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

Abstract

IntroductionThe 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.MethodsThis 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.ResultsAt the end of the study, 29.5% of patients maintained liraglutide treatment and reached the HbA1c target. Mean (±SD) HbA1c, 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/m2; 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%.ConclusionThe 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.FundingNovo Nordisk A/S.Trial RegistrationClinicalTrials.gov identifier, NCT01226966.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-015-0245-x) contains supplementary material, which is available to authorized users.

Interindividual differences in the clinical effectiveness of liraglutide in Type 2 diabetes: a real‐world retrospective study conducted in Spain

“…At baseline, individuals presented elevated triglyceride and LDL, in the range of those observed in previous retrospective studies [22,23]. The study population was characterized by elevated BP (SBP 153 mmHg and DBP 86 mmHg) which, in the case of SBP, was higher than those in other observational studies [16,18,19,[22][23][24]. Taken together, participants initiated on liraglutide were obese and at advanced stages of the disease, with uncontrolled HbA 1c , lipid levels and BP.…”

Clinical Effectiveness of Liraglutide in Type 2 Diabetes Treatment in the Real-World Setting: A Systematic Literature Review

“…The majority of the studies assessed the clinical effectiveness of liraglutide without an active comparator (81.4%; N  = 35) [28, 29, 31, 34, 36–39, 41–49, 51–55, 57, 60–64, 66–71]. Real-world studies with comparators were less frequently observed (18.6%; N  = 8); the most common comparators for liraglutide were: sitagliptin or any DPP-4i ( N  = 6) [32, 33, 35, 40, 56, 58], exenatide ( N  = 3) [33, 35, 50], glimepiride or any other SUs ( N  = 2) [30, 35], pioglitazone or other TZDs ( N  = 1) [35], and MET ( N  = 1) [35]; note: these numbers do not add up because some studies had more than one comparator.…”

“…Ghuman et al [37] reported 1 case of pancreatitis among 152 patients that were followed for up to 20 months. In the EVIDENCE study (ClinicalTrials.gov identifier: NCT01226966), 3152 patients were followed up to 24 months [36], in that period 8 medical AEs related to pancreatic pathologies (pancreatitis [ N  = 1], acute pancreatitis [ N  = 4], increased lipasemia [ N  = 1], and hepato-pancreatic biological disorder [ N  = 1]) and eight AEs linked to thyroid pathologies (goiter [ N  = 2], hyperthyroidism [ N  = 1], hypothyroidism [ N  = 1], thyroid disorder [ N  = 1], thyroid nodule [ N  = 1], thyroid cancer [non-encapsulated papillary carcinoma; N  = 1], and thyroidectomy with no known etiology [ N  = 1]) were reported. In this observational study, one patient died of pancreatic tumor 4 months after starting treatment with liraglutide.…”

What have we learnt from “real world” data, observational studies and meta‐analyses

“…An observational multicentre prospective study of 3152 French adults with T2DM who were about to start treatment with liraglutide and were randomly recruited from the Centre de Gestion, de Documentation, d'Informatique et de Marketing (CEGEDIM) database in which 29.5% of patients reached the HbA1c target of <7% after 2 years of follow‐up . There were significant improvements in HbA1c, FPG, weight and BMI 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).…”