ArticleMedical care2016
Disparities in Discontinuing Rosiglitazone Following the 2007 FDA Safety Alert.
Article in Medical care, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Quality of Reporting on the Evaluation of Risk Minimization Programs: A Systematic Review.Drug safety · 2020Pooled it
- Thiazolidinedione Use and Risk of Bacterial Enteric Infection Among Adults With Type 2 Diabetes Mellitus.Open forum infectious diseases · 2026Article
- Gut-derived PPAR-γ signaling and risk of bacterial enteric infection: insight from thiazolidinedione users in a US population-based study.medRxiv : the preprint server for health sciences · 2024Article
- An Update on the Molecular and Cellular Basis of Pharmacotherapy in Type 2 Diabetes Mellitus.International journal of molecular sciences · 2023Review
- Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies.Pharmacology research & perspectives · 2020Article
- Patient and provider-level factors associated with changes in utilization of treatments in response to evidence on ineffectiveness or harm.International journal of health economics and management · 2020Article
- Repurposing rosiglitazone, a PPAR-γ agonist and oral antidiabetic, as an inhaled formulation, for the treatment of PAH.Journal of controlled release : official journal of the Controlled Release Society · 2018Article
- The Impact of US FDA and Health Canada Warnings Related to the Safety of High-dose Simvastatin.Drugs - real world outcomes · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
backgroundResponsiveness to the Food and Drug Administration (FDA) rosiglitazone safety alert, issued on May 21, 2007, has not been examined among vulnerable subpopulations of the elderly.
objectiveTo compare time to discontinuation of rosiglitazone after the safety alert between black and white elderly persons, and across sociodemographic and economic subgroups. RESEARCH
designA cohort study. SUBJECTS: Medicare fee-for-service enrollees in 2007 who were established users of rosiglitazone identified from a 20% national sample of pharmacy claims. MEASURES: Outcome of interest was time to discontinuation of rosiglitazone after the May alert. We modeled the number of days following the warning to the end of the days' supply for the last rosiglitazone claim during the study period (May 21, 2007-December 31, 2007) using multivariable proportional hazards models.
resultsMore than 67% of enrollees discontinued rosiglitazone within six months of the advisory. In adjusted analysis, white enrollees (hazard ratio=0.90; 95% confidence interval, 0.86-0.94) discontinued rosiglitazone later than the comparison group of black enrollees. Enrollees with a history of low personal income also discontinued later than their comparison group (hazard ratio=0.84; 95% confidence interval, 0.81-0.87). There were no observed differences across quintiles of area-level socioeconomic status.
conclusionsWhite race and a history of low personal income modestly predicted later discontinuation of rosiglitazone after the FDA's safety advisory in 2007. The impact of FDA advisories can vary among sociodemographic groups. Policymakers should continue to monitor whether risk management policies reach their intended populations.
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Registered trials
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