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Stella Trompet, MSc; J. Wouter Jukema, MD, PhD; Ian Ford, PhD; James Shepherd, MD, PhD; Jacobijn Gussekloo, MD, PhD; Brendan M. Buckley, MD, PhD; Rudi G. J. Westendorp, MD, PhD; Anton J. M. de Craen, PhD

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Golomb et al¹ report that subjects in the randomized placebo-controlled University of California, San Diego (UCSD), statin study had significantly reduced blood pressure after a 6-month treatment period with statins. The design of this trial, including its primary and secondary outcome measures, was published in 2004.² The previously defined primary outcome measures of the UCSD statin study included cognition, irritability and aggression, and serotonin. Secondary outcome measures included mood, quality of life, sleep, and secondary aggression measures.² We note that blood pressure was not prespecified as either a primary or secondary outcome measure. A priori identification and documentation of outcome measures is important in research on intended effects; otherwise, one could be tempted to . . . [Full Text of this Article]

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