Skip navigation

Etoricoxib for gout

Clinical bottom line

On the basis of two studies of rigorous design and adequate size, etoricoxib is as efficacious as indomethacin for gout, with fewer adverse events.


Reference

HR Schumacher et al. Randomised double blind trial of etoricoxib and indometacin in treatment of acute gouty arthritis. BMJ 2002 324: 1488-1492.

Rubin et al. Efficacy and safety profile of treatment with etoricoxib 120 mg once daily compared with indomethacin 50 mg three times daily in acute gout. Arthritis & Rheumatism 2004 50: 598-606.

Study

The details of the studies are shown in Table 1. They were characterised by good design (American Rheumatology Association criteria for diagnosis, properly randomised and with double dummy design, stratified for single or several joint involvement, large, attention to adverse events).

Table 1: Etoricoxib and indomethacin for gout

Reference

Design

Included patients

Outcomes

Results

Schumacher et al, 2002
Quality score 5/5
Randomised, double-blind, parallel-group with 120 mg etoricoxib once a day (75) or indomethacin 50 mg three times a day (75) for eight days. Gout defined by ARA criteria and with adequate pain, tenderness and swelling for a sensitive assay. Pain in study joint, plus tenderness, swelling, global assessment to treatment by patient and investigator Patients matched at baseline. Identical results, with symptoms subsiding over four hours to 7 days. Initial pain score of 2.9 (max 4 points for extreme pain) fell to below 1 by day 4. With etoricoxib, 30% of patients had no or mild pain by 4 hours, over 50% by 2 days, and 80% by 5 days. No difference between etoricoxib and indomethacin.

More adverse events with indomethacin.

Rubin et al, 2004

Quality score 4/5

Randomised, double-blind, parallel-group with 120 mg etoricoxib once a day (103) or indomethacin 50 mg three times a day (86) for eight days. Gout defined by ARA criteria and with adequate pain, tenderness and swelling for a sensitive assay. Pain in study joint, plus tenderness, swelling, global assessment to treatment by patient and investigator Patients matched at baseline. Identical results, with symptoms subsiding over four hours to 7 days. Initial pain score of 2.9 (max 4 points for extreme pain) fell by 1.8 points by day 8. No difference between etoricoxib and indomethacin.

More adverse events with indomethacin (37% with drug-related AE) than etoricoxib (17%). Erythema 18% with indomethacin, 7% with etoricoxib.

 

Results

There was no difference between etoricoxib 120 mg once a day and 50 mg indomethacin three times a day in terms of efficacy, both for the primary end point of pain, and for secondary end points of tenderness, swelling or global evaluation of response to treatment in either trial. Etoricoxib 120 mg once daily and indomethacin 50 mg three times daily were equally effective in reducing pain from acute gout.

Adverse events occurred less frequently with etoricoxib than with indomethacin (Table 2). For any adverse event reported, the number needed to treat to prevent one adverse event (NNTp) was 7 for etoriocoxib compared with indomethacin. Drug-related clinical adverse experiences determined by the investigator to be possibly, probably or definitely drug related were significantly lower (19%) for etoricoxib than indomethacin (42%), with an NNTp of 4. Gastrointestinal adverse events were also lower with etoricoxib than indomethacin, with an NNTp of 8.Adverse event discontinuations and serious adverse events were lower with etoricoxib than indomethacin, though the small number of events precluded any sensible analysis.

Table 2: Adverse event analysis

 
Number with
Percent with
 
Adverse event
Etoricoxib 120 mg
Indomethacin 150 mg
Etoricoxib 120 mg
Indomethacin 150 mg
Relative risk (95% CI)
NNTp (95% CI)
Any
80/178
94/161
45
58
0.8 (0.6 to 0.95)
7 (4 to 35)
Drug-related
34/178
67/161
19
42
0.5 (0.3 to 0.7)
4 (3 to 8)
Gastrointestinal
16/178
35/161
9
22
0.4 (0.2 to 0.7)
8 (5 to 20)
AE discontinuation
7/178
13/161
4
8
0.5 (0.2 to 1.2)
Serious
1/178
3/161
0.6
1.9
0.3 (0.1 to 2.9)

 

Comment

These two trials have as many patients with indomethacin as do all the other randomised trials in gout. It is remarkable how little information there is on treatment effects, and this trial sets new standards in both size and quality. No other paper we have found even approaches it.

What it says is that etoricoxib once a day is as effective as traditional indomethacin, but with fewer adverse events.