Desogestrel

MONTREAL -- The addition of simvastatin to an oral contraceptive regimen significantly reduces hirsutism and elevated levels of total testosterone in women with polycystic ovary syndrome, according to a study conducted by Antoni J. Duleba, M.D., of Yale University, New Haven, Conn., and associates.

"This is the first report that simvastatin improves a clinical end point of treatment of polycystic ovary syndrome/hirsutism," Dr. Duleba, the lead investigator, said in an interview.

The data were presented by another investigator in the study, Beata Banaszewska, M.D., at the conjoint annual meeting of the American Society for Reproductive Medicine and the Canadian Fertility and Andrology Society.

Oral contraceptive pills "do reduce testosterone levels, but in this crossover study, we can appreciate that statins have a greater power to this effect," Dr. Banaszewska, of Poznan University of Medical Sciences in Poland, said at the meeting.

PCOS affects 5%-10% of women of childbearing age, according to Dr. Duleba. Estimates of the cost of evaluation and care in the United States annually are about $4 billion. "We still don't have satisfactory medical treatments for PCOS; symptomatic treatments only partly improve the situation, and long term, these patients are at increased risk of cardiovascular problems," he said.

The study randomized 48 PCOS patients (mean age 24 years) into two treatment groups.

One group received oral contraceptive pills (OCP) alone (20-mcg ethinyl estradiol and 150-mcg desogestrel) for 12 weeks, after which 20-mg simvastatin was added to their regimen daily for 12 more weeks.

The other group first received the combined drug regimen for 12 weeks and then was given OCP alone for 12 weeks. Clinical, endocrine, and metabolic evaluations were performed at baseline, at crossover (12 weeks), and at 24 weeks.

"Simvastatin induced a decrease of total testosterone by 18% below the effect of OCP," Dr. Duleba said. "This effect was paralleled by a 16% decrease of free testosterone below the effect of OCP. We also found that the hirsutism declined, and there was a strong trend toward an improvement in acne, which did not reach statistical significance."

A simvastatin-attributable decline of hirsutism was modestly but significantly greater than with OCP alone; this 4% difference was statistically significant.

"Patients were very happy ... they did not want to stop," Dr. Duleba said.

"Typically, in PCOS, there is an abnormal hypothalamic-pituitary function characterized by elevated LH. It's usually measured by the ratio of LH to FSH, and we observed that statins also improved this ratio," he added. Simvastatin, in comparison with OCP, decreased LH by 24% and the LH-FSH ratio by 22%.

Furthermore, simvastatin (as compared with OCP) decreased total cholesterol by 12%, LDL cholesterol by 21%, and triglycerides by 18%-preventing the OCP-induced rise in triglycerides.

"So the statin not only normalized androgens, it also normalized hypothalamic-pituitary function. And of course, the statin improved lipid profiles," Dr. Duleba said.

BMI was not significantly affected by either treatment.

BY BRUCE K. DIXON

Chicago Bureau

Kate Johnson of the Montreal Bureau contributed to this report.

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