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Health Canada has received confirmation from the manufacturer, Confidence Inc,. through the U.S. Food and Drug Administration, that the affected bottles have been distributed in Canada. The lot being recalled is Lot Number 3001006.EXP.102009. …

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09-04-2007

Cycle: Bernucci sacked by T-Mobile after positive test

LAGOS DE COVADONGA, Spain, Sept 4 Reuters - Italian rider Lorenzo Bernucci has been

sacked by T-Mobile for failing a drugs test during August’s Tour of Germany, the team

said on Tuesday.

“The T-Mobile Team last night terminated Lorenzo Bernucci’s (contract) upon notice

from the UCI (International Cycling Union) of his A-sample positive test for sibutramine,”

the German team announced on its Web site (www.t-mobile-team.com).

Sibutramine is an appetite suppressant.

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The …
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“These are very difficult patients to treat,” explained Dr. Marcus of the Karolinska Institute in Stockholm where the trial was conducted.
These patients are extremely resistant to behavioral treatments that help normal children, and often have a very low quality of life, he said at the meeting, which was cosponsored by the American Diabetes Association.
The trial enrolled 50 obese young peon pie who were 7 to 20 years old and had a range of disorders: mental retardation or attention-deficit-hyperactivity disorder (21 children), central nervous system lesions (10), Lawrence-Moon-Bardet-Biedl syndrome (6), Prader-Willi syndrome (4), myelomeningocele (4), Mb Down syndrome (3), and mutation in the MC4R gene (2).
Half of the children started on sibutramine and crossed over to placebo after 20 weeks. The other half started on placebo and switched to sibutramine. In 38 children, doses were escalated from 10 to 15 mg because of unsatisfactory weight loss, but Dr. Marcus said the best dose is still uncertain.
The group that started on sibutramine experienced a 0.72 reduction in BMI while on the drug, followed by a 0.43 rebound when they went on placebo. Conversely, the group that started on placebo lost 0.06 in BMI during the first half of the trial and 0.68 when they went on sibutramine.
Dr. Marcus acknowledged that these amounts are small, compared with other weight-loss studies, but described them as significant for the population. He said sibutramine slowed weight gain in some children who were in a weight-increase phase, while having an extreme effect in others.
“One child lost 40 kilos,” he said, cautioning that the subgroups in the study were too small to make comparisons by disorder.
Sibutramine was generally well tolerated, according to Dr. Marcus. Five children dropped out of the study–three because of recurrence of CNS tumors and two because they did not comply with the treatment.
Four youngsters were on concurrent selective serotonin reuptake inhibitors (SS-RIs); no side effects were reported with the combination. Three children were diagnosed with severe depression while on placebo.
Dr. Marcus said the children are now off sibutramine because it is only approved for ages 16 and older. He announced plans to start another dose trial that would enable them to resume treatment.
The trial was supported by the Swedish Research Council, the Swedish Children’s Cancer Foundation, Abbott Scandinavia AB (distributor of sibutramine), and the Freemasons in Stockholm Foundation for Children’s Welfare.
COPYRIGHT 2005 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

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The primary study end point was change in binge frequency as expressed in the number of days per week featuring one or more binge eating episodes. From a baseline of 5 days per week, binge frequency declined by 66% with sibutramine and 41% with placebo.
Full remission of binge episodes was attained in 47% of patients on sibutramine and 27% on placebo, he continued.
The only two adverse effects more common in the sibutramine group were dry mouth and constipation, both classified as mild to moderate.
Patients on sibutramine lost a mean of 7.4 kg; those on placebo gained 1.4 kg.
Scores on both the Beck Depression Inventory and the Binge Eating Scale declined with placebo, but dropped by a significantly greater margin in patients on sibutramine.
The Brazilian study was well received at the conference, which was sponsored by the University of New Mexico. There is as yet no approved medication for treatment of BED, which accounts for up to two-thirds of all eating disorder diagnoses.
Dr. James E. Mitchell called Dr. Appolinario’s trial “quite important.”
“The amount of weight loss was substantial, despite the fact that it was a relatively brief study,” noted Dr. Mitchell, president and scientific director of the Neuropsychiatric Research Institute, in Fargo, N.D.
Dr. McElroy characterized sibutramine’s significant benefits in each of the three major domains of BED–binge eating, obesity, and depression–as “winning the Trifecta.”
How could a single agent classified as an appetite suppressant exert significant effects in three such disparate domains? “The appetite suppressants work on neurotransmitters–and we have some preliminary evidence of neurotransmitter dysfunction in eating disorders,” explained Dr. McElroy, professor of psychiatry and codirector of the psychopharmacology research program at the University of Cincinnati.
She presented highlights of the other randomized double-blind sibutramine trial. The details were provided to her by Denise E. Wilfley; Ph.D., principal investigator in the still-to-be-published study, which Dr. McElroy described as “the largest and longest study to date of any medication in BED.”
The trial involved 304 BED patients who were randomized to 15 mg/day of sibutramine or placebo for 6 months. There were 115 dropouts.
“People with eating disorders are impulsive,” Dr. McElroy observed. “I work with bipolar patients, and bingers are way less impulsive than [bipolar patients], but they are impulsive, and it’s hard for them to stick with something. High dropout rates are inherent to the illness, in my personal opinion.”
The mean number of binge days per week dropped from 3.0 to 0.6 in sibutramine-treated patients, which was significantly better than the decline from 2.8 to 1.1 days with placebo. The sibutramine group also had significant weight loss.
The irony for Dr. McElroy is that although these two trials have convinced her that sibutramine is first-line pharmacotherapy in BED on the basis of its efficacy and tolerability, she can’t prescribe the appetite suppressant except with great difficulty because in Ohio it’s a scheduled drug. “We’ve really got to get sibutramine unscheduled in Ohio,” she said.
COPYRIGHT 2003 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

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This issue offers an update regarding the suspected association of magnetic resonance imaging (MRI) contrast agents with a rare and potentially life-threatening skin disease; an article on cardiovascular adverse reactions linked to a contraindicated use of sibutramine (Meridia); and an article on adverse effects leading to the removal of the Swedish Adjustable Gastric Band, a medical device used to treat …

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COPYRIGHT 2000 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

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Mean changes in basal blood glucose were small, but the difference between the two groups was statistically significant, the investigators said. Treatment benefits also were seen in the levels of glycated hemoglobin (Hb[A.sub.1c]), serum triglycerides, and HDL cholesterol.
COPYRIGHT 2005 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

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Along with declines in glucose, insulin, and triglyceride levels, sibutramine helped the teenagers improve their psychological and emotional well-being and their school and social functioning. “The improvements were significantly greater in the sibutramine group than in the placebo group.” Dr. Berkowitz said.
Few long-term studies have addressed adolescent obesity. Mainly they have looked at behavioral changes in diet and exercise. “Most report a loss of only 1-4 kg, with participants still overweight at the end of the study,” Dr. Berkowitz said.
Sibutramine is not approved for use in patients under age 16.
The trial enrolled 498 patients aged 12-16 years (mean age 13.6 years). All of the participants had a BMI that was two units above the 95th percentile for their ages. Two-thirds of the patients in the study were female.
“These were very overweight teenagers,” Dr. Berkowitz noted, reporting that the population had a mean BMI of 36 kg/[m.sup.2]. The investigators drew conclusions from changes in BMI rather than absolute weight because teenagers are still growing in height.
All the patients started the trial on 10 mg of sibutramine or placebo in the morning. If they had lost less than 10% of body weight at 6 months, the dose was increased to 15 mg. The regimen also included behavioral programs for all of the participants, he noted.
The patients who received sibutramine reduced their BMI by 8.2% on average, with a mean absolute reduction of 2.9 kg/[m.sup.2]. The control group on placebo achieved only a 0.8% reduction, with a mean absolute reduction of 0.3 kg/[m.sup.2].
Changes in risk factors were more significant, Dr. Berkowitz said at the meeting, which was cosponsored by the American Diabetes Association.
The sibutramine arm had a 5.9% reduction in triglyceride level, vs. a 9% elevation in the teenagers who received placebo. HDL cholesterol increased 7% with sibutramine but stayed the same with placebo. Insulin levels went down 10.8% in the sibutramine arm, but rose 30.2% in the control group, he reported.
Systolic blood pressure and pulse rates were similar in the two groups, as were the rates of most adverse events (headaches and flu being the most frequent). Tachycardia was significantly more common among those who received sibutramine: 13% vs. 6%, Dr. Berkowitz said.
Three-fourths of 368 teenagers on sibutramine completed the study, but less than two-thirds of 130 in the placebo group continued to the end, perhaps because of dissatisfaction with the amount of weight loss. Only 5% of the sibutramine arm and 6% of the control group withdrew because of adverse events.
Pending Food and Drug Administration review of data from the clincal trial, Dr. Berkowitz suggested that physicians might consider using sibutramine off label in obese teenagers with serious medical problems. He cautioned, however, that physicians should be very careful to use it as indicated in the labeling for adults.
Dr. Berkowitz received grant support from and is a consultant to and advisory board member of Abbott Laboratories, which markets sibutramine.
BY JANE SALODOF MACNEIL
Contributing Writer
COPYRIGHT 2005 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

Obesity doubles the chances of premature death
Diabetes, heart disease, high blood cholesterol, high blood pressure and stroke are some problems caused by obesity
Believe it or not, obesity is also associated with certain types of cancer. Obese women are more likely to die from cancer of the gallbladder, breast, uterus, cervix and ovaries

Obesity is a condition in which there is an excess proportion of total fat in the body. Obesity is normally measured with the help of body mass index or BMI. A person is considered overweight if his or her BMI is between 25 and 29.9; a person is considered obese if his or her BMI is over 30. If a person’s BMI is more than 40, he is said to be morbidly obese.
If you are over weight or obese, you should seek obesity treatment before it becomes too late. Losing weight is tough, if you are overweight or obese, you might be very well aware of this. However, if you want to lose weight, help is available.
There are many obesity treatments available in the market - prescription as well as non-prescription. If you want clinically proven obesity treatment approved by medical authorities, go for prescription drugs. Currently there are three drugs available for obesity treatment; they are Acomplia, Reductil and Xenical.
Acomplia blocks CB1 receptors and reduces cravings for food and helps decrease appetite and control hunger. Acomplia is also said to increase blood levels of “good fats” called HDL-cholesterol and reduce blood levels of “bad fats” called triglycerides. When used with a calorie reduced diet and exercise, Acomplia can prove to be a great obesity treatment.
Another obesity treatment drug which works like Acomplia is Reductil . It works as a satiety enhancer drug. The active ingredient in Reductil is sibutramine hydrochloride which works by blocking the nerve cells that release and reabsorb noradrenaline and serotonin and enhance the feeling of fullness. If you take Reductil, you will want to eat less as compared to your huge diet at present and this will help you to lose weight.
Xenical works differently as compared to Acomplia and Reductil. Xenical blocks the action of the fat-digesting lipase enzymes in the intestine. Xenical blocks 30% of dietary fat from being digested and throws it out from your body.