|Etoricoxib versus indometacin in the treatment of Chinese patients with acute gouty arthritis: a randomized double-blind trial|
|Li Ting1; Chen Shun-le1; Dai Qing1; Han Xing-hai2; Li Zhan-guo3; Wu Dong-hai4; Zhang Xiao5; Gu Jie-ruo6; Yang Nan-ping7; Sun Ling-yun8; Zhang Miu-jia9; Li Xing-fu10; Bao Chun-de1|
|关键词||gout arthritis etoricoxib indometacin cyclooxygenase-2|
|刊名||CHINESE MEDICAL JOURNAL|
|WOS标题词||Science & Technology|
|类目[WOS]||Medicine, General & Internal|
|研究领域[WOS]||General & Internal Medicine|
|关键词[WOS]||ORAL INDOMETHACIN ; CLINICAL-TRIAL ; CELECOXIB ; EFFICACY ; CYCLOOXYGENASE-2 ; MANAGEMENT ; DICLOFENAC ; OSTEOARTHRITIS ; ROFECOXIB ; INHIBITOR|
Background Acute gout is an intensely painful, inflammatory arthritis. Although the non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for this condition, the efficacy is based on only a few studies, particularly in China. We tried to assess the safety and efficacy of etoricoxib in the treatment of acute gouty arthritis in China.
Methods A randomized, double-blind, active comparator study was conducted at 10 sites in China. Patients (n=178; >= 18 years of age) with acute gouty attack (<48 hours) were treated for 5 days with etoricoxib (120 mg/d; n=89) or indometacin (75 mg twice daily; n=89). The primary efficacy end point was self-assessed pain in the affected joint (0-4 point Likert scale) from days 2-5. Secondary end points included investigator assessments of tenderness and swelling, patient/investigator global assessments of response to therapy, and patients discontinuing treatment. Safety was assessed by adverse events (AEs).
Results Etoricoxib and indometacin had comparable primary and secondary end points. Mean change difference from baseline from days 2-5 was 0.03 (95% confidence interval (CI) -0.19 to 0.25; P=0.6364), which fell within the prespecified comparative bounds of -0.5 to 0.5. No severe AEs were associated with etoricoxib use. Non-severe AEs were mainly digestive and general, and most (73.7%) were mild, although they caused withdrawal of two subjects in the etoricoxib group, due to bilateral renal calculi and uronephrosis of the left kidney (unrelated to etoricoxib) and fever and chills (potentially etoricoxib-related). Overall, AEs were similar, although the absolute number of AEs in the etoricoxib group (n=31) was less than the indometacin group (n=34).
Conclusions Etoricoxib (120 mg once daily) is effective in treating acute gout, is generally safe and well-tolerated, and is comparable in efficacy to indometacin (75 mg twice daily).
|资助机构||Merck Sharp & ; Dohme, a subsidiary of Merck Company, Inc.|
|作者单位||1.Shanghai Jiao Tong Univ, Sch Med, Renji Hosp, Dept Rheumatol, Shanghai 200001, Peoples R China|
2.Changhai Hosp, Dept Rheumatol, Shanghai 200438, Peoples R China
3.Beijing Univ, Peoples Hosp, Dept Rheumatol, Beijing 100044, Peoples R China
4.China Japan Friendship Hosp, Dept Rheumatol, Beijing 100029, Peoples R China
5.Guangdong Prov Peoples Hosp, Dept Rheumatol, Guangzhou 510120, Guangdong, Peoples R China
6.Sun Yat Sen Univ, Affiliated Hosp 3, Dept Rheumatol, Guangzhou 510630, Guangdong, Peoples R China
7.Sichuan Univ, West China Hosp, Dept Rheumatol, Chengdu 610041, Sichuan, Peoples R China
8.Nanjing Drum Tower Hosp, Dept Rheumatol, Nanjing 210008, Jiangsu, Peoples R China
9.Jiangsu Prov Hosp, Dept Rheumatol, Nanjing 210029, Jiangsu, Peoples R China
10.Qilu Hosp, Dept Rheumatol, Jinan 250012, Shandong, Peoples R China
|Li Ting,Chen Shun-le,Dai Qing,et al. Etoricoxib versus indometacin in the treatment of Chinese patients with acute gouty arthritis: a randomized double-blind trial[J]. CHINESE MEDICAL JOURNAL,2013,126(10):1867-1871.|
|APA||Li Ting.,Chen Shun-le.,Dai Qing.,Han Xing-hai.,Li Zhan-guo.,...&Bao Chun-de.(2013).Etoricoxib versus indometacin in the treatment of Chinese patients with acute gouty arthritis: a randomized double-blind trial.CHINESE MEDICAL JOURNAL,126(10),1867-1871.|
|MLA||Li Ting,et al."Etoricoxib versus indometacin in the treatment of Chinese patients with acute gouty arthritis: a randomized double-blind trial".CHINESE MEDICAL JOURNAL 126.10(2013):1867-1871.|