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Title: Simvastatin Improves Metabolic Profile and Clinical Symptoms Associated with Polycystic Ovary Syndrome: Presented at ASRM

"Simvastatin Improves Metabolic Profile and Clinical Symptoms Associated with Polycystic Ovary Syndrome: Presented at ASRM"

By Amanda Strong MONTREAL, QC -- October 20, 2005 -- Simvastatin therapy appears to reduce the clinical symptoms of polycystic ovary syndrome (PCOS), researchers reported here at the annual meeting of the American Society of Reproductive Medicine (ASRM). Although statins have a long history of use for reduction of dyslipidemia and other cardiovascular risk factors, this is the first study to look at their use for treatment of PCOS, said Robert Spaczyński MD, Assistant Professor of Medicine, Poznan University of Medical Sciences, Poznan, Poland. "PCOS is the second most common cause of metabolic disorder after diabetes," Dr. Spaczyński said during his presentation on October 18[^th. "Antiandrogenics can improve the clinical parameters; however they have no benefit on metabolic parameters. Patients with PCOS are more likely to develop cardiovascular disease earlier than similar age- and BMI [body mass index]-matched women."

In a prospective, crossover study, Dr. Spaczyński and colleagues enrolled 48 women with PCOS who were not receiving hormonal treatment for 3 months prior to study entry.

For a duration of 24 weeks, half of the women received simvastatin plus an oral contraceptive (OC) consisting of 20 mcg ethinyl estradiol and 150 mcg desogestrel for the first 12 weeks, followed by the OC alone for 12 weeks. The other half of the cohort received the OC alone for 12 weeks, followed by 12 weeks of the OC plus simvastatin. The OC was used because simvastatin has been associated with teratogenic effects.

Lead author Beata Banaszewska, MD, PhD, Assistant Professor of Medicine, Poznan University, who presented the findings here on October 16^th, said that compared with O) alone, simvastatin reduced total testosterone by 18% (P = .004) and free testosterone by 16% (P = .09). Hirsutism was reduced slightly, by 4% (P = .02), as was acne, however this endpoint failed to reach statistical significance.

Fertility-related markers were also improved. Simvastatin decreased luteinizing hormone (LH) levels by 24% (P = .002) and the LH to follicle stimulating hormone ratio by 22% (P < .001). Dehydroepiandrosterone sulfate was not affected in either group.

As expected, simvastatin decreased total cholesterol levels by 12% (P < .01) and low-density lipoprotein cholesterol levels by 21% (P < .001). With OC alone, triglyceride levels increased by 20%; however, no increase was observed when the women used the OC with simvastatin (P = .003). BMI was not significantly affected by either treatment.

This study's findings point to the possibility of using agents other than the classic anti-androgens and insulin sensitizers to treat PCOS, Spaczyński. "Possibly, it may affect endocrine profiles and have excellent effects in terms of long-term consequence, as well as improving the short-term clinical signs that normally bother the patient," Dr. Spaczyński said.

However he hesitated to make any clinical recommendations, since the data are preliminary. "This is a short study of 24-weeks, so we don't know if it will be good to start [women with PCOS] on a statin now to take it for the rest of their lives. We have to be very cautious," he said.

This study is a continuation of a previous 12-week study that investigated the effect of OC and simvastatin on metabolic and endocrine aspects associated with PCOS. It is the first to investigate hirsutism, he said.

The study was supported by a United States National Institutes of Health (NIH) grant.

[Presentation title: Simvastatin Improves Hyperandrogenism, Hyperandrogenemia, LH and Lipid Profile in Women With PCOS: A Randomized, Cross-over Study. O-131]

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