Issue 214 Item 13 Rosiglitazone Shows Promise as Treatment for Polycystic Ovary

Rosiglitazone (Avandia) therapy can improve ovulation and insulin sensitivity in women with polycystic ovary syndrome (PCOS) and insulin resistance. PCOS is associated with an excess of male hormones, which disrupts ovulation and leads to menstrual irregularities. Insulin resistance, a common finding in PCOS patients, leads to elevated levels of insulin, which stimulates androgen release, making the problem worse. Therefore, by promoting a drop in insulin levels, insulin-sensitizing agents could, in theory, improve the symptoms of PCOS.

"Over 20 years ago, the association between PCOS and insulin resistance was unearthed," lead author Dr. Nicholas Cataldo, from Stanford University in California, stated. "About 10 years ago, people started using metformin to treat women with PCOS."

Although metformin has proven to be an effective treatment for PCOS, "many women experience gastrointestinal side effects, such as diarrhea, nausea, and loss of appetite," Dr. Cataldo said. "So, it has not been an ideal agent."
Troglitazone, an insulin sensitizer approved for use in 1997, was studied briefly as a treatment for PCOS before it was taken off the market in 2000 after being linked to rare but serious liver side effects, Dr. Cataldo noted. "The encouraging findings seen with this drug, lead us to conduct the present study looking at rosiglitazone," a currently available glitazone that was approved in 1999.

In the study, 42 women with PCOS and insulin resistance were randomized to receive one of three rosiglitazone doses for 12 weeks.

"As expected, treatment with rosiglitazone improved their insulin resistance and reduced their insulin levels, an effect that was most pronounced with the highest dose (8 mg)," Dr. Cataldo said. "On the reproductive side, we were happy to see that 55% of the women ovulated at least once during the 12-week period. Untreated, these women would probably ovulate just once or twice a year."

In addition, rosiglitazone was well tolerated and did not produce the troubling gastrointestinal side effects often seen with metformin, he added.

Because rosiglitazone is limited in its ability to reduce androgen levels, Dr. Cataldo said he does not envision the drug being taken on a continuous basis for problems like hirsutism. Rather, "I see the drug being used on a short-term basis as a means to promote ovulation," he said.

The findings were presented this week at the 86th annual meeting of The Endocrine Society in New Orleans. ENDO 2004: The Endocrine Society 86th Annual Meeting
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