Licogliflozin versus Placebo in Women with Polycystic Ovary Syndrome (PCOS): A Randomised, Double-Blind, Phase 2 Trial

2021 ◽  
Author(s):  
Susanne Tan ◽  
Stanislav Ignatenko ◽  
Frank Wagner ◽  
Anuja Dokras ◽  
Jochen Seufert ◽  
...  
2008 ◽  
Vol 89 (5) ◽  
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Author(s):  
Åsa Lindholm ◽  
Marie Bixo ◽  
Inger Björn ◽  
Pål Wölner-Hanssen ◽  
Mats Eliasson ◽  
...  

2011 ◽  
Vol 95 (5) ◽  
pp. 1849-1852 ◽  
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Nazia Raja-Khan ◽  
Allen R. Kunselman ◽  
Cynthia S. Hogeman ◽  
Christy M. Stetter ◽  
Laurence M. Demers ◽  
...  

2010 ◽  
Vol 56 (11) ◽  
pp. 1696-1700 ◽  
Author(s):  
Thozhukat Sathyapalan ◽  
John Shepherd ◽  
Charlotte Arnett ◽  
Anne-Marie Coady ◽  
Eric S Kilpatrick ◽  
...  

BACKGROUND It has been shown that many women with polycystic ovary syndrome (PCOS) are 25-hydroxyvitamin D (25OHD) insufficient. Both statin treatment and vitamin D supplementation have been shown to improve biochemical hyperandrogenemia, insulin resistance, and markers of inflammation in patients with PCOS, raising the possibility that some of the statin effects are mediated through vitamin D. METHODS We conducted this randomized, double-blind placebo controlled study to assess the effect of atorvastatin on serum 25OHD concentrations in patients with PCOS. Forty medication-naive patients with PCOS were randomized to either atorvastatin 20 mg daily or placebo for 3 months. After completing the initial 3 months of atorvastatin or placebo, both groups of patients participated in a 3-month extension study with metformin 1500 mg daily. We measured changes in 25OHD concentrations by use of tandem mass spectrometry. RESULTS Mean (SD) baseline 25OHD concentrations were comparable between the 2 groups [45.9 (2.4) vs 44.8 (1.8) nmol/L; P = 0.7]. There was a significant increase in 25OHD concentrations with atorvastatin [45.9 (2.4) vs 60.8 (3.5) nmol/L] compared with placebo [44.8 (1.8) vs 41.8 (3.2) nmol/L; P = 0.02]. Three-month treatment with metformin maintained the improvement of 25OHD with atorvastatin compared to baseline [45.9 (2.4) vs 61.8 (3.5), P ≤ 0.01). There were no significant changes in 25OHD concentrations in the placebo group after 12 weeks of metformin. CONCLUSIONS Among patients with polycystic ovary syndrome, 12 weeks of atorvastatin led to a clinically significant rise in 25OHD concentrations. This may represent a beneficial pleiotropic effect of statins on 25OHD concentrations.


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