Maintenance treatment with esomeprazole following initial relief of non-steroidal anti-inflammatory drug-associated upper gastrointestinal symptoms: The NASA2 and SPACE2 studies

Christopher J. Hawkey, Nicholas J. Talley, James M. Scheiman, Roger H. Jones, Göran Långström, Jorgen Næsdal, Neville D. Yeomans, Herman Mielants, Walter F. Kean, Vavřincová, Wolfgang W. Bolten, Michael Buchner, Johannes Habbig, Gabriele Bianchi Porro, Jean François Bergmann, Francis Philippe, P. Demeter, Olav Bjørneboe, Dariusz Kleczkowski, Janusz RudzinskiJosef Rovenský, Anne Halland, Angel Lanas, Kjell Arne Ung, Atul Patel

Research output: Contribution to journalArticle

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Abstract

Non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclo-oxygenase-2 (COX-2) inhibitors, cause upper gastrointestinal (GI) symptoms that are relieved by treatment with esomeprazole. We assessed esomeprazole for maintaining long-term relief of such symptoms. Six hundred and ten patients with a chronic condition requiring anti-inflammatory therapy who achieved relief of NSAID-associated symptoms of pain, discomfort, or burning in the upper abdomen during two previous studies were enrolled and randomly assigned into two identical, multicentre, parallel-group, placebo-controlled studies of esomeprazole 20 mg or 40 mg treatment (NASA2 [Nexium Anti-inflammatory Symptom Amelioration] and SPACE2 [Symptom Prevention by Acid Control with Esomeprazole] studies; ClinicalTrials.gov identifiers NCT00241514 and NCT00241553, respectively) performed at various rheumatology, gastroenterology, and primary care clinics. Four hundred and twenty-six patients completed the 6-month treatment period. The primary measure was the proportion of patients with relapse of upper GI symptoms, recorded in daily diary cards, after 6 months. Relapse was defined as moderate-to-severe upper GI symptoms (a score of more than or equal to 3 on a 7-grade scale) for 3 days or more in any 7-day period. Esomeprazole was significantly more effective than placebo in maintaining relief of upper GI symptoms throughout 6 months of treatment. Life-table estimates (95% confidence intervals) of the proportion of patients with relapse at 6 months (pooled population) were placebo, 39.1% (32.2% to 46.0%); esomeprazole 20 mg, 29.3% (22.3% to 36.2%) (p = 0.006 versus placebo); and esomeprazole 40 mg, 26.1% (19.4% to 32.9%) (p = 0.001 versus placebo). Patients on either non-selective NSAIDs or selective COX-2 inhibitors appeared to benefit. The frequency of adverse events was similar in the three groups. Esomeprazole maintains relief of NSAID-associated upper GI symptoms in patients taking continuous NSAIDs, including selective COX-2 inhibitors.

Original languageEnglish
Article numberR17
JournalArthritis Research and Therapy
Volume9
DOIs
Publication statusPublished - 2007

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Esomeprazole
Anti-Inflammatory Agents
Pharmaceutical Preparations
Placebos
Cyclooxygenase Inhibitors
Therapeutics
Recurrence
Life Tables
Rheumatology
Gastroenterology
Abdomen
Primary Health Care
Confidence Intervals

ASJC Scopus subject areas

  • Rheumatology
  • Medicine(all)

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Maintenance treatment with esomeprazole following initial relief of non-steroidal anti-inflammatory drug-associated upper gastrointestinal symptoms : The NASA2 and SPACE2 studies. / Hawkey, Christopher J.; Talley, Nicholas J.; Scheiman, James M.; Jones, Roger H.; Långström, Göran; Næsdal, Jorgen; Yeomans, Neville D.; Mielants, Herman; Kean, Walter F.; Vavřincová; Bolten, Wolfgang W.; Buchner, Michael; Habbig, Johannes; Porro, Gabriele Bianchi; Bergmann, Jean François; Philippe, Francis; Demeter, P.; Bjørneboe, Olav; Kleczkowski, Dariusz; Rudzinski, Janusz; Rovenský, Josef; Halland, Anne; Lanas, Angel; Ung, Kjell Arne; Patel, Atul.

In: Arthritis Research and Therapy, Vol. 9, R17, 2007.

Research output: Contribution to journalArticle

Hawkey, CJ, Talley, NJ, Scheiman, JM, Jones, RH, Långström, G, Næsdal, J, Yeomans, ND, Mielants, H, Kean, WF, Vavřincová, Bolten, WW, Buchner, M, Habbig, J, Porro, GB, Bergmann, JF, Philippe, F, Demeter, P, Bjørneboe, O, Kleczkowski, D, Rudzinski, J, Rovenský, J, Halland, A, Lanas, A, Ung, KA & Patel, A 2007, 'Maintenance treatment with esomeprazole following initial relief of non-steroidal anti-inflammatory drug-associated upper gastrointestinal symptoms: The NASA2 and SPACE2 studies', Arthritis Research and Therapy, vol. 9, R17. https://doi.org/10.1186/ar2124
Hawkey, Christopher J. ; Talley, Nicholas J. ; Scheiman, James M. ; Jones, Roger H. ; Långström, Göran ; Næsdal, Jorgen ; Yeomans, Neville D. ; Mielants, Herman ; Kean, Walter F. ; Vavřincová ; Bolten, Wolfgang W. ; Buchner, Michael ; Habbig, Johannes ; Porro, Gabriele Bianchi ; Bergmann, Jean François ; Philippe, Francis ; Demeter, P. ; Bjørneboe, Olav ; Kleczkowski, Dariusz ; Rudzinski, Janusz ; Rovenský, Josef ; Halland, Anne ; Lanas, Angel ; Ung, Kjell Arne ; Patel, Atul. / Maintenance treatment with esomeprazole following initial relief of non-steroidal anti-inflammatory drug-associated upper gastrointestinal symptoms : The NASA2 and SPACE2 studies. In: Arthritis Research and Therapy. 2007 ; Vol. 9.
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T2 - The NASA2 and SPACE2 studies

AU - Hawkey, Christopher J.

AU - Talley, Nicholas J.

AU - Scheiman, James M.

AU - Jones, Roger H.

AU - Långström, Göran

AU - Næsdal, Jorgen

AU - Yeomans, Neville D.

AU - Mielants, Herman

AU - Kean, Walter F.

AU - Vavřincová,

AU - Bolten, Wolfgang W.

AU - Buchner, Michael

AU - Habbig, Johannes

AU - Porro, Gabriele Bianchi

AU - Bergmann, Jean François

AU - Philippe, Francis

AU - Demeter, P.

AU - Bjørneboe, Olav

AU - Kleczkowski, Dariusz

AU - Rudzinski, Janusz

AU - Rovenský, Josef

AU - Halland, Anne

AU - Lanas, Angel

AU - Ung, Kjell Arne

AU - Patel, Atul

PY - 2007

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N2 - Non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclo-oxygenase-2 (COX-2) inhibitors, cause upper gastrointestinal (GI) symptoms that are relieved by treatment with esomeprazole. We assessed esomeprazole for maintaining long-term relief of such symptoms. Six hundred and ten patients with a chronic condition requiring anti-inflammatory therapy who achieved relief of NSAID-associated symptoms of pain, discomfort, or burning in the upper abdomen during two previous studies were enrolled and randomly assigned into two identical, multicentre, parallel-group, placebo-controlled studies of esomeprazole 20 mg or 40 mg treatment (NASA2 [Nexium Anti-inflammatory Symptom Amelioration] and SPACE2 [Symptom Prevention by Acid Control with Esomeprazole] studies; ClinicalTrials.gov identifiers NCT00241514 and NCT00241553, respectively) performed at various rheumatology, gastroenterology, and primary care clinics. Four hundred and twenty-six patients completed the 6-month treatment period. The primary measure was the proportion of patients with relapse of upper GI symptoms, recorded in daily diary cards, after 6 months. Relapse was defined as moderate-to-severe upper GI symptoms (a score of more than or equal to 3 on a 7-grade scale) for 3 days or more in any 7-day period. Esomeprazole was significantly more effective than placebo in maintaining relief of upper GI symptoms throughout 6 months of treatment. Life-table estimates (95% confidence intervals) of the proportion of patients with relapse at 6 months (pooled population) were placebo, 39.1% (32.2% to 46.0%); esomeprazole 20 mg, 29.3% (22.3% to 36.2%) (p = 0.006 versus placebo); and esomeprazole 40 mg, 26.1% (19.4% to 32.9%) (p = 0.001 versus placebo). Patients on either non-selective NSAIDs or selective COX-2 inhibitors appeared to benefit. The frequency of adverse events was similar in the three groups. Esomeprazole maintains relief of NSAID-associated upper GI symptoms in patients taking continuous NSAIDs, including selective COX-2 inhibitors.

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