Editor note: On 09/30/2004, Merck the maker of Vioxx, issued a worldwide recall, halting sales of the drug. On 04/07/2005, Following scrutiny of the class of arthritis drugs known as NSAIDs and COX-2 inhibitors, the FDA announced planned regulatory actions. See: Questions & Answers: FDA Actions On COX-2 Inhibitors & NSAIDs Fallout from the Vioxx recall will continue for years to come.
Dateline: June 22, 2000
Rival Reports For Celebrex & Vioxx
You might expect the makers of COX-2 selective inhibitor drugs, Celebrex (celecoxib) and Vioxx (rofecoxib), to report on advantages over older NSAIDS (nonsteroidal anti-inflammatory drugs) for the treatment of arthritis.
However, in an effort to snag the lion's share of a multi-billion dollar pharmaceutical market, both Pharmacia and Merck & Co., the makers of the rival COX-2 selective inhibitor drugs, made bold claims at EULAR 2000 (the annual meeting of the European League Against Rheumatology) about being the better choice for arthritis patients. Instead of merely challenging the older NSAIDS, Celebrex and Vioxx are battling each other.
Vioxx (Rofecoxib)
Study results indicate that Vioxx 25 mg., manufactured by Merck & Co., reduced osteoarthritis pain at night and at rest more effectively than Celebrex 200 mg. or acetaminophen 4000 mg. The study was based on 382 patients, all of whom had osteoarthritis of the knee. The average age of the participants was 63 years old. The six- week, multi-center, randomized study compared:
- Vioxx 12.5 mg. once-daily
- Vioxx 25 mg. once-daily
- Celebrex 200 mg. once-daily
- acetaminophen 1000 mg. four-times daily
Two standard osteoarthritis measures were used to assess patient response: The WOMAC Index, a self-administered patient questionnaire, and the Patient and Investigator Global Assessment of Response to Therapy scale. Assessments were completed on the first six days of treatment, and again following two, four, and six weeks of treatment.
Assessments of early efficacy produced similar results for Vioxx 25 mg., Celebrex 200 mg., and acetaminophen 4000 mg. However, more patients taking Vioxx 25 mg. daily reported good response to treatment at 6 weeks than patients taking either Celebrex 200 mg. or acetaminophen 4000 mg.
Vioxx 12.5 mg. and Celebrex 200 mg. were not statistically different on any measure in early efficacy or at the 6 week interval. All of the treatments in this study were considered generally safe and well-tolerated. Significant differences in the incidence of clinical adverse events for the treatments studied were not reported.
Celebrex (Celecoxib)
Also at EULAR, another study which pit Celebrex against Vioxx indicated that hypertensive, osteoarthritis patients taking Vioxx experienced significant increases in edema and systolic blood pressure compared to patients taking Celebrex. Within two weeks of the onset of the study, a significant number of patients taking Vioxx had an increase in systolic blood pressure measuring greater than or equal to 20 mmHg. versus patients taking Celebrex.
Approximately 800 hypertensive, osteoarthritic patients participated in the six-week, multi-center, randomized, double-blind, parallel study. All participants were being treated with medication for hypertension. The study was specifically designed to assess cardiorenal events associated with Celebrex 200 mg. and Vioxx 25 mg. All of the study participants were 65 years or older, considered representative of most osteoarthritis patients. Assessments were conducted at baseline, and again following weeks one, two, and six for edema and systolic blood pressure.
By the end of the study, approximately 60 percent more Vioxx patients exhibited systolic blood pressure elevations of 20 mmHg. or more compared to patients taking Celebrex. This notable effect on systolic blood pressure was observed statistically as early as week two and substantiated at week six.
Conclusions
From the new information, it can be concluded that not only are there differences between COX-2 selective drugs and older NSAIDS, but differences also exist between drugs within the COX-2 drug class. Future studies will help sort out the debate, "Which is better? Celebrex or Vioxx?" For now, Pharmacia and Merck will keep the debate raging on.
Related Resources
Sources: Merck, Pharmacia Vie For Arthritis Market, June 22, 2000, Reuters; Arthritis Drugs Tested Head-to-Head, June 22, 2000, Associated Press; Vioxx Associated With Significant Increases In Blood Pressure And Edema VS. Celebrex, June 22, 2000, Press Release, MS & L
First published: 6/22/2000
