Abstract
Oral naproxen/esomeprazole magnesium (Vimovo™) is a fixed-dose combination of an NSAID and a proton pump inhibitor. The combination is indicated to provide relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients at risk of developing NSAID-associated gastric ulcers (US), and in patients who are at risk of developing NSAID-associated gastric and/or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient (EU).
References
Lanza FL, Chan FK, Quigley EM. Guidelines for prevention of NSAID-related ulcer complications. Am J Gastroenterol 2009 Mar; 104 (3): 728–38
Blandizzi C, Tuccori M, Colucci R, et al. Clinical efficacy of esomeprazole in the prevention and healing of gastrointestinal toxicity associated with NSAIDs in elderly patients. Drugs Aging 2008; 25 (3): 197–208
Musumba C, Pritchard DM, Pirmohamed M. Review article: cellular and molecular mechanisms of NSAID-induced peptic ulcers. Aliment Pharmacol Ther 2009 Sep 15; 30 (6): 517–31
Laine L. Nonsteroidal anti-inflammatory drug gastropathy. Gastrointest Endosc Clin N Am 1996 Jul; 6 (3): 489–504
Chan FK, Abraham NS, Scheiman JM, et al. Management of patients on nonsteroidal anti-inflammatory drugs: a clinical practice recommendation from the First International Working Party on Gastrointestinal and Cardiovascular Effects of Nonsteroidal Anti-inflammatory Drugs and Anti-platelet Agents. Am J Gastroenterol 2008 Nov; 103 (11): 2908–18
Scheiman JM, Hindley CE. Strategies to optimize treatment with NSAIDs in patients at risk for gastrointestinal and cardiovascular adverse events. Clin Ther 2010 Apr; 32 (4): 667–77
van Soest EM, Valkhoff VE, Mazzaglia G, et al. Suboptimal gastroprotective coverage of NSAID use and the risk of upper gastrointestinal bleeding and ulcers: an observational study using three European databases. Gut 2011 Dec; 60 (12): 1650–9
Goldstein JL, Hochberg MC, Fort JG, et al. Clinical trial: the incidence of NSAID-associated endoscopic gastric ulcers in patients treated with PN 400 (naproxen plus esomeprazole magnesium) vs. enteric-coated naproxen alone. Aliment Pharmacol Ther 2010 Aug; 32 (3): 401–13
Vimovo® (naproxen and esomeprazole magnesium) delayed release tablets: US prescribing information. Wilmington (DE): AstraZeneca LP, 2012 Jan
Vimovo® 500 mg/20 mg modified release tablets: UK prescribing information. Luton: AstraZeneca UK Ltd, 2011 Sep 9
Miner Jr P, Plachetka J, Orlemans E, et al. Clinical trial: evaluation of gastric acid suppression with three doses of immediate-release esomeprazole in the fixed-dose combination of PN 400 (naproxen/esomeprazole magnesium) compared with naproxen 500 mg and enteric-coated esomeprazole 20 mg: a randomized, open-label, phase I study in healthy volunteers. Aliment Pharmacol Ther 2010; 32 (3): 414–24
Angiolillo DJ, Hwang C, Datto C, et al. Impact of a fixed-dose combination of naproxen and esomeprazole magnesium on serum thromboxane B2 inhibition by low-dose aspirin over 5 days in healthy adults: a phase I, randomized, double-blind, placebo-controlled, noninferiority trial. Clin Ther 2011 Dec; 33 (12): 1883–93
Wang-Smith L, Fort J, Zhang Y, et al. Pharmacokinetics and relative bioavailability of a fixed-dose combination of enteric-coated naproxen and non-enteric-coated esomeprazole magnesium. J Clin Pharmacol 2012 May; 52 (5): 670–80
Hochberg MC, Fort JG, Svensson O, et al. Fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole has comparable efficacy to celecoxib for knee osteoarthritis: two randomized trials. Curr Med Res Opin 2011; 27 (6): 1243–53
Cryer BL, Sostek MB, Fort JG, et al. A fixed-dose combination of naproxen and esomeprazole magnesium has comparable upper gastrointestinal tolerability to celecoxib in patients with osteoarthritis of the knee: results from two randomized, parallel-group, placebo-controlled trials. Ann Med 2011; 43 (8): 594–605
Sostek MB, Fort JG, Estborn L, et al. Long-term safety of naproxen and esomeprazole magnesium fixed-dose combination: phase III study in patients at risk for NSAID-associated gastric ulcers. Curr Med Res Opin 2011; 27 (4): 847–54
Dhillon S. Naproxen/esomeprazole fixed-dose combination for the treatment of arthritic symptoms and to reduce the risk of gastric ulcers. Drugs Aging 2011; 28 (3): 237–48
Acknowledgements and Disclosures
This article was updated from Drugs & Aging 2011; 28 (3): 237-48,[17] and reviewed by M. Baraka, Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt; R. Day, Therapeutics Centre, St Vincent’s Hospital, Sydney, NSW, Australia; E. Obarcanin, Sarajevo, Bosnia and Herzegovina.
The preparation of this article was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on the articles. Changes resulting from comments received were made by the authors on the basis of scientific and editorial merit.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Lyseng-Williamson, K.A., Dhillon, S. Fixed-dose naproxen/esomeprazole magnesium: a guide to its use to treat arthritic symptoms and reduce gastric ulcer risk. Drugs Ther Perspect 28, 1–5 (2012). https://doi.org/10.1007/BF03262111
Published:
Issue Date:
DOI: https://doi.org/10.1007/BF03262111