The story of Vioxx—no pain and a lot of gain: ethical concerns regarding conduct of the pharmaceutical industry

Cahana, Alex; Mauron, Alex

doi:10.1007/s00540-006-0432-7

Cited by 5 publications

(3 citation statements)

References 7 publications

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“…The risk–benefit ratio of roflumilast could change when it is widely used in a real-world practice since patients with significant cardiopulmonary abnormalities were excluded in most of the included studies (Table 1). A long-term safety profile of roflumilast needs to be established with postmarketing surveillance since such information is typically unknown for an entirely new class of medicines and their long-term side effects could be revealed only in a postmarketing study as happened with rofecoxib [Cahana and Mauron, 2006].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of roflumilast in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis

Oba

Lone

2012

Ther Adv Respir Dis

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Abstract:Background: Roflumilast, a phosphodiesterase 4 inhibitor, has been shown to improve lung function and reduce exacerbation rates, but is associated with adverse events (AEs). The purpose of this study was to systematically review the clinical effectiveness and safety of roflumilast. Methods: A systematic search was made of MEDLINE, Cochrane trials database, DARE and CINAHL. Randomized, controlled trials of more than 12 weeks' duration comparing roflumilast with placebo were reviewed. Studies were pooled to yield relative risk (RR), incident rate difference or weighted mean differences with 95% confidence intervals (CIs). Results: Eight trials (8698 patients) met the inclusion criteria. Roflumilast significantly reduced moderate to severe exacerbations (RR 0.85; 95% CI 0.80-0.91) compared with placebo, but not severe exacerbations (RR 0.83; 95% CI 0.68-1.01) or mortality (RR 0.90; 95% CI 0.63-1.28). Roflumilast significantly improved lung function relative to placebo, but not quality of life measures. AEs (RR 1.11; 95% CI 1.03-1.19) and discontinuations of treatment due to AEs (RR 1.63; 95% CI 1.45-1.84) were significantly more frequent with roflumilast than placebo. In the chronic obstructive pulmonary disease (COPD) Safety Pool (12,054 patients), the overall incidence of serious AEs did not differ between groups. However, atrial fibrillation (0.4% versus 0.2%; p = 0.02) and suicidality (0.08% versus 0%) were more frequent with roflumilast than placebo. Conclusions: The efficacy of roflumilast appears modest compared with other available therapies for COPD. Further studies are needed to investigate the risk-benefit ratio and longterm safety of roflumilast before its wider use.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of roflumilast in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis

Oba

Lone

2012

Ther Adv Respir Dis

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“…The withdrawing of Vioxx drug from sale did not mean resignation from the therapy using coxibs (Cahana and Mauron 2006 ). Celecoxib, which showed a considerably smaller prothrombotic action in the trials than rofecoxib, is still a popular drug, also in Poland.…”

Section: Discussionmentioning

confidence: 99%

Does administration of non-steroidal anti-inflammatory drug determine morphological changes in adrenal cortex: ultrastructural studies

Matysiak

Jodłowska‐Jędrych

2010

Protoplasma

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Rofecoxib (Vioxx© made by Merck Sharp & Dohme, the USA) is a non-steroidal anti-inflammatory drug which belongs to the group of selective inhibitors of cyclooxygenasis-2, i.e., coxibs. Rofecoxib was first registered in the USA, in May 1999. Since then the drug was received by millions of patients. Drugs of this group were expected to exhibit increased therapeutic action. Additionally, there were expectations concerning possibilities of their application, at least as auxiliary drugs, in neoplastic therpy due to intensifying of apoptosis. In connection with the withdrawal of Vioxx© (rofecoxib) from pharmaceutical market, attempts were made to conduct electron-microscopic evaluation of cortical part of the adrenal gland in preparations obtained from animals under influence of the drug. Every morning animals from the experimental group (15 rats) received rofecoxib (suspension in physiological saline)—non-steroidal anti-inflammatory drug (Vioxx©, Merck Sharp and Dohme, the USA), through an intragastric tube in the dose of 1.25 mg during 8 weeks. In the evaluated material, there was found a greater number of secretory vacuoles and large, containing cholesterol and other lipids as well as generated glucocorticoids, lipid drops in cytoplasm containing prominent endoplasmic reticulum. There were also found cells with cytoplasm of smaller density—especially in apical and basal parts of cells. Mitochondria occasionally demonstrated features of delicate swelling. The observed changes, which occurred on cellular level with application of large doses of the drug, result from mobilization of adaptation mechanisms of the organism.

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“…Still non-opioid options, especially in the US, are shrinking rather than growing. The removal of marketed cyclooxygenase-2 (COX-2) inhibitors from the US market ( 3 ) and other jurisdictions, and the failure of approval for newer COX-2 agents ( 4 ) have made this situation even more acute. With few NMEs coming online, development has focused on recycling already approved traditional opioids with novel delivery systems ( 5 , 6 ) or abuse deterrent formulations ( 7 ).…”

Section: Introductionmentioning

confidence: 99%

Exploiting Injury-Induced Peripheral Opioid Receptor Changes in Novel Analgesic Development for Chronic Pain

Hartrick¹

2022

Front. Pain Res.

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The story of Vioxx—no pain and a lot of gain: ethical concerns regarding conduct of the pharmaceutical industry

Cited by 5 publications

References 7 publications

Efficacy and safety of roflumilast in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis

Efficacy and safety of roflumilast in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis

Does administration of non-steroidal anti-inflammatory drug determine morphological changes in adrenal cortex: ultrastructural studies

Exploiting Injury-Induced Peripheral Opioid Receptor Changes in Novel Analgesic Development for Chronic Pain

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