Statin therapy worsens insulin sensitivity in women with polycystic ovary syndrome (PCOS): a prospective, randomized, double-blind, placebo-controlled study

J Clin Endocrinol Metab. 2013 Dec;98(12):4798-807. doi: 10.1210/jc.2013-2674. Epub 2013 Oct 23.


Context: Statins have been shown to improve hyperandrogenism in women with polycystic ovary syndrome (PCOS). However, their use has also been associated with impairment of glucose metabolism and an increased risk of type 2 diabetes mellitus. Because women with PCOS are prone to disturbances in glucose metabolism, statin therapy could also have negative effects.

Objective: Our objective was to explore the effects of atorvastatin therapy on hormonal and metabolic parameters in women with PCOS.

Design and setting: We conducted a randomized, double-blind, placebo-controlled 6-month follow-up study conducted at Oulu University Hospital, Finland.

Patients: Women with PCOS (Rotterdam criteria) were treated with atorvastatin (20 mg/d, n = 15) or placebo (n = 13) for 6 months.

Interventions: Fasting serum samples were collected at baseline and at 3 and 6 months. Oral and iv glucose tolerance tests were performed at 0 and 6 months.

Main outcome measures: Androgen secretion and glucose metabolism were measured.

Results: Fasting levels and area under the curve of insulin increased significantly and insulin sensitivity (insulinogenic and Matsuda indexes) decreased during 6 months of atorvastatin therapy. Serum levels of dehydroepiandrosterone sulfate decreased in the atorvastatin group, whereas no change was observed in serum testosterone levels. Levels of C-reactive protein, total and low-density lipoprotein-cholesterol, and triglycerides decreased significantly during statin therapy.

Conclusions: Atorvastatin therapy improves chronic inflammation and lipid profile, but it impairs insulin sensitivity in women with PCOS. Because women with PCOS have an increased risk of developing type 2 diabetes mellitus, the results suggest that statin therapy should be initiated on the basis of generally accepted criteria and individual risk assessment of cardiovascular disease, and not only because of PCOS.

Trial registration: NCT01072097.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Androgen Antagonists / adverse effects
  • Androgen Antagonists / therapeutic use
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Atorvastatin
  • Body Mass Index
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Glucose Intolerance / chemically induced
  • Glucose Tolerance Test
  • Heptanoic Acids / adverse effects*
  • Heptanoic Acids / therapeutic use
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects*
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use
  • Hyperandrogenism / etiology
  • Hyperandrogenism / prevention & control
  • Hyperinsulinism / chemically induced
  • Hyperlipidemias / etiology
  • Hyperlipidemias / prevention & control
  • Insulin Resistance*
  • Insulin-Secreting Cells / drug effects
  • Insulin-Secreting Cells / metabolism
  • Middle Aged
  • Overweight / complications
  • Polycystic Ovary Syndrome / complications
  • Polycystic Ovary Syndrome / drug therapy*
  • Polycystic Ovary Syndrome / immunology
  • Polycystic Ovary Syndrome / physiopathology
  • Pyrroles / adverse effects*
  • Pyrroles / therapeutic use


  • Androgen Antagonists
  • Anti-Inflammatory Agents, Non-Steroidal
  • Heptanoic Acids
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Pyrroles
  • Atorvastatin

Associated data