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The risk of sudden cardiac arrest and ventricular arrhythmia with rosiglitazone versus pioglitazone: real-world evidence on thiazolidinedione safety
- Source :
- Cardiovascular Diabetology, Vol 19, Iss 1, Pp 1-11 (2020), Cardiovascular Diabetology
- Publication Year :
- 2020
- Publisher :
- BMC, 2020.
-
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.
- Subjects :
- Male
Cardiac arrhythmias
lcsh:Diseases of the circulatory (Cardiovascular) system
Time Factors
Propensity score
Databases, Factual
Endocrinology, Diabetes and Metabolism
030204 cardiovascular system & hematology
0302 clinical medicine
Risk Factors
030212 general & internal medicine
Thiazolidinedione
Original Investigation
education.field_of_study
Incidence
Hazard ratio
Middle Aged
3. Good health
Treatment Outcome
Cohort studies
Female
medicine.symptom
Cardiology and Cardiovascular Medicine
Rosiglitazone
medicine.drug
Adult
medicine.medical_specialty
medicine.drug_class
Population
Risk Assessment
03 medical and health sciences
Internal medicine
Type 2 diabetes mellitus
medicine
Humans
Hypoglycemic Agents
education
Aged
Pioglitazone
Medicaid
business.industry
Pharmacoepidemiology
Arrhythmias, Cardiac
Sudden cardiac arrest
Protective Factors
United States
Sudden cardiac death
Death, Sudden, Cardiac
Diabetes Mellitus, Type 2
lcsh:RC666-701
Propensity score matching
Thiazolidinediones
business
Subjects
Details
- Language :
- English
- ISSN :
- 14752840
- Volume :
- 19
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Cardiovascular Diabetology
- Accession number :
- edsair.doi.dedup.....590ea592080f6d1227af1eaf4a728691