Randomized, double-blind, placebo-controlled study of the effects of raloxifene and conjugated equine estrogen on plasma homocysteine levels in healthy postmenopausal women

Objective: To investigate the long-term effects of raloxifene on fasting pl asma homocysteine levels in postmenopausal women compared with conjugated e quine estrogen (CEE). Design: Randomized, double-blind, placebo-controlled study. Setting: Outpatient department of a university hospital. Patient(s): Fifty- two hysterectomized, healthy postmenopausal women. Intervention(s): Oral raloxifene in two dosages (60 mg/d [n = 13] and 150 m g/d [n = 13]), oral CEE (0.625 mg/d [n = 13], and placebo (n = 13) were giv en for 24 months. Main Outcome Measure(s): Fasting plasma homocysteine concentrations. Result(s): Plasma homocysteine levels were not altered in the placebo group . After 12 months, a significant reduction versus baseline in the mean plas ma homocysteine level (-16%) was found only in the raloxifene 150-mg group. The mean change in plasma homocysteine levels within this group also was s ignificantly different from the changes versus baseline found in the placeb o group (+2%) and the raloxifene 60-mg group (-2%), but not different from those found in the CEE group (-8%). After 24 months, plasma homocysteine le vels were decreased significantly in the raloxifene 150-mg and CEE groups c ompared with both baseline (-13% and -10%, respectively) and placebo values (-15% and -11%, respectively). No significant change in plasma homocystein e levels was observed in the raloxifene 60-mg group. Conclusion(s): Raloxifene has a favorable, dose-related effect on plasma ho mocysteine levels in postmenopausal women. (Fertil Steril(R) 1998;70:1085-9 . (C) 1998 by American Society for Reproductive Medicine.)