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| |  EULAR: Osteoarthritis Drug Celebrex (Celecoxib) Less Likely To Cause Increased Blood Pressure Than Vioxx (Rofecoxib) NICE, FRANCE -- June 22, 2000 -- New data derived from the first-ever head-to-head safety study presented that compares Pharmacia's COX-2 inhibitor Celebrex® (celecoxib capsules) with Merck's Vioxx® (rofecoxib) show that hypertensive osteoarthritis (OA) patients taking Vioxx experienced statistically significantly more increases in edema and systolic blood pressure compared with those taking Celebrex. These findings were presented today during the XV European United League Against Rheumatism Congress (EULAR). Specifically, Vioxx-treated patients experienced a two-fold increase in clinically significant edema compared to the Celebrex-treated patients. Of greater importance, results reveal that within two weeks of the start of the study, significantly more patients on Vioxx had clinically meaningful increases in systolic blood pressure (greater than or equal to 20 mmHg) versus those on Celebrex. An estimated 43 million Americans -- nearly one out of every six people -- suffer from arthritis. Of those, approximately 18 million (42 percent) also have hypertension. Osteoarthritis is the most common form of arthritis. "For the first time we have a direct safety comparison of these compounds on a level playing field, in the same patient population, which helps us gain a better assessment of safety differences between these two COX-2 inhibitors," said Andrew Whelton, MD, a nephrologist and adjunct professor of medicine at Johns Hopkins University School of Medicine, who presented the findings today during a satellite symposium sponsored by Pharmacia and Pfizer Inc at EULAR. "This study provides compelling evidence that Celebrex and Vioxx affect hypertensive arthritis patients differently, suggesting that not all COX-2 inhibitors are the same." The six-week, multi-center, randomized, double-blind, parallel study of approximately 800 hypertensive OA patients -- all of whom were being treated with anti-hypertensive medication -- was designed to compare the incidence of clinically significant, cardiorenal events associated with Celebrex (200 mg once daily) with that of Vioxx (25 mg once daily). These two doses are the most frequently prescribed doses of both products -- and are also clinically similar in efficacy, according to another new head-to-head OA study presented today at a symposium, sponsored by Pharmacia and Pfizer Inc. Participants in the cardiorenal safety study were age 65 or older, with more than half of patients between the ages of 65 to 74. Importantly, the age group studied is representative of the majority of OA patients. Patient assessments were conducted at baseline and then at weeks one, two and six to examine key measures of cardiorenal safety such as edema and systolic blood pressure. In addition to a significant increase in the incidence of edema among patients taking Vioxx (p less than 0.05), researchers found that by the end of the study nearly 60 percent more patients on Vioxx than on Celebrex (a 1.6-fold higher incidence that was statistically significant: p less than 0.05) experienced systolic blood pressure elevations of 20 mmHg or more, a measure of clinically significant hypertension. This statistical difference in systolic blood pressure levels between Celebrex and Vioxx was observed as early as week two of the study and was confirmed again at week six. Additional study analyses are under way. Patients who have a known allergic reaction to celecoxib, certain sulfa drugs called sulfonamides, aspirin or NSAIDs, or who are in their third trimester of pregnancy should not use Celebrex. As with all NSAIDs, serious GI tract ulcerations can occur without warning symptoms. Physicians and patients should remain alert to the signs and symptoms of GI bleeding. Concomitant administration of aspirin with Celebrex may result in an increased risk of GI ulceration or other complications, compared to Celebrex alone. Celebrex does not affect platelet function and therefore should not be used for cardiovascular prophylaxis. As with all NSAIDs, Celebrex should be used with caution in patients with fluid retention, hypertension, or heart failure. In studies, the most common side effects of Celebrex were dyspepsia, diarrhea and abdominal pain, which were generally mild to moderate. Related Links: Celebrex (celecoxib), Pharmacia, Vioxx (rofecoxib) and Merck & Co., Inc.
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