© 2007 The Authors. 906 Journal compilation © 2007 Diabetes UK. Diabetic Medicine, 24, 906– 910 DIABETICMedicine DOI: 10.1111/j.1464-5491.2007.02165.x Abstract Aims Epidemiological and experimental data suggest that activation of the oestrogen receptor pathway limits the incidence and the progression of diabetic nephropathy. We tested the hypothesis that raloxifene protects against increasing urinary albumin excretion in post-menopausal women with Type 2 diabetes in a randomized pilot clinical trial. Methods We included 39 post-menopausal women with Type 2 diabetes and micro- or macro-albuminuria in a 6-month, double-blind, placebo-controlled trial: 20 received placebo and 19 received 60 mg raloxifene per day. The albumin : creatinine ratio (ACR) in urine was determined on three consecutive days during the week before randomization and during the week before the final visit. Results One patient in each group dropped out in the first 3 weeks, leaving 37 patients for the analysis (19 on placebo and 18 on raloxifene). From randomization to the final visit, mean ACR was unchanged in the placebo group {277 μg/mg (67; 651) [median (interquartile range)] vs. 284 μg/mg (79; 1508)} but decreased slightly in the raloxifene group [376 μg/mg (67; 615) vs. 243 μg/mg (103; 549)]. This corresponds to a change of +24 (-37; +517) for the placebo group vs. -10 μg/mg (-36; +16) for the raloxifene group (P = 0.11). In multivariate analysis, raloxifene treatment (P adjusted = 0.013), baseline low-density lipoprotein (LDL) cholesterol (P adjusted = 0.023) and change in LDL cholesterol (P adjusted = 0.008) were related to the absolute change in ACR. Adverse effects were similar in the two groups. Conclusions These results suggest that raloxifene may limit the progression of albuminuria in post-menopausal women with diabetes; further studies in a larger population are warranted. Diabet. Med. 24, 906–910 (2007) Keywords albumin : creatinine ratio, diabetic nephropathy, raloxifene, randomized controlled trial, selective oestrogen receptor modulator Abbreviations ACR, albumin : creatinine ratio; ACE-I, angiotensin-converting enzyme inhibitors; ARB, angiotensin receptor blockers; BP, blood pressure; ER, oestrogen receptor; GFR, glomerular filtration rate; HDL, high-density lipoprotein; HPLC, high-performance liquid chromatography; HRT, hormone replacement therapy; LDL, low-density lipoprotein; SERM, selective estrogen receptor modulator Correspondence to: S. Hadjadj, Endocrinology, Poitiers University Hospital, 2 rue la Milétrie—BP 577–86021 Poitiers Cedex—France. E-mail: s.hadjadj@chu-poitiers.fr Blackwell Publishing Ltd Oxford, UK DME Diabetic Medicine 0742-3071 Blackwell Publishing, 2007 24 Short Report Short report Raloxifene and diabetic nephropathy S. Hadjadj et al. Effect of raloxifene—a selective oestrogen receptor modulator—on kidney function in post-menopausal women with Type 2 diabetes: results from a randomized, placebo-controlled pilot trial S. Hadjadj*†, P. Gourdy‡, P. Zaoui§, B. Guerci¶, N. Roudaut**, J. F. Gautier††, M. Chabin‡‡, G. Mauco†§§, S. Ragot¶¶, for the RADIAN (Raloxifene in Diabetic Nephropathy) Study Group *CHU Poitiers, Endocrinology, Poitiers, †INSERM ERM 324, Poitiers, ‡Toulouse University Hospital, Rangueil Hospital, Diabetology Department, Toulouse, INSERM U U858; IFR 31, Toulouse, §Grenoble University Hospital, Nephrology Unit, Grenoble, ¶Jeanne d’Arc Hospital, Medicine G, and CIC (Clinic Research Center) Dommartin les Toul, **Brest University Hospital, Internal Medicine, Endocrinology, Brest, ††Paris Saint Louis Hospital, Endocrinology, Paris, ‡‡Poitiers University Hospital, Pharmacy, Poitiers, §§Poitiers University Hospital, Biochemistry, Poitiers and ¶¶Poitiers University Hospital, Clinical Research Center, Methodology Unit, Poitiers, France Accepted 31 January 2007