PCOS'ers should be offered treatment with Zocor - lower androgens and cholesterol
Zocor-simvastatin is a medication typically used to treat high cholesterol. Recent evidence suggests that Zocor may be a useful treatment for PCOS – polycystic ovary syndrome.
PCOS Study
A recent study presented at the annual meeting of the Society for Gynecologic Investigation is the first to look at the effects of these medications in women with PCOS. Women with PCOS are often found to have high cholesterol and triglycerides.
The PCOS patients in the study were first placed on birth control pills. This was necessary because Zocor and related medications, known collectively as statins, are contraindicated in pregnancy. One half of the PCOS patients also received Zocor.
PCOS Study Results
A comparison of the hormone levels in these patients before treatment and again after 12 weeks showed was quite impressive. Testosterone is a hormone that is commonly elevated in PCOS. Testosterone belongs to a class of hormones known as androgens. Androgens are what many people think of as male type hormones. In women, when testosterone levels are elevated, such as in PCOS patients, they can have problems with unwanted hair growth, acne and hair loss. In this study, testosterone fell by an average of 41% in the group that received the combined birth control and Zocor. By contrast, in the birth control alone group, levels fell by only 14%.
Another androgen that can be elevated in PCOS patients is dehydroepiandrosterone sulfate (DHEAS). DHEAS elevations in PCOS patients have been treated with steroids and is associated with numerous side effects. DHEAS levels fell 26% in the combined birth control and Zocor patients and 28% in the birth control alone group.
PCOS patients can also show abnormal patterns in pituitary hormones luteinizing hormone (LH) and follicle stimulating hormone (FSH). In most healthy women, their levels of FSH and LH are about the same. PCOS patients, on the other hand, will sometimes have elevated LH levels and consequently an elevated LH to FSH ratio. In this study of PCOS patients, the group that was receiving birth control pills alone had a reduction of LH of about 9%. The group that also took Zocor had a 43% in the LH levels. As a result, the LH:FSH ratio declined significantly in the combined group (44%) but fell by only 12% in the birth control group.
As expected, the Zocor group showed improved cholesterol levels. Total cholesterol was 10% lower with the addition of Zocor. Using birth control pills alone, the total cholesterol rose by 8%. Low-density lipoprotein (LDL) cholesterol dropped by 24% in the Zocor patients, but stayed the same in the birth control patients. Zocor did not have a beneficial effect on triglycerides. This makes sense since triglyceride levels can be elevated due to insulin resistance in PCOS patients and Zocor did nothing to improve insulin resistance.
Conclusions Based on the results of this study, women with PCOS, especially those with high cholesterol should be offered treatment with statins. PCOS patients are known to bat greater risk for developing heart disease. It is important to try to decrease as many risk factors as possible.
However, women who are attempting pregnancy should not take statins.
I wonder, how would Zocor work for a woman who has high testosterone but not terribly high cholesterol (and no signs of developing it)? Would it work the same way as giving a non-IR woman Metformin?
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I wonder, how would Zocor work for a woman who has high testosterone but not terribly high cholesterol (and no signs of developing it)? Would it work the same way as giving a non-IR woman Metformin?
Good question. I wasn't able to gain access to the full studies online, but below I've posted the abstracts to the studies, along with the contact information for one of the lead researchers who is designated as the contact for the full study. If someone gets in contact, please ask them to send in in PDF form, so we can post it here.
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Effects of Simvastatin and Oral Contraceptive Agent on Polycystic Ovary Syndrome: Prospective, Randomized, Crossover Trial
The Journal of Clinical Endocrinology & Metabolism Vol. 92, No. 2 456-461
Beata Banaszewska, Leszek Pawelczyk, Robert Z. Spaczynski, James Dziura and Antoni J. Duleba
Department of Gynecology/Obstetrics (B.B., L.P., R.Z.S.), Poznan University of Medical Sciences, 60-535 Poznan, Poland; and Departments of Epidemiology and Public Health (J.D.), and Obstetrics and Gynecology (A.J.D.), Yale University School of Medicine, New Haven, Connecticut 06520
Address all correspondence and requests for reprints to: Antoni J. Duleba, Yale University School of Medicine, Department of Obstetrics and Gynecology, 333 Cedar Street, New Haven, Connecticut 06510. E-mail: antoni.duleba@yale.edu.
Context: Polycystic ovary syndrome (PCOS) is associated with hyperandrogenism and cardiovascular risks including dyslipidemia and systemic inflammation. In vitro, statins decrease proliferation and steroidogenesis of ovarian theca-interstitial cells.
Objective: The study objective was to compare effects of two treatments of PCOS: simvastatin plus oral contraceptive pill (OCP) vs. OCP alone.
Design: In a prospective, crossover trial, 48 women with PCOS were randomized to either simvastatin plus OCP for 12 wk followed by OCP alone for an additional 12 wk, or to OCP alone for 12 wk and, subsequently, simvastatin plus OCP for an additional 12 wk. Evaluations were performed at baseline, after 12 wk (crossover), and after 24 wk. Data were analyzed using a random effects model.
Setting: The study was conducted in an academic medical center.
Primary Outcome: Serum total testosterone was the primary outcome measure.
Results: Total testosterone decreased by 38% after Statin + OCP, whereas OCP alone led to a 26% decrease; the statin-attributable effect was significant (P < 0.004). Free testosterone declined by 58% after Statin + OCP, significantly more than the 35% decline after OCP alone (P = 0.006).
Hirsutism decreased by 8.1% after Statin + OCP, a greater effect than the 4.7% decrease after OCP alone (P = 0.02).
Statin decreased LH, but not FSH or prolactin. Statin + OCP decreased total and low-density lipoprotein cholesterol by 7.5% and 20%, respectively. OCP alone led to a 5% increase of total cholesterol without effect on low-density lipoprotein cholesterol. Statin prevented OCP induced increase of triglycerides. C-reactive protein decreased by 45% after Statin + OCP, a significantly different effect (P = 0.006) than a 6% increase after OCP alone. Soluble vascular cell adhesion molecule 1 decreased by 18% after Statin + OCP, a greater decline than the 10% decrease after OCP alone (P = 0.01).
Conclusions: Simvastatin improved endocrine/clinical aspects of PCOS and had beneficial effects on lipid profile and markers of systemic inflammation.
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Simvastatin improves biochemical parameters in women with polycystic ovary syndrome: results of a prospective, randomized trial.
Duleba AJ, Banaszewska B, Spaczynski RZ, Pawelczyk L.
Department of Obstetrics and Gynecology, Yale University School of Medicine, New Haven, Connecticut 06520-8063, USA. antoni.duleba@yale.edu
OBJECTIVE: To test the hypothesis that statins improve hyperandrogenemia in women with polycystic ovary syndrome (PCOS). DESIGN: Prospective, randomized trial.
SETTING: Academic medical center.
PATIENT(S): Forty-eight women with PCOS.
INTERVENTION(S): Subjects were randomized to a statin group (simvastatin, 20 mg daily plus oral contraceptive pill [OCP]; n = 24) or an OCP group (OCP alone; n = 24).
MAIN OUTCOME MEASURE(S): Serum T. RESULT(S): Baseline parameters of both groups were comparable. After 12 weeks of treatment, serum T levels declined by 41% in the statin group and by 14% in the OCP group. In the statin group, there was a greater decrease of LH (43% decrease vs. 9% in the OCP group) and a greater decline of LH/FSH ratio (44% vs. 12%). In the statin group, total cholesterol declined by 10% and low-density lipoprotein (LDL) by 24%. In the OCP group, total cholesterol increased by 8%, and LDL was unchanged.
CONCLUSION(S): This is the first study demonstrating that statin decreases T levels and normalizes gonadotropin levels in women with PCOS. Statin therapy might offer a novel approach, providing endocrine and cardiovascular benefits.
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Androgen and lipid profiles in adolescents with polycystic ovary syndrome who were treated with two forms of combined oral contraceptives.
Mastorakos G, Koliopoulos C, Creatsas G.
2nd Department of Obstetrics and Gynecology, University of Athens, Aretaieion Hospital, Athens, Greece. mastorak@mail.kapatel.gr
OBJECTIVE: To compare the effects of cyproterone acetate and desogestrel, as part of combined oral contraceptives, on lipid metabolism and hirsutism of adolescents with polycystic ovary syndrome (PCOS).
DESIGN: Prospective randomized clinical trial.
SETTING: Outpatient gynecology clinic (referral center) of a university.
PATIENT(S): Twenty-eight adolescent girls with clinical and biological hyperandrogenism and six or less menses during the past 12 months.
INTERVENTION(S): Group A (n = 14) received 0.15 mg of desogestrel plus 0.030 mg of ethinyl estradiol daily. Group B (n = 14) received 2 mg of cyproterone acetate plus 0.035 mg of ethinyl estradiol daily. Treatment was given for 21 days followed by a 7-day rest for a period of 12 months.
MAIN OUTCOME MEASURE(S): Hirsutism and lipid profile were evaluated before initiation and at 3, 6, 9, and 12 months of treatment. Androgen profile was evaluated before and at 12 months of treatment.
RESULT(S): A significant decline of the Ferriman-Gallway hirsutism score was observed from the sixth month of therapy in both groups. During therapy, the levels of testosterone, free testosterone, Delta(4)-androstenedione, and 17OH-progesterone decreased significantly, whereas sex hormone-binding globulin (SHBG) increased significantly in both groups. The level of total cholesterol and low density lipoprotein (LDL) cholesterol increased significantly, whereas high density lipoprotein (HDL) cholesterol and apolipoprotein A-I increased significantly from the third month of therapy in both groups. Total cholesterol/HDL cholesterol and LDL cholesterol/HDL cholesterol ratios remained unchanged. The levels of triglycerides increased significantly in the cyproterone acetate-treated group after the third month.
CONCLUSION(S): Treatment of adolescent girls with PCOS with the two studied formulations is comparably effective in decreasing hirsutism and androgen levels. Both combined oral contraceptives are associated with an increase of total cholesterol, LDL cholesterol, and HDL cholesterol levels and no change of the total cholesterol/HDL cholesterol and LDL cholesterol/HDL cholesterol ratios. Treatment with the cyproterone acetate combined oral contraceptive is associated with a tendency toward increasing the levels of triglycerides.
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Thanks! Do you mind putting it in the Child/Adolecent/Teen Articles Links Thread when you get a chance? I'm going to post a link to this thread on the support thread.