Charles M. Beasley, Jr and Roy Tamura: What We Know and Do Not Know by Conventional Statistical Standards About Whether a Drug Does or Does Not Cause a Specific Side Effect (Adverse Drug Reaction)

Hector Warnes’ comment on Postscript

        I read your excellent study three times. I was impressed by the premarketing risk study (CDER) published in 2005 (p.49) and by two key findings in your own study: a reduced peripheral insulin sensitivity based on lower Rd. and an increased corticosterone concentration from baseline. Were the patients with these findings more likely to experience metabolic dysregulation on follow up?

        I also came across a basic science study by Li H, Peng S, Li S et al. published in Nature  in 2019, "Chronic olanzapine administration causes metabolic syndrome through inflammatory cytokines in rodent models of insulin resistance," which has settled my doubts about the mechanism of adverse side effects of olanzapine. I wonder if you would agree with their findings.

Reference:

Li H, Peng S, Li S, Liu S, Lv Y, Yang N, Yu L, Deng Y-H, Zhang Z, Fang M, Huo Y, Chen Y, Sun T, Li W. Chronic olanzapine administration causes metabolic syndrome through inflammatory cytokines in rodent models of insulin resistance. Sci Rep 2019; 9:1582.

March 5, 2020