EULAR: New COX-2 Inhibitor Etoricoxib Looks Promising for Back Pain, Rheumatoid Arthritis and Acute Gouty Arthritis

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EULAR: New COX-2 Inhibitor Etoricoxib Looks Promising for Back Pain,

Rheumatoid Arthritis and Acute Gouty Arthritis

By Alison Palkhivala

Special to DG News

STOCKHOLM, SWEDEN -- June 17, 2002 -- The new investigational COX-2

inhibitor etoricoxib is showing promise with respect to providing relief in

many painful conditions, including back pain, rheumatoid arthritis (RA), and

acute gouty arthritis (AGA).

The drug also appears to have a favorable renovascular safety profile.

Several studies on etoricoxib were presented here this week at the Annual

European Congress of Rheumatology (EULAR).

In a study led by Dr. J. A. Boice from the department of clinical research

at Merck & Co., Inc., Rahway, United States, 150 adults with AGA of less

than 48 hours' duration were randomized to treatment with etoricoxib 120 mg

daily or indomethacin 50 mg TID for eight days. Response was equally fast

and effective with both drugs, according to both the patients' and the

investigators' assessments of pain, tenderness, and inflammation.

Another study, led by Dr. G. P. Geba from the clinical development

department of Merck & Co in West Point, United States, compared treatment

with etoricoxib 60 and 90 mg to placebo in 325 patients with chronic low

back pain. After three months, patients in both etoricoxib groups reported

significantly reduced pain and disability compared to placebo patients.

Dr. S. P. Curtis, also from the department of clinical research at Merck &

Co., Inc., Rahway, led another study in which 891 RA patients were

randomized to treatment with etoricoxib 90 mg daily, naproxen 500 mg BID, or

placebo. Among the 687 patients who completed the 12 week study, patients on

etoricoxib and naproxen had significantly greater improvement than placebo

patients on parameters that included counts of tender and swollen joints,

patient and investigator assessment of disease activity, Stanford Health

Assessment Questionnaire (HAQ) results, American College of Rheumatology

(ACR) 20 response criteria, and patient assessments of pain. Both treatments

were well tolerated.

Another study with RA patients, this time led by Dr. A. Melian from the

clinical immunology department at Merck & Co., Inc., Rahway, compared

quality of life assessment among 816 RA patients randomized to treatment

with etoricoxib 90 mg daily, naproxen 500 mg BID, or placebo for 12 weeks.

The investigators used the Medical Outcomes Trust SF-36 to assess quality of

life, which assesses eight quality of life domains. At the end of the study,

all of these domains were improved with etoricoxib compared to placebo, and

five (physical functioning, role-physical pain, general health perceptions,

pain, and social functioning) were significantly improved for etoricoxib

patients compared to those on naproxen.

Dr. S. P. Curtis and colleagues evaluated the safety of renovascular safety

with etoricoxib by collecting data on 3,348 patients who participated in one

of eight phase III clinical trials with the drug. They found that the risk

of developing low extremity edema and hypertension while taking etoricoxib

was low and similar to the risks seen with other non-steroidal

anti-inflammatories (NSAIDs), including naproxen and ibuprofen.

These studies were all performed in conjunction with Merck & Co., Inc.,

manufacturers of etoricoxib.