Source: DGNews  |  Posted 9 years ago

By Roberta Friedman, PhD

BALTIMORE, MD -- May 16, 2003 -- Rofecoxib and celecoxib are no more likely than acetaminophen to produce hypertension, according to analyses of trials that compared these agents in patients with osteoarthritis of the knee.

Gregory Geba, MD, of Merck & Co., in West Point, Pennsylvania, presented the findings on the blood pressure safety of the two selective cyclooxigenase 2 (COX-2) blockers in posters here May 15th at the 2003 Annual Scientific Meeting of the American Geriatrics Society.

Inhibition of COX-2 is believed to affect renal blood flow and tubular function in some patients, according to the researchers. They analysed two similarly designed trials that tested 12.5 and 25 mg of rofecoxib, 200 mg of celecoxib 4000 mg of acetaminophen in a total of 1,960 patients.

The end point in both studies was patients' self reported global assessment of joint pain at baseline and at 6 weeks of treatment. The trials also collected data on adverse events that doctors designated as being hypertension-related, and changes in both systolic and diastolic pressures.

"Patients got more monitoring that is usual for osteoarthritis" treatment, noted Merck scientist, Gregory Geba, MD.

"The vast majority of patients do not have elevations" of blood pressure after taking any of these dosages for 6 weeks, Dr. Geba said. Incidence of any adverse events that could be ascribed to hypertension ranged from 1.3% to 2.8%.

Mean changes in pressures were on the order of 0.5 to 2.0 mm Hg for systolic and 0.1 to 1.0 for diastolic readings. No differences among treatment groups reached statistical significance, including rate of treatment discontinuation due to hypertension.

Dr. Geba said that either acetaminophen is not without a risk of hypertension or NSAIDs and COX-2 inhibitors "are not producing hypertension above a background rate".

[Study title: Analysis of Hypertension Adverse Experiences Among Osteoarthritis Patients Treated with Rofecoxib, Celecoxib, or Acetaminophen in the VACT Trials. Abstract P-187]