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Real-world persistence with liraglutide 3.0 mg for weight management and the SaxendaCare® patient support program.

ABSTRACT: Objective:Weight management medications can significantly increase patients' chances of achieving a clinically meaningful weight loss if patients persist with treatment. This retrospective observational study of de-identified medical records of 311 patients is the first real-world study examining persistence with liraglutide 3.0 mg in Canada, and also investigates associations between the SaxendaCare® patient support program and persistence and weight loss. Methods:Overall persistence was assessed, as well as associations of enrollment in SaxendaCare®, persistence and weight loss. Results:Overall mean (standard deviation) persistence with liraglutide 3.0 mg was 6.3 (4.1) months, and 67.5% (n = 210) and 53.7% (n = 167) of patients persisted for ?4 and ? 6 months, respectively. Enrollment in SaxendaCare® was associated with significantly longer persistence with liraglutide 3.0 mg and greater weight loss. Patients enrolled in SaxendaCare® (n = 119) persisted for 7.9 (4.0) versus 5.2 (3.8) months for those not enrolled (n = 184) (p < 0.001), and had significantly greater percent weight loss after 6 months regardless of the duration of their persistence (-7.9% vs -5.5% from baseline, p < 0.01). Conclusions:These findings suggest that, in clinical settings, persistence with liraglutide 3.0 mg can exceed 6 months, and that enrolling in SaxendaCare® may be associated with comparatively longer persistence and, regardless of persistence, greater weight loss.

SUBMITTER: Wharton S

PROVIDER: S-EPMC7448157 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Real-world persistence with liraglutide 3.0 mg for weight management and the SaxendaCare® patient support program.

Wharton Sean S Haase Christiane L CL Kamran Elham E Liu Aiden A Mancini Johanna J Neish Drew D Pakseresht Arash A Power G Sarah GS Christensen Rebecca Ag RA

Obesity science & practice 20200415 4

<h4>Objective</h4>Weight management medications can significantly increase patients' chances of achieving a clinically meaningful weight loss if patients persist with treatment. This retrospective observational study of de-identified medical records of 311 patients is the first real-world study examining persistence with liraglutide 3.0 mg in Canada, and also investigates associations between the SaxendaCare® patient support program and persistence and weight loss.<h4>Methods</h4>Overall persist ...[more]

PMID: 32874673

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Project description:IntroductionData from randomized controlled trials show that liraglutide 3.0 mg, in combination with diet and exercise, is associated with greater weight loss than diet and exercise alone in patients with obesity. In practice, the utilization of weight loss drugs is influenced by various factors, including the cost of treatment. We conducted a retrospective, observational study to assess the effectiveness of liraglutide 3.0 mg and patients' persistence on treatment, in a real-world setting.MethodsData were extracted from de-identified electronic medical records from an obesity management clinic in Switzerland. Changes in body weight and blood pressure were evaluated in the full cohort (N = 277, 19% of whom had undergone bariatric surgery) and subgroups who were persistent on liraglutide 3.0 mg for at least 4 months (n = 236), 7 months (n = 159), or 12 months (n = 71).ResultsMedian persistence on liraglutide was 6.8 months. Median maximum dose received was 1.5 mg, and 13.7% of patients reached the maintenance dose of 3.0 mg. Mean 7-month weight change from baseline in the full cohort was -4.1 kg (95% confidence interval: -5.0, -3.2; p < 0.001; -4.2%). Weight change was -4.4 kg (-4.7%) in the ≥4-month persistence subgroup at 4 months, -5.1 kg (-5.3%) in the ≥7-month persistence subgroup at 7 months, and -7.5 kg (-7.1%) in the ≥12-month persistence subgroup at 12 months (all p < 0.001). In the full cohort, 40% and 14% of patients lost ≥5% and >10% of body weight at 7 months, respectively. Weight loss did not differ significantly according to history of bariatric surgery (p = 0.94). Diastolic blood pressure decreased (from 87.0 to 83.9 mm Hg at 7 months; p = 0.018), with no significant changes in systolic blood pressure. Approximately two-thirds of patients did not have health insurance that could cover the cost of liraglutide.ConclusionIn a real-world setting with low insurance coverage and with most patients not reaching the recommended maintenance dose of 3.0 mg, the use of liraglutide, in combination with diet and exercise, was associated with clinically meaningful weight loss.

Project description:AimsLiraglutide, a GLP-1 receptor agonist, regulates appetite via receptors in the brain. Because of concerns regarding the potential of centrally-acting anti-obesity medications to affect mental health, pooled neuropsychiatric safety data from all phase 2 and 3a randomized, double-blind trials with liraglutide 3.0?mg were evaluated post hoc.MethodsData from the liraglutide weight-management programme were pooled. Across trials, individuals with a body mass index ?30 or ?27?kg/m2 with weight-related comorbidities were randomized to once-daily subcutaneous liraglutide 3.0?mg (n?=?3384) or placebo (n?=?1941), both with a 500?kcal/d deficit diet, plus exercise. Adverse events related to neuropsychiatric safety were collected in all trials. Additionally, in the phase 3a trials, validated mental-health questionnaires were prospectively and systematically administered.ResultsIn the pooled analysis of 5325 randomized and exposed individuals, rates of depression (2.1 vs 2.1 events/100 person-years) and anxiety (1.9 vs 1.7 events/100 person-years) through adverse event reporting were similarly low in liraglutide and placebo groups. Nine (0.3%) individuals receiving liraglutide and 2 (0.1%) receiving placebo reported adverse events of suicidal ideation or behaviour. In phase 3a trials, mean baseline Patient Health Questionnaire-9 scores of 2.8?±?3.0 vs 2.9?±?3.1 for liraglutide vs placebo improved to 1.8?±?2.7 vs 1.9?±?2.7, respectively, at treatment end; 34/3291 individuals (1.0%) receiving liraglutide 3.0?mg vs 19/1843 (1.0%) receiving placebo reported suicidal ideation on the Columbia-Suicide Severity Rating Scale.ConclusionsResults of this exploratory pooled analysis provide no cause for concern regarding the neuropsychiatric safety of treatment with liraglutide 3.0?mg in patients similar to those included in the examined trials. Although there was a small numerical imbalance in suicidal ideation with liraglutide through adverse event reporting, no between-treatment imbalances in suicidal ideation/behaviour or depression were noted through prospective questionnaire assessments.

Dataset Information

Real-world persistence with liraglutide 3.0 mg for weight management and the SaxendaCare® patient support program.

Publications

Real-world persistence with liraglutide 3.0 mg for weight management and the SaxendaCare® patient support program.

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