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Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management.

ABSTRACT: Obesity has a negative impact on health-related quality of life (HRQoL). The SCALE Obesity and Prediabetes study investigated the effect of liraglutide 3.0 mg, as adjunct to diet and exercise, on HRQoL in patients with obesity [body mass index (BMI) ? 30 kg m(-2) ] or overweight (BMI ? 27 kg m(-2) ) with comorbidity. Participants were advised on a 500 kcal d(-1) deficit diet and a 150-min week(-1) exercise programme and were randomised 2:1 to once-daily subcutaneous liraglutide 3.0 mg or placebo. HRQoL was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) and Short-Form 36 (SF-36) v2 health questionnaires. Individuals on liraglutide 3.0 mg (n = 2046) had significantly greater improvements in IWQOL-Lite total score (10.6 ± 13.3) vs. placebo (n = 1020) (7.7 ± 12.8) and SF-36 physical (PCS) and mental (MCS) component summary scores (PCS, 3.6 ± 6.8; MCS, 0.2 ± 8.1) vs. placebo (PCS, 2.2 ± 7.7; MCS, -0.9 ± 9.1). The estimated treatment differences were IWQOL-Lite total score 3.1 (95% CI: 2.2; 4.0), P < 0.0001; SF-36 PCS 1.7 (95% CI: 1.2; 2.2), P < 0.0001 and MCS 0.9 (95% CI: 0.3; 1.5), P = 0.003. All subscales of the IWQOL-Lite and SF-36 were significantly improved with liraglutide 3.0 mg vs. placebo. More patients on liraglutide 3.0 mg experienced meaningful improvement on the IWQOL-Lite total (P < 0.0001) and the SF-36 PCS (P < 0.0001) scores.

SUBMITTER: Kolotkin RL

PROVIDER: S-EPMC5084798 | biostudies-other | 2016 Aug

REPOSITORIES: biostudies-other

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Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management.

Kolotkin R L RL Fujioka K K Wolden M L ML Brett J H JH Bjorner J B JB

Clinical obesity 20160519 4

Obesity has a negative impact on health-related quality of life (HRQoL). The SCALE Obesity and Prediabetes study investigated the effect of liraglutide 3.0 mg, as adjunct to diet and exercise, on HRQoL in patients with obesity [body mass index (BMI) ≥ 30 kg m(-2) ] or overweight (BMI ≥ 27 kg m(-2) ) with comorbidity. Participants were advised on a 500 kcal d(-1) deficit diet and a 150-min week(-1) exercise programme and were randomised 2:1 to once-daily subcutaneous liraglutide 3.0 mg or placebo ...[more]

PMID: 27198973

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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.

Project description:Abstract The objective of the SCALE IBT trial (NCT02963935) was to compare the weight loss of liraglutide 3.0 mg, a medication approved by the Food and Drug Administration for chronic weight management, to placebo, both in combination with 56 weeks of intensive behavior therapy (IBT) (i.e. reduced calorie intake, increased physical activity [max target: 250 mins/week], and 23 counseling sessions). The primary outcomes of the study were assessed in the intention-to-treat sample, regardless of individuals’ medication adherence. The weight loss estimated in the primary analysis, regardless of drug adherence, was 7.5% versus 4.0% for liraglutide 3.0 mg and placebo, respectively, reflecting a treatment difference favoring liraglutide 3.0 mg of 3.5% (95% CI: 1.6%; 5.3%; p=0.0003). In this pre-specified secondary analysis, we sought to determine the expected effect of liraglutide 3.0 mg on weight loss, as compared to placebo, if all randomized individuals had adhered to study drug for 56 weeks. A total of 282 individuals with obesity (BMI ≥30 kg/m2) were randomized in a 1:1 ratio to 56 weeks of IBT combined with daily injections of either liraglutide 3.0 mg or placebo. The weight loss, based on the assumption that all individuals adhered to the medication, was estimated using two different approaches. The first approach (mixed model repeated measures; MMRM) estimated the weight loss that would have been achieved if all individuals adhered to the trial drug by utilizing information from individuals still on drug after the point of a given individual’s discontinuation to provide a (counter-factual) weight change as if the individual in question had not discontinued the drug. The second (covariate) approach used a regression model to calculate the weight change of individuals with full adherence to trial drug by including adherence as a moderator of the effect of treatment condition on weight change. The MMRM approach yielded a weight loss difference of 4.6% (95% CI: 2.6%; 6.5%; p<0.0001), and the covariate approach yielded a weight loss difference of 4.6% (95% CI: 2.8%; 6.5%; p<0.0001), with both estimates favoring liraglutide 3.0 mg. As such, there was good agreement between the two statistical approaches for estimating the effect of liraglutide 3.0 mg versus placebo for individuals who adhere to trial product for 56 weeks. The estimated placebo-subtracted weight loss for liraglutide at week 56 of approximately 4.6% in medication-adherent individuals therefore indicates that underlying assumptions are robust. We believe this finding is an important supplement to the study’s primary outcome and can inform practitioners’ expectations when prescribing liraglutide 3.0 mg in combination with IBT for 56 weeks. Supported by Novo Nordisk.

Project description:Abstract Liraglutide 3.0 mg is approved by the Food and Drug Administration for chronic weight management in the United States as an adjunct to reduced caloric diet and increased physical activity. The objective of the SCALE IBT trial (NCT02963935) was to compare the weight loss for liraglutide 3.0 mg to placebo, both in combination with intensive behavioral therapy (IBT) (i.e. reduced calorie intake, increased physical activity [max target: 250 min/week], and 23 counseling sessions). The present pre-specified exploratory sub-analysis determined the individual contributions of adherence to study medication, and to the adjunct diet and physical activity interventions on weight change. A total of 282 individuals with obesity (BMI ≥30 kg/m2) were randomized to treatment for 56 weeks. Adherence to study medication was recorded on a weekly basis by individuals’ self-reports of taking at least one dose in the preceding week. Adherence to dietary recommendations was assessed via the individuals’ completion of food diaries (at least one entry per day on 5 days or more in the preceding week was considered adherent). Adherence to physical activity recommendations was assessed using electronic activity trackers by comparing measured active minutes to the program goal (starting at 100 min/week increasing to 250 min/week; achieving 50% of target in the preceding week was considered to be adherent). The proportion of randomized individuals who were adherent decreased steadily through the study for all three intervention components. The effect of adherence on body weight was evaluated through an ANOVA model that included dietary information, physical activity and medication adherence and their interaction with randomized treatment. The model was reduced by removing non-significant terms, leaving only the main effect of adherence to diet and physical activity, and the effects of adherence to study medication. As estimated in the final model, adherence to dietary recommendations throughout the trial provided a ‑7.2% reduction in initial body weight (95% CI: -10.4%; -4.0%; p<0.0001); adherence to physical activity recommendations provided -2.0% (95% CI: ‑3.2%; -0.8%; p=0.0009); and adherence to liraglutide 3.0 mg provided an additional loss of -6.5% (95% CI: ‑10.2%; ‑2.9%; p=0.0005). As expected, adherence to placebo did not have a statistically significant effect on weight loss (mean contribution of -1.9%, 95% CI: -5.6%; 1.9%; p=0.33). In conclusion, this sub-analysis indicated that adherence to dietary recommendations and liraglutide injections provided clinically relevant weight loss, whereas the effect of physical activity was more modest in size. Supported by Novo Nordisk.

Dataset Information

Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management.

Publications

Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management.

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