Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice--EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study

Jean-Francois Gautier, Luc Martinez, Alfred Penfornis, Eveline Eschwège, Guillaume Charpentier, Benoît Huret, Suliya Madani, Pierre Gourdy, Jean-Francois Gautier, Luc Martinez, Alfred Penfornis, Eveline Eschwège, Guillaume Charpentier, Benoît Huret, Suliya Madani, Pierre Gourdy

Abstract

Introduction: The aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice.

Methods: This observational, prospective, multicenter study included 3152 adults with type 2 diabetes who had recently started or were about to start liraglutide treatment. During 2 years of follow-up, an evaluation of the reasons for prescribing liraglutide, maintenance dose of liraglutide, changes in combined antidiabetic treatments, level of glycemic control, change in body weight and body mass index (BMI), patient satisfaction with diabetes treatment and safety of liraglutide were investigated. The primary study endpoint was the proportion of patients still receiving liraglutide and presenting with HbA1c <7.0% after 2 years of follow-up.

Results: At the end of the study, 29.5% of patients maintained liraglutide treatment and reached the HbA(1c) target. Mean (±SD) HbA(1c), fasting plasma glucose concentration, body weight and BMI were significantly reduced from baseline [8.46% (±1.46) to 7.44% (±1.20); 180 (±60) to 146 (±44) mg/dL; 95.2 (±20.0) to 91.1 (±19.6) kg; 34.0 (±7.2) to 32.5 (±6.9) kg/m(2); respectively, all P < 0.0001]. Patient treatment satisfaction increased, with the mean diabetes treatment satisfaction questionnaire status version score increasing from 22.17 (±7.64) to 28.55 (±5.79), P < 0.0001. The main adverse event type was gastrointestinal, with a frequency of 10.9%, and the percentage of patients suffering ≥1 hypoglycemic episode decreased from 6.9% to 4.4%.

Conclusion: The results of the EVIDENCE study suggest that the effectiveness of liraglutide in real-world clinical practice is similar to that observed in randomized controlled trials.

Funding: Novo Nordisk A/S.

Trial registration: ClinicalTrials.gov identifier, NCT01226966.

Keywords: BMI; Liraglutide; Observational; Type 2 diabetes; Weight.

Figures

Fig. 1
Fig. 1
Distribution of patients during the study. Asterisks some patients had thoroughly completed the 2 years of follow-up though the physician filled an end of study form out with a reason for withdrawal from study. These patients (20 in total) were included in the EAS population and counted as withdrawals from study. Double asterisks patients lost to follow-up or moved. AE adverse event, EAS effectiveness analysis set, FAS full analysis set, FPG fasting plasma glucose, PEA population for primary endpoint analysis, PROAS patient-reported outcomes analysis set
Fig. 2
Fig. 2
Change in liraglutide dose by visits—EAS. EAS effectiveness analysis set

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