PMID- 23673101 OWN - NLM STAT- MEDLINE DCOM- 20131213 LR - 20220330 IS - 2542-5641 (Electronic) IS - 0366-6999 (Linking) VI - 126 IP - 10 DP - 2013 TI - Etoricoxib versus indometacin in the treatment of Chinese patients with acute gouty arthritis: a randomized double-blind trial. PG - 1867-71 AB - 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). FAU - Li, Ting AU - Li T AD - Department of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200001, China. FAU - Chen, Shun-le AU - Chen SL FAU - Dai, Qing AU - Dai Q FAU - Han, Xing-Hai AU - Han XH FAU - Li, Zhan-Guo AU - Li ZG FAU - Wu, Dong-Hai AU - Wu DH FAU - Zhang, Xiao AU - Zhang X FAU - Gu, Jie-Ruo AU - Gu JR FAU - Yang, Nan-Ping AU - Yang NP FAU - Sun, Ling-Yun AU - Sun LY FAU - Zhang, Miu-Jia AU - Zhang MJ FAU - Li, Xing-Fu AU - Li XF FAU - Bao, Chun-de AU - Bao CD LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - China TA - Chin Med J (Engl) JT - Chinese medical journal JID - 7513795 RN - 0 (Cyclooxygenase Inhibitors) RN - 0 (Pyridines) RN - 0 (Sulfones) RN - WRX4NFY03R (Etoricoxib) RN - XXE1CET956 (Indomethacin) SB - IM MH - Adult MH - Aged MH - Arthritis, Gouty/*drug therapy MH - Cyclooxygenase Inhibitors/adverse effects/*therapeutic use MH - Double-Blind Method MH - Etoricoxib MH - Female MH - Humans MH - Indomethacin/adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - Pyridines/adverse effects/*therapeutic use MH - Sulfones/adverse effects/*therapeutic use EDAT- 2013/05/16 06:00 MHDA- 2013/12/18 06:00 CRDT- 2013/05/16 06:00 PHST- 2013/05/16 06:00 [entrez] PHST- 2013/05/16 06:00 [pubmed] PHST- 2013/12/18 06:00 [medline] PST - ppublish SO - Chin Med J (Engl). 2013;126(10):1867-71.