A report of three multiclinic trials evaluating arbaprostil in arthritic patients with ASA/NSAID gastric mucosal damage

A. R. Euler, M. Safdi, J. Rao, R. Jaszewski, J. Welsh, V. Le, Jeffrey Raskin, R. Fleischmann, M. Razzaque, G. Champion, G. Gottlieb, D. Nashel, L. Van Der Veer, J. Levine, M. Barreiro, D. Cheatum, H. Mena, E. Budiman-Mak, S. Roth, H. GaskillB. Levine, J. Swinehart, G. McClain, D. Riff, D. Graham, T. Phan, M. Burns, J. Lookabaugh, D. Wood

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Abstract

Three randomized, placebo-controlled multiclinic trials involving arbaprostil dosages of (a) 10 μg; (b) 25 μg; and (c) 10, 25, or 50 μg orally for 4 wk in patients older than 18 yr with rheumatoid arthritis or osteoarthritis who had endoscopically documented nonsteroidal antiinflammatory drug-associated gastric mucosal damage were conducted in the United States. All patients continued taking the nonsteroidal antiinflammatory drugs and were reendoscoped after 4 wk of therapy. Success at that time was defined as complete resolution of all gastric mucosal damage. Six hundred fifty-eight patients were enrolled in the three trials. Significantly more patients experienced healing in the arbaprostil treatment groups in all trials compared with those who received placebo. The healing rates in the various trials were 68% and 32% (10 μg vs. placebo; p = 0.007); 77% and 23% (25 μ g vs. placebo; p < 0.001); and 52%, 46%, 35%, and 16% (50, 25, and 10 μg vs. placebo; p < 0.001, <0.001, and 0.002, respectively). Diarrhea, mostly of a mild nature, was the only arbaprostil-associated side effect and was found with the 25- and 50-μg dosages (33% and 59%, respectively). No exacerbation of arthritis signs or symptoms was found. Arbaprostil at doses with varying effects on gastric acid secretion (25 and 50 μ]g) was documented in these trials to be an effective and safe agent for healing gastric mucosal damage associated with aspirin or other nonsteroidal antiinflammatory drugs in patients with either rheumatoid arthritis or osteoarthritis without adversely affecting joint symptomatology.

Original languageEnglish
Pages (from-to)1549-1557
Number of pages9
JournalGastroenterology
Volume98
Issue number6
StatePublished - Dec 1 1990
Externally publishedYes

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Arbaprostil
Non-Steroidal Anti-Inflammatory Agents
Arthritis
Stomach
Placebos
Gastrointestinal Agents
Anti-Inflammatory Agents
Osteoarthritis
Rheumatoid Arthritis
Gastric Acid
Pharmaceutical Preparations
Aspirin
Signs and Symptoms
Diarrhea
Joints
Therapeutics

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Euler, A. R., Safdi, M., Rao, J., Jaszewski, R., Welsh, J., Le, V., ... Wood, D. (1990). A report of three multiclinic trials evaluating arbaprostil in arthritic patients with ASA/NSAID gastric mucosal damage. Gastroenterology, 98(6), 1549-1557.

A report of three multiclinic trials evaluating arbaprostil in arthritic patients with ASA/NSAID gastric mucosal damage. / Euler, A. R.; Safdi, M.; Rao, J.; Jaszewski, R.; Welsh, J.; Le, V.; Raskin, Jeffrey; Fleischmann, R.; Razzaque, M.; Champion, G.; Gottlieb, G.; Nashel, D.; Van Der Veer, L.; Levine, J.; Barreiro, M.; Cheatum, D.; Mena, H.; Budiman-Mak, E.; Roth, S.; Gaskill, H.; Levine, B.; Swinehart, J.; McClain, G.; Riff, D.; Graham, D.; Phan, T.; Burns, M.; Lookabaugh, J.; Wood, D.

In: Gastroenterology, Vol. 98, No. 6, 01.12.1990, p. 1549-1557.

Research output: Contribution to journalArticle

Euler, AR, Safdi, M, Rao, J, Jaszewski, R, Welsh, J, Le, V, Raskin, J, Fleischmann, R, Razzaque, M, Champion, G, Gottlieb, G, Nashel, D, Van Der Veer, L, Levine, J, Barreiro, M, Cheatum, D, Mena, H, Budiman-Mak, E, Roth, S, Gaskill, H, Levine, B, Swinehart, J, McClain, G, Riff, D, Graham, D, Phan, T, Burns, M, Lookabaugh, J & Wood, D 1990, 'A report of three multiclinic trials evaluating arbaprostil in arthritic patients with ASA/NSAID gastric mucosal damage', Gastroenterology, vol. 98, no. 6, pp. 1549-1557.
Euler AR, Safdi M, Rao J, Jaszewski R, Welsh J, Le V et al. A report of three multiclinic trials evaluating arbaprostil in arthritic patients with ASA/NSAID gastric mucosal damage. Gastroenterology. 1990 Dec 1;98(6):1549-1557.
Euler, A. R. ; Safdi, M. ; Rao, J. ; Jaszewski, R. ; Welsh, J. ; Le, V. ; Raskin, Jeffrey ; Fleischmann, R. ; Razzaque, M. ; Champion, G. ; Gottlieb, G. ; Nashel, D. ; Van Der Veer, L. ; Levine, J. ; Barreiro, M. ; Cheatum, D. ; Mena, H. ; Budiman-Mak, E. ; Roth, S. ; Gaskill, H. ; Levine, B. ; Swinehart, J. ; McClain, G. ; Riff, D. ; Graham, D. ; Phan, T. ; Burns, M. ; Lookabaugh, J. ; Wood, D. / A report of three multiclinic trials evaluating arbaprostil in arthritic patients with ASA/NSAID gastric mucosal damage. In: Gastroenterology. 1990 ; Vol. 98, No. 6. pp. 1549-1557.
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abstract = "Three randomized, placebo-controlled multiclinic trials involving arbaprostil dosages of (a) 10 μg; (b) 25 μg; and (c) 10, 25, or 50 μg orally for 4 wk in patients older than 18 yr with rheumatoid arthritis or osteoarthritis who had endoscopically documented nonsteroidal antiinflammatory drug-associated gastric mucosal damage were conducted in the United States. All patients continued taking the nonsteroidal antiinflammatory drugs and were reendoscoped after 4 wk of therapy. Success at that time was defined as complete resolution of all gastric mucosal damage. Six hundred fifty-eight patients were enrolled in the three trials. Significantly more patients experienced healing in the arbaprostil treatment groups in all trials compared with those who received placebo. The healing rates in the various trials were 68{\%} and 32{\%} (10 μg vs. placebo; p = 0.007); 77{\%} and 23{\%} (25 μ g vs. placebo; p < 0.001); and 52{\%}, 46{\%}, 35{\%}, and 16{\%} (50, 25, and 10 μg vs. placebo; p < 0.001, <0.001, and 0.002, respectively). Diarrhea, mostly of a mild nature, was the only arbaprostil-associated side effect and was found with the 25- and 50-μg dosages (33{\%} and 59{\%}, respectively). No exacerbation of arthritis signs or symptoms was found. Arbaprostil at doses with varying effects on gastric acid secretion (25 and 50 μ]g) was documented in these trials to be an effective and safe agent for healing gastric mucosal damage associated with aspirin or other nonsteroidal antiinflammatory drugs in patients with either rheumatoid arthritis or osteoarthritis without adversely affecting joint symptomatology.",
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AU - Jaszewski, R.

AU - Welsh, J.

AU - Le, V.

AU - Raskin, Jeffrey

AU - Fleischmann, R.

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AU - Champion, G.

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AU - Nashel, D.

AU - Van Der Veer, L.

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AU - Levine, B.

AU - Swinehart, J.

AU - McClain, G.

AU - Riff, D.

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