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.
RCT Entities:
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 PCOSpatients. 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 ureanitrogen 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.
Authors: Trevor J Orchard; Marinella Temprosa; Ronald Goldberg; Steven Haffner; Robert Ratner; Santica Marcovina; Sarah Fowler Journal: Ann Intern Med Date: 2005-04-19 Impact factor: 25.391
Authors: Richard S Legro; Evan R Myers; Huiman X Barnhart; Sandra A Carson; Michael P Diamond; Bruce R Carr; William D Schlaff; Christos Coutifaris; Peter G McGovern; Nicholas A Cataldo; Michael P Steinkampf; John E Nestler; Gabriella Gosman; Linda C Guidice; Phyllis C Leppert Journal: Fertil Steril Date: 2006-09-11 Impact factor: 7.329
Authors: Nora E Straznicky; Mariee T Grima; Elisabeth A Lambert; Nina Eikelis; Tye Dawood; Gavin W Lambert; Paul J Nestel; Kazuko Masuo; Carolina I Sari; Reena Chopra; Justin A Mariani; Markus P Schlaich Journal: J Hypertens Date: 2011-03 Impact factor: 4.844
Authors: William C Knowler; Elizabeth Barrett-Connor; Sarah E Fowler; Richard F Hamman; John M Lachin; Elizabeth A Walker; David M Nathan Journal: N Engl J Med Date: 2002-02-07 Impact factor: 91.245
Authors: Richard S Legro; Huiman X Barnhart; William D Schlaff; Bruce R Carr; Michael P Diamond; Sandra A Carson; Michael P Steinkampf; Christos Coutifaris; Peter G McGovern; Nicholas A Cataldo; Gabriella G Gosman; John E Nestler; Linda C Giudice; Phyllis C Leppert; Evan R Myers Journal: N Engl J Med Date: 2007-02-08 Impact factor: 91.245
Authors: Tracy L Setji; Nicole D Holland; Linda L Sanders; Kathy C Pereira; Anna Mae Diehl; Ann J Brown Journal: J Clin Endocrinol Metab Date: 2006-02-21 Impact factor: 5.958
Authors: A L L Rocha; L C Faria; T C M Guimarães; G V Moreira; A L Cândido; C A Couto; F M Reis Journal: J Endocrinol Invest Date: 2017-06-13 Impact factor: 4.256