Vimovo well tolerated by arthritis patients at risk for gastric ulcers

April 1, 2011

Naproxen/esomeprazole magnesium (Vimovo, AstraZeneca and Pozen) 500/20-mg delayed-release tablets was generally well tolerated in osteoarthritis patients requiring daily NSAID therapy who were at risk for NSAID-associated ulcers, according to an open-label, multicenter phase 3 study.

Naproxen/esomeprazole magnesium (Vimovo, AstraZeneca and Pozen) 500/20-mg delayed-release tablets was generally well tolerated in osteoarthritis patients (OA) requiring daily nonsteroidal anti-inflammatory drug (NSAID) therapy who were at risk for NSAID-associated ulcers, according to an open-label, multicenter phase 3 study.

Vimovo is a fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole magnesium, an ulcer risk-reducing proton pump inhibitor, approved for the relief of signs and symptoms of OA. Researchers studied H. Pylori-negative patients aged 18 and older with OA, rheumatoid arthritis (RA), ankylosing spondylitis (AS), or other conditions requiring daily NSAID therapy. The patients were at risk for NSAID-associated gastric ulcers because of age (at least 50 years) or history of ulcer in the past 5 years. Patients received Vimovo twice daily for 12 months.

No new or unexpected safety issues emerged throughout the treatment period among all 239 patients in the study. The most common adverse events were dyspepsia (7.9%), constipation (5.9%), and nausea (5.0%). Among the 135 patients who completed the trial, the most common adverse events were upper respiratory tract infection (9.6%), dyspepsia (5.9%), back pain (5.2%), and contusion (5.2%).

Vimovo is not recommended for the initial treatment of acute pain because the absorption of naproxen is delayed compared to the absorption from other naproxen-containing products, reported AstraZeneca. As with other NSAIDs, Vimovo may increase the risk of heart attack and stroke. The risk increases with longer use of NSAIDs and in patients with heart disease.

Results from the study were reported at the recent annual meeting of the American Academy of Pain Medicine and published in Current Medical Research & Opinion.