SAN FRANCISCO — Simvastatin improved menstrual regularity in women with polycystic ovary syndrome—and it did so more effectively than either metformin or a combination of both drugs in a randomized study that compared the three treatments.
Furthermore, simvastatin was more effective than the metformin or combination treatment for reducing cardiovascular risk factors, including lipid profile and systemic inflammation, and was at least as effective for improving clinical and biochemical measures of hyperandrogenism, according to data presented at the annual meeting of the American Society for Reproductive Medicine.
Dr. Leszek Pawelczyk of the University of Medical Sciences in Poznan, Poland and his colleagues randomized 60 women with PCOS to receive simvastatin (20 mg/day), metformin (850 mg twice daily), or a combination of the two. Dr. Pawelczyk reported 6-month study data at the meeting.
The prospective study included only nonobese women who were not using oral contraceptives or other hormonal therapies.
The three treatment groups were comparable at baseline with regard to demographic and clinical characteristics; they averaged 2.5 menses every 6 months. The 18 women in the simvastatin group had an 89% increase in the number of menses after 6 months of treatment, compared with a 32% increase in the 19 women in the metformin group, and a 68% increase in the 23 women in the combination group. The differences between the groups were statistically significant.
All groups experienced a significant decrease in body mass index, hirsutism, acne scores, and total and free testosterone levels, but the differences in these measures were not statistically improved in the combination therapy group, compared with the simvastatin and metformin groups. For example, testosterone decreased 27% in the simvastatin group, 19% in the metformin group, and 15% in the combination group. Body mass index decreased 2.2% in the simvastatin group, 4.3% in the metformin group, and 5.8% in the combination group.
Similarly, there was no additive effect of combination therapy on total cholesterol, LDL cholesterol, and C-reactive protein in the combination group.
Improvements in these measures were seen only in the presence of simvastatin, and the improvement was not greater in the combination group.
Given the increasing evidence that statins benefit women with PCOS, they “may be a very good option in these patients,” Dr. Pawelczyk said in response to an audience member's question about whether he would recommend treatment in PCOS patients now, or wait for further study.
He noted, however, that this treatment is not an option in patients who are planning to become pregnant because statins have been associated with birth defects.