Pharmacology Update

Naproxen and Esomeprazole Delayed-Release Tablets (Vimovo®)

By William T. Elliott, MD, FACP, and James Chan, PharmD, PhD. Dr. Elliott is Chair, Formulary Committee, Northern California Kaiser Permanente; and Assistant Professor of Medicine, University of California, San Francisco. Dr. Chan is Pharmacy Quality and Outcomes Manager, Kaiser Permanente, Oakland, CA. Drs. Elliott and Chan report no financial relationship to this field of study.

A combination of a nonsteroidal anti-inflammatory agent and a proton pump inhibitor has been approved by the FDA. Naproxen and esomeprazole (NAP/ESO) is marketed as a delayed-release tablet as Vimovo™ by AstraZeneca.

Indications

NAP/ESO is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.1

Dosage

The recommended dose is one tablet twice daily. The dose should be based on the lowest effective dose. NSAIDs are not recommended for patients with moderate or severe renal dysfunction or severe hepatic dysfunction.

NAP/ESO is available as 375 mg/20 mg and 500 mg/ 20 mg delayed-release tablets.

Potential Advantages

NAP/ESO reduced the cumulative incidence of gastric ulcers compared to enteric-coated naproxen alone.1

Potential Disadvantages

NAP/ESO is more expensive than taking generic naproxen and omeprazole separately. Esomeprazole is the active isomer of omeprazole and is currently not available in the generic form.

Comments

The effectiveness of NAP/ESO in preventing gastric ulcers was based on two randomized, double-blind trials.1 Adult patients with a documented history of gastric or duodenal ulcers that required daily NSAIDs were randomized to NAP/ESO 500 mg/20 mg twice daily (n = 428) or enteric-coated naproxen 500 mg twice daily (n = 426). The cumulative incidences of gastric ulcers at 6 months were 4.1% compared to 24.3%, respectively. A higher percent of subjects discontinued naproxen than NAP/ESO (12% vs 4%). The efficacy of NAP/ESO was shown in two 12-week randomized, placebo-controlled trials in subjects with osteoarthritis.1

Clinical Implications

Gastrointestinal complications associated with NSAID have been well documented. The risk is enhanced in patients who have a history of previous GI events, are age > 65 years, take high doses of NSAID, and those who concurrently use aspirin, anticoagulants, or corticosteroids.2,3 Helicobacter pylori infection increases the risk of peptic ulceration; therefore, testing and eradication should be considered. The Practice Parameter Committee of the American College of Gastroenterology recommends NSAID plus misoprostol or a PPI in patient with moderate GI risk and low cardiovascular risk.2 Naproxen + misoprostol or a PPI is recommended for patients with low or moderate GI risk but high CV risk (low-dose aspirin is required). In patients with high GI and CV risk, NSAIDs should be avoided. In those with high GI risk but low CV risk, a COX-2 inhibitor with a PPI or misoprostol is recommended. NAP/ESO provides a NSAID/PPI combination in a single tablet. However, the use of generic versions of naproxen and omeprazole is less expensive. The cost of a 30-day supply of Vimovo is $106.06 compared to $88.44 for generic versions of naproxen 500 mg and omeprazole 40 mg taken separately.4

References

1. Vimovo Prescribing Information. Wilmington, DE: AstraZeneca; April 2010.

2. Lanza FL, et al. Guidelines for prevention of NSAID-related ulcer complications. Am J Gastroenterol 2009;104:728-738.

3. Lazzaroni M, Porro GB. Management of NSAID-induced gastrointestinal toxicity: Focus on proton pump inhibitors. Drugs 2009;69:51-69.

4. Latimer N, et al. Cost effectiveness of COX 2 selective inhibitors and traditional NSAIDs alone or in combination with a proton pump inhibitor for people with osteoarthritis. BMJ 2009;339:b2538; doi:10.1136/bmj.b2538.

5. RxUSA. Available at: http://rxusa.com/html. Accessed May 26, 2010.