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: May 16, 2001
Replicate Study Favors Celebrex
At the 2001 annual meeting of the American Geriatric Society and in a statement from Pharmacia Corporation (acquired later by Pfizer), results were announced from a six-week, replicate study of COX-2 selective inhibitors in hypertensive-treated, osteoarthritis patients, 65 years and older. The study, sponsored by Pharmacia Corporation (the makers of Celebrex), confirmed that more patients taking Vioxx exhibited "statistically significant and clinically important" increases in systolic blood pressure and edema than patients taking Celebrex.
About The Study
810 patients were enrolled in the first study, while 1,100 patients participated in the second study. Participants in both studies were 65 years of age or older and were being treated for hypertension. More than half of the participants were between 65 and 74 years old. The study drugs were Celebrex (celecoxib) and Vioxx(rofecoxib), and were administered at the "most commonly prescribed and maximum recommended doses for osteoarthritis:
- Celebrex 200 mg./once-daily
- Vioxx 25 mg./once-daily
Patient assessments were performed at baseline, one week, two weeks, and six weeks. At any time during the study, clinically meaningful endpoints were:
- increases in systolic blood pressure of more than 20 mm.Hg (or above 140 mm.Hg)
- increases in edema (weight gain of 3% or more)
- the need to increase medication to control either blood pressure or edema
Study Results
In both studies, the changes in systolic blood pressure were consistently higher in the Vioxx group than in the Celebrex group.
- In the first study, significantly more patients on Vioxx (16.5%) experienced increases in systolic blood pressure than those patients taking Celebrex (10.9%).
- In the replicate study, 14.9% of patients taking Vioxx experienced increases in systolic blood pressure compared to 6.9% of patients taking Celebrex.
- In both studies, no distinct differences were found in diastolic blood pressure for either the Vioxx or Celebrex group.
Increases in edema were higher in patients taking Vioxx than in patients taking Celebrex.
- In the first study, 9.5% of the Vioxx patients experienced clinically significant increase in edema compared to 4.9% of Celebrex patients.
- In the replicate study, 7.7% of the Vioxx patients experienced clinically significant increase in edema compared to 4.6% of Celebrex patients.
Merck Disputes Findings
Merck, the maker of Vioxx, is disputing the study results and conclusions being drawn. Merck contends that the dose of Vioxx used in the study was twice what is recommended for elderly and/or hypertensive patients. Merck's prescribing information recommends a starting dose of 12.5 mg./once-daily. In response to Merck's claim, a spokesperson for Pharmacia was quoted in the news as saying, "If you look at what's happening in the real world, 83% of Vioxx scripts are for the 25 mg. dose".
Arthritis and hypertension are the first and second most common chronic conditions among people over 65 years old. Approximately 43 million Americans suffer with arthritis. Of the 43 million arthritis sufferers, about 18 million also have hypertension. The effect of arthritis drugs on the cardiovascular and renal systems is an important consideration for prescribing physicians.
Related Resources
Sources: Second Large Study Confirms Different Blood Pressure and Edema Effects Between Celebrex and Vioxx, Press Release, Pharmacia Corp., 5/11/01; Pharmacia, Merck Clash Over Safety of Celecoxib, Rofecoxib, Reuters/Medscape, 5/14/01
First published: 5/16/2001
