An additional oral contraceptive regimen may promote weight loss in adolescents as a result of bariatric surgery, the researcher said.

In a pilot study of 10 patients, adolescents receiving standard care costs of phentermine (Lomaira, Adipex-P) ոպ topiramate (Trokendi XR, Qudexy XR և Topamax) saw a 4.3-point drop in BMI after 12 weeks compared with : with an increase of 2.3 points among placebo users (Q:= 0.04), according to Jaime Moore, MD, School of Medicine, University of Colorado, APA.

The prospective, randomized controlled trial (RCT) included young people who had already had a gastrectomy but still had persistent severe obesity for 6-12 months after surgery և / or saw 26%, 28%, or 31% less weight. the loss at 6, 9 և 12 months after surgery, Moore explained in a presentation at the ObesityWeek virtual meeting.

“As far as we know, this is the first pilot RCT therapy for adolescent obesity after bariatric surgery,” he explained. “Preliminary efficacy data support a greater reduction in BMI with phentermine topiramate versus placebo for 12 weeks.”

The mean age of the patients in the study was 16 years. Exclusion criteria included hypothalamic obesity, a history of certain heart diseases, glaucoma, hyperthyroidism, and / or other anti-obesity medications for the past 6 months.

A total of five patients were randomly assigned to the active treatment group, while five were in the placebo group. On average, the group was about 7.5 months after surgery, which resulted in a 20% weight loss average. Almost all the patients were women.

During the 3-week enhancement phase, patients were started on 4 mg of phentermine in combination with 25 mg of topiramate for immediate release. It was later added to և 8 mg phentermine / 50 mg topiramate և 12 mg / 75 mg. A target dose of 16 mg phentermine / 100 mg topiramate was administered during week 4, if tolerated. However, the mean maximum tolerated dose was 8 mg / 50 mg.

Tolerance has been shown to be a problem in these patients, as almost all patients on this combination therapy have reported anxiety, irritability, restlessness, difficulty concentrating, mental fog, and paraesthesia. By comparison, almost none of the patients taking placebo reported any of these adverse events (AD).

For severe AEs, significantly more patients using phentermine / topiramate had difficulty with dietary recommendations (60% vs. 0% placebo). It is possible that one of the participants in the active treatment had cholelithiasis in connection with the treatment, while no one in the placebo group had it.

However, there was no difference between the treatment groups when it came to depressive mood, memory, sleep, rash, fatigue, headache, shortness of breath, chest pain, change in taste, nausea / vomiting, diarrhea, or constipation.

Although there was no difference between the groups in systolic or diastolic blood pressure or heart rate, those receiving active treatment saw lower bicarbonate levels (-4.8 mmol / L versus baseline -0.6 mmol / L: placebo) in the 4th week of treatment. However, this appears to have returned by շաբաթ12 weeks (from baseline -1.6 mmol / L at +1.6 mmol / L placebo).

“Based on this feasibility data, we really see the need for multifaceted collaboration between these drugs and other drugs, including GLP-1 receptor agonists,” Moore explained. However, he noted that although GLP-1 receptor agonists have shown great results in adults, this class of agents has not yet been independently tested in adolescents. The study’s summary states that Moore “may discuss the inappropriate use of phentermine / topiramate in adolescents after bariatric surgery during this presentation.”

“Our large adolescent bariatric surgery centers in the United States perform 35 to 50 surgeries a year,” he said. And, of course, only some of them can benefit from additional medication. So compared to adults, our pool is much smaller starting. ”

Future studies should consider the timing of postoperative pharmacological interventions that affect hunger and satiety, as interventions may be more deliberately combined with eating behaviors to alleviate nutritional concerns, Moore said.

As for tolerance, it “can be improved by using a single drug against combination therapy,” Moore admitted, adding that both agents in the study were oral therapies, so injectable versions may produce more “predictable” tolerance results.

  • Kristen Monaco is a staff writer focusing on endocrinology, psychiatry and nephrology news. Outside of New York, he has been with the company since 2015.

Discoveries:

The study was funded by the Colorado Nutrition Obesity Research Center Pilot & Feasibility Award, the Children’s Hospital Colorado Research Institute Research Scholar Award, and the Colorado Institute of Clinical Translation and MicroGrant և Pediatric Nutrition Foundation Start-up Funds.

Moore has no connection to the industry.

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