Etoricoxib as effective, less toxic than indomethacin for acute gout

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Rheumawire

Feb 25, 2004

Etoricoxib as effective, less toxic than indomethacin for acute gout

Fort Worth, TX - Once-daily etoricoxib (ArcoxiaTM, Merck & Co) is as

effective as indomethacin for the treatment of acute gout and produces

significantly fewer drug-related side effects, Dr Bernard Rubin

(University of North Texas Health Science Center, Fort Worth) reports in

the February 2004 issue of Arthritis & Rheumatism [1].

The new report, which confirms earlier work by Schumacher et al [2],

suggests a wider role for COX-2 inhibitors in acute gout. " The

implications are very important, although etoricoxib is not yet approved

for use in the US, " Rubin tells rheumawire. " It's the first time that

COX-2 inhibitors have been shown to be comparable in anti-inflammatory

and analgesic effect to indomethacin and to be safe and well tolerated. "

The randomized, double-blind, active-comparator study was sponsored by

Merck & Co. It was conducted at 42 sites and included a total of 189 men

and women aged 18 or older who were experiencing an acute gout attack.

Participants were treated with either etoricoxib at 120 mg once a day or

indomethacin at 50 mg 3 times a day for 8 days.

The primary efficacy end point was the patient's assessment of pain.

Secondary efficacy end points were onset of efficacy, reduction in signs

of inflammation, and both patient's and investigator's global

assessments of response.

There were slightly fewer adverse events overall in the

etoricoxib-treated patients (43.7% vs 57.0%), and drug-related adverse

events were significantly lower (16.5% vs 37.2%, p<0.05). Specifically,

the incidence of gastrointestinal and cardiovascular adverse effects,

including an increase in blood pressure or hypertension, were lower

among patients taking etoricoxib than those taking indomethacin. These

trends also held in patients older than age 50.

Still, decisions regarding the choice of drug for the individual patient

should be guided by risk/benefit assessments based on specific patient

characteristics, evidence provided by randomized clinical trials that

address the efficacy and safety of these drugs, and cost considerations,

the researchers conclude.

Merck announced December 30, 2003 that it has submitted a new drug

application (NDA) for Arcoxia to the US Food and Drug Administration.

The drug is already available in 38 other countries. Merck's NDA

includes osteoarthritis, rheumatoid arthritis, acute gouty arthritis,

chronic low back pain, acute pain, dysmenorrhea, and ankylosing

spondylitis.

Mann

Sources

1. Rubin BR, Burton R, Navarra S, 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: a randomized controlled trial.

Arthritis Rheum 2004 Feb; 50(2):598-606.

2. Schumacher HR Jr, Boice JA, Daikh DI, et al. Randomised double blind

trial of etoricoxib and indometacin in treatment of acute gouty

arthritis. BMJ 2002 Jun 22; 324(7352):1488-92.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org