Novo Nordisk Drug Helps Healthy Lose Weight, Axe Blood Pressure
The study involving 564 people found just five months of liraglutide injections shaved 4.8 kilograms (10.6 pounds) to 7.2 kilograms from their frames, compared with 4.1 kilograms for those on Xenical and 2.8 kilograms for those given placebo.
The research suggests that liraglutide may be more effective than currently available treatments for obesity. About half of Europeans and two-thirds of Americans are overweight, and 30 percent are considered obese, studies show. Few treatments are available. Novo Nordisk, based in Bagsvaerd, Denmark, funded the research that appears in the journal Lancet and has another trial under way.
“Overall, the results of this study indicate the potential benefit of liraglutide, in conjunction with an energy-deficit diet, in the treatment of obesity and associated risk factors,” said the researchers, led by Arne Astrup, from the University of Copenhagens department of human nutrition. “Liraglutide offers a new mode of action for the treatment of obesity and improved efficacy compared with currently available therapies.”
The research is the second of three phases of trials generally needed to win regulatory approval. Novo Nordisk said it is waiting to hear from U.S. regulators this quarter about the use of the drug for diabetes before it starts additional weight loss trials. Liraglutide is already approved for diabetics in Europe, where its marketed under the name Victoza.
Lower Blood Pressure
Blood pressure levels dropped in all patients taking liraglutide, while signs of impending diabetes, marked by slightly elevated blood sugar levels, fell by as much as 96 percent, the study found.
“Liraglutide improved several factors associated with cardiovascular events over 20 weeks, which are regarded as more clinically relevant than weight loss per se,” the researchers said. “The long-term risk-benefit profile for liraglutide, as well as its weight maintenance capabilities, remain to be established.”
The most common side effects were nausea and vomiting, which generally occurred within the first month. There were no signs of other serious side effects, including pancreatitis, psychiatric complications or thyroid cancer. Participants in the study also followed a calorie-restricted diet and increased their physical activity.
Increased Obesity
The rising rates of obesity during the past two decades have coincided with a dramatic increase in diabetes, leading many public health officials to declare that epidemics are under way with both conditions.
Healthy patients in Astrups study lost more weight than diabetics in earlier studies who were taking the same doses of the drug, said George Bray, from Louisiana State Universitys division of clinical obesity and metabolism in Baton Rouge, in an editorial. It may be that people without diabetes are more responsive to the drug, which stimulates insulin production, slows the emptying of the stomach, and decreases food intake, he said.
“Whether long-term use of an injectable drug is palatable as a treatment for obesity is yet to be established,” Bray wrote. “From what we do know about GLP-1 agonists and their mechanisms, we can be optimistic that their promise for the treatment of obesity will be fulfilled.”
Past Setbacks
Efforts to develop obesity drugs have suffered setbacks. Sanofi-Aventis SA pulled Acomplia off European shelves last year after regulators recommended suspension of sales. The medicine failed to win the backing of a U.S. advisory panel in 2007 after it was linked to suicide.
Merck & Co. last year stopped development of taranabant, in the same class of medicine as Acomplia, because it made people depressed and irritable. Pfizer Inc., the worlds biggest drugmaker, also ended early-stage work on obesity treatments as part of a research overhaul last year.
GlaxoSmithKline Plc sells a form of Xenical, known chemically as orlistat, in a lower-dose, over-the-counter formulation known as Alli.
— Editors: Phil Serafino, Kristen Hallam