Under-reporting of cardiovascular events in the rofecoxib Alzheimer disease studies

Madigan, David; Sigelman, Daniel W.; Mayer, James W.; Furberg, Curt D.; Avorn, Jerry

doi:10.1016/j.ahj.2012.05.002

Cited by 23 publications

(11 citation statements)

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“…In accordance with these concepts, research funded by drug companies has been reported to be subject to selective publication, selective reporting, and multiple publications [25]. Previous researchers reported that pharmaceutical companies have suppressed studies reporting severe adverse effects [26, 27]. Kasenda et al [28] reported on reasons for discontinuation of clinical trials.…”

Section: Discussionmentioning

confidence: 99%

The association of funding source on effect size in randomized controlled trials: 2013–2015 – a cross-sectional survey and meta-analysis

Delgado

2017

Trials

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BackgroundTrials financed by for-profit organizations have been associated with favorable outcomes of new treatments, although the effect size of funding source impact on outcome is unknown. The aim of this study was to estimate the effect size for a favorable outcome in randomized controlled trials (RCTs), stratified by funding source, that have been published in general medical journals.MethodsParallel-group RCTs published in The Lancet, New England Journal of Medicine, and JAMA between 2013 and 2015 were identified. RCTs with binary primary endpoints were included. The primary outcome was the OR of patients’ having a favorable outcome in the intervention group compared with the control group. The OR of a favorable outcome in each trial was calculated by the number of positive events that occurred in the intervention and control groups. A meta-analytic technique with random effects model was used to calculate summary OR. Data were stratified by funding source as for-profit, mixed, and nonprofit. Prespecified sensitivity, subgroup, and metaregression analyses were performed.ResultsFive hundred nine trials were included. The OR for a favorable outcome in for-profit-funded RCTs was 1.92 (95% CI 1.72–2.14), which was higher than mixed source-funded RCTs (OR 1.34, 95% CI 1.25–1.43) and nonprofit-funded RCTs (OR 1.32, 95% CI 1.26–1.39). The OR for a favorable outcome was higher for both clinical and surrogate endpoints in for-profit-funded trials than in RCTs with other funding sources. Excluding drug trials lowered the OR for a favorable outcome in for-profit-funded RCTs. The OR for a favorable surrogate outcome in drug trials was higher in for-profit-funded trials than in nonprofit-funded trials.ConclusionsFor-profit-funded RCTs have a higher OR for a favorable outcome than nonprofit- and mixed source-funded RCTs. This difference is associated mainly with the use of surrogate endpoints in for-profit-financed drug trials.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1872-0) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

The association of funding source on effect size in randomized controlled trials: 2013–2015 – a cross-sectional survey and meta-analysis

Delgado

2017

Trials

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“…In another study to verify the effectiveness by rofecoxib 25 mg in prevention of adenomatous polyps, a two-three fold increased risk of cardiovascular events has been reported [73]. The relative cardiovascular risk by 2.24-2.3 for rofecoxibis confirmed in a meta-analysis [74]. For anaesthesiologist the most important question is: can selective and non-selective NSAIDs be utilized in the perioperative period?…”

Section: Cardiovascular Risk and Postoperative Cardiovascular Effectsmentioning

confidence: 88%

The Use of NSAIDs in the Postoperative Period: Advantage and Disadvantages

2015

JACCOA

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“…The risks associated with rofecoxib were not properly represented in the trial reports, which falsely reported rofecoxib's benefits on the gastrointestinal system as greater than its risks on the cardiovascular system [7]. This resulted in 88,000 to 140,000 serious cases of heart disease in the United States alone, thus resulting in the removal of rofecoxib from the market in 2004 [8].…”

Section: Abstract R é S U M émentioning

confidence: 99%