[Effect of 6-month treatment with oral antiandrogen alone and in combination with insulin sensitizers on body composition, hormonal and metabolic parameters in women with polycystic ovary syndrome (PCOS) in order to determine therapeutic strategy].
PCOS is a complex disorder with variability of phenotypes, characterized by hyperandrogenic, anovulatory and metabolic components. The later is a result of specific insulin resistant state with compensatory hyperinsulinaemia. Oral hormonal contraceptives (OHC) are a treatment of first choice in hyperandrogenic PCOS women who do not desire conception. Addition of insulin sensitizers might counteract unfavourable metabolic consequences of OHC monotherapy and could result in additional benefits for treated PCOS women.


OBJECTIVE
To compare the effects of 3 therapeutic regimens widely used in practice--OHC alone and in combination with metformin or rosiglitazone on body weight and anthropometric proportions, hormonal and metabolic alterations.


METHODS
The study comprised of 44 women with proven PCOS, divided in 3 therapeutic groups: 1st group--with Diane35 alone; 2nd group--with Diane35 + metformin; 3rd group--with Diane35 + rosiglitazone. Body weight, fat mass and distribution, hormonal levels, metabolic parameters (insulin and blood glucose during oGTT lipid profile) were studied before and after a 6-month treatment.


RESULTS
Monotherapy with Diane35 did not lead to changes in body weight, fat mass and distribution; had beneficial influence on some of the hormonal alterations in PCOS, but did not achieved significant antiandrogenic effect; did not induce changes in carbohydrate tolerance while having mild negative effect on insulinaemia; had an unfavourable although mild influence on lipid parameters including atherogenic indices except the HDL-cholesterol; did not show side effects on liver and vascular function. Combined treatment with Diane35 and metformin led to reduction of weight, fat mass and abdominal fat distribution; possessed significant antiandrogenic effect; did not decrease blood glucose levels; supressed glucose-stimulated insulin levels; had beneficial effect on HDL-cholesterol and neutral effect on other lipid parameters and atherogenic indices; decreased diastolic blood pressure. Combined treatment with Diane 35 and rosiglitazone did not induce changes in body weight, fat mass and abdominal fat distribution; possessed significant antiandrogenic effect; did not influence fasting and postchalange glucose levels; suppressed fasting hyperinsulinaemia and HOMA-index, respectively; had neutral effect on the levels of lipid parameters and atherogenic indices.
Orbetsova
M
M
Kamenov
Z
Z
Kolarov
G
G
Zakharieva
S
S
Khristov
V
V
Atanasova
I
I
Shigarminova
R
R
Milcheva
B
B
Genchev
G
G
D000726:Androgen Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D001786:Blood Glucose / Q000378:metabolism; D001823:Body Composition / Q000187:drug effects*; D017373:Cyproterone Acetate / Q000008:administration & dosage / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D007328:Insulin / Q000378:metabolism*; D008055:Lipids / Q000097:blood; D008687:Metformin / Q000008:administration & dosage / Q000627:therapeutic use; D011085:Polycystic Ovary Syndrome / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D000077154:Rosiglitazone; D045162:Thiazolidinediones / Q000008:administration & dosage / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome
D000726:Androgen Antagonists; D001786:Blood Glucose; D004338:Drug Combinations; D007004:Hypoglycemic Agents; D007328:Insulin; D008055:Lipids; D045162:Thiazolidinediones; D000077154:Rosiglitazone; D004997:Ethinyl Estradiol; D017373:Cyproterone Acetate; C032640:Cyproterone acetate, ethinyl estradiol drug combination; D008687:Metformin