Table 2 Summary of results from secondary analyses | Medicaid and Optum
Analysis,a prespecified and conducted in Medicaid unless otherwise noted | Results | ||
|---|---|---|---|
N | aHR for rosiglitazoneb and sudden cardiac arrest/ventricular arrhythmia | aHR for rosiglitazoneb and sudden cardiac death/fatal ventricular arrhythmia | |
Limiting maximum follow-up time to 30 days | 379,598 | 0.91 (0.67–1.23) | 1.09 (0.73–1.64) |
Limiting maximum follow-up time to 6 years (post hoc) | 379,598 | 0.90 (0.74–1.09) | 1.08 (0.83–1.40) |
Limiting study period to time before January 1, 2007 (post hoc) | 315,196 | 0.90 (0.74–1.11) | 1.00 (0.76–1.30) |
Decreasing permissible grace period between contiguous thiazolidinedione dispensings from 15 to 7 days | 379,598 | 0.95 (0.77–1.18) | 1.17 (0.88–1.56) |
Increasing permissible grace period between contiguous thiazolidinedione dispensings from 15 to 30 days | 379,598 | 0.97 (0.81–1.15) | 1.08 (0.83–1.40) |
Excluding, as a censoring criterion, the occurrence of a VA diagnosis not meeting the outcome definition | 379,598 | 0.91 (0.75–1.10) | 1.08 (0.84–1.41) |
Exclusion of persons with an any-claim type, any-position diagnosis of SCA or VA ever prior to cohort entry | 374,694 | 0.89 (0.73–1.08) | 1.05 (0.80–1.37) |
Exclusion of empiric covariates from the PS thought to be strong correlates of exposure but not associated with the outcome | 384,976 | 0.90 (0.75–1.10) | 1.08 (0.83–1.41) |
Limiting outcomes to fatal events | 379,598 | – | 1.09 (0.84–1.41) |
Examining thiazolidinedione dose–response relationships and limiting maximum follow-up time to 90 days | See Additional file 1: Figure S4 | ||
Examining the same estimands in an independent, commercial health insurance dataset (Optum Clinformatics Data Mart, 2000–2016), also see □ in Fig. 2 | 195,742 | 0.88 (0.61–1.28) | Not applicable, as our Optum dataset does not record death in any setting |
Examining effect modification by | N | p-value for interaction term | aHR for rosiglitazone† and sudden cardiac arrest/ventricular arrhythmia |
|---|---|---|---|
Concomitant use of drugs that inhibit hepatic CYP450-based metabolism of thiazolidinediones | |||
CYP2C8 inhibitors | 379,598 | 0.10 | Since the interaction term p-values did not meet the prespecified threshold for statistical significance, stratified results are not presented |
CYP2C9 inhibitors | 379,598 | 0.95 | |
CYP3A4 inhibitors | 379,598 | 0.69 | |
Concomitant use of drugs with a “known risk of TdP” | 379,598 | 0.44 | |
Concomitant use of drugs with a “known”, “possible”, or “conditional risk of TdP” | 379,598 | 0.18 | |
Other high-risk subgroups | |||
Age group | 379,598 | 0.86 | |
Sex | 379,598 | 0.01 | Among women: 1.16 (0.89–1.52) Among men: 0.71 (0.54–0.93) |
Race | 379,598 | 0.56 | Since the interaction term p-values did not meet the prespecified threshold for statistical significance, stratified results are not presented |
Nursing home residence | 379,598 | 0.72 | |
Ischemic heart disease | 379,598 | 0.58 | |
Conduction disorders | 379,598 | 0.36 | |
HF/cardiomyopathy | 379,598 | 0.92 | |
Kidney disease | 379,598 | 0.38 | |
Liver disease | 379,598 | 0.86 |