PMID- 15110132
OWN - NLM
STAT- MEDLINE
DCOM- 20040813
LR  - 20190922
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 26
IP  - 3
DP  - 2004 Mar
TI  - A single-blind, randomized, controlled trial to assess the efficacy and 
      tolerability of rofecoxib, diclofenac sodium, and meloxicam in patients with 
      acute gouty arthritis.
PG  - 399-406
AB  - BACKGROUND: Acute attacks of gouty arthritis are characterized by the rapid onset 
      of severe pain, swelling, and erythema of the affected joint. Nonsteroidal 
      anti-inflammatory drugs are considered the drugs of first choice for treating 
      acute gout. Rofecoxib is a specific cyclooxygenase-2 inhibitor, which has 
      demonstrated analgesic efficacy in the setting of acute pain. Whether it is 
      effective in the treatment of acute gouty arthritis remains to be evaluated. 
      OBJECTIVE: The aim of this study was to assess the efficacy and tolerability of 
      rofecoxib compared with diclofenac sodium sustained release (SR) and meloxicam in 
      the treatment of acute gouty arthritis. METHODS: In this single-blind, 
      randomized, controlled, parallel-group study, patients aged > or =18 years with 
      acute gout within 48 hours of onset were randomized to receive oral treatment 
      with 2 tablets of rofecoxib (25 mg), diclofenac (75 mg), or meloxicam (7.5 mg) 
      once daily for 7 days. The primary outcome measures were patients global 
      assessment of response to therapy and investigator assessment of response to 
      therapy on days 3 and 8. Other efficacy measurements included investigator 
      assessment of total inflammatory scores on days 3 and 8 and patient assessment of 
      pain intensity during the first 12 hours of treatment. RESULTS: Sixty-two 
      patients (53 men, 9 women; mean [SD] age, 51.1 [12.1] years) were assigned to 
      receive rofexocib (n = 20), diclofenac (n = 21), or meloxicam (n = 21). For 
      patient global response to therapy on days 3 and 8, rofecoxib was associated with 
      analgesic efficacy in significantly more patients compared with meloxicam (84.2% 
      vs 40.0% of patients [ P=0.005] and 94.7% vs 60.0% of patients [ P=0.02], 
      respectively); no significant differences versus diclofenac were found. 
      Similarly, for investigator global assessment of response to therapy, a greater 
      percentage of responders was found in the rofecoxib group compared with the 
      meloxicam group on day 3 (88.9% vs 40.0% of patients [ P=0.02 ]), but the 
      difference was not significant on day 8. A greater percentage of responders was 
      found in the rofecoxib group compared with the diclofenac group on day 3 (88.9% 
      vs 47.3% [ P=0.007 ]), but the difference was not significant on day 8. Compared 
      with baseline, all regimens showed significant improvement in total inflammatory 
      scores on days 3 and 8 (all P<0.01 ). During the first 12 hours after dosing, 
      pain intensity score was significantly reduced with rofecoxib starting at 0.5 
      hours ( P<0.05 ), but not with diclofenac or meloxicam. Clinical adverse events 
      (AEs) were reported in 4 (20.0%), 7 (33.3%), and 6 (28.6%) patients in the 
      rofecoxib, diclofenac, and meloxicam groups, respectively; the most common AEs 
      reported were edema in 1 patient each in the rofecoxib (5.0%) and meloxicam 
      (4.8%) groups and 2 patients (9.5%) in the diclofenac group and abdominal (1 
      [5.0%], 1 [4.8%], and 2 [9.5%], respectively). No significant differences in 
      tolerability were found among the 3 treatment groups. CONCLUSIONS: In this study 
      of patients with acute gouty arthritis, rofecoxib 50 mg once daily provided more 
      effective treatment than diclofenac sodium SR 150 mg and meloxicam 15 mg 
      administered orally once daily for 7 days in > or = 1 efficacy assessment of 
      overall analgesic effect on day 3 or day 8. Rofecoxib achieved a rapid onset of 
      pain relief, demonstrating significant improvement 30 minutes after dosing. All 
      of the regimens appeared well tolerated in the population studied.
FAU - Cheng, Tien-Tsai
AU  - Cheng TT
AD  - Section of Allergy, Immunology and Rheumatology, Department of Internal Medicine, 
      Chang Gung Memorial Hospital, Taiwan, Republic of China. tiantsai@ms2.hinet.net
FAU - Lai, Han-Ming
AU  - Lai HM
FAU - Chiu, Chun-Kai
AU  - Chiu CK
FAU - Chem, Ying-Chou
AU  - Chem YC
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Lactones)
RN  - 0 (Sulfones)
RN  - 0 (Thiazines)
RN  - 0 (Thiazoles)
RN  - 0QTW8Z7MCR (rofecoxib)
RN  - 144O8QL0L1 (Diclofenac)
RN  - VG2QF83CGL (Meloxicam)
SB  - IM
MH  - Acute Disease
MH  - Anti-Inflammatory Agents, Non-Steroidal/adverse effects/*therapeutic use
MH  - Arthritis, Gouty/*drug therapy
MH  - Diclofenac/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Lactones/adverse effects/*therapeutic use
MH  - Male
MH  - Meloxicam
MH  - Middle Aged
MH  - Single-Blind Method
MH  - Sulfones
MH  - Thiazines/adverse effects/*therapeutic use
MH  - Thiazoles/adverse effects/*therapeutic use
EDAT- 2004/04/28 05:00
MHDA- 2004/08/17 10:00
CRDT- 2004/04/28 05:00
PHST- 2004/01/11 00:00 [accepted]
PHST- 2004/04/28 05:00 [pubmed]
PHST- 2004/08/17 10:00 [medline]
PHST- 2004/04/28 05:00 [entrez]
AID - S0149291804900355 [pii]
AID - 10.1016/s0149-2918(04)90035-5 [doi]
PST - ppublish
SO  - Clin Ther. 2004 Mar;26(3):399-406. doi: 10.1016/s0149-2918(04)90035-5.