NEW YORK (Reuters Health) – A new study on Saxenda as a weight-loss treatment for obese adolescents has concluded that it can reduce BMI by at least 5% in 43% of patients and by at least 10% in 26%.
But in the typical case, the subcutaneous treatment, expected to cost more than $22,000 per year based on pricing data on the website goodrx.com, didn’t bring the teens below the obese level, which is a BMI below 30.
Among the 125 participants aged 12-18 years randomly assigned to take the drug, whose starting BMI averaged 35.3, there was an absolute decline of 1.39 points (4.29%). For the 126 members of the placebo group, who started off at 35.8, there was an increase of 0.19 points (0.35%), which was significantly different from the change in the treatment group.
In both groups, when the treatment stopped, BMI levels rose. The rise was steepest among liraglutide recipients. The increase showed signs of starting at week 42, 14 weeks before discontinuation of therapy, but that may have been due to an end-of-study lapse in compliance, the authors write in the New England Journal of Medicine.
There was no significant improvement in quality of life between the two groups.
“Based on current evidence, we believe that the mean reduction in BMI with liraglutide in the trial was clinically meaningful,” chief author Dr. Aaron Kelly of the University of Minnesota, in Minneapolis, told Reuters Health by email.
He would not say how many – if any – patients dropped out of the obesity category thanks to the treatment, explaining that “we did not perform that analysis.”
Dr. Celeste Corcoran of Brown University and Hasbro Children’s Hospital in Providence, Rhode Island, who was not connected with the research, told Reuters Health by phone that the findings are encouraging because the only drug on the market for childhood obesity is orlistat, sold under the brand names Xenical and Alli, and it “has an efficacy, at best, of a 3% decrease of BMI, and that’s if the patients can tolerate it. So this is a big deal.”
Side effects led 10.4% of the liraglutide patients to discontinue treatment. None of the placebo recipients halted their injections.
The biggest problem was gastrointestinal problems, experienced by 64.8% of liraglutide patients and 36.5% of placebo recipients (P<0.001), mostly as the liraglutide dose was being gradually increased to 3 mg per day. Nausea occurred in 42.4% of drug recipients versus 14.3% given placebo (P<0.001). The rates for vomiting were 34.4% and 4.0% respectively (P<0.001).
Orlistat, in contrast, causes “fatty loose stools and a lot of flatulence,” said Dr. Corcoran, an expert in childhood obesity.
Liraglutide’s manufacturer, Novo Nordisk, which sells the drug under the brand names Victoza and Saxenda, paid for the study on Saxenda, the results of which were also part of ENDO 2020 virtual sessions.
Dr. Kelly is an unpaid consultant to the company, which paid for outside assistance with preparation of the manuscript.
An estimated 107.7 million children and adults worldwide are obese and at least 70% of children who are obese before puberty are destined to carry that extra weight into adulthood.
In the new study, all of the adolescents, ages 12 to 17 from Belgium, Mexico, Russia, Sweden and the United States, were also given lifestyle therapy that included counseling in healthy nutrition and physical activity for weight management. Children with type 1 diabetes were excluded.
“Some studies indicate that even temporary weight loss may have long-term benefits,” the researchers write, “but the extent to which this applies in adolescents and the extent to which long-term adherence to pharmacotherapy can be expected are unknown.”
The adherence rate of over 80% was higher than other trials, but there was evidence from blood samples that the rate may have slacked off toward the end of the test, which may explain why BMI levels started to creep up again before treatment officially ended, Dr. Kelly said.
It’s not surprising that BMI levels went back up after treatment stopped, said Dr. Corcoran. “The whole point is you need to continue the medication.”
“I want this drug to be (Food and Drug Administration)-approved for teens because it’s hard” to find an effective treatment for them, she said. “You don’t get great results in kids and in teens, so this is exciting.”
Study on Saxenda SOURCE: https://bit.ly/2WVL6A7 The New England Journal of Medicine, online March 31, 2020