Prevention of ulcers by esomeprazole in at-risk patients using non-selective NSAIDs and COX-2 inhibitors

James M. Scheiman, Neville D. Yeomans, Nicholas J. Talley, Nimish Vakil, Francis K L Chan, Z. Tulassay, Jorge L. Rainoldi, Leszek Szczepanski, Kjell Arne Ung, Dariusz Kleczkowski, Henrik Ahlbom, Jørgen Næsdal, Christopher Hawkey

Research output: Contribution to journalArticle

215 Citations (Scopus)

Abstract

OBJECTIVES: Proton pump inhibitors reduce ulcer recurrence in non-steroidal anti-inflammatory drug (NSAID) users, but their impact in at-risk ulcer-free patients using the current spectrum of prescribed agents has not been clearly defined. We assessed esomeprazole for ulcer prevention in at-risk patients (≥60 yr and/or ulcer history) taking NSAIDs, including COX-2 inhibitors. Such studies are particularly relevant, given that concerns regarding adverse cardiovascular outcomes among COX-2 inhibitor users may prompt re-evaluation of their use. METHODS: We conducted two similar double-blind, placebo-controlled, randomized, multicenter studies; VENUS (United States) and PLUTO (multinational). A total of 844 and 585 patients requiring daily NSAIDs, including COX-2 inhibitors were randomized to receive esomeprazole (20 or 40 mg) or placebo, daily for 6 months. RESULTS: In the VENUS study, the life table estimated proportion of patients who developed ulcers over 6 months (primary variable, intent-to-treat population) was 20.4% on placebo, 5.3% on esomeprazole 20 mg (p <0.001), and 4.7% on esomeprazole 40 mg (p <0.0001). In the PLUTO study, the values were 12.3% on placebo, 5.2% with esomeprazole 20 mg (p= 0.018), and 4.4% with esomeprazole 40 mg (p= 0.007). Significant reductions were observed for users of both non-selective NSAIDs and COX-2 inhibitors. Pooled ulcer rates for patients using COX-2 inhibitors (n = 400) were 16.5% on placebo, 0.9% on esomeprazole 20 mg (p <0.001) and 4.1% on esomeprazole 40 mg (p= 0.002). Esomeprazole was well tolerated and associated with better symptom control than placebo. CONCLUSIONS: For at-risk patients, esomeprazole was effective in preventing ulcers in long-term users of NSAIDs, including COX-2 inhibitors.

Original languageEnglish
Pages (from-to)701-710
Number of pages10
JournalAmerican Journal of Gastroenterology
Volume101
Issue number4
DOIs
Publication statusPublished - Apr 2006

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Esomeprazole
Cyclooxygenase 2 Inhibitors
Non-Steroidal Anti-Inflammatory Agents
Ulcer
Placebos
Life Tables
Proton Pump Inhibitors
Drug Users
Multicenter Studies
Anti-Inflammatory Agents

ASJC Scopus subject areas

  • Gastroenterology

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Prevention of ulcers by esomeprazole in at-risk patients using non-selective NSAIDs and COX-2 inhibitors. / Scheiman, James M.; Yeomans, Neville D.; Talley, Nicholas J.; Vakil, Nimish; Chan, Francis K L; Tulassay, Z.; Rainoldi, Jorge L.; Szczepanski, Leszek; Ung, Kjell Arne; Kleczkowski, Dariusz; Ahlbom, Henrik; Næsdal, Jørgen; Hawkey, Christopher.

In: American Journal of Gastroenterology, Vol. 101, No. 4, 04.2006, p. 701-710.

Research output: Contribution to journalArticle

Scheiman, JM, Yeomans, ND, Talley, NJ, Vakil, N, Chan, FKL, Tulassay, Z, Rainoldi, JL, Szczepanski, L, Ung, KA, Kleczkowski, D, Ahlbom, H, Næsdal, J & Hawkey, C 2006, 'Prevention of ulcers by esomeprazole in at-risk patients using non-selective NSAIDs and COX-2 inhibitors', American Journal of Gastroenterology, vol. 101, no. 4, pp. 701-710. https://doi.org/10.1111/j.1572-0241.2006.00499.x
Scheiman, James M. ; Yeomans, Neville D. ; Talley, Nicholas J. ; Vakil, Nimish ; Chan, Francis K L ; Tulassay, Z. ; Rainoldi, Jorge L. ; Szczepanski, Leszek ; Ung, Kjell Arne ; Kleczkowski, Dariusz ; Ahlbom, Henrik ; Næsdal, Jørgen ; Hawkey, Christopher. / Prevention of ulcers by esomeprazole in at-risk patients using non-selective NSAIDs and COX-2 inhibitors. In: American Journal of Gastroenterology. 2006 ; Vol. 101, No. 4. pp. 701-710.
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abstract = "OBJECTIVES: Proton pump inhibitors reduce ulcer recurrence in non-steroidal anti-inflammatory drug (NSAID) users, but their impact in at-risk ulcer-free patients using the current spectrum of prescribed agents has not been clearly defined. We assessed esomeprazole for ulcer prevention in at-risk patients (≥60 yr and/or ulcer history) taking NSAIDs, including COX-2 inhibitors. Such studies are particularly relevant, given that concerns regarding adverse cardiovascular outcomes among COX-2 inhibitor users may prompt re-evaluation of their use. METHODS: We conducted two similar double-blind, placebo-controlled, randomized, multicenter studies; VENUS (United States) and PLUTO (multinational). A total of 844 and 585 patients requiring daily NSAIDs, including COX-2 inhibitors were randomized to receive esomeprazole (20 or 40 mg) or placebo, daily for 6 months. RESULTS: In the VENUS study, the life table estimated proportion of patients who developed ulcers over 6 months (primary variable, intent-to-treat population) was 20.4{\%} on placebo, 5.3{\%} on esomeprazole 20 mg (p <0.001), and 4.7{\%} on esomeprazole 40 mg (p <0.0001). In the PLUTO study, the values were 12.3{\%} on placebo, 5.2{\%} with esomeprazole 20 mg (p= 0.018), and 4.4{\%} with esomeprazole 40 mg (p= 0.007). Significant reductions were observed for users of both non-selective NSAIDs and COX-2 inhibitors. Pooled ulcer rates for patients using COX-2 inhibitors (n = 400) were 16.5{\%} on placebo, 0.9{\%} on esomeprazole 20 mg (p <0.001) and 4.1{\%} on esomeprazole 40 mg (p= 0.002). Esomeprazole was well tolerated and associated with better symptom control than placebo. CONCLUSIONS: For at-risk patients, esomeprazole was effective in preventing ulcers in long-term users of NSAIDs, including COX-2 inhibitors.",
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T1 - Prevention of ulcers by esomeprazole in at-risk patients using non-selective NSAIDs and COX-2 inhibitors

AU - Scheiman, James M.

AU - Yeomans, Neville D.

AU - Talley, Nicholas J.

AU - Vakil, Nimish

AU - Chan, Francis K L

AU - Tulassay, Z.

AU - Rainoldi, Jorge L.

AU - Szczepanski, Leszek

AU - Ung, Kjell Arne

AU - Kleczkowski, Dariusz

AU - Ahlbom, Henrik

AU - Næsdal, Jørgen

AU - Hawkey, Christopher

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N2 - OBJECTIVES: Proton pump inhibitors reduce ulcer recurrence in non-steroidal anti-inflammatory drug (NSAID) users, but their impact in at-risk ulcer-free patients using the current spectrum of prescribed agents has not been clearly defined. We assessed esomeprazole for ulcer prevention in at-risk patients (≥60 yr and/or ulcer history) taking NSAIDs, including COX-2 inhibitors. Such studies are particularly relevant, given that concerns regarding adverse cardiovascular outcomes among COX-2 inhibitor users may prompt re-evaluation of their use. METHODS: We conducted two similar double-blind, placebo-controlled, randomized, multicenter studies; VENUS (United States) and PLUTO (multinational). A total of 844 and 585 patients requiring daily NSAIDs, including COX-2 inhibitors were randomized to receive esomeprazole (20 or 40 mg) or placebo, daily for 6 months. RESULTS: In the VENUS study, the life table estimated proportion of patients who developed ulcers over 6 months (primary variable, intent-to-treat population) was 20.4% on placebo, 5.3% on esomeprazole 20 mg (p <0.001), and 4.7% on esomeprazole 40 mg (p <0.0001). In the PLUTO study, the values were 12.3% on placebo, 5.2% with esomeprazole 20 mg (p= 0.018), and 4.4% with esomeprazole 40 mg (p= 0.007). Significant reductions were observed for users of both non-selective NSAIDs and COX-2 inhibitors. Pooled ulcer rates for patients using COX-2 inhibitors (n = 400) were 16.5% on placebo, 0.9% on esomeprazole 20 mg (p <0.001) and 4.1% on esomeprazole 40 mg (p= 0.002). Esomeprazole was well tolerated and associated with better symptom control than placebo. CONCLUSIONS: For at-risk patients, esomeprazole was effective in preventing ulcers in long-term users of NSAIDs, including COX-2 inhibitors.

AB - OBJECTIVES: Proton pump inhibitors reduce ulcer recurrence in non-steroidal anti-inflammatory drug (NSAID) users, but their impact in at-risk ulcer-free patients using the current spectrum of prescribed agents has not been clearly defined. We assessed esomeprazole for ulcer prevention in at-risk patients (≥60 yr and/or ulcer history) taking NSAIDs, including COX-2 inhibitors. Such studies are particularly relevant, given that concerns regarding adverse cardiovascular outcomes among COX-2 inhibitor users may prompt re-evaluation of their use. METHODS: We conducted two similar double-blind, placebo-controlled, randomized, multicenter studies; VENUS (United States) and PLUTO (multinational). A total of 844 and 585 patients requiring daily NSAIDs, including COX-2 inhibitors were randomized to receive esomeprazole (20 or 40 mg) or placebo, daily for 6 months. RESULTS: In the VENUS study, the life table estimated proportion of patients who developed ulcers over 6 months (primary variable, intent-to-treat population) was 20.4% on placebo, 5.3% on esomeprazole 20 mg (p <0.001), and 4.7% on esomeprazole 40 mg (p <0.0001). In the PLUTO study, the values were 12.3% on placebo, 5.2% with esomeprazole 20 mg (p= 0.018), and 4.4% with esomeprazole 40 mg (p= 0.007). Significant reductions were observed for users of both non-selective NSAIDs and COX-2 inhibitors. Pooled ulcer rates for patients using COX-2 inhibitors (n = 400) were 16.5% on placebo, 0.9% on esomeprazole 20 mg (p <0.001) and 4.1% on esomeprazole 40 mg (p= 0.002). Esomeprazole was well tolerated and associated with better symptom control than placebo. CONCLUSIONS: For at-risk patients, esomeprazole was effective in preventing ulcers in long-term users of NSAIDs, including COX-2 inhibitors.

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