Effect of Raloxifen on Renal Function in Post-Menopausal Women with Diabetic Nephropathy: a Double Blind Clinical Trial

Abstract

Background: This study evaluates the effects of the selective estrogen receptor modulators (SERMs), raloxifen, on renal function in post- menopausal women with type 2 diabetes mellitus. Methods: Thirty-seven post-menopausal women with Type 2 diabetes and diabetic nephropathy included in a 4-month, double-blind, placebo-controlled trial. 18 patients received 60 mg raloxifene per day and 19 patients received placebo. Baseline and end-study body mass index (BMI), blood pressure (BP), fasting plasma glucose (FPG), HbA1C, lipid profiles and serum creatinine (Cr) were measured. Albumin/creatinin ratio (ACR) and GFR were calculated for all the participants. Results: Mean ACR log was decreased significantly in the raloxifene group (2.4 ± 0.63 μg/mg vs. 1.89 ± 0.8 μg/ mg; P=0.009), but slight-non-significant changes in the placebo group were seen (2.16 ± 0.53 vs. 2.12 ± 0.83; P=0.8). In addition, compared with placebo, raloxifene resulted in no significant changes in GFR, HbA1C, lipid profiles and BMI. After considering variables like age, sex, duration of diabetes, duration of menopause, BMI, systolic blood pressure (SBP) and diastolic blood pressure (DBP) as confounding factors the improving effect of raloxifene on ACR remained significant. Conclusion: These results suggest that raloxifene may limit the progression of albuminuria in post-menopausal women with diabetes; further studies in a larger population may be warranted.