Miglioramenti della qualità di vita correlata alla salute (HRQoL) con Liraglutide 3 mg rispetto a placebo per la gestione del peso

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Abstract

[automatically translated] Objective: Obesity has a negative impact on health-related quality of life (HRQoL), the severity of which depends on the severity of obesity. The study SCALE (Satiety and Clinical Adiposity - Liraglutide Evidence) Obesity and Prediabetes evaluated the efficacy of 3 mg liraglutide in addition to diet and exercise on HRQoL in patients with overweight or obesity, with or without prediabetes. Methods: The subjects (BMI ≥ 27 kg / m2 with comorbidities or ≥ 1 ≥ 30 kg / m2) were randomized (2: 1), to receive liraglutide 3 mg (n = 2487) or placebo (n = 1244) a fly sc per day, in addition to a program of intervention on lifestyle (low-calorie diet with 500 kcal / day deficit and 150 min / week of physical exercise). The quality of health-related life (HRQoL) was assessed using questionnaires IWQOL-Lite (weight Impact on Quality of Life-Lite) and SF-36 v2 (Short-Form 36) at baseline, 6-month and 1 year (end of study). The TRIM-Weight Questionnaire (Impact related to the specific treatment for the weight) was completed 6 months and at the end of the study. Data were reported as mean ± standard deviation (SD). conducted statistical analysis: ANCOVA with LOCF. Results: Baseline characteristics: 78.5% female, age 45.1 years, weight 106.2 kg, BMI 38.3 kg / m2. The subjects treated with liraglutide 3 mg showed significantly greater improvements in total score of 'IWQOL-Lite [(10.6 ± 13.3) vs placebo (7.6 ± 12.8; AND 3.1 [95% CI: 2.2; 4.0]; p <0. 0001)] and in the scores of the domains related to the physical state (PCS) and mental (MCS) of 'SF-36 (PCS, 3.6 ± 6.8; MCS, 0.2 ± 8.1) vs placebo (PCS, 2.2 ± 7.7; MCS - 0.9 ± 9.1) (ED 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]), with a greater weight loss (-8.0 ± 6.7%) compared to placebo (-2.6 ± 5.7%; ED -5.4% [95% CI: -5.8; -5.0]; p <0.0001). All scores of sub-domains IWQOL-Lite and SF-36 were significantly better with liraglutide 3.0 mg vs placebo. The probability of achieving an improvement, however slight, clinically important was higher with liraglutide 3 mg vs placebo in the total score of 'IWQOL-Lite (1.59 [1:35; 1.88], p <0.001) and the PCS of' SF- 36 patients (1.69 [1.43; 2.00], p <0.0001). The total score of the TRIM-Weight was higher at the end of the study with liraglutide 3 mg (83.1 ± 10.7) vs placebo (81.0 ± 9.4, AND 2.1 [95% CI: 1.3; 3.0], p <0.0001). Discussion: the use of liraglutide 3 mg, in addition to diet and exercise, was associated with clinically significant improvements in physical health domains on HRQoL compared with placebo. Conclusion: Treatment with 3 mg liraglutide significantly improves HRQoL, including physical function and mental health, in patients who are overweight or obese, compared to placebo.
Original languageItalian
Pages268-268
Number of pages1
Publication statusPublished - 2015

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