Written by Stuart Stevens | Wednesday, 19 July 2006
Ukmedix has recieved the reports of the clinical testing of the weight loss drug Reductil (sibutramine) on teenagers. At present the drug is only allowed for use in adults and teenager under 16 and children are not allowed to be prescribed the drug. The recent research shows that the Reductil drug when used with behaviour therapy and counselling has helped many very obese teenagers shed an an average of 14lbs over the year of the trial. The teenagers who were given the placebo pill put on 4 pounds in weight on average. The trials were done on children from the age of 12 to 16 and presented in the Annals of Internal Medicine.
It is of some concern that teenagers are likely to abuse the use of weight loss drugs as they get very self concious about their weight and may not use them properly if they are given access to them. This clinical trial was the first large testing of Reductil with obese teenagers and was important as there has been less time and money utilised looking at the effects of weight loss drugs and supplements in children compared to the time and money spent on adults.
The results showed similar benefits to those shown in adults with reductions in BMI and body weight as well as the lower triglycerides levels and an increase in HDL cholesterol in those teenagers using the Reductil. The only relevant and significant side effect was rapid heart beat known medically as tachycardia.
In all the researchers looked at nearly 500 very obese teenagers at 33 different clinics all over the US. In the research the teenagers were randomized into two seperate double blinded groups with one group getting the Meridia and the other one receiving the placebo. Both of the groups were given weight loss counselling.
The different treatment centres had their own counselling plans and they all used approaches that allowed the teenagers to self-monitor their eating patterns, physical exercise and problem solving when it came to eating. The counselling put emphasis on the increase in physical exercise and eating healthy nutritious food.
The results showed that by the finish of the research the 281 teenagers who got the Reductil she an average of 14lbs and that the 79 teenagers in the placebo control group put on 4lbs. Also BMI decreased by 9.4% in the Reductil group compared to 1.2% with the placebo control group. The researchers took note of the fact that the teenagers were still growing over the course of the testing and many gained in height and went through puberty.
This research may be used as an argument for the FDA of the United States and the EMEA in the European Union to allow doctors to prescribe the Reductil drug to teenagers. It is likely however the the FDA will have serious concerns about allowing a potentially dangerous appetite supressant to get into the hands of young teenagers who may abuse the Reductil which has been shown to have side affects that affect the heart.
