Metformin and/or clomiphene do not adversely affect liver or renal function in women with polycystic ovary syndrome
Mira Aubuchon, Allen R Kunselman, William D Schlaff, Michael P Diamond, Christos Coutifaris, Sandra A Carson, Michael P Steinkampf, Bruce R Carr, Peter G McGovern, Nicholas A Cataldo, Gabriella G Gosman, John E Nestler, Evan R Myers, Richard S Legro, Reproductive Medicine Network, K Barnhart Jr, L Mastroianni, L Martino, K Timbers, L Lambe, R DeWire, H Yang, C Bodine, D Mark, E Puscheck, K Ginsburg, K Collins, R Leach, F Yelian, M Perez, J Buster, P Amato, M Torres, W C Dodson, C Gnatuk, J Ober, L Demers, D Heller, J Colon, G Weiss, A Solnica, K Gatlin, S Hahn, M Roark, R Blackwell, V Willis, L Love, K Laychak, M Nazmy, D Stovall, W Evans, K Turner, L Giudice, J Chang, P Malcolm, C Coddington, K Faber, P Leppert, P Casson, H Zhang, Mira Aubuchon, Allen R Kunselman, William D Schlaff, Michael P Diamond, Christos Coutifaris, Sandra A Carson, Michael P Steinkampf, Bruce R Carr, Peter G McGovern, Nicholas A Cataldo, Gabriella G Gosman, John E Nestler, Evan R Myers, Richard S Legro, Reproductive Medicine Network, K Barnhart Jr, L Mastroianni, L Martino, K Timbers, L Lambe, R DeWire, H Yang, C Bodine, D Mark, E Puscheck, K Ginsburg, K Collins, R Leach, F Yelian, M Perez, J Buster, P Amato, M Torres, W C Dodson, C Gnatuk, J Ober, L Demers, D Heller, J Colon, G Weiss, A Solnica, K Gatlin, S Hahn, M Roark, R Blackwell, V Willis, L Love, K Laychak, M Nazmy, D Stovall, W Evans, K Turner, L Giudice, J Chang, P Malcolm, C Coddington, K Faber, P Leppert, P Casson, H Zhang
Abstract
Context: Nonalcoholic fatty liver disease is common to insulin-resistant states such as polycystic ovary syndrome (PCOS). Metformin (MET) is often used to treat PCOS but information is limited as to its effects on liver function.
Objective: We sought to determine the effects of MET on serum hepatic parameters in PCOS patients.
Design: This was a secondary analysis of a randomized, doubled-blind trial from 2002-2004.
Setting: This multi-center clinical trial was conducted in academic centers.
Patients: Six hundred twenty-six infertile women with PCOS with serum liver function parameters less than twice the upper limit of normal were included.
Interventions: Clomiphene citrate (n = 209), MET (n = 208), or combined (n = 209) were given for up to 6 months.
Main outcome measure: The percent change from baseline in renal and liver function between- and within-treatment arms was assessed.
Results: Renal function improved in all treatment arms with significant decreases in serum blood urea nitrogen levels (range, -14.7 to -21.3%) as well as creatinine (-4.2 to -6.9%). There were similar decreases in liver transaminase levels in the clomiphene citrate and combined arms (-10% in bilirubin, -9 to -11% in transaminases) without significant changes in the MET arm. When categorizing baseline bilirubin, aspartate aminotransferase, and alanine aminotransferase into tertiles, there were significant within-treatment arm differences between the tertiles with the highest tertile having the largest decrease from baseline regardless of treatment arm.
Conclusion: Women with PCOS can safely use metformin and clomiphene even in the setting of mildly abnormal liver function parameters, and both result in improved renal function.
Trial registration: ClinicalTrials.gov NCT00068861.
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Source: PubMed