A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management
PBN-AR
Instytucja
Instytut Medycyny Doświadczalnej i Klinicznej im. Mirosława Mossakowskiego Polskiej Akademii Nauk
Informacje podstawowe
Główny język publikacji
en
Czasopismo
New England Journal of Medicine
ISSN
0028-4793
EISSN
Wydawca
MASSACHUSETTS MEDICAL SOC
DOI
URL
Rok publikacji
2015
Numer zeszytu
1
Strony od-do
11-22
Numer tomu
373
Identyfikator DOI
Liczba arkuszy
1,30
Autorzy przekładu
(liczba autorów przekładu: 0)
Słowa kluczowe
en
LIFE-STYLE INTERVENTION
QUALITY-OF-LIFE
NONDIABETIC ADULTS
GLP-1 ANALOG
OBESITY
OVERWEIGHT
TOLERABILITY
METAANALYSIS
MAINTENANCE
PARAMETERS
Streszczenia
Język
en
Treść
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.)
Cechy publikacji
discipline:Medycyna
discipline:Medicine
Original article
Original article presents the results of original research or experiment.
Oryginalny artykuł naukowy
Oryginalny artykuł naukowy przedstawia rezultaty oryginalnych badań naukowych lub eksperymentu.
Inne
System-identifier
PBN-R:691920
CrossrefMetadata from Crossref logo
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