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Nexium (esomeprazole magnesium) is a proton pump inhibitor (PPI), indicated for the following:
- Gastroesophageal reflux disease (GERD)
- treatment of erosive esophagitis
- long-term management of patients with healed esophagitis to prevent relapse
- symptomatic treatment of GERD
- In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori (H pylori) and
- healing of H pylori-associated duodenal ulcer
- prevention of relapse of peptic ulcers in patients with H pylori-associated ulcers
- Patients requiring continued non-steroidal anti-inflammatory drug (NSAID) therapy
- healing of gastric ulcers associated with NSAID therapy
- prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk
- Prolonged treatment after i.v.-induced prevention of rebleeding of peptic ulcers
- Treatment of Zollinger-Ellison syndrome
Source: AstraZeneca.com
Nexium: Efficacy in GERD
Physicians have identified a spectrum of GERD patients, ranging from those who experience lifestyle-related inconveniencing GERD to those with persistent, recurring GERD that is frustrating and disruptive in daily life. [1],[2],[3],[4],[5],[6],[7],[8]
Nexium is particularly suitable for patients who present to the doctor with persistent, recurring GERD symptoms.[3-8] These patients have often suffered from symptoms for a long period and will have tried lifestyle changes, over the counter (OTC) medications and other treatments, but remain uncontrolled.
Nexium: Efficacy in Preventing Peptic Ulcer Rebleed
Nexium i.v. is indicated for the prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers. The i.v. treatment should be followed by oral acid suppression therapy. Nexium oral also has an indication for prolonged treatment after i.v.-induced prevention of rebleeding peptic ulcers.
In a large, multinational, randomized, double-blind, placebo-controlled study that was conducted across Europe, Asia and Africa, Nexium significantly reduced the number of patients having a rebleed after initial endoscopic treatment of peptic ulcer bleeding by almost half. The treatment was found to be more effective within three, seven, and 30 days and significantly reduced the use of hospital resources compared to placebo.[9] Nexium was also considered to be well tolerated with an adverse event profile similar to placebo.[9],[10]
Until now, no other PPI has demonstrated an overall benefit in high risk peptic ulcer bleeding patients in published international, multi-centre studies of peptic ulcer bleeding in predominantly Caucasian patient populations.[11],[12],[13],[14],[15]
Nexium Peptic Ulcer Bleed Study
PUB study design; i.v.., intravenous [9]
Nexium: Efficacy Compared with All Other PPIs
Clinical studies have confirmed that a Nexium dosage of 40 mg once daily provides powerful acid control compared with standard doses of all other proton pump inhibitors (PPIs). This allows for predictable and long-lasting control of GERD symptoms and effective healing and maintenance treatment of erosions in the esophagus.
In particular, the effectiveness of Nexium has been confirmed by a five-way crossover study in which patients with GERD received each PPI for five days, at the approved dose for healing reflux esophagitis, with a ‘wash-out’ period (in which patient takes placebo medication only) between each treatment.[16]
Get more details about this Nexium study
On day five of treatment, Nexium, 40 mg once daily, maintained the intragastric pH above 4 (thus limiting the damage caused to the esophagus by reflux acid) for a mean of 14 hours – significantly longer than with:
- omeprazole, 20mg once daily (11.8 hours)
- lansoprazole, 30mg once daily (11.5 hours)
- pantoprazole, 40mg once daily (10.1 hours)
- rabeprazole, 20mg once daily (12.1 hours)
(where p<0.001 for Nexium versus each other PPI).
Furthermore, the superiority of Nexium in controlling acid compared with the other PPIs became apparent on the first day of dosing.
A reanalysis of the results of this study was conducted which confirmed the outcomes with Nexium maintaining intragastric pH above 4 for a mean of 15.3 hours, significantly longer than the comparator treatments, (omeprazole 12.9; lansoprazole 12.7; pantoprazole 11.2 and rabeprazole 13.3).[17]
Nexium, 40 mg once daily, also controlled the intragastric pH above 4 for at least 12 hours during the 24-hour period in more patients with GERD than any other PPI. Acid control with Nexium is therefore more predictable than with other PPIs, providing greater reliability of response.16
How Do the PPIs Compare? [3],[4],[18],[19]
PPI Comparison Table
Nexium is more effective than other proton pump inhibitors in healing and maintaining associated symptoms, and offers favourable cost-effectiveness.
References
- Fass R, Thomas S, Traxler B, Sostek M. Patient reported outcome of heartburn improvement: doubling the proton pump inhibitor (PPI) dose in patients who failed standard dose PPI versus switching to a different PPI. Gastroenterology 2004;126 Suppl 2:A37
- Johnson DA, Orr WC, Crawley JA, Traxler B, McCullough J et al. Effect of esomeprazole on nighttime heartburn and sleep quality in patients with GERD: a randomized, placebo-controlled trial. Am J Gastroenterol 2005;100:1914–22
- Kahrilas P, Falk G, Johnson D, Schmitt C, Collins D, Whipple J et al. Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux esophagitis patients: a randomized controlled trial. Aliment Pharmacol Ther 2000;14:1249–58
- Richter J, Kahrilas J, Johanson J, Maton P, Breiter J, Hwang C et al. Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: a randomized controlled trial. Am J Gastroenterol 2001;96:656–65
- Vakil NB, Shaker R, Johnson DA, Kovacs T, Baerg RD, Hwang C et al. The new proton pump inhibitor esomeprazole is effective as a maintenance therapy in GERD patients with healed erosive esophagitis: a 6-month, randomized, double-blind, placebo-controlled study of efficacy and safety. Aliment Pharmacol Ther 2001;15:926–35
- Johnson DA, Benjamin SB, Vakil NB, Goldstein JL, Lamet M, Whipple J et al. Esomeprazole once daily for 6 months is effective therapy for maintaining healed erosive esophagitis and for controlling gastroesophageal reflux disease symptoms: a randomized, double-blind, placebo-controlled study of efficacy and safety. Am J Gastroenterol 2001;96:27–34
- Lauritsen K, Junghard O, Eklund S, Wiklund I. The effect of esomeprazole 40 mg on healing, reflux symptoms and quality of life in patients with reflux esophagitis. Gastroenterology 2002;122:A200 (and associated poster)
- Talley N Junghard O, Wiklund I. Improvement in health-related quality of life following esomeprazole treatment in patients with endoscopy-negative gastroesophageal reflux disease. J Gastroenterol Hepatol 2002;17 Suppl:A18
- Sung J, Barkun A, Kuipers E et al., Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. Annals of Internal Medicine 2009:150:7
- Kuipers E, Sung J, Barkun A et al. High-dose intravenous esomeprazole is safe and well tolerated in patients with peptic ulcer bleeding. Abstract presented at UEGW 2008
- Sung J, Mössner J, Barkun A, et al. on behalf of the PUB Study Group. Intravenous esomeprazole for re-bleeding: rationale / design of the Peptic Ulcer Bleed Study, Alimentary Pharmacology & Therapeutics 2008; 27, 666–677
- Van Rensburg C, Racz I, Bailey R et al. Prevention of peptic ulcer rebleeding using continuous infusion of pantoprazole versus rantidine: A multicenter multinational, randomized, double-blind parallel group comparison. Canadian Journal of Gastroenterology 2004 (e-supplement): Abs 149
- Jensen D, Pace S, Soffer E et al. 315 Study Group. Continuous infusion of pantoprazole versus ranitidine for prevention of ulcer rebleeding: A U.S. multicenter, randomized, double-blind study. American Journal of Gastroenterology 2006; 101:1991-
- Hasselgren G, Lind T, Lundell L et al. Continuous infusion of omeprazole in elderly patients with peptic ulcer bleeding. Results of a placebo-controlled study. Scandinavian Journal of Gastroenterology 1997;32 (4):328-33
- Schaffalitzky de Muckadell O, Havelund T, Harding H et al. Effect of omeprazole on the outcome of endoscopically treated bleeding peptic ulcers. Randomized double-blind placebo-controlled multicentre study. Scandianvian Journal of Gastroenterology 1997;32 (4):320-7
- Miner P et al. Gastric acid control with esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole: a 5-way cross-over study. Am J Gastroenterol 2003;98: 2616–20.
- Miner P Jr, Katz PO, Chen YS, Sostek M, Pandolfino J, Kahrials PJ. Reanalysis of intragastric pH results based on updated correction factors for Slimline(R) and Zinetics(TM) 24 single-use pH catheters. Am J Gastroenterol 2006;101(2):404-5, 406
- Labenz J, Armstrong D, Lauritsen K, Katelaris P, Schmidt S, Schütze K et al. A randomised comparative study of esomeprazole 40 mg versus pantoprazole 40 mg for healing erosive esophagitis: the EXPO study. Aliment Pharmacol Ther 2005;21:739–46
- Lauritsen K, Devière J, Bigard M, Bayerdörffer E, Mózsik G, Murray F et al. Esomeprazole 20 mg and lansoprazole 15 mg in maintaining healed reflux esophagitis. Metropole Study Results. Aliment Pharmacol Ther 2003;17:333–41
