[FONT="]Background: Albuterol is a beta-2 agonist that has been demonstrated to increase muscle strength in studies in animals and humans. Based on a pilot study of extended-release albuterol Repetabs in children with dystrophinopathies, the authors conducted a randomized, double-blind, placebo-controlled study with a crossover design.[/FONT]
[FONT="]Methods: Fourteen boys with Duchenne or Becker muscular dystrophy, 6 to 11 years old, completed two treatment periods (albuterol and placebo), 12 weeks each, separated by a 12-week washout period. As the albuterol Repetab formulation was no longer available, an alternate extended release albuterol was used (Volmax, 12 mg per day). Outcome measurements included 1) lean body mass, 2) fat mass, 3) isometric knee extensor and flexor moments, 4) manual muscle testing, and 5) timed functional tests.[/FONT]
[FONT="]Results: Lean body mass was significantly higher for subjects following albuterol treatment compared to placebo treatment, while fat mass was significantly lower. No differences were found in isometric knee moments or manual muscle tests. Time to run/walk 30 feet was improved following albuterol.[/FONT]
[FONT="]Conclusions: Short-term treatment with extended release albuterol may increase lean body mass, decrease fat mass, and improve functional measures in patients with dystrophinopathies. However, the significant change in strength of specific muscle groups found in the pilot study was not observed in the present study. These findings may be attributed to differences in the drug release and kinetics between Repetab and Volmax formulations as they affect the concentration of available beta-2 receptors on the muscle cell surface differently.[/FONT]
[FONT="]Our data indicate that the combination of caffeine and albuterol can increase lean mass and decrease fat mass during growth and weight gain.[/FONT]
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[FONT="]Previous studies done at Pennington Biomedical have demonstrated that the equivalent of oral albuterol 4mg three times a day (tid) with oral caffeine 100mg tid reduces body fat and increases lean tissue in rodents more than the addition of the effect of the two components separately. The combination of albuterol with caffeine changed body composition without changing food intake. An adult male taking albuterol 4 mg orally tid plus caffeine 100mg orally tid increased lean mass by 1.25% and decreased fat mass by 1.2% over a two month period. These effects are expected to be even greater in a growing adolescent. This pilot project will take the first step towards trying to understanding the safety and potential efficacy of this drug combination. The prospect of using inexpensive medications already approved in the pediatric population for the treatment of asthma as a novel treatment for adolescent obesity addresses a medical need that is presently unmet.[/FONT]
[FONT="]Food restriction in adolescence is not only difficult to accomplish, but it also raises concerns about growth and development. A medication approved for the treatment of obesity in the adolescent age group that improves body composition by reducing body fat and increasing lean tissue without needing to restrict food intake would be a useful tool for physicians who address the treatment of obesity in adolescents. Albuterol is a medication, approved for ages 6 and older, used for the treatment of asthma and has also been shown to increase muscle strength and lean body mass in children with spinal muscular atrophy and in healthy young men during an exercise training program. A drug approved for the treatment of adolescent obesity that increases lean tissue, decreases fat tissue and can be given in conjunction with lifestyle modifications would be welcomed by both pediatricians who treat these adolescents and by adolescents who are stigmatized by their obesity.[/FONT]
[FONT="]A provisional patent has been submitted by Pennington Biomedical Research Center to protect the combination of caffeine and albuterol in a 1:25 ratio for synergistically increasing muscle mass and decreasing fat mass as a potential treatment for obesity in adolescents.[/FONT]
[FONT="]This study will be a double-blinded, randomized, placebo-controlled, pilot study in which subjects will be randomized to receive either placebo or a combination of Albuterol 4 mg and Caffeine 100mg three times per day orally for a total of 8 weeks. Each subject will continue on the study intervention for the entire duration of treatment[/FONT]
[FONT="]Methods: Fourteen boys with Duchenne or Becker muscular dystrophy, 6 to 11 years old, completed two treatment periods (albuterol and placebo), 12 weeks each, separated by a 12-week washout period. As the albuterol Repetab formulation was no longer available, an alternate extended release albuterol was used (Volmax, 12 mg per day). Outcome measurements included 1) lean body mass, 2) fat mass, 3) isometric knee extensor and flexor moments, 4) manual muscle testing, and 5) timed functional tests.[/FONT]
[FONT="]Results: Lean body mass was significantly higher for subjects following albuterol treatment compared to placebo treatment, while fat mass was significantly lower. No differences were found in isometric knee moments or manual muscle tests. Time to run/walk 30 feet was improved following albuterol.[/FONT]
[FONT="]Conclusions: Short-term treatment with extended release albuterol may increase lean body mass, decrease fat mass, and improve functional measures in patients with dystrophinopathies. However, the significant change in strength of specific muscle groups found in the pilot study was not observed in the present study. These findings may be attributed to differences in the drug release and kinetics between Repetab and Volmax formulations as they affect the concentration of available beta-2 receptors on the muscle cell surface differently.[/FONT]
[FONT="]Our data indicate that the combination of caffeine and albuterol can increase lean mass and decrease fat mass during growth and weight gain.[/FONT]
- - - Updated - - -
[FONT="]Previous studies done at Pennington Biomedical have demonstrated that the equivalent of oral albuterol 4mg three times a day (tid) with oral caffeine 100mg tid reduces body fat and increases lean tissue in rodents more than the addition of the effect of the two components separately. The combination of albuterol with caffeine changed body composition without changing food intake. An adult male taking albuterol 4 mg orally tid plus caffeine 100mg orally tid increased lean mass by 1.25% and decreased fat mass by 1.2% over a two month period. These effects are expected to be even greater in a growing adolescent. This pilot project will take the first step towards trying to understanding the safety and potential efficacy of this drug combination. The prospect of using inexpensive medications already approved in the pediatric population for the treatment of asthma as a novel treatment for adolescent obesity addresses a medical need that is presently unmet.[/FONT]
[FONT="]Food restriction in adolescence is not only difficult to accomplish, but it also raises concerns about growth and development. A medication approved for the treatment of obesity in the adolescent age group that improves body composition by reducing body fat and increasing lean tissue without needing to restrict food intake would be a useful tool for physicians who address the treatment of obesity in adolescents. Albuterol is a medication, approved for ages 6 and older, used for the treatment of asthma and has also been shown to increase muscle strength and lean body mass in children with spinal muscular atrophy and in healthy young men during an exercise training program. A drug approved for the treatment of adolescent obesity that increases lean tissue, decreases fat tissue and can be given in conjunction with lifestyle modifications would be welcomed by both pediatricians who treat these adolescents and by adolescents who are stigmatized by their obesity.[/FONT]
[FONT="]A provisional patent has been submitted by Pennington Biomedical Research Center to protect the combination of caffeine and albuterol in a 1:25 ratio for synergistically increasing muscle mass and decreasing fat mass as a potential treatment for obesity in adolescents.[/FONT]
[FONT="]This study will be a double-blinded, randomized, placebo-controlled, pilot study in which subjects will be randomized to receive either placebo or a combination of Albuterol 4 mg and Caffeine 100mg three times per day orally for a total of 8 weeks. Each subject will continue on the study intervention for the entire duration of treatment[/FONT]
