ROOTS: A multicenter study in Belgium to evaluate the effectiveness and safety of liraglutide (Victoza®) in type 2 diabetic patients

Buysschaert, Martin; d'Hooge, D; Preumont, Vanessa

doi:10.1016/j.dsx.2015.05.001

Cited by 23 publications

(34 citation statements)

References 20 publications

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“…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.…”

Section: Resultsmentioning

confidence: 99%

“…Study attributes and patient baseline characteristics from the included studies are provided in supplementary file 2. Of the 38 full-text publications, 18 studies reported an average follow-up duration of ≥12 months [29–33, 36–40, 42–47], followed by 15 studies with an average follow-up period of ≥6–12 months [34, 48, 49, 52–60, 62, 73]. The remaining five studies had an average follow-up period of ≤6 months [64, 66, 67, 69, 70].…”

Section: Resultsmentioning

confidence: 99%

“…The identified studies reported mean baseline HbA1c in the range of 7.5–9.8% and end-of-study HbA1c ranging from <6% to 8.5% after liraglutide treatment [29–34, 36–50, 52–60, 62, 64, 66, 67, 69, 70]. It was reported that liraglutide therapy led to a mean HbA1c change from baseline of −0.6% to −2.26% (see Fig.…”

Section: Resultsmentioning

confidence: 99%

“…Among these, 28 were full-text publications [29–32, 34, 36, 37, 39, 40, 42, 43, 46, 48, 49, 51–55, 57–59, 62, 63, 65, 67, 69]. Only 4 studies had a follow-up period of <6 months [63, 65, 67, 69].…”

Section: Resultsmentioning

confidence: 99%

“…Only 4 studies had a follow-up period of <6 months [63, 65, 67, 69]. The remaining studies were equally divided between study follow-up durations of ≥6–12 months ( N = 12) [34, 48, 49, 51–55, 57–59, 62] and ≥12 months ( N = 12) [29–32, 36, 37, 39, 40, 42, 43, 46, 62]. …”

Section: Resultsmentioning

confidence: 99%

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

Ostawal¹,

Mocevic

Kragh

et al. 2016

Diabetes Ther

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IntroductionIn 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.MethodsA 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.ResultsOf 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.ConclusionEvidence 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.FundingNovo Nordisk A/S, Søborg, Denmark.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-016-0180-0) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

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

Ostawal¹,

Mocevic

Kragh

et al. 2016

Diabetes Ther

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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

et al. 2015

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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.

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Effectiveness and Persistence of Liraglutide Treatment Among Patients with Type 2 Diabetes Treated in Primary Care and Specialist Settings: A Subgroup Analysis from the EVIDENCE Study, a Prospective, 2-Year Follow-up, Observational, Post-Marketing Study

et al. 2017

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IntroductionThe objective of this subgroup analysis is to investigate the effectiveness of liraglutide in people with type 2 diabetes (T2D) treated within the primary care physician (PCP) and specialist care settings.MethodsEVIDENCE is a prospective, observational study of 3152 adults with T2D recently starting or about to start liraglutide treatment in France. We followed patients in the PCP and specialist settings for 2 years to evaluate the effectiveness of liraglutide in glycemic control and body weight reduction. Furthermore, we evaluated the changes in combined antihyperglycemic treatments, the reasons for prescribing liraglutide, patient satisfaction, and safety of liraglutide in these two treatment settings.ResultsAfter 2 years of follow-up, 477 out of 1209 (39.0%) of PCP and 297 out of 1398 (21.2%) of specialist-treated patients still used liraglutide and maintained the glycated hemoglobin (HbA1c) target of <7.0%. Significant reductions from baseline were observed in both PCP- and specialist-treated cohorts in mean HbA1c (−1.22% and −0.8%, respectively), fasting plasma glucose (FPG) concentration (−39 and −23 mg/dL), body weight (−4.4 and −3.8 kg), and body mass index (BMI) (−1.5 and −1.4 kg/m2), all p < 0.0001. Reductions in HbA1c and FPG were significantly greater among PCP- compared with specialist-treated patients, p < 0.0001 for both. Patient treatment satisfaction was also significantly increased in both cohorts. Reported gastrointestinal adverse events were less frequent among PCP-treated patients compared with specialist-treated patients (4.5% vs. 16.1%).ConclusionDespite differences in demography and clinical characteristics of patients treated for T2D in PCP and specialty care, greater reduction in HbA1c and increased glycemic control durability were observed with liraglutide in primary care, compared with specialist care. These data suggest that liraglutide treatment could benefit patients in primary care by delaying the need for further treatment intensification.Trial RegistrationClinicalTrials.gov identifier, NCT01226966.FundingNovo Nordisk A/S.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-017-0476-0) contains supplementary material, which is available to authorized users.

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ROOTS: A multicenter study in Belgium to evaluate the effectiveness and safety of liraglutide (Victoza®) in type 2 diabetic patients

Cited by 23 publications

References 20 publications

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

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

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

Effectiveness and Persistence of Liraglutide Treatment Among Patients with Type 2 Diabetes Treated in Primary Care and Specialist Settings: A Subgroup Analysis from the EVIDENCE Study, a Prospective, 2-Year Follow-up, Observational, Post-Marketing Study

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