title: The Effect of Eighteen-Month Metformin Treatment in Obese Adolescents: Comparison of Results Obtained in Daily Practice with Results from a Clinical Trial.
abstract: Background. In a recent randomized controlled trial (RCT) in obese adolescents, 18 month-treatment with metformin versus placebo was reported to lead to stabilisation of the BMI. This study aimed to compare the effect of metformin on BMI in obese adolescents in daily practice versus results obtained in an RCT.Methods. Obese adolescents treated off label with metformin in daily practice in an outpatient clinic with a follow-up of ≥18 months were identified. Anthropometric and biochemical data were collected at baseline and at 18 months. Patients treated with metformin for 18 months in an RCT were used for comparison. BMI was compared between the two groups.Results. Nineteen patients (median age 14.3 (interquartile range 11.7-15.7) years, BMI 31.3 (28.8-33.8) kg/m2) treated in daily practice were compared to 23 patients receiving metformin in the RCT (age 13.6 (12.6-15.3) years, BMI 29.8 (28.1-34.5) kg/m2). BMI change after 18 months was -0.36 (-2.10-1.58) versus +0.22 (-2.87-1.27) kg/m2for the two groups, respectively. In the multivariable model, BMI change was not statistically significantly different between the two groups (p= 0.61).Conclusion. Treatment with metformin in obese adolescents in daily practice resulted in a comparable change in BMI as observed in an RCT. This trial is registered with ClinicalTrials.gov number: NCT01487993.
authors.affiliation: Department of Pediatrics, St. Antonius Hospital, Nieuwegein/Utrecht, P.O. Box 2500, 3430 EM Nieuwegein, Netherlands.
authors.forename: Marloes P
authors.identifier: 0000-0001-8789-4331
authors.initials: MP
authors.lastname: van der Aa
authors.affiliation: Department of Pediatrics, St. Antonius Hospital, Nieuwegein/Utrecht, P.O. Box 2500, 3430 EM Nieuwegein, Netherlands.
authors.forename: Vera
authors.initials: V
authors.lastname: Hoving
authors.affiliation: Department of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein/Utrecht, P.O. Box 2500, 3430 EM Nieuwegein, Netherlands.
authors.forename: Ewoudt M W
authors.initials: EM
authors.lastname: van de Garde
authors.affiliation: Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, P.O. Box 80082, 3508 TB Utrecht, Netherlands.
authors.forename: Antonius
authors.initials: A
authors.lastname: de Boer
authors.affiliation: Department of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein/Utrecht, P.O. Box 2500, 3430 EM Nieuwegein, Netherlands.
authors.forename: Catherijne A J
authors.initials: CA
authors.lastname: Knibbe
authors.affiliation: Department of Pediatrics, St. Antonius Hospital, Nieuwegein/Utrecht, P.O. Box 2500, 3430 EM Nieuwegein, Netherlands.
authors.forename: Marja M J
authors.identifier: 0000-0001-9581-3044
authors.initials: MM
authors.lastname: van der Vorst
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior; D002648:Child; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000627:therapeutic use*; D018579:Patient Selection; D063766:Pediatric Obesity / Q000188:drug therapy* / Q000378:metabolism; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents; D008687:Metformin