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Dexlansoprazole Modified Release

In Erosive Oesophagitis and Non-Erosive Reflux Disease

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Abstract

Dexlansoprazole modified release (dexlansoprazole MR) is an orally administered delayed-release formulation of the R-enantiomer of the proton pump inhibitor lansoprazole that is effective in improving the healing of all grades of erosive oesophagitis, maintaining the healing of erosive oesophagitis and in the treatment of symptomatic non-erosive reflux disease (NERD).

In two large, identical, 8-week, randomized, double-blind, multicentre phase III trials, dexlansoprazole MR 60 mg once daily achieved complete healing in ≥92% of patients with all grades of erosive oesophagitis (primary endpoint) and was noninferior to lansoprazole 30 mg once daily using life-table analysis.

Moreover, in a randomized, double-blind, multicentre phase III trial in patients with healed erosive oesophagitis, dexlansoprazole MR 30 mg once daily was significantly more effective than placebo in maintaining healing following 6 months’ treatment (primary endpoint).

In addition, the proportion of 24-hour heartburn-free days (primary endpoint) was significantly greater in recipients of dexlansoprazole MR 30 mg once daily than in recipients of placebo following 4 weeks’ treatment in a large, randomized, double-blind, multicentre phase III trial in patients with NERD.

Dexlansoprazole MR 30 or 60 mg once daily was generally well tolerated in a pooled analysis of clinical trials of up to 12 months’ duration.

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Acknowledgements and Disclosures

This manuscript was reviewed by K.M. Olsen, Department of Pharmacy Practice, University of Nebraska Medical Center, Omaha, Nebraska, USA; D.A. Peura, Division of Gastroenterology and Hepatology, University of Virginia Health Sciences Center, Charlottesville, Virginia, USA.

The preparation of this review 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 this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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  1. Adis, a Wolters Kluwer Business, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, Auckland, 0754, New Zealand

    Jamie D. Croxtall & Lesley J. Scott

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  1. Jamie D. Croxtall
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  2. Lesley J. Scott
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Correspondence to Jamie D. Croxtall.

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Croxtall, J.D., Scott, L.J. Dexlansoprazole Modified Release. Drugs 70, 1593–1601 (2010). https://doi.org/10.2165/11295960-000000000-00000

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