IMPACT OF A NEW FORMULATION OF LOW-DOSE MICRONIZED MEDROXYPROGESTERONE AND 17-BETA ESTRADIOL ON LIPID PROFILES IN MENOPAUSAL WOMEN

Objective: To evaluate the impact of cyclical low-dose micronised medr oxyprogesterone (5 mg/day for the last 12 days of each 28-day cycle) i n combination with 17-beta estradiol (2 mg/day continuously) on lipid profiles in postmenopausal women treated for 12 months. Design and Set ting: Open, noncomparative, prospective study carried out in general p ractice. Patients and Results: 98 female patients were enrolled; seven failed to meet entry criteria, 20 withdrew after developing adverse e vents, three were lost to follow up and one withdrew for personal reas ons; 67 (67.3%) completed 12 months' treatment. Levels of total choles terol (6.42 mmol/L at baseline) fell 8.4% (p = 0.0001) after 12 months ' treatment, while total triglycerides (1.39 mmol/L at baseline) incre ased by 12.2% (p = 0.007), low density lipoprotein cholesterol (4.27 m mol/L at baseline) fell 18.3% (p = 0.0001) and high density lipoprotei n (HDL) cholesterol (1.59 mmol/L at baseline) increased by 6.9% (p = 0 .0001). The most frequently reported adverse events were menorrhagia, breast tenderness, cervical polyps or cysts, bloating, fatigue or leth argy, influenza or influenza-like syndrome, back pain and headaches. C onclusions: Treatment with oral micronised 17-beta estradiol 2 mg/day continuously and medroxyprogesterone 5 mg/day for 12 days of each 28-d ay cycle lead to changes in lipid profiles in postmenopausal women tha t had favourable implications for the risk of development of coronary heart disease. The 17-beta estradiol-induced increase in the level of HDL cholesterol was maintained during combination with low-dose cyclic al medroxyprogesterone for 12 months.