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"Obesity - therapy"
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Once-Weekly Semaglutide in Adolescents with Obesity
A once-weekly, 2.4-mg dose of subcutaneous semaglutide, a glucagon-like peptide-1 receptor agonist, is used to treat obesity in adults, but assessment of the drug in adolescents has been lacking.
In this double-blind, parallel-group, randomized, placebo-controlled trial, we enrolled adolescents (12 to <18 years of age) with obesity (a body-mass index [BMI] in the 95th percentile or higher) or with overweight (a BMI in the 85th percentile or higher) and at least one weight-related coexisting condition. Participants were randomly assigned in a 2:1 ratio to receive once-weekly subcutaneous semaglutide (at a dose of 2.4 mg) or placebo for 68 weeks, plus lifestyle intervention. The primary end point was the percentage change in BMI from baseline to week 68; the secondary confirmatory end point was weight loss of at least 5% at week 68.
A total of 201 participants underwent randomization, and 180 (90%) completed treatment. All but one of the participants had obesity. The mean change in BMI from baseline to week 68 was -16.1% with semaglutide and 0.6% with placebo (estimated difference, -16.7 percentage points; 95% confidence interval [CI], -20.3 to -13.2; P<0.001). At week 68, a total of 95 of 131 participants (73%) in the semaglutide group had weight loss of 5% or more, as compared with 11 of 62 participants (18%) in the placebo group (estimated odds ratio, 14.0; 95% CI, 6.3 to 31.0; P<0.001). Reductions in body weight and improvement with respect to cardiometabolic risk factors (waist circumference and levels of glycated hemoglobin, lipids [except high-density lipoprotein cholesterol], and alanine aminotransferase) were greater with semaglutide than with placebo. The incidence of gastrointestinal adverse events was greater with semaglutide than with placebo (62% vs. 42%). Five participants (4%) in the semaglutide group and no participants in the placebo group had cholelithiasis. Serious adverse events were reported in 15 of 133 participants (11%) in the semaglutide group and in 6 of 67 participants (9%) in the placebo group.
Among adolescents with obesity, once-weekly treatment with a 2.4-mg dose of semaglutide plus lifestyle intervention resulted in a greater reduction in BMI than lifestyle intervention alone. (Funded by Novo Nordisk; STEP TEENS ClinicalTrials.gov number, NCT04102189.).
Journal Article
A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity
Adolescents with obesity and a poor response to lifestyle therapy alone were randomly assigned to receive either liraglutide or placebo subcutaneously once daily, in addition to lifestyle therapy. The use of liraglutide led to a significantly greater reduction in the standard-deviation score for the body-mass index than placebo.
Journal Article
Aerobic or Resistance Exercise, or Both, in Dieting Obese Older Adults
In a study of diet and several exercise modes to reverse frailty and prevent weight-loss–induced reduction in muscle and bone in obese older adults, weight loss plus combined aerobic and resistance exercise was the most effective method of improving functional status.
More than a third of persons 65 years of age or older in the United States are obese,
1
and this group constitutes a population vulnerable to adverse outcomes, because obesity exacerbates the age-related decline in physical function and causes frailty.
2
–
5
However, appropriate management of obesity in older adults remains controversial, given the reported reduction in relative health risks associated with increasing body-mass index in this group.
6
Moreover, an important concern is that weight loss could worsen frailty by accelerating the age-related decline in muscle and bone mass and resultant sarcopenia and osteopenia.
7
,
8
Given the positive effects of exercise . . .
Journal Article
Liraglutide for Children 6 to <12 Years of Age with Obesity — A Randomized Trial
Obesity often develops in childhood. In children (6 to <12 years of age) with obesity, treatment with liraglutide for 56 weeks plus lifestyle interventions induced a greater mean change in BMI than lifestyle interventions alone.
Journal Article
Healthy Weight Loss Maintenance with Exercise, Liraglutide, or Both Combined
In this trial, adults with obesity without diabetes were randomly assigned, after an 8-week low-calorie diet, to 1 year of placebo, an exercise program, liraglutide, or exercise plus liraglutide. Combined treatment with exercise and liraglutide improved healthy weight loss maintenance more than either treatment alone.
Journal Article
Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide
Objective:
Having demonstrated short-term weight loss with liraglutide in this group of obese adults, we now evaluate safety/tolerability (primary outcome) and long-term efficacy for sustaining weight loss (secondary outcome) over 2 years.
Design:
A randomized, double-blind, placebo-controlled 20-week study with 2-year extension (sponsor unblinded at 20 weeks, participants/investigators at 1 year) in 19 European clinical research centers.
Subjects:
A total of 564 adults (
n
=90–98 per group; body mass index 30–40 kg m
−2
) enrolled, 398 entered the extension and 268 completed the 2-year trial. Participants received diet (500 kcal deficit per day) and exercise counseling during 2-week run-in, before being randomly assigned (with a telephone or web-based system) to once-daily subcutaneous liraglutide (1.2, 1.8, 2.4 or 3.0 mg,
n
=90–95), placebo (
n
=98) or open-label orlistat (120 mg × 3,
n
=95). After 1 year, liraglutide/placebo recipients switched to liraglutide 2.4 mg, then 3.0 mg (based on 20-week and 1-year results, respectively). The trial ran from January 2007–April 2009 and is registered with
Clinicaltrials.gov
, number NCT00480909.
Results:
From randomization to year 1, liraglutide 3.0 mg recipients lost 5.8 kg (95% confidence interval 3.7–8.0) more weight than those on placebo and 3.8 kg (1.6–6.0) more than those on orlistat (
P
⩽0.0001; intention-to-treat, last-observation-carried-forward). At year 2, participants on liraglutide 2.4/3.0 mg for the full 2 years (pooled group,
n
=184) lost 3.0 kg (1.3–4.7) more weight than those on orlistat (
n
=95;
P
<0.001). Completers on liraglutide 2.4/3.0 mg (
n
=92) maintained a 2-year weight loss of 7.8 kg from screening. With liraglutide 3.0 mg, 20-week body fat decreased by 15.4% and lean tissue by 2.0%. The most frequent drug-related side effects were mild to moderate, transient nausea and vomiting. With liraglutide 2.4/3.0 mg, the 2-year prevalence of prediabetes and metabolic syndrome decreased by 52 and 59%, with improvements in blood pressure and lipids.
Conclusion:
Liraglutide is well tolerated, sustains weight loss over 2 years and improves cardiovascular risk factors.
Journal Article
Multicenter, Placebo-Controlled Trial of Lorcaserin for Weight Management
In this trial, obese or overweight adults were randomly assigned to receive the selective serotonin 2C receptor agonist lorcaserin or placebo for 52 weeks, along with diet and exercise counseling. Lorcaserin use, in conjunction with behavioral modification, was associated with significant weight loss, improved maintenance of weight loss, and improved levels of cardiovascular biomarkers.
In obese or overweight adults, lorcaserin use in conjunction with behavioral modification was associated with significant weight loss, improved maintenance of weight loss, and improved levels of cardiovascular biomarkers.
Activation of the 5-hydroxytryptamine (5-HT, or serotonin) receptor 5-HT
2C
decreases food intake through the proopiomelanocortin system of neurons.
1
–
3
Lorcaserin is a small-molecule agonist of the serotonin 2C (5-HT
2C
) receptor designed to promote weight loss. Study of the nonselective serotonergic agonists fenfluramine and dexfenfluramine, which enhance presynaptic serotonin release and block its reuptake, validated serotonin receptors as pharmacologic targets for weight loss.
4
Unfortunately, use of these agents increases the risk of serotonin-associated valvulopathy,
5
–
8
which is thought to occur through agonism of 5-HT
2B
receptors expressed on cardiac valvular interstitial cells.
9
–
11
Lorcaserin was designed to selectively . . .
Journal Article
A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management
Background Obesity is a chronic disease with serious health consequences, but weight loss is difficult to maintain through lifestyle intervention alone. Liraglutide, a glucagon-like peptide-1 analogue, has been shown to have potential benefit for weight management at a once-daily dose of 3.0 mg, injected subcutaneously. Methods We conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension. We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification. The coprimary end points were the change in body weight and the proportions of patients losing at least 5% and more than 10% of their initial body weight. Results At baseline, the mean (±SD) age of the patients was 45.1±12.0 years, the mean weight was 106.2±21.4 kg, and the mean BMI was 38.3±6.4; a total of 78.5% of the patients were women and 61.2% had prediabetes. At week 56, patients in the liraglutide group had lost a mean of 8.4±7.3 kg of body weight, and those in the placebo group had lost a mean of 2.8±6.5 kg (a difference of −5.6 kg; 95% confidence interval, −6.0 to −5.1; P<0.001, with last-observation-carried-forward imputation). A total of 63.2% of the patients in the liraglutide group as compared with 27.1% in the placebo group lost at least 5% of their body weight (P<0.001), and 33.1% and 10.6%, respectively, lost more than 10% of their body weight (P<0.001). The most frequently reported adverse events with liraglutide were mild or moderate nausea and diarrhea. Serious events occurred in 6.2% of the patients in the liraglutide group and in 5.0% of the patients in the placebo group. Conclusions In this study, 3.0 mg of liraglutide, as an adjunct to diet and exercise, was associated with reduced body weight and improved metabolic control. (Funded by Novo Nordisk; SCALE Obesity and Prediabetes NN8022-1839 ClinicalTrials.gov number, NCT01272219.)
Journal Article