 mg, tegoprazan 100 mg and lansoprazole 30 mg once daily for 4 or 8 weeks. The primary endpoint was the cumulative proportion of patients with healed ulcers confirmed by endoscopy up to 8 weeks from treatment initiation. Symptoms and safety were assessed. RESULTS:In the full analysis set, the cumulative healing rates at week 8 were 94.8% (91/96) for the tegoprazan 50 mg, 95.0% (94/99) for the tegoprazan 100 mg and 95.7% (89/93) for the lansoprazole 30 mg groups. At week 4, the respective healing rates were 90.6% (87/96), 91.9% (91/99), and 89.2% (83/93). In per protocol analysis, 4-week healing rates were 95.4% (84/88), 94.6% (88/93) and 92.9% (79/85) for tegoprazan 50 mg, tegoprazan 100 mg and lansoprazole 30 mg, respectively. Both doses of tegoprazan were non-inferior to lansoprazole in ulcer healing at 4 and 8 weeks. The incidence of drug-related treatment-emergent adverse events did not differ among groups. The increase in serum gastrin concentration was not higher in tegoprazan-treated patients than in lansoprazole-treated patients. CONCLUSIONS:Tegoprazan 50 or 100 mg were not inferior to lansoprazole 30 mg once daily in the treatment of gastric ulcers. 10.1111/apt.15865