Polycystic ovary syndrome treated with new approach in Stanford study

June 16, 2004

STANFORD, Calif. - A common diabetes medication is effective at treating symptoms of polycystic ovary syndrome, according to a Stanford University School of Medicine study. Nicholas Cataldo, MD, adjunct clinical instructor of obstetrics and gynecology, is presenting his findings at the annual meeting of the Endocrine Society in New Orleans.

"We've found that rosiglitazone is a promising, well-tolerated new treatment for both the metabolic and ovarian abnormalities in polycystic ovary syndrome," said Cataldo.

Polycystic ovary syndrome, or PCOS, is characterized by an excess of male hormones that disrupts normal ovulation and leads to symptoms such as irregular or absent menstrual periods and multiple, small ovarian cysts. Many women with PCOS also have a metabolic abnormality known as insulin resistance, which causes their bodies to over-produce insulin. This, in fact, is often the culprit behind the excess male hormones: too much insulin may cause the ovary to produce too much androgen, a male hormone. The disorder affects 5 to 10 percent of women of reproductive age and is the most common cause of irregular menstruation.

"There is a lot of room here to improve the health and overall lifestyle of women with PCOS," noted Cataldo.

Women with untreated PCOS face an increased risk of diabetes, heart disease, high blood pressure and cancer of the endometrium; fertility problems are also common. Cataldo said traditional treatment for the disease has depended on whether the woman is seeking to become pregnant. Fertility drugs are prescribed for those who are, while birth control pills and anti-androgens are prescribed for those who are not.

Diabetes medications called insulin sensitizers are also often used to treat PCOS. One of these, metformin, has been effective in both reducing excess androgens and promoting ovulation and regular menstrual cycles. The medication has major stomach side effects, however, and Cataldo said many women aren't able to handle a dose large enough to help their ovaries.

Cataldo said rosiglitazone, a newer kind of insulin sensitizer, does not appear to have the same side effects as metformin. The drug hadn't been extensively studied in PCOS before, prompting Cataldo to launch his study.

During the study, Cataldo and his team examined the effects of three doses of rosiglitazone, assigned at random and given for 12 weeks to 42 women with both PCOS and insulin resistance. Cataldo said the researchers "hypothesized that it would work the same as the older insulin sensitizers."

The researchers found that more than half the women ovulated while taking rosiglitazone, and that insulin resistance, as measured by an index called SSPG, fell by 28 percent for women on the highest dose (8 mg). Androgen levels fell in some, but not all, of the women who ovulated. Small, favorable effects on cholesterol levels were also noted.

"The work is promising because it points to the use of a new group of drugs, the glitazones, in an off-label context for the treatment of PCOS," said Cataldo. "This gives us another medication to treat insulin resistance and ovarian dysfunction."

Cataldo said a benefit of this treatment - which he said makes "women with PCOS look like women without the disorder" - is that it can be taken by both women who are trying to become pregnant and women who are not. He pointed out that the drug doesn't consistently lower testosterone levels like other insulin sensitizers have been shown to do, so it might not be the ideal treatment for women with high levels of this hormone.

Because Cataldo's study focused on PCOS patients with insulin resistance, he said future studies should address whether this drug can be helpful to other women with PCOS. He said data is also needed on the safety of the drug during early pregnancy.
Stanford collaborators on this study include Fahim Abbasi, MD; Tracey McLaughlin, MD; Marina Basina, MD; Patricia Fechner, MD; Gerald Reaven, MD; and Linda Giudice, MD, PhD. The study was entirely funded by the National Institutes of Health.

Stanford University Medical Center integrates research, medical education and patient care at its three institutions - Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital at Stanford. For more information, please visit the Web site of the medical center's Office of Communication & Public Affairs at http://mednews.stanford.edu.

EMBARGOED FOR RELEASE UNTIL: June 16, 2004, at 3 a.m. Pacific time to coincide with a presentation at the Endocrine Society Annual Meeting in New Orleans

Stanford University Medical Center

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