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Statins for Polycystic Ovaries?

Women with polycystic ovarian syndrome (PCOS) struggle with a variety of problems to varying degrees. The most common are obesity, erratic periods, increased body hair (hirsutism), intractable acne and fertility problems. There is a lot of research activity on this area of medicine. Now, a new study carried out in Poland and just published in the December 2009 issue of the Journal of Clinical Endocrinology & Metabolism reports some new interesting results.

The study results showed that Simvastatin, a commonly used statin to lower cholesterol, is superior to Metformin for treating women with polycystic ovarian syndrome (PCOS), and is just as effective as a combination of both drugs.

Using Metformin in PCOS

Metformin is a long established drug used to control blood sugar in people with adult onset diabetes (Type 2 diabetes). It is also commonly used in the management of women with polycystic ovarian syndrome (PCOS) and has been shown to decrease circulating levels of the hormone testosterone, reduce ovarian volume, and heighten insulin sensitivity. However, some studies on the effect of Metformin have failed to demonstrate any improvement in the lipid derangements common in PCOS, leading some researchers to try using statins.

To compare the treatments, Dr. Beata Banaszewska from Poznan University of Medical Sciences, Poland, and colleagues studied the effects of Metformin (850 mg twice daily), Simvastatin (20 mg once daily), or both, in a 3-month trial of 136 women with PCOS. Most of the women (113) completed the study.

Total testosterone, the primary outcome measure, declined to a similar extent in all 3 treatment groups, the authors report. The decline in free testosterone level was also significant and comparable in the 3 groups.

Effect of Metformin and Simvastatin in PCOS

All 3 groups described above had similar improvements in acne score, reductions in hirsutism, declines in body-mass index, and improvements in markers of systemic inflammation and endothelial function.

Only Simvassimvastatin in PCOStatin, however, significantly improved lipid profile, lowered levels of the hormone dehydroepiandrosterone sulphate (DHEAS), and increased insulin sensitivity, the investigators report.

The combination of Simvastatin and Metformin was not significantly superior to Simvastatin alone for any of the variables studied.

None of the women experienced symptoms suggestive of rhabdomyolysis (breakdown of muscle tissue), abnormal liver or kidney function tests, or other serious adverse events.

"This report indicates that statin use may represent a promising novel treatment of many features of PCOS including hyperandrogenism (high levels of male sex hormones or androgens) and a broad range of cardiovascular risk factors," the authors conclude.

"However," they caution, "routine use of statins in the treatment of PCOS cannot be advocated yet. Furthermore, large studies on diverse populations are needed to re-evaluate their effectiveness and safety."

Statins effects on the fetus

They go on to warn that since statins are potentially teratogenic (can cause fetal abnormalities), young women with PCOS using these need to be on a reliable form of contraception. This may be a stumbling block for a substantial proportion of PCOS sufferers since some are also actively trying to conceive whilst trying to combat other problems associated with the condition.

It has to be said however that the results of this study are potentially significant and may, if replicated in larger studies, add a useful weapon in the armoury for managing this common condition.

Metformin, PCOS and miscarriage

This report comes hot on the heels of another report on polycystic ovarian syndrome management by Italian researchers reported in the November 2009 issue of the medical journal Fertility and Sterility.

Their study showed that using Metformin before conception has no effect on the relatively high risk of abortion (miscarriage) in women with polycystic ovarian syndrome (PCOS), Italian researchers report in the November issue of Fertility and Sterility.

Dr. Stefano Palomba of the University of Catanzaro Magna Graecia and colleagues note that in recent years, Metformin has been widely prescribed to PCOS patients to treat menstrual dysfunction and in some cases in a bid to improve fertility. However, it is not clear whether the agent decreases the rate of miscarriage among women with the disorder, a rate that seems to be three times as high as it is in women unaffected by this condition.

To investigate further, the researchers conducted a systematic literature review and identified 17 randomized controlled trials involving more than 1700 patients.

A subsequent meta-analysis showed that Metformin had no effect on miscarriage risk. This was also true when subgroups such as those receiving gonadotrophins for controlled ovarian stimulation were considered. Furthermore, results were not altered by intention-to-treat or per-protocol analysis.

Thus, the researchers conclude that there is "no statistically significant benefit of pregestational Metformin administration on the miscarriage risk in PCOS patients who received the drug as monotherapy (on its own) or combined with other fertility drugs."

Whilst this study and its results are not sufficient to draw definitive conclusions, the information is an important addition in our understanding of the condition and how we manage the various problems associated with it.

The full subject of Polycystic ovarian syndrome (PCOS) is discussed here:

By Dr Joe Kabyemela, MD