title: Short term monotherapy with GLP-1 receptor agonist liraglutide or PDE 4 inhibitor roflumilast is superior to metformin in weight loss in obese PCOS women: a pilot randomized study.
abstract: OBJECTIVE
  To evaluate whether liraglutide or roflumilast significantly affects body weight when compared to metformin in obese women with PCOS.
  A 12-week prospective randomized open-label study was conducted with 45 obese women with PCOS diagnosed by the ASRM-ESHRE Rotterdam criteria. They were randomized to metformin (MET) 1000 mg BID or liraglutide (LIRA) 1.2 mg QD s.c. or roflumilast (ROF) 500 mcg QD. The primary outcome was change in measures of obesity.
  
  
  RESULTS
  Forty-one patients (aged 30.7 ± 7.9 years, BMI 38.6 ± 6.0 kg/m2, mean ± SD) completed the study. Subjects treated with LIRA lost on average 3.1 ± 3.5 kg (p = 0.006), on ROF 2.1 ± 2.0 kg (p = 0.002) vs. 0.2 ± 1.83 kg in MET group. BMI decreased for 1.1 ± 1.26 kg/m2 in LIRA (p = 0.006), for 0.8 ± 0.99 kg/m2 in ROF (p = 0.001) vs. 0.1 ± 0.67 kg/m2 in MET. LIRA was superior to MET in reducing weight (p = 0.022), BMI (p = 0.020), waist circumference (p = 0.007). LIRA also resulted in decrease in VAT area (p = 0.015) and more favorable dynamics in glucose homeostasis during OGTT. ROF resulted in reduction of waist circumference (p = 0.023). In addition, ROF led to testosterone reduction (p = 0.05) and increase in menstrual frequencies (p = 0.009) when compared to baseline.
  
  
  CONCLUSIONS
  Short-term monotherapy with liraglutide or roflumilast was associated with significant weight loss in obese PCOS. Liraglutide was superior to metformin, whereas roflumilast resulted in greater, yet not statistically significant, mean weight loss when compared to metformin. Reduction of body weight with liraglutide resulted in improvement of body composition.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02187250 .
authors.affiliation: Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Ljubljana, Zaloska 7, SI-1000, Ljubljana, Slovenia.
authors.forename: Mojca
authors.initials: M
authors.lastname: Jensterle
authors.affiliation: Department of Obstetrics and Gynecology, Reproductive Unit, University Medical Centre Ljubljana, Zaloska 7, 1525, Ljubljana, Slovenia.
authors.forename: Vesna
authors.initials: V
authors.lastname: Salamun
authors.affiliation: Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Ljubljana, Zaloska 7, SI-1000, Ljubljana, Slovenia.
authors.forename: Tomaz
authors.initials: T
authors.lastname: Kocjan
authors.affiliation: Department of Obstetrics and Gynecology, Reproductive Unit, University Medical Centre Ljubljana, Zaloska 7, 1525, Ljubljana, Slovenia.
authors.forename: Eda
authors.initials: E
authors.lastname: Vrtacnik Bokal
authors.affiliation: Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Ljubljana, Zaloska 7, SI-1000, Ljubljana, Slovenia. andrej.janez@kclj.si.
authors.forename: Andrej
authors.initials: A
authors.lastname: Janez
mesh_terms: D000328:Adult; D000631:Aminopyridines / Q000008:administration & dosage*; D001549:Benzamides / Q000008:administration & dosage*; D054703:Cyclic Nucleotide Phosphodiesterases, Type 4 / Q000378:metabolism; D003521:Cyclopropanes / Q000008:administration & dosage; D005260:Female; D000067757:Glucagon-Like Peptide-1 Receptor / Q000037:antagonists & inhibitors / Q000378:metabolism; D006801:Humans; D000069450:Liraglutide / Q000008:administration & dosage*; D008687:Metformin / Q000008:administration & dosage; D009765:Obesity / Q000150:complications / Q000188:drug therapy* / Q000235:genetics; D058988:Phosphodiesterase 4 Inhibitors / Q000008:administration & dosage; D011085:Polycystic Ovary Syndrome / Q000150:complications / Q000188:drug therapy* / Q000235:genetics; D015431:Weight Loss / Q000187:drug effects
chemical_list: D000631:Aminopyridines; D001549:Benzamides; D003521:Cyclopropanes; D000067757:Glucagon-Like Peptide-1 Receptor; D058988:Phosphodiesterase 4 Inhibitors; C424423:Roflumilast; D000069450:Liraglutide; D008687:Metformin; D054703:Cyclic Nucleotide Phosphodiesterases, Type 4