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Lipid Effects of Hormone Replacement Therapy With Sequential Transdermal 17-Beta–Estradiol and Oral Dydrogesterone

From the Department of Obstetrics and Gynaecology, North Middlesex Hospital and Royal Free and University College Medical School, Royal Free Campus, London, United Kingdom; Ella Gordon Unit, St. Mary’s Hospital, Portsmouth, United Kingdom; and Solvay Healthcare Ltd, Southampton, United Kingdom.

Address reprint requests to: Jose J. Nieto, MRCOG, Department of Obstetrics and Gynecology, Royal Free and University College Medical School, Royal Free Campus, Pond Street, London, NW3 2QG, United Kingdom

Objective: To assess the effects on lipid and lipoprotein levels of a combination therapy of matrix patch and oral sequential dydrogesterone.

Methods: The lipid effects of transdermal estradiol (E2) (80 µg/day continuously) and oral dydrogesterone (10 mg from days 15–28 of each cycle) were assessed in a multicenter, prospective, open, baseline-controlled study. Subjects were 42 healthy, postmenopausal women who had not had hysterectomies. Fasting blood samples were taken at baseline, day 14 of cycle 3 (estrogen alone), and day 25 of cycle 6 (estrogen and progestogen). The main outcome measures were changes from baseline in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides after six cycles.

Results: Thirty-six subjects completed six cycles and in the 28 with complete data, HDL cholesterol increased by 10.6% from 65.25 to 72.2 mg/dL (95% confidence interval [CI] 2.32, 11.58, P = .005) and LDL cholesterol fell by 5.1% from 130.9 to 124.3 mg/dL (95% CI 13.9, 1.16, P = .07). There was a nonsignificant decrease in LDL cholesterol from 130.9 at baseline to 124.3 mg/dL at 6 months and in triglycerides from 110.6 to 107.1 mg/dL.

Conclusion: Sequential treatment with transdermal E2 and oral dydrogesterone increased HDL cholesterol, without the accompanying increase in triglycerides that occurs with oral estrogen replacement therapy.