6533b860fe1ef96bd12c3b6e
RESEARCH PRODUCT
A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management.
Xavier Pi-sunyerArne AstrupKen FujiokaFrank GreenwayAlfredo HalpernMichel KrempfDavid C. W. LauCarel W Le RouxViolante OrtizChristine Bjorn JensenJohn P. H. WildingA HamannA BarakatM BlüherT LinnAlberto Dalle MolleA SegnerP StüblerR Tosch-sistingF PaciniF SantiniG MarchesiniCm RotellaC InvittiR VettorS BuscemiPm RayaFc Freijoo De Barbará RgR CarraroEr BobilloC De La CuestaC FarsangA CsaszarB Zahorska-markiewiczD Pupek-musialikE FranekL OstrowskaM Olszanecka-glinianowiczN LalicD MicicB LudvikB PaulweberR PragerA ScheenL Van GaalAv AstrupK HermansenS MadsbadA RissanenS NieminenM SavolainenM KrempfM RomonM LavilleM MarreR MiraF FinucaneA VeenendaalF Van BerkumS Johannsson-vidarsdóttirV Van De WalleE MeestersJ HjelmesæthTo KlemsdalB KulsengB Bach-kliegelK LaederachL VilligerA GolayS BilzT SathyapalanS BainS Kumar Le Roux CwMe LeanB McgowanT RehmanJ WildingG WittertI CatersonJ ProiettoJ PrinsB Geloneze NetoJl GrossAr ChacraA HalpernA Suplicy HdeFc ChowHp ThackerM ChadhaH ChandaliaA UnnikrishnanS KalraN DeshpandeM ShunmugaveluVc DeshmukhM MaislosGs LiebermanI ShimonN SternD NabriskiE KarnieliN ShehadehG Gonzalez-galvezR Arechavaleta-granell Mdel Violante Ortiz RmGm FrancoI GurievaLa SuplotovaE TroshinaLa RuyatkinaEa VoychikS MartsevichMa StartsevaMe SeeberA BadatG EllisY AltuntasS GulerE UlgenT DelibasiT ChettyR HartJ JanzenI LabonteD LauJ LiutkusD O'keefeR PadwalTp RansomR TytusSj WeisnagelJ AdlerK AquaSl AronoffGw BedelTc BlevinsJ BlumenauAp BrockmyreRs CallR CanadasLb ChaykinK CohenJk ConrowMg DavisHj DowneySr DrosmanS DuckorH FarmerJ FarrellS FehnelMp FinneranR ForbesA ForkerM FredrickK FujiokaSa GellerS GillL GlaserSn GrecoFl GreenwayW HarperL HermanJ HoekstraR IngebretsenR IsonRk JainR KaplanSr KasterGa HaaseB KerznerJl KirsteinW KoltunDr KriegerCe LewisR MadderRn MarpleEj McdermottCj MelloAb MillerJ MullenJ NardandreaP O'neilF Pi-sunyerRm PucilloC RheeS RedrickA PardiniJ RothmanDm RubinoG SellersT SmithWd ByarsJ SouferAm SussmanK PatrickEl SchrammM Van CleeffSr BergHr WyattJa. Simonsubject
Blood GlucoseCounselingMaleType 2 diabeteslaw.inventionBody Mass IndexRandomized controlled trialWeight losslawGlucagon-Like Peptide 1Weight managementSubcutaneousMedicine (all)ReducingNauseaGeneral MedicineMiddle AgedCombined Modality Therapy3. Good healthFemaletype 2 diabetesmedicine.symptomHumanmedicine.drugAdultDiarrheamedicine.medical_specialtyDiet ReducingInjections SubcutaneousInjections SubcutaneouPlaceboInjectionsDouble-Blind MethodInternal medicineWeight LossmedicineHumansHypoglycemic AgentsObesityExerciseHypoglycemic AgentLiraglutidebusiness.industryLiraglutidemedicine.diseaseWeight LoDietEndocrinologybusiness[SDV.AEN]Life Sciences [q-bio]/Food and NutritionBody mass index[SDV.MHEP]Life Sciences [q-bio]/Human health and pathologyDyslipidemiaAdult; Blood Glucose; Body Mass Index; Combined Modality Therapy; Counseling; Diarrhea; Diet Reducing; Double-Blind Method; Exercise; Female; Glucagon-Like Peptide 1; Humans; Hypoglycemic Agents; Injections Subcutaneous; Liraglutide; Male; Middle Aged; Nausea; Obesity; Weight Loss; Medicine (all)description
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.).
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2015-07-02 | The New England journal of medicine |