Risk factors for NSAID-associated upper GI clinical events in a long-term prospective study of 34 701 arthritis patients

L. Laine, S. P. Curtis, B. Cryer, A. Kaur, C. P. Cannon

Research output: Contribution to journalArticle

46 Citations (Scopus)

Abstract

Nonsteroidal anti-inflammatory drugs (NSAID)-related GI effects vary based on patient characteristics. Aims To assess risk factors for NSAID-associated upper GI clinical events and dyspepsia. Methods Patients ≥50 years with osteoarthritis or rheumatoid arthritis were randomized to etoricoxib or diclofenac in a prespecified intent-to-treat analysis of three double-blind randomized trials. Potential risk factors for upper GI clinical events (bleeding, perforation, obstruction, or ulcer), complicated events (perforation, obstruction, bleeding) and discontinuations due to dyspepsia were assessed with Cox proportional hazard models. Results Significant predictors of clinical events and complicated events included age ≥65 years [hazards ratios (HRs) = 2.25 (1.84-2.76), 4.09 (2.82-5.92)], prior event [HRs = 2.57 (1.94-3.39), 3.23 (2.09-5.00)], low-dose aspirin [HRs = 2.34 (1.87-2.92), 3.41 (2.33-5.00)] and corticosteroid [HRs = 1.85 (1.41-2.43), 2.09 (1.29-3.38)]. Predictors of discontinuation due to dyspepsia included prior dyspepsia [HR = 1.78 (1.44-2.00)], prior event [HR = 1.78 (1.40-2.27)] and age ≥65 years [HR = 1.35 (1.16-1.57)]. Conclusions Assessment for age ≥65 years, prior upper GI clinical events and low-dose aspirin use are key in identifying patients who should either avoid NSAIDs or employ management strategies to reduce NSAID-associated upper GI events. Prior dyspepsia or upper GI clinical events and age ≥65 years also predict an increased risk of developing dyspepsia severe enough to necessitate discontinuation of NSAIDs.

Original languageEnglish (US)
Pages (from-to)1240-1248
Number of pages9
JournalAlimentary Pharmacology and Therapeutics
Volume32
Issue number10
DOIs
StatePublished - Nov 2010

Fingerprint

Dyspepsia
Arthritis
Anti-Inflammatory Agents
Prospective Studies
Pharmaceutical Preparations
etoricoxib
Non-Steroidal Anti-Inflammatory Agents
Aspirin
Hemorrhage
Diclofenac
Proportional Hazards Models
Osteoarthritis
Ulcer
Rheumatoid Arthritis
Adrenal Cortex Hormones

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Risk factors for NSAID-associated upper GI clinical events in a long-term prospective study of 34 701 arthritis patients. / Laine, L.; Curtis, S. P.; Cryer, B.; Kaur, A.; Cannon, C. P.

In: Alimentary Pharmacology and Therapeutics, Vol. 32, No. 10, 11.2010, p. 1240-1248.

Research output: Contribution to journalArticle

@article{884d0a1d4dab4d7fa81f90bceb1a771c,
title = "Risk factors for NSAID-associated upper GI clinical events in a long-term prospective study of 34 701 arthritis patients",
abstract = "Nonsteroidal anti-inflammatory drugs (NSAID)-related GI effects vary based on patient characteristics. Aims To assess risk factors for NSAID-associated upper GI clinical events and dyspepsia. Methods Patients ≥50 years with osteoarthritis or rheumatoid arthritis were randomized to etoricoxib or diclofenac in a prespecified intent-to-treat analysis of three double-blind randomized trials. Potential risk factors for upper GI clinical events (bleeding, perforation, obstruction, or ulcer), complicated events (perforation, obstruction, bleeding) and discontinuations due to dyspepsia were assessed with Cox proportional hazard models. Results Significant predictors of clinical events and complicated events included age ≥65 years [hazards ratios (HRs) = 2.25 (1.84-2.76), 4.09 (2.82-5.92)], prior event [HRs = 2.57 (1.94-3.39), 3.23 (2.09-5.00)], low-dose aspirin [HRs = 2.34 (1.87-2.92), 3.41 (2.33-5.00)] and corticosteroid [HRs = 1.85 (1.41-2.43), 2.09 (1.29-3.38)]. Predictors of discontinuation due to dyspepsia included prior dyspepsia [HR = 1.78 (1.44-2.00)], prior event [HR = 1.78 (1.40-2.27)] and age ≥65 years [HR = 1.35 (1.16-1.57)]. Conclusions Assessment for age ≥65 years, prior upper GI clinical events and low-dose aspirin use are key in identifying patients who should either avoid NSAIDs or employ management strategies to reduce NSAID-associated upper GI events. Prior dyspepsia or upper GI clinical events and age ≥65 years also predict an increased risk of developing dyspepsia severe enough to necessitate discontinuation of NSAIDs.",
author = "L. Laine and Curtis, {S. P.} and B. Cryer and A. Kaur and Cannon, {C. P.}",
year = "2010",
month = "11",
doi = "10.1111/j.1365-2036.2010.04465.x",
language = "English (US)",
volume = "32",
pages = "1240--1248",
journal = "Alimentary Pharmacology and Therapeutics",
issn = "0269-2813",
publisher = "Wiley-Blackwell",
number = "10",

}

TY - JOUR

T1 - Risk factors for NSAID-associated upper GI clinical events in a long-term prospective study of 34 701 arthritis patients

AU - Laine, L.

AU - Curtis, S. P.

AU - Cryer, B.

AU - Kaur, A.

AU - Cannon, C. P.

PY - 2010/11

Y1 - 2010/11

N2 - Nonsteroidal anti-inflammatory drugs (NSAID)-related GI effects vary based on patient characteristics. Aims To assess risk factors for NSAID-associated upper GI clinical events and dyspepsia. Methods Patients ≥50 years with osteoarthritis or rheumatoid arthritis were randomized to etoricoxib or diclofenac in a prespecified intent-to-treat analysis of three double-blind randomized trials. Potential risk factors for upper GI clinical events (bleeding, perforation, obstruction, or ulcer), complicated events (perforation, obstruction, bleeding) and discontinuations due to dyspepsia were assessed with Cox proportional hazard models. Results Significant predictors of clinical events and complicated events included age ≥65 years [hazards ratios (HRs) = 2.25 (1.84-2.76), 4.09 (2.82-5.92)], prior event [HRs = 2.57 (1.94-3.39), 3.23 (2.09-5.00)], low-dose aspirin [HRs = 2.34 (1.87-2.92), 3.41 (2.33-5.00)] and corticosteroid [HRs = 1.85 (1.41-2.43), 2.09 (1.29-3.38)]. Predictors of discontinuation due to dyspepsia included prior dyspepsia [HR = 1.78 (1.44-2.00)], prior event [HR = 1.78 (1.40-2.27)] and age ≥65 years [HR = 1.35 (1.16-1.57)]. Conclusions Assessment for age ≥65 years, prior upper GI clinical events and low-dose aspirin use are key in identifying patients who should either avoid NSAIDs or employ management strategies to reduce NSAID-associated upper GI events. Prior dyspepsia or upper GI clinical events and age ≥65 years also predict an increased risk of developing dyspepsia severe enough to necessitate discontinuation of NSAIDs.

AB - Nonsteroidal anti-inflammatory drugs (NSAID)-related GI effects vary based on patient characteristics. Aims To assess risk factors for NSAID-associated upper GI clinical events and dyspepsia. Methods Patients ≥50 years with osteoarthritis or rheumatoid arthritis were randomized to etoricoxib or diclofenac in a prespecified intent-to-treat analysis of three double-blind randomized trials. Potential risk factors for upper GI clinical events (bleeding, perforation, obstruction, or ulcer), complicated events (perforation, obstruction, bleeding) and discontinuations due to dyspepsia were assessed with Cox proportional hazard models. Results Significant predictors of clinical events and complicated events included age ≥65 years [hazards ratios (HRs) = 2.25 (1.84-2.76), 4.09 (2.82-5.92)], prior event [HRs = 2.57 (1.94-3.39), 3.23 (2.09-5.00)], low-dose aspirin [HRs = 2.34 (1.87-2.92), 3.41 (2.33-5.00)] and corticosteroid [HRs = 1.85 (1.41-2.43), 2.09 (1.29-3.38)]. Predictors of discontinuation due to dyspepsia included prior dyspepsia [HR = 1.78 (1.44-2.00)], prior event [HR = 1.78 (1.40-2.27)] and age ≥65 years [HR = 1.35 (1.16-1.57)]. Conclusions Assessment for age ≥65 years, prior upper GI clinical events and low-dose aspirin use are key in identifying patients who should either avoid NSAIDs or employ management strategies to reduce NSAID-associated upper GI events. Prior dyspepsia or upper GI clinical events and age ≥65 years also predict an increased risk of developing dyspepsia severe enough to necessitate discontinuation of NSAIDs.

UR - http://www.scopus.com/inward/record.url?scp=78249268852&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=78249268852&partnerID=8YFLogxK

U2 - 10.1111/j.1365-2036.2010.04465.x

DO - 10.1111/j.1365-2036.2010.04465.x

M3 - Article

C2 - 20955443

AN - SCOPUS:78249268852

VL - 32

SP - 1240

EP - 1248

JO - Alimentary Pharmacology and Therapeutics

JF - Alimentary Pharmacology and Therapeutics

SN - 0269-2813

IS - 10

ER -