title: Clinical Effectiveness of Liraglutide in Type 2 Diabetes Treatment in the Real-World Setting: A Systematic Literature Review.
abstract: BACKGROUND
  In clinical trials, liraglutide has proven to be an effective drug for the treatment of type 2 diabetes mellitus (T2DM). The real-world effectiveness of liraglutide has been investigated in numerous studies. The aim of this systematic literature review is to collate evidence on the real-world clinical effectiveness of liraglutide.
  
  
  METHODS
  A review of publications from Medline, EMBASE, the Cochrane Library, and conference proceedings was conducted to identify observational studies that assessed the clinical effectiveness of liraglutide in real-world clinical practice. This review was conducted according to the National Institute of Health and Care Excellence (NICE) guidance. No language or time limits were applied, except to the conference proceedings (2013-2015). Endpoints for data extraction were decided a priori. Study quality appraisal was done for full-text journal articles.
  
  
  RESULTS
  Of 124 publications included in the review, 43 were full-text articles. Liraglutide significantly reduces glycated hemoglobin (HbA1c) within 6 months of initiating treatment (mean change in HbA1c from baseline: -0.9% to -2.2%; HbA1c <7.0%: 29.5-65.0%). The NICE composite endpoint (HbA1c reduction ≥1% and weight reduction ≥3%) was met in 16.9-47.0% of patients with liraglutide treatment. Liraglutide therapy led to a mean change in absolute weight from baseline of -1.3 to -8.65 kg. Liraglutide treatment was well tolerated in patients with T2DM. The rate of occurrence of hypoglycemia with liraglutide monotherapy was ≤0.8%. Hypoglycemia was more common in patients taking antidiabetic medications (0.0-15.2%) together with liraglutide. The beneficial glycemic and weight effect of liraglutide therapy in patients with T2DM was maintained for at least 12 months.
  
  
  CONCLUSIONS
  Evidence from observational studies reflecting real-world clinical practice demonstrates that liraglutide therapy improves glycemic control with a low risk of hypoglycemia, and is associated with significant weight loss in patients with T2DM. These observations are consistent with clinical trial findings.
  
  
  BACKGROUND
  Novo Nordisk A/S, Søborg, Denmark.
authors.affiliation: Pharmerit GmbH, Berlin, Germany.
authors.forename: Amrita
authors.initials: A
authors.lastname: Ostawal
authors.affiliation: Novo Nordisk A/S, Søborg, Denmark.
authors.forename: Emina
authors.initials: E
authors.lastname: Mocevic
authors.affiliation: Novo Nordisk A/S, Søborg, Denmark.
authors.forename: Nana
authors.initials: N
authors.lastname: Kragh
authors.affiliation: Pharmerit International, Rotterdam, The Netherlands. wxu@pharmerit.com.
authors.forename: Weiwei
authors.initials: W
authors.lastname: Xu
keywords: Effectiveness; HbA1c; Hypoglycemia; Liraglutide; Literature review; Real-world evidence; Safety; Type 2 diabetes; Weight