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The Effect of Atorvastatin in Patients with Polycystic Ovary Syndrome: A Randomized Double-Blind Placebo-Controlled Study

Department of Diabetes and Endocrinology (T.S., S.L.A.), University of Hull, Hull HU6 7RX, United Kingdom; Department of Clinical Biochemistry (E.S.K.), Hull Royal Infirmary, Hull HU3 2JZ, United Kingdom; and Department of Obstetric Ultrasound (A.-M.C.), Hull and East Yorkshire Women’s and Children’s Hospital, Hull HU3 2PZ, United Kingdom

Address all correspondence and requests for reprints to: Thozhukat Sathyapalan, Michael White Diabetes Centre, 220-236 Analby Road, Hull Royal Infirmary, Hull HU3 2JZ, United Kingdom. E-mail: tsathyapal{at}rediffmail.com.

Context: Polycystic ovary syndrome (PCOS) is associated with increased risk of cardiovascular morbidity, whereas statins are proven to reduce cardiovascular mortality and morbidity through lipid-lowering and perhaps through their pleiotropic effects. Statins can also reduce testosterone in vitro by inhibiting ovarian theca-interstitial cell proliferation and steroidogenesis and reducing inflammation in vivo.

Objective: Our objective was to assess the effect of atorvastatin on inflammatory markers, insulin resistance, and biochemical hyperandrogenemia in patients with PCOS.

Design and Setting: We conducted a randomized, double-blind, placebo-controlled study at a tertiary care setting in United Kingdom.

Patients: Patients included 40 medication-naive patients with PCOS and biochemical hyperandrogenemia.

Methods: Patients were randomized to either atorvastatin 20 mg daily or placebo.

Main Outcome Measures: The primary endpoint of the study was a change in the inflammatory marker high-sensitivity C-reactive protein. The secondary endpoints were a change in insulin resistance and total testosterone.

Results: After 12 wk atorvastatin, there was a significant reduction (mean ± SEM) in total cholesterol (4.6 ± 0.2 vs. 3.4 ± 0.2 mmol/liter, P < 0.01), low-density lipoprotein cholesterol (2.9 ± 0.2 vs. 1.8 ± 0.2 mmol/liter, P < 0.01), triglycerides (1.34 ± 0.08 vs. 1.08 ± 0.13 mmol/liter, P <0.01), high-sensitivity C-reactive protein (4.9 ± 1.4 vs. 3.4 ± 1.1 mg/liter, P = 0.04), free androgen index (13.4 ± 0.6 vs. 8.7 ± 0.4, P < 0.01), testosterone (4.1 ± 0.2 vs. 2.9 ± 0.1 nmol/liter, P < 0.01) and insulin resistance as measured by homeostasis model assessment for insulin resistance (HOMA-IR) (3.3 ± 0.4 vs. 2.7 ± 0.4). There was a significant increase in SHBG (31.1 ± 1.0 vs. 35.3 ± 1.2 nmol/liter, P < 0.01). There was a positive correlation between the reduction in HOMA-IR in the atorvastatin group with the reduction in triglycerides and the reduction of free androgen index. There was a significant deterioration of HOMA-IR in the placebo group (3.0 ± 0.4 vs. 3.8 ± 0.5).

Conclusions: This study suggests that atorvastatin is effective in reducing inflammation, biochemical hyperandrogenemia, and metabolic parameters in patients with PCOS after a 12-wk period.

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