Statin therapy may decrease the levels of serum steroid hormones, including testosterone and cortisol, accompanied by lowering low-density lipoprotein cholesterol (LDL-C) levels, which remains to be investigated. The aim of this study is to examine the association between steroid hormones and lipids under statin therapy and its clinical impact on the cardiovascular event risk from a viewpoint of steroid hormone metabolism. Using a population dataset extracted from the standard versus intEnsive statin therapy for hyper-cholesteroleMic Patients with diAbetic retinopaTHY (EMPATHY) study, we analyzed the correlation between steroid hormones and lipid profiles at registration and 1 year after registration, comparing between male patients with or without cardiovascular events (CV events) within 4 years (CV events + ; n = 100, and CV events − ; n = 100, respectively) after prognostic score matching. The risk for CV events was evaluated using conditional logistic regression analysis. Testosterone levels were lower in the CV events + group than in the CV events − group at registration (5.2 ± 2.2 vs. 7.6 ± 4.1 ng/mL, p < 0.001). Testosterone levels were lowered to 5.1 ng/mL on average in proportion with LDL-C lowering, and Δtestosterone was correlated with ΔLDL-C during 1 year after registration. Cortisol levels were not correlated with LDL-C levels. In addition, testosterone levels at 1 year after registration were not associated with cardiovascular event risk. In male hypercholesterolemic patients with diabetic retinopathy, testosterone levels were positively correlated with LDL-C levels, which were mildly lowered in proportion with LDL-C lowering under mild statin therapy. This decrease in testosterone levels under statin therapy was not related to the increase in cardiovascular event risk. Clinical trial registration: UMIN 000003486. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004199.
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