Novo Nordisk's diabetes drug liraglutide works best as a weight-loss treatment when combined with vigorous exercise, according to the results of the EudraCT study. The one-year test, preceded by an eight-week 800-kcal-per-day diet, showed the combination treatment cut participants' weight by 20.9 pounds (9.5 kg, P<0.001) compared with normal activity and placebo injections, more than twice the reduction seen with vigorous exercise alone (4.1 kg, P=0.03). With liraglutide and no additional exercise, participants lost 15.0 pounds (6.8 kg) relative to the control condition (P<0.001), researchers report in the New England Journal of Medicine. The company, which markets the drug under the brand name Victoza, paid for the study. Liraglutide costs about $1,780 per month according to prices on goodrx.com and works through appetite suppression. "Only the combination strategy was associated with improvements in the glycated hemoglobin level, insulin sensitivity, and cardiorespiratory fitness," the researchers discovered. However, people taking liraglutide were more likely to have an increased heart rate and cholelithiasis. Surgery is currently considered the most effective weight-loss strategy for people who are morbidly obese. The loss is usually 20% to 30% compared to the 16% seen in EudraCT. But the surgery isn't reversible and "when you have weight lost by gastric bypass, you also lose a lot of muscle mass, which may not be that beneficial to improve your health," senior author Dr. Signe Torekov of the University of Copenhagen told Reuters Health in a telephone interview. The exercise component, which in the trial mostly consisted of cycling and running, will also increase a person's fitness rating, "which is very much associated with increased survival," she noted. The test of 195 volunteers was done at Hvidovre Hospital in Denmark and the University of Copenhagen. All had to have lost at least 5% of their weight before being assigned to a test group. The average reduction on that diet was 12%. All had a BMI of 32 to 43. The change in weight at week 52 was based on the weight of patients when they got their group assignment. The difference in body weight at week 52 between the two liraglutide groups was not statistically significant, with exercise patients losing an additional 5.9 pounds (2.7 kg, P=0.13). But the difference in the two exercise groups, where the volunteers typically exercised about 2.5 times per week, was significant. The people who also received liraglutide lost an average of 11.9 pounds (5.4 kg) more (P=0.004). Ultimately, 10% in the control group lost at least 15% of their body weight. The rates were 29% with liraglutide alone, 30% with exercise alone, and 49% with both the drug and exercise. The rates for a loss of at least 10% of body weight were 28%, 59%, 45% and 69% respectively. Liraglutide recipients tended to have more nausea, diarrhea, constipation, vomiting, dizziness, fatigue, dyspepsia, palpitations, and influenza or influenza-like symptoms. "The nausea and other side effects were often more pronounced at the beginning and they do wane," said Dr. Torekov, a professor of clinical translational metabolism. Her team said the findings may not apply to people over 65, people with coexisting conditions such as type 2 diabetes, and those who can't or won't adhere to an exercise program of moderate or vigorous intensity. She said this study is "the first to show you can actually use exercise as a means to attain a healthy weight loss. Most studies focus on saying to people, 'Eat healthy and exercise more.' But it's not often that you get details on whether people actually exercised or whether they were just advised to. Many studies may not measure if they actually increased their fitness ratings. This is a study where we know you actually did it." —Gene Emery Source
