Serious adverse events cluster in participants experiencing the primary composite cardiovascular endpoint: A post-hoc analysis of the SPRINT trial
American Journal of Hypertension Jan 26, 2020
Botchway A, et al. - Given fewer primary cardiovascular composite study endpoints (CVD events) and lower mortality were reported among intensively treated participants in the SPRINT study, although a serious adverse event (SAE) was reported in 38% of participants, so herein, researchers examined the link of SAEs with CVD events (myocardial infarction, acute coronary syndrome, decompensated heart failure, stroke, or death from cardiovascular causes). Among those experiencing a CVD event vs those not experiencing a CVD event, SAEs occurred in 96% and 34%, respectively. The strongest predictor of SAEs in all risk groups was experiencing a CVD event, as revealed in adjusted Cox models. Only in the second atherosclerotic cardiovascular disease (ASCVD) risk tertile, intensive treatment was identified as an independent predictor of SAEs. Findings are suggestive of a multifactorial etiology for the development of SAEs. Mostly, the occurrence of SAEs was associated with pre-randomization patient features, most prominently ASCVD risk, which, in turn, associates with in-study CVD events.
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