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A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management

  • Autori: Pi Sunyer, X.; Astrup, A.; Fujioka, K.; Greenway, F.; Halpern, A.; Krempf, M.; Lau, D.; le Roux, C.; Violante Ortiz, R.; Jensen, C.; Wilding, ; J., C.; Barakat, A.; Blüher, M.; Linn, T.; Mölle, A.; Segner, A.; Stübler, P.; Tosch Sisting, R.; Pacini, F.; Santini, F.; Marchesini, G.; Rotella, C.; Invitti, C.; Vettor, R.; Buscemi, S.; Raya, P.; Freijoo, F.; de Barbará, R.; Carraro, R.; Bobillo, E.; de la Cuesta, C.; Farsang, C.; Csaszar, A.; Zahorska Markiewicz, B.; Pupek Musialik, D.; Franek, E.; Ostrowska, L.; Olszanecka Glinianowicz, M.; Lalic, N.; Micic, D.; Ludvik, B.; Paulweber, B.; Prager, R.; Scheen, A.; Van Gaal, L.; Astrup, A.; Hermansen, K.; Madsbad, S.; Rissanen, A.; Nieminen, S.; Savolainen, M.; Krempf, M.; Romon, M.; Laville, M.; Marre, M.; Mira, R.; Finucane, F.; Veenendaal, A.; van Berkum, F.; Johannsson Vidarsdóttir, S.; Van de Walle, V.; Meesters, E.; Hjelmesæth, J.; Klemsdal, T.; Kulseng, B.; Bach Kliegel, B.; Laederach, K.; Villiger, L.; Golay, A.; Bilz, S.; Sathyapalan, T.; Bain, S.; Kumar, S.; Le Roux, C.; Lean, M.; Mcgowan, B.; Rehman, T.; Wilding, J.; Wittert, G.; Caterson, I.; Proietto, J.; Prins, J.; Geloneze Neto, B.; Gross, J.; Chacra, A.; Halpern, A.; Suplicy Hde, A.; Chow, F.; Thacker, H.; Chadha, M.; Chandalia, H.; Unnikrishnan, A.; Kalra, S.; Deshpande, N.; Shunmugavelu, M.; Deshmukh, V.; Maislos, M.; Lieberman, G.; Shimon, I.; Stern, N.; Nabriski, D.; Karnieli, E.; Shehadeh, N.; Gonzalez Galvez, G.; Arechavaleta Granell Mdel, R.; Violante Ortiz, R.; Franco, G.; Gurieva, I.; Suplotova, L.; Troshina, E.; Ruyatkina, L.; Voychik, E.; Martsevich, S.; Startseva, M.; Seeber, M.; Badat, A.; Ellis, G.; Altuntas, Y.; Guler, S.; Ulgen, E.; Delibasi, T.; Chetty, T.; Hart, R.; Janzen, J.; Labonte, I.; Lau, D.; Liutkus, J.; O'Keefe, D.; Padwal, R.; Ransom, T.; Tytus, R.; Weisnagel, S.; Adler, J.; Aqua, K.; Aronoff, S.; Bedel, G.; Blevins, T.; Blumenau, J.; Brockmyre, A.; Call, R.; Canadas, R.; Chaykin, L.; Cohen, K.; Conrow, J.; Davis, M.; Downey, H.; Drosman, S.; Duckor, S.; Farmer, H.; Farrell, J.; Fehnel, S.; Finneran, M.; Forbes, R.; Forker, A.; Fredrick, M.; Fujioka, K.; Geller, S.; Gill, S.; Glaser, L.; Greco, S.; Greenway, F.; Harper, W.; Herman, L.; Hoekstra, J.; Ingebretsen, R.; Ison, R.; Jain, R.; Kaplan, R.; Kaster, S.; Haase, G.; Kerzner, B.; Kirstein, J.; Koltun, W.; Krieger, D.; Lewis, C.; Madder, R.; Marple, R.; Mcdermott, E.; Mello, C.; Miller, A.; Mullen, J.; Nardandrea, J.; O'Neil, P.; Pi Sunyer, F.; Pucillo, R.; Rhee, C.; Redrick, S.; Pardini, A.; Rothman, J.; Rubino, D.; Sellers, G.; Smith, T.; Byars, W.; Soufer, J.; Sussman, A.; Patrick, K.; Schramm, E.; Van Cleeff, M.; Berg, S.; Wyatt, H.; Simon, J.
  • Anno di pubblicazione: 2015
  • Tipologia: Articolo in rivista (Articolo in rivista)
  • OA Link: http://hdl.handle.net/10447/140072

Abstract

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.).