The risk of sudden cardiac arrest and ventricular arrhythmia with rosiglitazone versus pioglitazone: real-world evidence on thiazolidinedione safety
Abstract Background The low cost of thiazolidinediones makes them a potentially valuable therapeutic option for the > 300 million economically disadvantaged persons worldwide with type 2 diabetes mellitus. Differential selectivity of thiazolidinediones for peroxisome proliferator-activated recept...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2020-02-01
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| Series: | Cardiovascular Diabetology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12933-020-00999-5 |
| _version_ | 1819199239968784384 |
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| author | Charles E. Leonard Colleen M. Brensinger Ghadeer K. Dawwas Rajat Deo Warren B. Bilker Samantha E. Soprano Neil Dhopeshwarkar James H. Flory Zachary T. Bloomgarden Joshua J. Gagne Christina L. Aquilante Stephen E. Kimmel Sean Hennessy |
| author_facet | Charles E. Leonard Colleen M. Brensinger Ghadeer K. Dawwas Rajat Deo Warren B. Bilker Samantha E. Soprano Neil Dhopeshwarkar James H. Flory Zachary T. Bloomgarden Joshua J. Gagne Christina L. Aquilante Stephen E. Kimmel Sean Hennessy |
| author_sort | Charles E. Leonard |
| collection | DOAJ |
| description | Abstract Background The low cost of thiazolidinediones makes them a potentially valuable therapeutic option for the > 300 million economically disadvantaged persons worldwide with type 2 diabetes mellitus. Differential selectivity of thiazolidinediones for peroxisome proliferator-activated receptors in the myocardium may lead to disparate arrhythmogenic effects. We examined real-world effects of thiazolidinediones on outpatient-originating sudden cardiac arrest (SCA) and ventricular arrhythmia (VA). Methods We conducted population-based high-dimensional propensity score-matched cohort studies in five Medicaid programs (California, Florida, New York, Ohio, Pennsylvania | 1999–2012) and a commercial health insurance plan (Optum Clinformatics | 2000–2016). We defined exposure based on incident rosiglitazone or pioglitazone dispensings; the latter served as an active comparator. We controlled for confounding by matching exposure groups on propensity score, informed by baseline covariates identified via a data adaptive approach. We ascertained SCA/VA outcomes precipitating hospital presentation using a validated, diagnosis-based algorithm. We generated marginal hazard ratios (HRs) via Cox proportional hazards regression that accounted for clustering within matched pairs. We prespecified Medicaid and Optum findings as primary and secondary, respectively; the latter served as a conceptual replication dataset. Results The adjusted HR for SCA/VA among rosiglitazone (vs. pioglitazone) users was 0.91 (0.75–1.10) in Medicaid and 0.88 (0.61–1.28) in Optum. Among Medicaid but not Optum enrollees, we found treatment effect heterogeneity by sex (adjusted HRs = 0.71 [0.54–0.93] and 1.16 [0.89–1.52] in men and women respectively, interaction term p-value = 0.01). Conclusions Rosiglitazone and pioglitazone appear to be associated with similar risks of SCA/VA. |
| first_indexed | 2024-12-23T03:13:11Z |
| format | Article |
| id | doaj.art-7be6dabc839f4bdbb7f63feb7e38ed6d |
| institution | Directory Open Access Journal |
| issn | 1475-2840 |
| language | English |
| last_indexed | 2024-12-23T03:13:11Z |
| publishDate | 2020-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Cardiovascular Diabetology |
| spelling | doaj.art-7be6dabc839f4bdbb7f63feb7e38ed6d2022-12-21T18:02:12ZengBMCCardiovascular Diabetology1475-28402020-02-0119111110.1186/s12933-020-00999-5The risk of sudden cardiac arrest and ventricular arrhythmia with rosiglitazone versus pioglitazone: real-world evidence on thiazolidinedione safetyCharles E. Leonard0Colleen M. Brensinger1Ghadeer K. Dawwas2Rajat Deo3Warren B. Bilker4Samantha E. Soprano5Neil Dhopeshwarkar6James H. Flory7Zachary T. Bloomgarden8Joshua J. Gagne9Christina L. Aquilante10Stephen E. Kimmel11Sean Hennessy12Center for Pharmacoepidemiology Research and Training, Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of PennsylvaniaCenter for Pharmacoepidemiology Research and Training, Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of PennsylvaniaCenter for Pharmacoepidemiology Research and Training, Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of PennsylvaniaCenter for Pharmacoepidemiology Research and Training, Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of PennsylvaniaCenter for Pharmacoepidemiology Research and Training, Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of PennsylvaniaCenter for Pharmacoepidemiology Research and Training, Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of PennsylvaniaCenter for Pharmacoepidemiology Research and Training, Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of PennsylvaniaCenter for Pharmacoepidemiology Research and Training, Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of PennsylvaniaDivision of Endocrinology and Metabolism, Department of Medicine, Icahn School of Medicine at Mount SinaiDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Harvard UniversityDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, Anschutz Medical Campus, University of ColoradoCenter for Pharmacoepidemiology Research and Training, Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of PennsylvaniaCenter for Pharmacoepidemiology Research and Training, Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of PennsylvaniaAbstract Background The low cost of thiazolidinediones makes them a potentially valuable therapeutic option for the > 300 million economically disadvantaged persons worldwide with type 2 diabetes mellitus. Differential selectivity of thiazolidinediones for peroxisome proliferator-activated receptors in the myocardium may lead to disparate arrhythmogenic effects. We examined real-world effects of thiazolidinediones on outpatient-originating sudden cardiac arrest (SCA) and ventricular arrhythmia (VA). Methods We conducted population-based high-dimensional propensity score-matched cohort studies in five Medicaid programs (California, Florida, New York, Ohio, Pennsylvania | 1999–2012) and a commercial health insurance plan (Optum Clinformatics | 2000–2016). We defined exposure based on incident rosiglitazone or pioglitazone dispensings; the latter served as an active comparator. We controlled for confounding by matching exposure groups on propensity score, informed by baseline covariates identified via a data adaptive approach. We ascertained SCA/VA outcomes precipitating hospital presentation using a validated, diagnosis-based algorithm. We generated marginal hazard ratios (HRs) via Cox proportional hazards regression that accounted for clustering within matched pairs. We prespecified Medicaid and Optum findings as primary and secondary, respectively; the latter served as a conceptual replication dataset. Results The adjusted HR for SCA/VA among rosiglitazone (vs. pioglitazone) users was 0.91 (0.75–1.10) in Medicaid and 0.88 (0.61–1.28) in Optum. Among Medicaid but not Optum enrollees, we found treatment effect heterogeneity by sex (adjusted HRs = 0.71 [0.54–0.93] and 1.16 [0.89–1.52] in men and women respectively, interaction term p-value = 0.01). Conclusions Rosiglitazone and pioglitazone appear to be associated with similar risks of SCA/VA.http://link.springer.com/article/10.1186/s12933-020-00999-5ThiazolidinedionesType 2 diabetes mellitusSudden cardiac deathCardiac arrhythmiasCohort studiesPharmacoepidemiology |
| spellingShingle | Charles E. Leonard Colleen M. Brensinger Ghadeer K. Dawwas Rajat Deo Warren B. Bilker Samantha E. Soprano Neil Dhopeshwarkar James H. Flory Zachary T. Bloomgarden Joshua J. Gagne Christina L. Aquilante Stephen E. Kimmel Sean Hennessy The risk of sudden cardiac arrest and ventricular arrhythmia with rosiglitazone versus pioglitazone: real-world evidence on thiazolidinedione safety Cardiovascular Diabetology Thiazolidinediones Type 2 diabetes mellitus Sudden cardiac death Cardiac arrhythmias Cohort studies Pharmacoepidemiology |
| title | The risk of sudden cardiac arrest and ventricular arrhythmia with rosiglitazone versus pioglitazone: real-world evidence on thiazolidinedione safety |
| title_full | The risk of sudden cardiac arrest and ventricular arrhythmia with rosiglitazone versus pioglitazone: real-world evidence on thiazolidinedione safety |
| title_fullStr | The risk of sudden cardiac arrest and ventricular arrhythmia with rosiglitazone versus pioglitazone: real-world evidence on thiazolidinedione safety |
| title_full_unstemmed | The risk of sudden cardiac arrest and ventricular arrhythmia with rosiglitazone versus pioglitazone: real-world evidence on thiazolidinedione safety |
| title_short | The risk of sudden cardiac arrest and ventricular arrhythmia with rosiglitazone versus pioglitazone: real-world evidence on thiazolidinedione safety |
| title_sort | risk of sudden cardiac arrest and ventricular arrhythmia with rosiglitazone versus pioglitazone real world evidence on thiazolidinedione safety |
| topic | Thiazolidinediones Type 2 diabetes mellitus Sudden cardiac death Cardiac arrhythmias Cohort studies Pharmacoepidemiology |
| url | http://link.springer.com/article/10.1186/s12933-020-00999-5 |
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