The effects of 2 mg chlormadinone acetate/30 mcg ethinylestradiol, alone or combined with spironolactone, on cardiovascular risk markers in women with polycystic ovary syndrome

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• 作者：Carolina Sales Vieira ; Wellington P. Martins ; Jana¨ªna Boldrini Fran?a Fern ; es ; Gustavo Mafaldo Soares ; Rosana Maria dos Reis ; Marcos Felipe Silva de S¨¢ ; Rui Alberto Ferriani
• 关键词：Contraceptives ; Oral ; Hormonal ; Cardiovascular diseases ; Polycystic ovary syndrome ; Spironolactone
• 刊名：Contraception
• 出版年：2012
• 出版时间：September, 2012
• 年：2012
• 卷：86
• 期：3
• 页码：268-275
• 全文大小：303 K

文摘

Background

Polycystic ovary syndrome (PCOS) is an endocrine disorder associated with metabolic dysfunction and changes in cardiovascular risk markers, and using oral contraceptives (OCs) may exert a further negative effect on these alterations in patients with PCOS. Thus, the primary objective of this study was to assess the effects on arterial function and structure of an OC containing chlormadinone acetate (2 mg) and ethinylestradiol (30 mcg), alone or combined with spironolactone (OC+SPL), in patients with PCOS.

Study Design

This was a randomized, controlled clinical trial. Fifty women with PCOS between 18 and 35 years of age were randomized by a computer program to use OC or OC+SPL. Brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index were evaluated at baseline and after 6 and 12 months. Serum markers for cardiovascular disease were also analyzed. The intragroup data were analyzed using analysis of variance with Tukey's post hoc test. A multivariate linear regression model was used to analyze the intergroup data.

Results

At 12 months, the increase in mean total cholesterol levels was greater in the OC+SPL group than in the OC group (27 % vs. 13 % , respectively; p=.02). The increase in mean sex hormone-binding globulin levels was greater in the OC group than in the OC+SPL group (424 % vs. 364 % , respectively; p=.01). No statistically significant differences between the groups were found for any of the other variables.

Conclusion

The addition of spironolactone to an OC containing chlormadinone acetate and ethinylestradiol conferred no cardiovascular risk-marker advantages in young women with PCOS.