Etoricoxib (MK-0663)
Celecoxib (Celebrex®)
Meloxicam (Mobic®)

SAT0064 Treatment with Etoricoxib (MK-0663), a COX-2 Selective Inhibitor, Resulted in Clinical Improvement in Knee Osteoarthritis (OA) Over 52 Weeks
SP Curtis, C Fisher, S Kafka, B Bockow, A Ko, A Compton, B Pramanik, BJ Gertz

This study assesses the safety and efficacy of MK-0663 in patients with knee osteoarthritis (OA). The methods used in this study are similar to that presented in abstract FRI0030 (MK-0663 in RA patients). Part I compared placebo (n=60) to MK-0663 at doses 5 mg (n=117), 10 mg (n=114), 30 mg (n=102), 60 mg (n=112) and 90 mg (n=112), once daily for 6 weeks. At the conclusion of 6 weeks, patients receiving placebo, 5 mg, and 10 mg MK-0663 were redistributed to another group and received either 30 mg, 60 mg, or 90 mg of MK-0663 or 150 mg of diclofenac for the remaining 46 weeks. Primary endpoints were the WOMAC VA 3.0 subscale, and patient and investigator global assessment of disease activity.

In part I, all patients receiving MK-0663 demonstrated a significantly greater efficacy that was dose related when compared to patients receiving placebo. This effect was maintained during the continuation of the study, with the 60 mg and 90 mg MK-0663 treatment groups proving to be more effective than the 30 mg dose of MK-0663. Improvements were similar to that observed in patients receiving diclofenac. Adverse events in part I were similar between the MK-0663 treatment groups and the placebo group. No new adverse events developed during part II of the study.

These data indicate that treatment with MK-0663 is efficacious and well-tolerated in patients with knee OA.

Editorial Comment: This is a well-tolerated, efficacious agent similar to the other available selective COX-2 inhibitors.

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OP0053 Success-1 in Osteoarthritis (OA) Trial: Celecoxib Significantly Reduces the Risk of Serious Upper GI Complications Compared to NSAIDs While Providing Similar Efficacy in 13,274 Randomized Patients
G Singh, J Goldstein, W Bensen, N Agrawal, G Eisen, J Fort, A Bello, S Boots
and
OP0093 Success-1 in osteoarthritis: celecoxib demonstrates similar efficacy to the conventional NSAIDs, diclofenac and naproxen in pateints with osteoarthritis treated in 39 countries in 6 continents
G Singh, J Goldstein, J Fort, A Bello, S Boots
and
OP0053 Celecoxib does not increase the risk of cardiac failure, edema, hypertension compared to NSAIDs: Results from Success-1: A double-blind, randomized trial in 13,274 OA patients
A Whelton, G Singh, W White, J Fort, A Bello

In these three abstracts, the authors present data from the Success-1 trial. The twelve week trial compared the efficacy, safety and tolerability of celecoxib 200 mg or 400 mg daily with either naproxen 1000 mg daily (U.S., Canada) or diclofenac 100 mg daily (Europe, Latin America, South Africa). In all, 1,142 centers were utilized, with 13,194 intent to treat patients.

Using outcome measures of patient assessment of arthritis pain (VAS) and night pain, celecoxib showed similar efficacy to diclofenac and naproxen. In addition the 200 mg and 400 mg doses of celecoxib were comparable.

GI events were reduced in the celecoxib treated patients. The following summarizes the GI events:

There were no differences between celecoxib and other NSAIDs in frequency of peripheral and generalized edema, cardiac failure and hypertension. Pervioius cardiac disease was similar in the two groups, as well as ASA use at baseline, 7.9% and 8.0% in the celecoxib and NSAID groups respectively.

Editorial Comment: This trial, although not surprising in its outcome, is remarkable for its size and multinational characteristic. It provides an enormous amount of data of controlled clinical experience with these agents. These data confirm prior studies showing that selective COX-2 inhibitors compared with non-selective NSAIDs have similar efficacy but are associated with lower GI side effects. The data also highlights the fact that both selective COX-2 agents and non-selective NSAIDSs are well tolerated and significant GI events are relatively infrequent in non-selected populations.

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OP0085 Meloxicam has a Low Risk of Serious Gastrointestinal Complications
G Singh and G Triadapfilopulous

This abstract is a review of the incidence of serious upper GI complications including perforation, obstruction and hemodynamically significant bleed in a pooled analysis of meloxicam clinical trials. For inclusion, trials were at least 3 weeks in duration and included at least 20 patients per arm. Thirty five trials were identified, with 27,039 patients on meloxicam or comparator NSAIDs.

Number of cases for all trials:

Editorial Comment: The weakness of the study is the limitations of the use of pooled data from a large number of clinical trials. Meloxicam has been only recently approved for use in the U.S., but has been in use in Europe for many years. It is not as selective for COX-2 as celecoxib and rofecoxib and thus it does not carry the selective COX-2 label in the U.S. It is interesting in this limited data set, that Meloxicam 7.5 mg - 22.5 mg daily, the likely doses to be used in clinical practice, had similar GI events per 100 years as reported with celecoxib (see abstract OP0053).

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