Bayer Release: 20+ Years Of Safety Data, Clinical Trials & Real-World Use Confirm Positive Benefit/Risk Profile Of ALEVE

Published: Nov 14, 2016

PRECISION trial studied long-term use of higher Rx NSAID doses

WHIPPANY, N.J., Nov. 13, 2016 /PRNewswire/ -- In over 20 years of safety data monitoring and availability as a non-prescription pain reliever, Bayer has seen no change in the positive benefit/risk profile of Aleve.  

Results published today from the Pfizer-sponsored PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen) trial are not applicable to the over-the-counter pain reliever ALEVE.

The trial, which was requested by the US FDA to evaluate the cardiovascular (CV) risk profile of Pfizer's celecoxib, studied long-term use (18-36 months) of higher-dosed prescription drugs in arthritis patients at increased CV risk. 

The PRECISION trial did not study the lower, non-prescription naproxen sodium dose contained in ALEVE*, nor the labeled direction of occasional, short-term use. Therefore, it is inappropriate to apply these trial results to ALEVE.  

Consumers should not be confused by reports of relative risk ratios in PRECISION, which make risk appear dramatically inflated when this is not the finding of the science nor the study.  Clinically significant reported GI effects were actually very low across all treatments -- including prescription doses of naproxen -- and importantly, not statistically different.  

The risk of serious GI side effects with naproxen sodium is well-studied and rare when taken as directed for short-term pain relief.[i] ** In PRECISION, even with long-term higher prescription doses, a very low absolute GI event rate was reported for naproxen, and was only 0.4% higher than those seen with celecoxib (1.5% vs 1.1% respectively).  

When taken as directed, Aleve safely and effectively relieves occasional pain. More doctors recommend Aleve than any other over-the-counter arthritis pain product, and it is the number one brand recommended by orthopedic doctors for minor arthritis pain.[ii]

* Up to 10 days at =660 mg per day

** All NSAID-containing products, including celecoxib, ibuprofen and naproxen, carry label warnings related to GI risk. Clinical trial data for naproxen demonstrates that GI bleeding is rare (0.01% to <0.1%, i.e., occurring in 1 in 10,000 to 1 in 1000 patients).

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[i] Company Core Data Sheet for Naproxen, Bayer.

[i] Naproxen Sodium Periodic Safety Update Reports 2007-2015. Data on file, Bayer.

[i] Tarone RE, Blot WJ, McLaughlin JK. Nonselective nonaspirin nonsteroidal anti-inflammatory drugs and gastrointestinal bleeding: relative and absolute risk estimates from recent epidemiologic studies. Am J Ther. 2004 Jan-Feb;11(1):17-25.

[i] Zhang W, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis and Cartilage 2008; 16:137-162, doi:10.1016/j.joca.2007.12.013

[i] Bansal V, et al. A look at the safety profile of over-the-counter naproxen sodium: a meta-analysis. J Clin Pharmacol 2001; 41: 127-138.

[i] DeArmond B, et al. Safety profile of over-the-counter naproxen sodium.  Clin Ther 1995; 17: 587-601.

[i] Lewis JD, et al. Risk of serious upper gastrointestinal toxicity with over-the-counter nonaspirin nonsteroidal anti-inflammatory drugs. Gastroenterology 2005; 129: 1865-1874.

[i] Biskupiak JE, et al. Gastrointestinal Complications of Over-the-Counter Nonsteroidal Antiinflammatory Drugs.  J Pain Palliat Care Pharmacother 2006; 20(3):7-14.

[i] Mellemkjaer L, et al. Upper gastrointestinal bleeding among users of NSAIDs: a population-based cohort study in Denmark. Br J Clin Pharmacol 2002 Feb;53(2):173-81.

[ii] Data on file, Bayer.

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SOURCE Bayer Corporation

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