Effect of Risk Factors on Complicated and Uncomplicated Ulcers in the TARGET Lumiracoxib Outcomes Study

Hawkey, Christopher J.; Weinstein, Wilfred M.; Smalley, Walter E.; Gitton, Xavier; Sallstig, Peter; Stricker, Kirstin; Krammer, Gerhard; Mellein, B.; Richard, Dominik; Matchaba, Patrice

doi:10.1053/j.gastro.2007.04.045

Cited by 24 publications

(12 citation statements)

References 20 publications

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“…Prospective outcome studies which have predefined GI endpoints, full recording of patient characteristics and study results, and blinded independent adjudication of endpoints by a central independent panel should help better define risk factors for GI events. However, relatively few such data have been published 10–12 . In addition, no prior prospective study has simulated ‘real‐world’ practice by allowing use of both low‐dose aspirin and PPIs, and no outcome study has assessed risk factors for the development of dyspepsia with NSAID use.…”

Section: Introductionmentioning

confidence: 99%

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

Laine

Curtis

Cryer

et al. 2010

Aliment Pharmacol Ther

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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.

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Section: Introductionmentioning

confidence: 99%

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

Laine

Curtis

Cryer

et al. 2010

Aliment Pharmacol Ther

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“…We were pleased that a majority of PCPs were aware of the potential drug interactions between aspirin and COX‐2 selective NSAIDs. As the CLASS (Celecoxib Long Term Arthritis Safety Study) trial originally taught us and subsequent studies have confirmed, concomitant aspirin therapy reduces or eliminates the GI safety benefits of COX‐2 selective NSAIDs 15, 26 . We were also impressed that most PCPs were aware of the potentially deleterious effects of ibuprofen on the antiplatelet effect of aspirin 27, 28 …”

Section: Discussionmentioning

confidence: 99%

“…As the CLASS (Celecoxib Long Term Arthritis Safety Study) trial originally taught us and subsequent studies have confirmed, concomitant aspirin therapy reduces or eliminates the GI safety benefits of COX-2 selective NSAIDs. 15,26 We were also impressed that most PCPs were aware of the potentially deleterious effects of ibuprofen on the antiplatelet effect of aspirin. 27,28 At the same time, our survey clearly identified a number of areas of confusion regarding the use of these agents.…”

Section: Discussionmentioning

confidence: 99%

“…Serious adverse events, ranging from dyspepsia to upper and lower gastrointestinal (GI) bleeding, perforation and obstruction, have been attributed to NSAID or aspirin use 7–12 . Cyclooxygenase‐2 (COX‐2) specific inhibitors (COX‐2 selective NSAIDs) provide an alternative to nonselective NSAIDs that confer a reduced risk for serious GI toxicity 13–16 . However, the withdrawal of two COX‐2 selective NSAIDs from the US market and failure to approve two others primarily for reasons of cardiovascular (CV) safety, 17–20 have negatively impacted the prescription of COX‐2 selective NSAIDs and have drawn attention to the use of gastroprotection concomitant with NSAID use 21 …”

Section: Introductionmentioning

confidence: 99%

“…[7][8][9][10][11][12] Cyclooxygenase-2 (COX-2) specific inhibitors (COX-2 selective NSAIDs) provide an alternative to nonselective NSAIDs that confer a reduced risk for serious GI toxicity. [13][14][15][16] However, the withdrawal of two COX-2 selective NSAIDs from the US market and failure to approve two others primarily for reasons of cardiovascular (CV) safety, [17][18][19][20] have negatively impacted the prescription of COX-2 selective NSAIDs and have drawn attention to the use of gastroprotection concomitant with NSAID use. 21 Primary care physicians (PCPs) are responsible for the largest proportion of NSAID prescriptions.…”

Section: Introductionmentioning

confidence: 99%

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Changing perceptions and practices regarding aspirin, nonsteroidal anti‐inflammatory drugs, and cyclooxygenase‐2 selective nonsteroidal anti‐inflammatory drugs among US primary care providers

El-Nachef

Scheiman

Fendrick

et al. 2008

Aliment Pharmacol Ther

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Comparison of central adjudication of outcomes and onsite outcome assessment on treatment effect estimates

Diakou

Trinquart²,

Hróbjartsson

et al. 2016

Cochrane Database of Systematic Reviews

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Data from 47 RCTs (275,078 patients) were used in the meta-analysis. We excluded 11 RCTs because of incomplete outcome data to calculate the OR for onsite and AC assessments. On average, there was no difference in treatment effect estimates from onsite assessors and AC (combined ROR: 1.00, 95% confidence interval (CI) 0.97 to 1.04; I(2) = 0%, 47 RCTs). The combined ROR was 1.00 (95% CI 0.96 to 1.04; I(2) = 0%, 35 RCTs) when onsite assessors were blinded; 0.76 (95% CI 0.48 to 1.12, I(2) = 0%, two RCTs) when AC assessed events identified independently from unblinded onsite assessors; and 1.11 (95% CI 0.96 to 1.27, I(2) = 0%, 10 RCTs) when AC assessed events identified by unblinded onsite assessors. However, there was a statistically significant interaction between these subgroups (P = 0.03) AUTHORS' CONCLUSIONS: On average, treatment effect estimates for subjective outcome events assessed by onsite assessors did not differ from those assessed by ACs. Results of subgroup analysis showed an interaction according to the blinded status of onsite assessors and the process used to submit data to AC. These results suggest that the use of ACs might be most important when onsite assessors are not blinded and the risk of misclassification is high. Furthermore, research is needed to explore the impact of the different procedures used to select events to adjudicate.

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Effect of Risk Factors on Complicated and Uncomplicated Ulcers in the TARGET Lumiracoxib Outcomes Study

Cited by 24 publications

References 20 publications

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

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

Changing perceptions and practices regarding aspirin, nonsteroidal anti‐inflammatory drugs, and cyclooxygenase‐2 selective nonsteroidal anti‐inflammatory drugs among US primary care providers

Comparison of central adjudication of outcomes and onsite outcome assessment on treatment effect estimates

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