Treatment of Obese Adolescents with Sibutramine: A Randomized, Double-Blind, Controlled Study

Abstract

Adolescent obesity is becoming a health problem in both developed and developing countries. Antiobesity drug therapy is not currently indicated for the treatment of adolescent obesity and remains investigational at this time. The aim of this study was to determine the efficacy and safety of sibutramine in obese adolescents. A randomized, double-blind, placebo-controlled trial, enrolling 60 adolescents, aged 14-17 yr, for 6 months was conducted. In the first month, all patients received placebo and a hypocaloric diet plus exercise orientation. For the next 6 months, participants received either sibutramine or placebo. Patients assigned to sibutramine group lost an average of 10.3 +/- 6.6 kg, and patients in placebo group lost 2.4 +/- 2.5 kg (P < 0.001). The mean body mass index reduction was significantly greater in the sibutramine group (3.6 +/- 2.5 kg/m(2)) than in the placebo group (0.9 +/- 0.9 kg/m(2); P < 0.001). No participant withdrew because of adverse events, and no difference in blood pressure or heart rate was noted between groups. There were no changes in echocardiographic parameters. In conclusion, sibutramine plus diet and exercise induced significantly more weight loss in obese adolescents.

Efficacy and safety of sibutramine in 2225 subjects with cardiovascular risk factors: short-term, open-label, observational study

“…14 However, in a recent study in obese adolescents treated with sibutramine, similar to our findings, a slight decrease in both blood pressure as well as heart rate was noted. 49 Currently, there is no similar explanation for the small fall in mean heart rate seen in this study. In patients with uncomplicated obesity, treatment with Short-term therapy with sibutramine Z Gaciong and G Placha sibutramine has been reported to be associated with a dose-dependent increase in heart rate with an overall mean increase of 3-7 bpm.…”

Rise in antiobesity drug prescribing for children and adolescents in the UK: a population‐based study

“…Similarly for sibutramine, published studies report that this drug is generally well tolerated in adolescents [21][22][23]. The largest trial, a randomized placebo-controlled trial in 498 obese adolescents over 12 months, reported that 76% of those in the sibutramine arm continued the drug for the full 12-month trial period, with only 6% of subjects withdrawing because of adverse events [22].…”

“…The largest trial, a randomized placebo-controlled trial in 498 obese adolescents over 12 months, reported that 76% of those in the sibutramine arm continued the drug for the full 12-month trial period, with only 6% of subjects withdrawing because of adverse events [22]. In a smaller randomized controlled trial of 60 obese adolescents over 6 months, 93% completed the 6-month trial and no subjects withdrew due to sibutramine side-effects [23]. In a further small randomized trial of 46 obese adolescents, 81% in the sibutramine arm completed the 6-month trial, but none withdrew because of adverse events [24].…”

“…Although we have no data on reasons for discontinuation in our study, our data suggest that both orlistat and sibutramine are more poorly tolerated and more rapidly discontinued in use in the general population than in highly selected, motivated and supported clinical trial populations. These differences may reflect the routine weight management support programmes that were integral parts of many of the clinical trials of orlistat and sibutramine [17,18,22,23].…”

‘Adventure therapy’ combined with cognitive-behavioral treatment for overweight adolescents

“…2.1-2.8 kg over the course of 20 sessions) and there is a trend toward weight gain at follow-up. [13][14][15][16][17][18] While recent studies demonstrate promising results from sibutramine and behavior therapy with overweight adolescents, 19,20 there is continued need for innovative psychosocial interventions in this area.…”