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Effect of Raloxifene on Serum Triglycerides in Women With a History of Hypertriglyceridemia While on Oral Estrogen Therapy

¹ Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University, Chicago, Illinois
² Division of Metabolism, Endocrinology, and Nutrition, University of Washington, Seattle, Washington
³ Lilly Research Laboratories, Indianapolis, Indiana

Address correspondence and reprint requests to Molly C. Carr, MD, Division of Endocrinology, Metabolism and Molecular Medicine, Feinberg School of Medicine, Northwestern University, 303 East Chicago Ave., Tarry 15-703, Chicago, IL 60611-3008. E-mail: carr{at}northwestern.edu

OBJECTIVE—Raloxifene hydrochloride is a selective estrogen receptor modulator that to date has not been shown to cause hypertriglyceridemia in normal, diabetic, or hypertriglyceridemic women. This study was designed to assess the effect of raloxifene on serum triglycerides in postmenopausal women who have a history of increased hypertriglyceridemia with oral estrogen therapy.

RESEARCH DESIGN AND METHODS—This was a single-center, uncontrolled, open-label study investigating the effects of 8 weeks of raloxifene (60 mg/day) therapy on plasma lipids. The study subjects were 12 postmenopausal women, ages 49–73 years, with a documented history of oral estrogen–induced hypertriglyceridemia (serum triglycerides 3.39 mmol/l [300 mg/dl]).

RESULTS—At week 2 of the study, three (25%) of the subjects withdrew from the trial because they developed marked hypertriglyceridemia (11.3 mmol/l [1,000 mg/dl]) during raloxifene therapy. These three women had higher baseline triglyceride and glucose levels, were not being treated with lipid-lowering agents, and were more likely to have diabetes than the other study subjects. The remaining nine patients (75%) completed the 8-week trial and experienced a nonsignificant increase in mean triglyceride levels from baseline to end point. Raloxifene treatment also resulted in a significant 16% decrease in hepatic lipase activity and a 26% increase in HDL₂ levels (P = 0.013 and 0.03, respectively).

CONCLUSIONS—Patients with a previous history of hypertriglyceridemia on oral estrogen therapy should have serum triglyceride levels monitored closely after beginning raloxifene therapy and may even require fibrate therapy before beginning raloxifene.

Abbreviations: HL, hepatic lipase • HRT, hormone replacement therapy • Lp(a), lipoprotein(a) • LPL, lipoprotein lipase • MORE study, Multiple Outcomes of Raloxifene Evaluation study

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