계명대학교 의학도서관 Repository

Comparison of the efficacy and safety of CELBESTA® versus CELEBREX® in patients with rheumatoid arthritis: a 6-week, multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority phase 4 clinical trial

Metadata Downloads
Author(s)
Hyun-Sook KimWon-Ho ChoiBo Young KimSung Soo KimSang-Il LeeSang-Hyon KimSung Jae ChoiGeun-Tae KimJin-Wuk HurMyeung-Su LeeYun Sung KimSeung-Jae Hong
Keimyung Author(s)
Kim, Sang Hyon
Department
Dept. of Internal Medicine (내과학)
Journal Title
Journal of international medical research
Issued Date
2020
Volume
48
Issue
6
Keyword
CELBESTA®CELEBREX®Korearheumatoid arthritispain reliefnon-inferioritygastrointestinal toxicityrenal toxicity
Abstract
Objectives:
Celecoxib is a selective cyclooxygenase (COX)-2 inhibitor that is commonly used to reduce the incidence of gastrointestinal (GI) complications in patients with rheumatoid arthritis (RA). CELBESTA® is a generic equivalent to CELEBREX®, a celecoxib preparation. This study compared the efficacy and safety of CELBESTA® and CELEBREX® in patients with RA.

Methods:
This was a multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority clinical trial. The primary endpoint was a change from baseline in self-assessed pain intensity determined using a 100-mm visual analog scale after 6 weeks of treatment.

Results:
After a washout period, 119 eligible subjects were randomized to one of two groups (CELBESTA® group, n = 61; CELEBREX® group, n = 58). CELBESTA® was not inferior to CELEBREX® because the upper limit of two-sided 95% confidence interval (CI) for the difference between the two groups (difference in the least square [LS] mean, -8.68 mm; two-sided 95% CI -16.59 mm to -0.77 mm) was less than the non-inferiority margin (10 mm). There were no significant differences in GI complications and renal toxicity.

Conclusions:
CELBESTA® was not inferior to CELEBREX® with regard to the pain relief efficacy in RA patients, and the tolerability and safety profiles were excellent and at similar levels for both preparations.
Keimyung Author(s)(Kor)
김상현
Publisher
School of Medicine (의과대학)
Citation
Hyun-Sook Kim et al. (2020). Comparison of the efficacy and safety of CELBESTA® versus CELEBREX® in patients with rheumatoid arthritis: a 6-week, multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority phase 4 clinical trial. Journal of international medical research, 48(6), 1–14. doi: 10.1177/0300060520931323
Type
Article
ISSN
1473-2300
Source
https://journals.sagepub.com/doi/10.1177/0300060520931323
DOI
10.1177/0300060520931323
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/43170
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
공개 및 라이선스
  • 공개 구분공개
파일 목록

Items in Repository are protected by copyright, with all rights reserved, unless otherwise indicated.