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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 ulcers, according to data presented at the annual meeting of the American Academy of Pain Medicine, National Harbor, Md.
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 One patient experienced acute renal failure and was withdrawn because of hematemesis.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.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
