Combined oral contraceptives plus spironolactone compared with metformin in women with polycystic ovary syndrome: a one-year randomized clinical trial. Issue 5 (November 2017)

• Record Type: Journal Article
• Authors: Alpañés, Macarena; Álvarez-Blasco, Francisco; Fernández-Durán, Elena; Luque-Ramírez, Manuel; Escobar-Morreale, Héctor F
• Is Part Of: European journal of endocrinology. Volume 177:Issue 5(2017)
• Page Start: 399
• Page End: 408
• Publication Date: 2017-11
• Subjects: Endocrinology -- Periodicals; 616.4005
• DOI: 10.1530/EJE-17-0516
• Languages: English
• ISSNs: 0804-4643

Abstract

Abstract : Objective: We aimed to compare a combined oral contraceptive (COC) plus the antiandrogen spironolactone with the insulin sensitizer metformin in women with polycystic ovary syndrome (PCOS). Design: We conducted a randomized, parallel, open-label, clinical trial comparing COC (30 μg of ethinylestradiol and 150 μg of desogestrel) plus spironolactone (100 mg/day) with metformin (850 mg b.i.d.) for one year in women with PCOS (EudraCT2008–004531–38). Methods: The composite primary outcome included efficacy (amelioration of hirsutism, androgen excess and menstrual dysfunction) and cardiometabolic safety (changes in the frequencies of disorders of glucose tolerance, dyslipidemia and hypertension). A complete anthropometric, biochemical, hormonal and metabolic evaluation was conducted every three months and data were submitted to intention-to-treat analyses. Results: Twenty-four patients were assigned to COC plus spironolactone and 22 patients to metformin. Compared with metformin, COC plus spironolactone caused larger decreases in hirsutism score (mean difference 4.6 points, 95% CI: 2.6–6.7), total testosterone (1.1 nmol/L, 0.4–1.7), free testosterone (25 pmol/L, 12–39), androstenedione (5.5 nmol/L, 1.8–9.2) and dehydroepiandrosterone sulfate (2.7 μmol/L, 1.4–4.0). Menstrual dysfunction was less frequent with COC plus spironolactone (OR: 0.06, 95% CI: 0.02–0.23). No differences were found in frequencies of abnormal glucose tolerance (OR: 1.7, 95% CI: 0.7–4.4), dyslipidemia (OR: 0.6, 95% CI: 0.2–1.8) or hypertension (OR: 0.3, 95% CI: 0.5–2.0). No major adverse events occurred and biochemical markers were similarly safe with both treatments. Conclusions: COC plus spironolactone was more effective than metformin for symptoms of PCOS showing similar safety and overall neutral effects on cardiometabolic risk factors.