Celebrex vs. Vioxx: Hypertension Variance
Jackson Orthopaedic Foundation participated in a study aimed to evaluate differences in blood pressure control in patients with preexisting co-morbid arthritis and hypertension who are being initiated on a COX-2 specific NSAID medication.
Results of the Study: Replicate Study Favors Celebrex
(From papers presented at the 2001 annual meeting of the American Geriatric Society)
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.
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
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.