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

Abstract

Objective: To investigate the long-term effects of raloxifene on fasting plasma homocysteine levels in postmenopausal women compared with conjugated equine 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 mg/d [n = 13]), oral CEE (0.625 mg/d [n = 13], and placebo (n = 13) were given 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 plasma homocysteine level (−16%) was found only in the raloxifene 150-mg group. The mean change in plasma homocysteine levels within this group also was significantly different from the changes versus baseline found in the placebo 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 levels were decreased significantly in the raloxifene 150-mg and CEE groups compared with both baseline (−13% and −10%, respectively) and placebo values (−15% and −11%, respectively). No significant change in plasma homocysteine levels was observed in the raloxifene 60-mg group. Conclusion(s): Raloxifene has a favorable, dose-related effect on plasma homocysteine levels in postmenopausal women.