Randomised clinical trial: tegoprazan, a novel potassium-competitive acid blocker, or lansoprazole in the treatment of gastric ulcer

被引：74

作者：

Cho, Yu Kyung ^{[1
]}

Choi, Myung-Gyu ^{[1
]}

Choi, Suck Chei ^{[2
]}

Lee, Kee Myung ^{[3
]}

Kim, Tae Oh ^{[4
]}

Park, Soo-Heon ^{[5
]}

Moon, Jeong Seop ^{[6
]}

Lim, Yun Jeong ^{[7
]}

Kang, Dae Hwan ^{[8
]}

Cheon, Gab Jin ^{[9
]}

Baik, Gwang Ho ^{[10
]}

Kim, Kyoung Oh ^{[11
]}

Cho, Kwang Bum ^{[12
]}

Jang, Jin Seok ^{[13
]}

Park, Jong-Jae ^{[14
]}

Son, Byoung Kwan ^{[15
]}

Jung, Hye-Kyung ^{[16
]}

Kim, Byung-Wook ^{[17
]}

Kim, Sung Kuk ^{[18
]}

Lee, Soo Teik ^{[19
]}

Cha, Jae Myung ^{[20
]}

Kim, Ah Rong ^{[21
]}

Kim, Eun Ji ^{[21
]}

Park, Hyun Wook ^{[21
]}

Song, Geun Seog ^{[21
]}

机构：

[1] Catholic Univ Korea, Seoul St Marys Hosp, Coll Med, Catholic Photomed Res Inst, Seoul, South Korea

[2] Wonkwang Univ Hosp, Iksan, South Korea

[3] Ajou Univ, Ajou Univ Hosp, Sch Med, Suwon, South Korea

[4] Inje Univ, Haeundae Paik Hosp, Sch Med, Busan, South Korea

[5] Catholic Univ Korea, Yeouido St Marys Hosp, Coll Med, Seoul, South Korea

[6] Inje Univ, Seoul Paik Hosp, Coll Med, Seoul, South Korea

[7] Dongguk Univ, Coll Med, Ilsan Hosp, Goyang, South Korea

[8] Pusan Natl Univ, Sch Med, Yangsan Hosp, Yangsan, South Korea

[9] Ulsan Univ, Gangneung Asan Hosp, Coll Med, Kangnung, South Korea

[10] Hallym Univ, Coll Med, Chuncheon Sacred Heart Hosp, Chunchon, South Korea

[11] Gachon Univ, Sch Med, Gil Med Ctr, Incheon, South Korea

[12] Keimyung Univ, Sch Med, Daegu, South Korea

[13] Dong A Univ, Coll Med, Busan, South Korea

[14] Korea Univ, Coll Med, Seoul, South Korea

[15] Eulji Univ Hosp, Seoul, South Korea

[16] Ewha Womans Univ, Mokdong Hosp, Seoul, South Korea

[17] Catholic Univ Korea, Incheon St Marys Hosp, Coll Med, Incheon, South Korea

[18] Kyungpook Univ, Sch Med, Daegu, South Korea

[19] Chonbuk Natl Univ, Med Sch, Jeonju, South Korea

[20] Kyung Hee Univ, KyungHee Univ Hosp Gangdong, Sch Med, Seoul, South Korea

[21] HK Inno N Corp, Clin Dev Div, Seoul, South Korea

来源：

ALIMENTARY PHARMACOLOGY & THERAPEUTICS | 2020年 / 52卷 / 05期

关键词：

GASTROESOPHAGEAL-REFLUX; VS; LANSOPRAZOLE; VONOPRAZAN; SECRETION; EFFICACY;

D O I：

10.1111/apt.15865

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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 percentages 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.

引用

页码：789 / 797

页数：9

共 21 条

[1] Randomised clinical trial: vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the healing of erosive oesophagitis [J].