title: Correlation between baseline characteristics and clinical outcomes in a large population of diabetes patients treated with liraglutide in a real-world setting in Italy.
abstract: OBJECTIVE
  Treatment with liraglutide in randomized controlled trials is associated with significant reductions in glycated hemoglobin (HbA1c) and weight loss in type 2 diabetes patients. The aim of this retrospective observational study was to investigate correlations of glycemic control and weight outcomes with baseline characteristics of patients starting liraglutide in outpatient clinics in Italy.
  
  
  METHODS
  Type 2 diabetes patients were followed from baseline to 4, 8, and 12 months. Changes in glycemic parameters, weight, blood pressure, and lipids were assessed. Subanalyses were performed according to baseline characteristics. Multivariate linear and logistic regressions were used to assess correlations between glycemic efficacy, weight reduction, and liraglutide discontinuation after 12 months and baseline characteristics.
  
  
  RESULTS
  Four hundred and eighty-one patients were included. Mean (SD) age at baseline was 57.3 (9.2) years, diabetes duration was 9.5 (6.8) years, weight was 106.7 (20.8) kg, body mass index (BMI; calculated as kg/m(2)) was 37.1 (6.6), HbA1c was 8.7% (1.3%), fasting plasma glucose was 168.5 (45.3) mg/dL; 38.2% were treated previously with insulin and 52.2% were treated with metformin alone. After 12 months, mean (SD) changes were HbA1c -1.2% (1.4%), fasting plasma glucose -28.3 (41.1) mg/dL, weight -3.5 (5.8) kg, BMI -1.3 (2.1), waist circumference -2.6 (6.7) cm (all, P < 0.001). Drop in weight and HbA1c did not differ between baseline BMI classes ≤30 or >30. Weight loss was unchanged among diabetes duration quartiles, and HbA1c reduction was significantly greater in patients with ≤4 years of diabetes duration (P = 0.01). Non-insulin-treated patients reached HbA1c ≤7% significantly more often than treated patients (44.2% vs 21.2%; odds ratio = 2.94; P < 0.001) and had significantly greater weight loss (-4.5 [8.2] kg vs -2.6 [5.4] kg; P = 0.03). Patients on metformin reached HbA1c target more frequently than others (43.1% vs 29.7%; odds ratio = 1.80; 95% CI, 1.05-3.07). Significant positive determinants for HbA1c reduction after 12 months were baseline HbA1c, age, and prior metformin monotherapy, and weight loss at 12 months was positively correlated with baseline weight, and negatively correlated with prior insulin treatment. Overall, 5.0% of patients interrupted liraglutide before the 12th month due to lack of glycemic control; they were less frequently treated with metformin only before liraglutide (29.2% vs 50.2%; P = 0.04).
  
  
  CONCLUSIONS
  Treatment with liraglutide in a real-world setting is associated with low therapy failure, good glycemic response, weight loss, and improvement in systolic blood pressure and lipid profile. The HbA1c drop did not differ among baseline BMI classes, indicating that efficacy is maintained in patients with lower BMI. The probability of reaching HbA1c ≤7% was significantly higher in patients previously treated with metformin alone and without any previous insulin. This could reinforce the hypothesis that better results with liraglutide could be achieved in patients after early metformin failure.
authors.affiliation: Department of Medicine, Diabetology and Dietetics Service, Padova University, Padua, Italy. Electronic address: annunziata.lapolla@unipd.it.
authors.forename: Annunziata
authors.initials: A
authors.lastname: Lapolla
authors.affiliation: Diabetology Service, ULSS 15 Alta Padovana, Cittadella, Padua, Italy.
authors.forename: Vera
authors.initials: V
authors.lastname: Frison
authors.affiliation: Diabetology Service, ULSS 15 Alta Padovana, Cittadella, Padua, Italy.
authors.forename: Michela
authors.initials: M
authors.lastname: Bettio
authors.affiliation: Diabetology Service, ULSS 15 Alta Padovana, Cittadella, Padua, Italy.
authors.forename: Michela
authors.initials: M
authors.lastname: Dal Pos
authors.affiliation: Diabetology Service, ULSS 15 Alta Padovana, Cittadella, Padua, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Rocchini
authors.affiliation: Diabetology Unit, ULSS 17, Monselice, Padua, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Panebianco
authors.affiliation: Diabetology Unit, ULSS 17, Monselice, Padua, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Tadiotto
authors.affiliation: Diabetology Unit, ULSS 17, Monselice, Padua, Italy.
authors.forename: Virgilio
authors.initials: V
authors.lastname: Da Tos
authors.affiliation: Diabetology Unit, ULSS 17, Monselice, Padua, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: D'Ambrosio
authors.affiliation: Diabetology Unit, S Bassiano Hospital, Bassano Del Grappa VI, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Marangoni
authors.affiliation: Diabetology Unit, S Bassiano Hospital, Bassano Del Grappa VI, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Ferrari
authors.affiliation: Diabetology Unit, S Bassiano Hospital, Bassano Del Grappa VI, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Pianta
authors.affiliation: Diabetology Unit, S Bassiano Hospital, Bassano Del Grappa VI, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Balzano
authors.affiliation: Diabetology Unit, S Giacomo Hospital, Castelfranco Veneto, Treviso, Italy.
authors.forename: Loris
authors.initials: L
authors.lastname: Confortin
authors.affiliation: Diabetology Unit, S Giacomo Hospital, Castelfranco Veneto, Treviso, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Lamonica
authors.affiliation: Diabetology Unit, S Giacomo Hospital, Castelfranco Veneto, Treviso, Italy.
authors.forename: Narciso
authors.initials: N
authors.lastname: Marin
authors.affiliation: Diabetology and Metabolic Diseases Unit, S Bortolo Hospital Vicenza, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Strazzabosco
authors.affiliation: Diabetology and Metabolic Diseases Unit, S Bortolo Hospital Vicenza, Italy.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Brun
authors.affiliation: Diabetology and Metabolic Diseases Unit, S Bortolo Hospital Vicenza, Italy.
authors.forename: Chiara Alberta
authors.initials: CA
authors.lastname: Mesturino
authors.affiliation: Diabetology and Metabolic Diseases Unit, S Bortolo Hospital Vicenza, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Simoncini
authors.affiliation: Diabetology and Metabolic Diseases Unit, S Bortolo Hospital Vicenza, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Zen
authors.affiliation: Department of Medicine, Diabetology and Dietetics Service, Padova University, Padua, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Bax
authors.affiliation: Department of Medicine, Diabetology and Dietetics Service, Padova University, Padua, Italy.
authors.forename: Barbara
authors.initials: B
authors.lastname: Bonsembiante
authors.affiliation: Department of Medicine, Diabetology and Dietetics Service, Padova University, Padua, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Cardone
authors.affiliation: Department of Medicine, Diabetology and Dietetics Service, Padova University, Padua, Italy.
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Dal Frà
authors.affiliation: Department of Medicine, Diabetology and Dietetics Service, Padova University, Padua, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Gallo
authors.affiliation: Department of Medicine, Diabetology and Dietetics Service, Padova University, Padua, Italy.
authors.forename: Michela
authors.initials: M
authors.lastname: Masin
authors.affiliation: Department of Medicine, Diabetology and Dietetics Service, Padova University, Padua, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Piarulli
authors.affiliation: Department of Medicine, Diabetology and Dietetics Service, Padova University, Padua, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Sartore
authors.affiliation: Diabetology Service, ULSS 15 Alta Padovana, Cittadella, Padua, Italy.
authors.forename: Natalino
authors.initials: N
authors.lastname: Simioni
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000187:drug effects; D015992:Body Mass Index; D001835:Body Weight; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use; D007558:Italy; D008055:Lipids / Q000097:blood; D000069450:Liraglutide / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D012189:Retrospective Studies
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D008055:Lipids; D000069450:Liraglutide; D008687:Metformin
keywords: GLP-1; glycemic control; liraglutide; type 2 diabetes; weight loss