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Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide
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Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide
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Journal Article
Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide
2012
Overview
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.
Publisher
Nature Publishing Group UK,Nature Publishing Group
Subject
/ Adult
/ Adults
/ Aged
/ Anti-Obesity Agents - therapeutic use
/ Diabetes
/ Diet
/ Drug Administration Schedule
/ Female
/ Glucagon-Like Peptide 1 - analogs & derivatives
/ Glucagon-Like Peptide 1 - therapeutic use
/ Health Promotion and Disease Prevention
/ Humans
/ Lipids
/ Male
/ Medicine
/ Obesity
/ Obesity - prevention & control
/ Original
/ Prediabetic State - diet therapy
/ Prediabetic State - drug therapy
/ Prediabetic State - epidemiology
/ Prediabetic State - prevention & control
/ Safety
