Comparative efficiency and safety of potassium competitive acid blockers versus Lansoprazole in peptic ulcer: a systematic review and meta-analysis

被引:8
作者
Dong, Yongqi [1 ]
Xu, Hongyan [2 ]
Zhang, Zhihuan [3 ]
Zhou, Zhihang [4 ]
Zhang, Qiang [5 ]
机构
[1] Wushan Cty Peoples Hosp Chongqing, Dept Gastroenterol, Chongqing, Peoples R China
[2] Chongqing Med Univ, Affiliated Hosp 2, Dept Infect Dis, Chongqing, Peoples R China
[3] Chongqing Med Univ, Affiliated Hosp 2, Dept Rheumatol & Immunol, Chongqing 400010, Peoples R China
[4] Chongqing Med Univ, Affiliated Hosp 2, Dept Gastroenterol, Chongqing 400010, Peoples R China
[5] Wushan Cty Peoples Hosp Chongqing, Dept Spinal Surg, Chongqing, Peoples R China
关键词
potassium competitive acid blocker; lansoprazole; peptic ulcer; vonoprazan; tegoprazan; keverprazan; VONOPRAZAN; EQUIVALENCE; MANAGEMENT; NONINFERIORITY; ESOMEPRAZOLE; INFECTION; THERAPY;
D O I
10.3389/fphar.2023.1304552
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Background: Lansoprazole, a proton-pump inhibitor (PPI), is the primary therapy for peptic ulcers (PU). Potassium competitive acid blockers (P-CAB) offer an alternative for acid suppression. However, the efficacy and safety of P-CABs versus lansoprazole in the management of PU has not been evaluated. Methods: Five databases were searched for randomized clinical trials in English until 31 August 2023. Data extraction provided outcome counts for ulcer healing, recurrent NSAID-related ulcer, and adverse events. The pooled effect, presented as rate difference (RD), was stratified by ulcer location, follow-up time, and the types of P-CAB, along with their corresponding 95% confidence intervals (95% CI). Results: The pooled healing rates of peptic ulcers were 95.3% (1,100/1,154) and 95.0% (945/995) for P-CABs and lansoprazole, respectively (RD: 0.4%, 95% CI: -1.4%-2.3%). The lower bounds of the 95% CI fell within the predefined non-inferiority margin of -6%. In subgroup analyses base on ulcer location, and follow-up time also demonstrated non-inferiority. The drug-related treatment-emergent adverse events (TEAEs) did not differ significantly among groups (RR: 0.997, 95% CI: 0.949-1.046, p = 0.893). However, P-CAB treatment was associated with an increased risk of the serious adverse events compared to lansoprazole (RR: 1.325, 95% CI: 1.005-1.747, p = 0.046). Conclusion: P-CABs demonstrated non-inferiority to lansoprazole in the management of peptic ulcer. The safety and tolerability profile are comparable, with similar TEAEs rates. However, P-CABs appear to have a higher risk of serious adverse events. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=458361 Identifier: PROSPERO (No. CRD42023458361).
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页数:9
相关论文
共 39 条
[1]   Meta-analysis of noninferiority and equivalence trials: ignoring trial design leads to differing and possibly misleading conclusions [J].
Acuna, Sergio A. ;
Dossa, Fahima ;
Baxter, Nancy .
JOURNAL OF CLINICAL EPIDEMIOLOGY, 2020, 127 :134-141
[2]   Intention-to-treat analysis may be more conservative than per protocol analysis in antibiotic non-inferiority trials: a systematic review [J].
Bai, Anthony D. ;
Komorowski, Adam S. ;
Lo, Carson K. L. ;
Tandon, Pranav ;
Li, Xena X. ;
Mokashi, Vaibhav ;
Cvetkovic, Anna ;
Findlater, Aidan ;
Liang, Laurel ;
Tomlinson, George ;
Loeb, Mark ;
Mertz, Dominik .
BMC MEDICAL RESEARCH METHODOLOGY, 2021, 21 (01)
[3]   Updated guidance for trusted systematic reviews: a new edition of the Cochrane Handbook for Systematic Reviews of Interventions [J].
Cumpston, Miranda ;
Li, Tianjing ;
Page, Matthew J. ;
Chandler, Jacqueline ;
Welch, Vivian A. ;
Higgins, Julian P. T. ;
Thomas, James .
COCHRANE DATABASE OF SYSTEMATIC REVIEWS, 2019, (10)
[4]   Strengthening systematic reviews in public health: guidance in the Cochrane Handbook for Systematic Reviews of Interventions, 2nd edition [J].
Cumpston, Miranda S. ;
McKenzie, Joanne E. ;
Welch, Vivian A. ;
Brennan, Sue E. .
JOURNAL OF PUBLIC HEALTH, 2022, 44 (04) :E588-E592
[5]   Association Between Proton Pump Inhibitor Therapy and Clostridium difficile Infection in a Meta-Analysis [J].
Deshpande, Abhishek ;
Pant, Chaitanya ;
Pasupuleti, Vinay ;
Rolston, David D. K. ;
Jain, Anil ;
Deshpande, Narayan ;
Thota, Priyaleela ;
Sferra, Thomas J. ;
Hernandez, Adrian V. .
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY, 2012, 10 (03) :225-233
[6]   The First-in-Class Potassium-Competitive Acid Blocker, Vonoprazan Fumarate: Pharmacokinetic and Pharmacodynamic Considerations [J].
Echizen, Hirotoshi .
CLINICAL PHARMACOKINETICS, 2016, 55 (04) :409-418
[7]  
[中华消化杂志编辑委员 Editorial Board of Chinese Journal of Digestion], 2023, [中华消化杂志, Chinese Journal of Digestion], V43, P176
[8]  
FoodDrug Administration, 2016, Center for drug evaluation and research (CDER) CfBEaRC, V56
[9]   Randomised clinical trial: safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of tegoprazan (CJ-12420), a novel potassium-competitive acid blocker, in healthy male subjects [J].
Han, Sungpil ;
Choi, Hee Youn ;
Kim, Yo Han ;
Nam, Ji Yeon ;
Kim, Bongtae ;
Song, Geun Seog ;
Lim, Hyeong-Seok ;
Bae, Kyun-Seop .
ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2019, 50 (07) :751-759
[10]  
HOWDEN CW, 1994, SCAND J GASTROENTERO, V29, P79