Long-term combo naproxen/esomeprazole safe, effective

No new or unexpected safety issues occurred during long-term treatment with a fixed-dose combination of naproxen and esomeprazole magnesium (Vimovo) in patients at risk of NSAID-associated upper gastrointestinal (GI) ulcers, according to data presented at the annual meeting of the American Academy of Pain Medicine, National Harbor, Md.

Chronic use of NSAIDs to relieve the signs and symptoms of arthritic conditions is associated with a risk of upper GI injury and cardiovascular events. The combination of delayed-release, enteric-coated naproxen and immediate-release esomeprazole was approved by FDA for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of ulcers in patients at risk for developing NSAID-related gastric ulcers. The long-term safety of this combination in patients requiring NSAID therapy who were at risk of such ulcers was evaluated in this study.

Researchers included 239 patients with osteoarthritis, rheumatoid arthritis, or other conditions requiring chronic NSAID treatment with a history of ulcer within the past 5 years in this open-label, multicenter, phase 3 study. All patients were treated with a fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole magnesium (500 mg/20 mg) twice daily for 12 months.

Overall, 135 patients completed the 12-month study, and adverse events occurred in 70.4%. In the overall safety population (n=239), 18.8% of patients withdrew from the study due to adverse events. The majority of adverse events that led to discontinuation were GI disorders (7.9%) or musculoskeletal and connective tissue disorders (4.6%). Increased creatinine levels occurred in 3 patients. One patient experienced acute renal failure and was withdrawn because of hematemesis.

Dyspepsia, nausea, and upper abdominal pain were the most common upper Gi adverse events, reported by 5.9%, 4.4%, and 3.0%, respectively. Importantly, the incidence of adverse events was similar in each age subgroup for populations aged <65 years and ≥65 years (33.5% and 39.7%, respectively, in the overall safety population; 28.3% and 34.9% in the completer population).

“This study shows the safety behind long-term use of this agent. These data are important for clinicians to have when considering therapy for their patients. Another important note is that young and old patients had similar safety profiles,” said Mark B. Sostek, MD, FACG, of AstraZeneca, Wilmington, Del.

This study was sponsored by Pozen Inc.