Metformin and/or Clomiphene Do Not Adversely Affect Liver or Renal Function in Women with Polycystic Ovary Syndrome
Year: 2011
Type: article
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.
DOI: 10.1210/jc.2011-1093
Authors: 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, for the Reproductive Medicine Network
Institutions: University of Missouri, Pennsylvania State University, University of Colorado Denver, Wayne State University, University of Pennsylvania, Baylor College of Medicine, University of Alabama, University of Alabama at Birmingham, The University of Texas Southwestern Medical Center, Rutgers, The State University of New Jersey, University of Medicine and Dentistry of New Jersey, Stanford University, University of Pittsburgh, Virginia Commonwealth University, Virginia Commonwealth University Medical Center, Duke University, Duke Medical Center, Duke Clinical Research Institute
Language: English
Subfield: Reproductive Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: Yale University, Kaiser Permanente, Wayne State University, University of Pennsylvania, University of Pittsburgh, Virginia Commonwealth University, National Institutes of Health, University of California, San Diego, National Institute of Child Health and Human Development, National Center for Research Resources, Eunice Kennedy Shriver National Institute of Child Health and Human Development
Awards: COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORK, COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORK, GHSU/WSU Cooperative Reproductive Medicine Network, COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORK, G2315977476, Colorado Reproductive Medicine Unit, G3214197136, GCRC RELOCATION AND EXPANSION PROJECT, General Clinical Research Center, General Clinical Research Center, Data Coordination Center for the RMN, COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORK, Cooperative Multicenter Reproductive Medicine Network, G745658556, The Utility of Empiric Medical Treatment of Infertile Oligo-asthenospermic Men, A RCT of preconception weight loss vs. OCP in overweight infertile PCOS women, Cooperative Multicenter Reproductive Medicine Network
OpenAlex ID: W1997739609