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Effects of simvastatin and metformin on polycystic ovary syndrome after six months of treatment.

ABSTRACT: A randomized trial on women with polycystic ovary syndrome (PCOS) compared simvastatin, metformin, and a combination of these drugs.The aim of the study was to evaluate long-term effects of simvastatin and metformin on PCOS.Women with PCOS (n = 139) were randomized to simvastatin (S), metformin (M), or simvastatin plus metformin (SM) groups. Evaluations were performed at baseline and at 3 and 6 months.The study was conducted at a university medical center.We measured the change of serum total testosterone.Ninety-seven subjects completed the study. Total testosterone decreased significantly and comparably in all groups: by 25.6, 25.6, and 20.1% in the S, M, and SM groups, respectively. Both simvastatin and metformin improved menstrual cyclicity and decreased hirsutism, acne, ovarian volume, body mass index, C-reactive protein, and soluble vascular cell adhesion molecule-1. Dehydroepiandrosterone sulfate declined significantly only in the S group. Total cholesterol and low-density lipoprotein cholesterol significantly declined only in the S and SM groups. Ongoing reduction of ovarian volume, decreased hirsutism, acne and testosterone were observed between 0 and 3 months as well as between 3 and 6 months. Improvement of lipid profile, C-reactive protein, and soluble vascular cell adhesion molecule-1 occurred only during the first 3 months of treatment, with little change thereafter. Treatments were well tolerated, and no significant adverse effects were encountered.Long-term treatment with simvastatin was superior to metformin. Improvement of ovarian hyperandrogenism continued throughout the duration of the study.

SUBMITTER: Banaszewska B

PROVIDER: S-EPMC3205889 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature

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Effects of simvastatin and metformin on polycystic ovary syndrome after six months of treatment.

Banaszewska Beata B Pawelczyk Leszek L Spaczynski Robert Z RZ Duleba Antoni J AJ

The Journal of clinical endocrinology and metabolism 20110824 11

<h4>Context</h4>A randomized trial on women with polycystic ovary syndrome (PCOS) compared simvastatin, metformin, and a combination of these drugs.<h4>Objective</h4>The aim of the study was to evaluate long-term effects of simvastatin and metformin on PCOS.<h4>Design</h4>Women with PCOS (n = 139) were randomized to simvastatin (S), metformin (M), or simvastatin plus metformin (SM) groups. Evaluations were performed at baseline and at 3 and 6 months.<h4>Setting</h4>The study was conducted at a u ...[more]

PMID: 21865358

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Project description:BackgroundObesity and insulin resistance (IR) are common features of polycystic ovary syndrome (PCOS). Metformin (MET) increases insulin sensitivity, but it is associated with unsatisfactory weight loss. The glucagon-like peptide-1 receptor agonist exenatide has been shown to reduce weight and IR in patients with diabetes. This study aimed to explore the therapeutic effects of exenatide once-weekly (QW) combined with MET on body weight, as well as metabolic and endocrinological parameters in overweight/obese women with PCOS.MethodsFifty overweight/obese women with PCOS diagnosed via the Rotterdam criteria were randomized to one of two treatment groups: MET (500 mg three times a day [TID]) or combination treatment (COM) (MET 500 mg TID, exenatide 2 mg QW) for 12 weeks. The primary outcomes were anthropometric changes associated with obesity, and the secondary outcomes included changes in reproductive hormone levels, glucose and lipid metabolism, and C-reactive protein.ResultsForty (80%) patients completed the study. COM therapy was superior to MET monotherapy in reducing weight (P = 0.045), body mass index (BMI) (P = 0.041), and waist circumference (P = 0.023). Patients in the COM group on an average lost 3.8 ± 2.4 kg compared with 2.1 ± 3.0 kg in the MET group. In the COM group, BMI and waist circumference decreased by 1.4 ± 0.87 kg/m2 and 4.63 ± 4.42 cm compared with 0.77 ± 1.17 kg/m2 and 1.72 ± 3.07 cm in the MET group, respectively. Moreover, levels of fasting glucose, oral glucose tolerance test (OGTT) 2-h glucose, and OGTT 2-h insulin were significantly lower with COM therapy than with MET (P < 0.050). Mild and moderate gastrointestinal reactions were the most common adverse events in both groups.ConclusionsCOM therapy was more effective than MET alone in reducing body weight, BMI, and waist circumference, and improving insulin sensitivity in overweight/obese women with PCOS, with acceptable short-term side effects.Trial registrationClinicalTrials.gov, NCT04029272. https://clinicaltrials.gov/ct2/show/NCT04029272.

Dataset Information

Effects of simvastatin and metformin on polycystic ovary syndrome after six months of treatment.

Publications

Effects of simvastatin and metformin on polycystic ovary syndrome after six months of treatment.

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