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Authors
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Professor of Medicine at Columbia University College of Physicians and SurgeonsXavier Pi-Sunyer, MD, MPH
Professor of Medicine at Columbia University College of Physicians and SurgeonsProfessor of Medicine at Columbia University College of Physicians and Surgeons
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Metabolic Medicine Physician, University College DublinCarel Le Roux, MBChB, FRCP, FRCPath, PhD
Metabolic Medicine Physician, University College DublinMetabolic Medicine Physician, University College Dublin
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Director, Nutrition and Metabolic Research Center; Director, Center for Weight Management at Scripps ClinicKen Fujioka, MD
Director, Nutrition and Metabolic Research Center; Director, Center for Weight Management at Scripps ClinicDirector, Nutrition and Metabolic Research Center; Director, Center for Weight Management at Scripps Clinic
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Professor of Medicine & Honorary Consultant Physician at University Hospital, Aintree, LiverpoolJohn Wilding, DM, FRCP
Professor of Medicine & Honorary Consultant Physician at University Hospital, Aintree, LiverpoolProfessor of Medicine & Honorary Consultant Physician at University Hospital, Aintree, Liverpool
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Professor of Medicine, Biochemistry and Molecular Biology at University of Calgary Cumming School of MedicineDavid Lau, MD, PhD, FRCPC
Professor of Medicine, Biochemistry and Molecular Biology at University of Calgary Cumming School of MedicineProfessor of Medicine, Biochemistry and Molecular Biology at University of Calgary Cumming School of Medicine
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International Medical Director at Novo Nordisk A/SChristine Bjørn Jensen, MD, PhD
International Medical Director at Novo Nordisk A/SInternational Medical Director at Novo Nordisk A/S
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Experts
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Medical Director at The Center for Obesity Medicine at Florida HospitalGitanjali Srivastava, MD FAAP FACP
Medical Director at The Center for Obesity Medicine at Florida HospitalMedical Director at The Center for Obesity Medicine at Florida Hospital
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Endocrinologist at the University of Colorado School of MedicineRobert Eckel, MD
Endocrinologist at the University of Colorado School of MedicineEndocrinologist at the University of Colorado School of Medicine
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Associate Professor of Medicine at Harvard Medical SchoolAllison Goldfine, MD
Associate Professor of Medicine at Harvard Medical SchoolAssociate Professor of Medicine at Harvard Medical School
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Obesity Medicine Physician at Massachusetts General Hospital and Harvard Medical SchoolFatima Cody Stanford, MD, MPH, MPA
Obesity Medicine Physician at Massachusetts General Hospital and Harvard Medical SchoolObesity Medicine Physician at Massachusetts General Hospital and Harvard Medical School
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Obesity Medicine Specialist at Baptist Health Medical GroupLisa DeRosimo, MD, MS
Obesity Medicine Specialist at Baptist Health Medical GroupObesity Medicine Specialist at Baptist Health Medical Group
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Professor and Chair in Obesity Research and Management at University of AlbertaArya Sharma, MD, PhD
Professor and Chair in Obesity Research and Management at University of AlbertaProfessor and Chair in Obesity Research and Management at University of Alberta
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President, Nashville Preventive Cardiology, PLLC; Preventive Cardiologist and Clinical Lipidologist; Obesity Expert, About.comYasmine Ali, MD, MSCI, FACC, FACP
President, Nashville Preventive Cardiology, PLLC; Preventive Cardiologist and Clinical Lipidologist; Obesity Expert, About.comPresident, Nashville Preventive Cardiology, PLLC; Preventive Cardiologist and Clinical Lipidologist; Obesity Expert, About.com
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Director, Obesity, Metabolism & Nutrition Institute at Massachusetts General Hospital/ Harvard Medical SchoolLee Kaplan, MD, PhD
Director, Obesity, Metabolism & Nutrition Institute at Massachusetts General Hospital/ Harvard Medical SchoolDirector, Obesity, Metabolism & Nutrition Institute at Massachusetts General Hospital/ Harvard Medical School
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Associate Professor of Nutrition and Epidemiology at Harvard T.H. Chan School of Public HealthLu Qi, MD, PhD, FAHA
Associate Professor of Nutrition and Epidemiology at Harvard T.H. Chan School of Public HealthAssociate Professor of Nutrition and Epidemiology at Harvard T.H. Chan School of Public Health
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Associate Professor, Pediatrics & Center for Community Health at UR Medicine's Golisano Children's HospitalStephen Cook, MD, MPH, FAAP, FTOS
Associate Professor, Pediatrics & Center for Community Health at UR Medicine's Golisano Children's HospitalAssociate Professor, Pediatrics & Center for Community Health at UR Medicine's Golisano Children's Hospital
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Associate Director, Obesity Prevention Program at Personalized Preventive Care ServiceJason Block, MD, MPH
Associate Director, Obesity Prevention Program at Personalized Preventive Care ServiceAssociate Director, Obesity Prevention Program at Personalized Preventive Care Service
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Co-Director, Center for Weight Management and Metabolic Surgery, Brigham and Women's Hospital; Chief of Endocrinology, Brigham and Women's Faulkner HospitalFlorencia Halperin, MD
Co-Director, Center for Weight Management and Metabolic Surgery, Brigham and Women's Hospital; Chief of Endocrinology, Brigham and Women's Faulkner HospitalCo-Director, Center for Weight Management and Metabolic Surgery, Brigham and Women's Hospital; Chief of Endocrinology, Brigham and Women's Faulkner Hospital
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Gastroenterology and Hepatology Fellow at Mayo ClinicAndres Acosta, MD, PhD
Gastroenterology and Hepatology Fellow at Mayo ClinicGastroenterology and Hepatology Fellow at Mayo Clinic
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Lead Moderators
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Endocrinology Fellow, NSW, AustraliaSu-Ann Ding, MD
Endocrinology Fellow, NSW, AustraliaEndocrinology Fellow, NSW, Australia
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Moderators
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Endocrinologist at University of Rochester Medical CenterSusanne Miedlich, MD
Endocrinologist at University of Rochester Medical CenterEndocrinologist at University of Rochester Medical Center
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General Internal Medicine Fellow at Johns HopkinsEva Tseng, MD, MPH
General Internal Medicine Fellow at Johns HopkinsGeneral Internal Medicine Fellow at Johns Hopkins
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Medical Student at Broad Institute
About the Discussion
@NEJM Ask the Authors & Experts: A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management
Original 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.)
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Authors
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Professor of Medicine at Columbia University College of Physicians and SurgeonsXavier Pi-Sunyer, MD, MPH
Professor of Medicine at Columbia University College of Physicians and Surgeons
Professor of Medicine at Columbia University College of Physicians and Surgeons
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Metabolic Medicine Physician, University College DublinCarel Le Roux, MBChB, FRCP, FRCPath, PhD
Metabolic Medicine Physician, University College Dublin
Metabolic Medicine Physician, University College Dublin
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Director, Nutrition and Metabolic Research Center; Director, Center for Weight Management at Scripps ClinicKen Fujioka, MD
Director, Nutrition and Metabolic Research Center; Director, Center for Weight Management at Scripps Clinic
Director, Nutrition and Metabolic Research Center; Director, Center for Weight Management at Scripps Clinic
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Professor of Medicine & Honorary Consultant Physician at University Hospital, Aintree, LiverpoolJohn Wilding, DM, FRCP
Professor of Medicine & Honorary Consultant Physician at University Hospital, Aintree, Liverpool
Professor of Medicine & Honorary Consultant Physician at University Hospital, Aintree, Liverpool
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Professor of Medicine, Biochemistry and Molecular Biology at University of Calgary Cumming School of MedicineDavid Lau, MD, PhD, FRCPC
Professor of Medicine, Biochemistry and Molecular Biology at University of Calgary Cumming School of Medicine
Professor of Medicine, Biochemistry and Molecular Biology at University of Calgary Cumming School of Medicine
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International Medical Director at Novo Nordisk A/SChristine Bjørn Jensen, MD, PhD
International Medical Director at Novo Nordisk A/S
International Medical Director at Novo Nordisk A/S
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Experts
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Medical Director at The Center for Obesity Medicine at Florida HospitalGitanjali Srivastava, MD FAAP FACP
Medical Director at The Center for Obesity Medicine at Florida Hospital
Medical Director at The Center for Obesity Medicine at Florida Hospital
-
Endocrinologist at the University of Colorado School of MedicineRobert Eckel, MD
Endocrinologist at the University of Colorado School of Medicine
Endocrinologist at the University of Colorado School of Medicine
-
Associate Professor of Medicine at Harvard Medical SchoolAllison Goldfine, MD
Associate Professor of Medicine at Harvard Medical School
Associate Professor of Medicine at Harvard Medical School
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Obesity Medicine Physician at Massachusetts General Hospital and Harvard Medical SchoolFatima Cody Stanford, MD, MPH, MPA
Obesity Medicine Physician at Massachusetts General Hospital and Harvard Medical School
Obesity Medicine Physician at Massachusetts General Hospital and Harvard Medical School
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Obesity Medicine Specialist at Baptist Health Medical GroupLisa DeRosimo, MD, MS
Obesity Medicine Specialist at Baptist Health Medical Group
Obesity Medicine Specialist at Baptist Health Medical Group
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Professor and Chair in Obesity Research and Management at University of AlbertaArya Sharma, MD, PhD
Professor and Chair in Obesity Research and Management at University of Alberta
Professor and Chair in Obesity Research and Management at University of Alberta
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President, Nashville Preventive Cardiology, PLLC; Preventive Cardiologist and Clinical Lipidologist; Obesity Expert, About.comYasmine Ali, MD, MSCI, FACC, FACP
President, Nashville Preventive Cardiology, PLLC; Preventive Cardiologist and Clinical Lipidologist; Obesity Expert, About.com
President, Nashville Preventive Cardiology, PLLC; Preventive Cardiologist and Clinical Lipidologist; Obesity Expert, About.com
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Director, Obesity, Metabolism & Nutrition Institute at Massachusetts General Hospital/ Harvard Medical SchoolLee Kaplan, MD, PhD
Director, Obesity, Metabolism & Nutrition Institute at Massachusetts General Hospital/ Harvard Medical School
Director, Obesity, Metabolism & Nutrition Institute at Massachusetts General Hospital/ Harvard Medical School
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Associate Professor of Nutrition and Epidemiology at Harvard T.H. Chan School of Public HealthLu Qi, MD, PhD, FAHA
Associate Professor of Nutrition and Epidemiology at Harvard T.H. Chan School of Public Health
Associate Professor of Nutrition and Epidemiology at Harvard T.H. Chan School of Public Health
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Associate Professor, Pediatrics & Center for Community Health at UR Medicine's Golisano Children's HospitalStephen Cook, MD, MPH, FAAP, FTOS
Associate Professor, Pediatrics & Center for Community Health at UR Medicine's Golisano Children's Hospital
Associate Professor, Pediatrics & Center for Community Health at UR Medicine's Golisano Children's Hospital
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Associate Director, Obesity Prevention Program at Personalized Preventive Care ServiceJason Block, MD, MPH
Associate Director, Obesity Prevention Program at Personalized Preventive Care Service
Associate Director, Obesity Prevention Program at Personalized Preventive Care Service
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Co-Director, Center for Weight Management and Metabolic Surgery, Brigham and Women's Hospital; Chief of Endocrinology, Brigham and Women's Faulkner HospitalFlorencia Halperin, MD
Co-Director, Center for Weight Management and Metabolic Surgery, Brigham and Women's Hospital; Chief of Endocrinology, Brigham and Women's Faulkner Hospital
Co-Director, Center for Weight Management and Metabolic Surgery, Brigham and Women's Hospital; Chief of Endocrinology, Brigham and Women's Faulkner Hospital
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Gastroenterology and Hepatology Fellow at Mayo ClinicAndres Acosta, MD, PhD
Gastroenterology and Hepatology Fellow at Mayo Clinic
Gastroenterology and Hepatology Fellow at Mayo Clinic
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Lead Moderators
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Endocrinology Fellow, NSW, AustraliaSu-Ann Ding, MD
Endocrinology Fellow, NSW, Australia
Endocrinology Fellow, NSW, Australia
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Moderators
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Endocrinologist at University of Rochester Medical CenterSusanne Miedlich, MD
Endocrinologist at University of Rochester Medical Center
Endocrinologist at University of Rochester Medical Center
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General Internal Medicine Fellow at Johns HopkinsEva Tseng, MD, MPH
General Internal Medicine Fellow at Johns Hopkins
General Internal Medicine Fellow at Johns Hopkins
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Medical Student at Broad Institute
