Table 1.
Simvastatin Use in PCOS
| Author/ (Year) | N (average age +/- SD)/ Study Design/ Duration | Meds Used | Cholesterol Outcomes | Other Findings | Labs |
|---|---|---|---|---|---|
| Duleba AJ, et al.15 (2006) | 48 PCOS women (statin group: 24 +/- 0.7; OCP group: 23.8 +/- 0.8), prospective randomized trial, 12 week study | Simvastatin (Sim) + OCP vs. OCP alone | -TC decreased by 10% vs. an 8% increase -LDL decreased by 24% vs. a 3% increase -HDL increased by 9% vs. 13% -TG increased by 5% vs. 21% |
-Serum T levels decreased by 41% vs. 14% (p=0.006) -LH/FSH decreased by 44% vs. 12% (p=.02) -LH level decreased by 43% vs. 9% (p=0.02) -Ferriman-Gallweyhirsutism score declined by 0.25+/- 0.1 points (p=0.03) vs. 0.13 +/- 0.09 (P=0.2) |
Serum T, LH, FSH, and prolactin levels, sex hormone-binding globulin, DHEAS, TC, TG, LDL |
| Banaszewska B, et al.16 (2007) Crossover study of Duleba AJ, et al.15 (2006) |
48 PCOS women (statin group: 24 +/- 0.7; OCP group: 23.8 +/- 0.8), prospective crossover randomized trial, 12 week study | Sim (+OCP) vs. OCP alone (evaluated a total of 24 weeks of both crossover arms) |
-TC and LDL decreased by 7.5% and 20%, respectively in statin group -OCP alone increased TC by 5% and no effect on LDL -Increases of HDL comparable in both groups -TG’s remained unchanged after -Statin + OCP group but increased 20% after OCP alone |
-Total T decreased by 38% vs. 26% (p=0.004) -Free T decreased by 58% vs. 35% (p=0.006) -Ferriman-Gallweyhirsutism score decreased by 8.1% vs. 4.7% (p=0.02) -LH decreased by 37% vs. 18% (p=0.002) -LH:FSH decreased by 40% vs. 25% (p=0.01) -High sensitivity-CRP decreased by 45% vs. 6% (p=0.006) |
Total T, free T, TC, TG, HDL, LDL, hs-CRP, LH, FSH, LS:FSH, prolactin |
| Banaszewska B, et al.17 (2009) | 113 PCOS women (Sim group: 26.1 +/- 0.6; Metformin (Met) group: 25.2 +/- 0.7; Sim +Met group: 24.7 +/- 0.6), prospective randomized trial, 3 month study | Sim, Met, or Sim + Met (Sim Met) |
-LDL decreased by 32% (Sim) and 40% (Sim Met) vs. a 2.1% increase (Met) -TC decreased by 20.6% (Sim) and 24% (Sim Met) vs. a 3.4% increase (Met) -TG decreased by 6.3% (Sim) and 22.7% (Sim Met) vs. a 0.6% increase (Met) |
-Total T decreased in all groups – 16.3% (Sim) (p<0.001), 13.6% (Met) (p<0.01) and 15.1% (Sim Met) (p<0.001) -Free T decreased in all groups – 13.5% (Sim) (p<0.001), 13.1% (Met) (p=0.02) and 11.1% (Sim Met) (p<0.01) -Ferriman-Gallweyhirsutism score decreased by 1.8% (Sim Met) (p=0.03) vs.1.7% (Sim) (p=0.06) and 3.7% (Met) (p=0.06) -Hs-CRP decreased in all groups -34% (Sim) (p<0.01), 52% (Met) (p<0.01) and 47% (Sim Met) (p=0.01) -Insulin decreased by 17.4% (Sim) (p<0.01) vs. 5.4% (Met) (p=0.38) and 13.1% (SimMet) (p=0.15) & insulin sensitivity increased by 14% (Sim) (p<0.01) vs. 6.3% (Met) (p=0.4) |
Total T, fasting insulin, insulin sensitivityCRP, DHEAS, LH, FSH, TC, LDL, BMI |
| Banaszewska B, et al.18 (2011) Extension study from Banaszewska B, et al.17 (2009) |
139 PCOS women (Sim group: 26.3 +/- 0.6; Met group: 26 +/- 0.6; Sim +Met group: 25.3 +/- 0.6), prospective randomized trial, 6 month study | Simvastatin (Sim), metformin (Met), or simvastatin + metformin (Sim Met) |
-LDL decreased by 31.6% (Sim) and 31.9% (Sim Met) vs. a 2.4% increase (Met) -TC decreased by 18.9% (Sim and Sim Met) vs. a 2.8% increase (Met) -TG decreased by 15% (Sim Met) vs. a 17.5% increase (Met) and a non-significant decrease in Sim -TC and LDL declined in subjects receiving Sim during first 3 months of treatment, with no significant change during next 3 months |
-Volume of ovaries decreased by 14.1% (Sim) (p<0.0001) and 7.3% (Sim Met) (p=0.04) vs 5.4% (Met) (p=0.06), with no change from 3 to 6 months in Met group -Number of spontaneous menses increased 71.3% (Sim) vs. 33.1% (Met) (p=0.03) and 73.3% (Sim Met) vs. 33.1% (Met) (p=0.02) -Total T decreased in all groups – 25.6% (Sim) (p<0.0001), 25.6% (Met) (p<0.0001) and 20.1% (Sim Met) (p<0.0001) -Free T decreased in all groups – 20.3% (Sim) (p<0.0001), 23.2% (Met) (p<0.0001) and 17.5% (Sim Met) (p=0.003) -Ferriman-Gallweyhirsutism score decreased in all groups – 12% (Sim) (p<0.0001), 8.9% (Met) (p<0.0001) and 11.7% (Sim Met) (p<0.0001) -Fasting insulin decreased only in Sim Met by 20.9% (p=0.02) vs. an increase of 11.1% (Met) |
Insulin, total and free testosterone, LH, FSH, prolactin, SHBG, DHEAS, change in total serum cholesterol, TG, HDL, LDL, hs-CRP |
| Kazerooni T, et al.19 (2010) | 84 PCOS women (Met + Sim group: 25.6 +/- 4.23; Met + placebo group: 24.9 +/- 5.81), prospective randomized double-blind placebo-controlled, 12 week study | Met (500mg 3x daily) + Sim vs. Met (500mg 3x daily) + placebo | -TC decreased by 29.5% vs 4.2% -HDL increased by14% vs. 1% decrease -LDL decreased by 18.5% vs. 1.5% -TG decreased by 32% vs. 5.3% |
-Total T decreased by 25.5% vs. 16.8% (p<0.001) -LH decreased by 46% vs. 10% (p=0.001) -LH:FSH ratio decreased by 38% vs. increased by 4% (p=0.009) -Ferriman-Gallweyhirsutism score decreased by 13% vs. 7% (p=0.019) |
Total T, serum LH, FSH, PRL, DHEAS, TC, fasting blood sugar, fasting insulin, TC, HDL, LDL, TG |
| Krysiak R, et al.20 (2014) | 14 PCOS women (ezetimibe group: 37 +/- 4; Sim group: 38 +/- 3), comparison study, 90 day study | Ezetimibe 10mg daily vs. Sim 40mg daily | -TC decreased by 21% vs. 23% LDL decreased by 29% vs. 24% -Neither group showed significantly altered levels of TG and HDL |
Total T decreased by 23% vs. 7% (p<0.01) Free T decreased by 32% vs.14% (p<0.01) |
Total T, free T, DHEAS, androstenedione, LH/FSH ratio, SHBG, prolactin, serum FSH and LH, LDL, TC, TG |
BMI, body mass index; CV, cardiovascular; DHEAS, dehydroepiandrosterone sulfates; FSH, follicle stimulating hormone; HDL, high density lipoprotein; hs-CRP, high sensitivity C-reactive protein; LDL, low density lipoprotein; LH, luteinizing hormone; M, mean; Met, Metformin; OCP, oral contraceptive; Sim, Simvastatin; T, testosterone; TC, total cholesterol; TG, triglyceride.