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 Dr. Antoni J. Duleba, 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, Dr. Beata Banaszewska, 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.
“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 were given OCP alone for 12 weeks. Clinical, endocrine, and metabolic evaluations were performed at baseline, at cross-over (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.”
A simvastatin-attributable decline of hirsutism was modestly but significantly greater than with OCP alone; this 4% difference was statistically significant.
Kate Johnson of the Montreal Bureau contributed to this report.
'This is the first report that simvastatin improves a clinical end point of treatment' of PCOS/hirsutism. DR. DULEBA