Author Affiliations: Therapeutics Initiative, Department of Anesthesiology, Pharmacology, and Therapeutics, Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.
We agree with Prasad and Vandross1 that the bar must be raised for primary prevention interventions. However, we advocate that a reduction in all-cause mortality falls short of what is needed: a reduction in both all-cause mortality and serious morbidity. This outcome is captured in the statistic “total people with at least 1 serious adverse event (SAE).” An SAE, according to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or requires intervention to prevent permanent impairment or damage.2 Total SAEs captures both expected and unexpected mortality and morbidity effects of a drug therapy. Furthermore, total SAEs must decrease in order to claim a net health benefit.
Wright JM, Bassett KL, Tejani AM. Raise the Bar Even Higher for Primary Prevention Interventions. Arch Intern Med. 2012;172(17):1352–1353. doi:10.1001/archinternmed.2012.3723
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