title: A randomized study on the influence of oral contraceptives containing ethinylestradiol combined with drospirenone or desogestrel on lipid and lipoprotein metabolism over a period of 13 cycles.
abstract: In this open-label, randomized study we compared the influence of a new oral contraceptive containing 30 microg ethinylestradiol and 3 mg drospirenone (EE + DRSP = Yasmin), with a reference preparation containing 30 microg ethinylestradiol and 150 microg desogestrel (EE + DSG = Marvelon) on the lipid profile. The primary target variables were total high-density lipoprotein (HDL) cholesterol, HDL2 cholesterol and low-density lipoprotein (LDL) cholesterol. These and additional lipid and lipoprotein fractions were measured at baseline and in the 3rd, 6th and 13th treatment cycles in a total of 50 volunteers, and also assessed after density gradient ultracentrifugation. A slight increase in mean total HDL cholesterol vs. baseline was found for the DRSP group (+12.8%) and the DSG group (+11.8%) after 13 treatment cycles. HDL2 cholesterol did not change remarkably in both groups. The mean LDL cholesterol values increased by 10.6% vs. baseline in the DSG group and remained nearly stable in the DRSP group (+1.8%). All measured values remained within the reference ranges. No statistically significant differences were found between the two treatment groups for those primary endpoints. A slight rise in mean total cholesterol was found for all cycles after the initiation of treatment. The mean increase after 1 year of treatment was approximately 8% in both treatment groups. Mean triglyceride levels increased for both treatment groups without leaving the reference range. The increase for total triglycerides was +73.6 % in the DRSP group and +61.3% in DSG group. For total phospholipids, an increase of +13.6% (DRSP) and +18.5% (DSG) over 13 cycles was measured. The apolipoproteins Apo A-I, Apo A-II and Apo B increased slightly more during DRSP treatment than during DSG treatment. The reduction of Apo E was similar in both groups. Lipoprotein (a) remained stable in the DRSP group, whereas it increased by +10.8% in the DSG group. In conclusion, the combined low-dose oral contraceptive Yasmin, with 30 microg ethinylestradiol and 3 mg of the novel progestogen drospirenone, as well as the reference preparation, had little impact on the lipid profile. While both preparations displayed a favorable lipid profile with increased total HDL cholesterol, the antiandrogenic or missing androgenic activity of Yasmin may be regarded as responsible for the stable LDL cholesterol levels. As a result, the ratio of total HDL:LDL was increased, a pattern that is usually considered clinically beneficial with respect to cardiovascular disease risk.
authors.affiliation: Department of Gynecology, University of Liege, Sart Tilman University Hospital, Liège, Belgium. U.Gaspard@chu.ulg.ac.be
authors.forename: U
authors.initials: U
authors.lastname: Gaspard
authors.forename: J
authors.initials: J
authors.lastname: Endrikat
authors.forename: J P
authors.initials: JP
authors.lastname: Desager
authors.forename: C
authors.initials: C
authors.lastname: Buicu
authors.forename: C
authors.initials: C
authors.lastname: Gerlinger
authors.forename: R
authors.initials: R
authors.lastname: Heithecker
mesh_terms: D000293:Adolescent; D000328:Adult; D000736:Androstenes / Q000008:administration & dosage / Q000494:pharmacology*; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood / Q000187:drug effects; D008078:Cholesterol, LDL / Q000097:blood / Q000187:drug effects; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000494:pharmacology*; D017135:Desogestrel / Q000008:administration & dosage / Q000494:pharmacology*; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000494:pharmacology*; D005260:Female; D006801:Humans; D008597:Menstrual Cycle; D011446:Prospective Studies; D014280:Triglycerides / Q000097:blood
chemical_list: D000736:Androstenes; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D003277:Contraceptives, Oral, Combined; D014280:Triglycerides; D004997:Ethinyl Estradiol; D017135:Desogestrel; D002784:Cholesterol; C035144:drospirenone