Hospitalizations for gastrointestinal and cardiovascular events in the CADEUS cohort of traditional or Coxib NSAID users

David Laharie, Cécile Droz-Perroteau, Jacques Bénichou, Michel Amouretti, Patrick Blin, Bernard Bégaud, Estelle Guiard, Sylvie Dutoit, Stéphanie Lamarque, Yola Moride, Fanny Depont, Annie Fourrier-Réglat, Nicholas Moore

Research output: Contribution to journalArticle

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Abstract

Aims: To assess hospital admission rates for gastrointestinal (GI) or cardiovascular (CV) events in real-life use of nonsteroidal anti-inflammatory drugs (NSAIDs). Methods: CADEUS is a real-life population-based cohort study of 23 535 coxib (celecoxib or rofecoxib) and 22 919 traditional NSAID (tNSAID) users. Each hospitalization reported between index day (NSAID delivery) and questionnaire submission (median = 75 days) was explored using hospital discharge summaries. An expert committee validated blindly serious GI and CV events according to predefined criteria. Results: Coxib users were older and had more GI history than tNSAID users. There were 21 hospitalizations for GI events, 12 in the coxib cohort and nine in the tNSAID cohort (respectively one and three upper GI haemorrhages and no ulcer perforations). Rates of GI events were 0.39 per 1000 patients 95% confidence interval (CI) 0.18, 0.75 for tNSAID users and 0.51 per 1000 patients (95% CI 0.26, 0.89) for coxib users. There were 21 hospitalizations for CV events, 13 in the coxib cohort and eight in the tNSAID cohort. None was fatal. Rates of CV events were, respectively, 0.59 (95% CI 0.24, 1.22), 0.51 (95% CI 0.19, 1.11) and 0.35 (95% CI 0.15, 0.69) per 1000 patients for celecoxib, rofecoxib and tNSAIDs. GI or CV event rates were not different between products even for patients >60 years old. Conclusions: Hospitalization rates for GI bleeding were 10-20 times lower than expected from published randomized clinical trials, probably because of differences in drug usage and concomitant gastroprotection. CV event rates conformed to those expected from general population data. These results emphasize the necessity of developing population healthcare databases to explore such low event rates.

Original languageEnglish (US)
Pages (from-to)295-302
Number of pages8
JournalBritish Journal of Clinical Pharmacology
Volume69
Issue number3
DOIs
StatePublished - Jan 1 2010
Externally publishedYes

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Celecoxib
Drug Users
Non-Steroidal Anti-Inflammatory Agents
Hospitalization
Anti-Inflammatory Agents
Confidence Intervals
Pharmaceutical Preparations
Population
Gastrointestinal Hemorrhage
Ulcer
Cohort Studies
Randomized Controlled Trials
History
rofecoxib
Databases
Hemorrhage
Delivery of Health Care

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)
  • Pharmacology

Cite this

Laharie, David ; Droz-Perroteau, Cécile ; Bénichou, Jacques ; Amouretti, Michel ; Blin, Patrick ; Bégaud, Bernard ; Guiard, Estelle ; Dutoit, Sylvie ; Lamarque, Stéphanie ; Moride, Yola ; Depont, Fanny ; Fourrier-Réglat, Annie ; Moore, Nicholas. / Hospitalizations for gastrointestinal and cardiovascular events in the CADEUS cohort of traditional or Coxib NSAID users. In: British Journal of Clinical Pharmacology. 2010 ; Vol. 69, No. 3. pp. 295-302.
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abstract = "Aims: To assess hospital admission rates for gastrointestinal (GI) or cardiovascular (CV) events in real-life use of nonsteroidal anti-inflammatory drugs (NSAIDs). Methods: CADEUS is a real-life population-based cohort study of 23 535 coxib (celecoxib or rofecoxib) and 22 919 traditional NSAID (tNSAID) users. Each hospitalization reported between index day (NSAID delivery) and questionnaire submission (median = 75 days) was explored using hospital discharge summaries. An expert committee validated blindly serious GI and CV events according to predefined criteria. Results: Coxib users were older and had more GI history than tNSAID users. There were 21 hospitalizations for GI events, 12 in the coxib cohort and nine in the tNSAID cohort (respectively one and three upper GI haemorrhages and no ulcer perforations). Rates of GI events were 0.39 per 1000 patients 95{\%} confidence interval (CI) 0.18, 0.75 for tNSAID users and 0.51 per 1000 patients (95{\%} CI 0.26, 0.89) for coxib users. There were 21 hospitalizations for CV events, 13 in the coxib cohort and eight in the tNSAID cohort. None was fatal. Rates of CV events were, respectively, 0.59 (95{\%} CI 0.24, 1.22), 0.51 (95{\%} CI 0.19, 1.11) and 0.35 (95{\%} CI 0.15, 0.69) per 1000 patients for celecoxib, rofecoxib and tNSAIDs. GI or CV event rates were not different between products even for patients >60 years old. Conclusions: Hospitalization rates for GI bleeding were 10-20 times lower than expected from published randomized clinical trials, probably because of differences in drug usage and concomitant gastroprotection. CV event rates conformed to those expected from general population data. These results emphasize the necessity of developing population healthcare databases to explore such low event rates.",
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Laharie, D, Droz-Perroteau, C, Bénichou, J, Amouretti, M, Blin, P, Bégaud, B, Guiard, E, Dutoit, S, Lamarque, S, Moride, Y, Depont, F, Fourrier-Réglat, A & Moore, N 2010, 'Hospitalizations for gastrointestinal and cardiovascular events in the CADEUS cohort of traditional or Coxib NSAID users', British Journal of Clinical Pharmacology, vol. 69, no. 3, pp. 295-302. https://doi.org/10.1111/j.1365-2125.2009.03588.x

Hospitalizations for gastrointestinal and cardiovascular events in the CADEUS cohort of traditional or Coxib NSAID users. / Laharie, David; Droz-Perroteau, Cécile; Bénichou, Jacques; Amouretti, Michel; Blin, Patrick; Bégaud, Bernard; Guiard, Estelle; Dutoit, Sylvie; Lamarque, Stéphanie; Moride, Yola; Depont, Fanny; Fourrier-Réglat, Annie; Moore, Nicholas.

In: British Journal of Clinical Pharmacology, Vol. 69, No. 3, 01.01.2010, p. 295-302.

Research output: Contribution to journalArticle

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T1 - Hospitalizations for gastrointestinal and cardiovascular events in the CADEUS cohort of traditional or Coxib NSAID users

AU - Laharie, David

AU - Droz-Perroteau, Cécile

AU - Bénichou, Jacques

AU - Amouretti, Michel

AU - Blin, Patrick

AU - Bégaud, Bernard

AU - Guiard, Estelle

AU - Dutoit, Sylvie

AU - Lamarque, Stéphanie

AU - Moride, Yola

AU - Depont, Fanny

AU - Fourrier-Réglat, Annie

AU - Moore, Nicholas

PY - 2010/1/1

Y1 - 2010/1/1

N2 - Aims: To assess hospital admission rates for gastrointestinal (GI) or cardiovascular (CV) events in real-life use of nonsteroidal anti-inflammatory drugs (NSAIDs). Methods: CADEUS is a real-life population-based cohort study of 23 535 coxib (celecoxib or rofecoxib) and 22 919 traditional NSAID (tNSAID) users. Each hospitalization reported between index day (NSAID delivery) and questionnaire submission (median = 75 days) was explored using hospital discharge summaries. An expert committee validated blindly serious GI and CV events according to predefined criteria. Results: Coxib users were older and had more GI history than tNSAID users. There were 21 hospitalizations for GI events, 12 in the coxib cohort and nine in the tNSAID cohort (respectively one and three upper GI haemorrhages and no ulcer perforations). Rates of GI events were 0.39 per 1000 patients 95% confidence interval (CI) 0.18, 0.75 for tNSAID users and 0.51 per 1000 patients (95% CI 0.26, 0.89) for coxib users. There were 21 hospitalizations for CV events, 13 in the coxib cohort and eight in the tNSAID cohort. None was fatal. Rates of CV events were, respectively, 0.59 (95% CI 0.24, 1.22), 0.51 (95% CI 0.19, 1.11) and 0.35 (95% CI 0.15, 0.69) per 1000 patients for celecoxib, rofecoxib and tNSAIDs. GI or CV event rates were not different between products even for patients >60 years old. Conclusions: Hospitalization rates for GI bleeding were 10-20 times lower than expected from published randomized clinical trials, probably because of differences in drug usage and concomitant gastroprotection. CV event rates conformed to those expected from general population data. These results emphasize the necessity of developing population healthcare databases to explore such low event rates.

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