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Showing posts with label diet pills. Show all posts
Showing posts with label diet pills. Show all posts

Four people on rimonabant had killed themselves

A major trial linked the drug to a slightly higher suicide rate. The trial wasn't testing the drug's weight loss benefits, but whether it might prevent heart problems. It was supposed to follow more than 18,000 patients in 42 countries for three years. Roughly half were given rimonabant while the other half were given a placebo. European officials shut it down and pulled the drug from the market. It was never licensed in the United States, but was sold as Acomplia, Riobant, Slimona, as well as under other names in Europe. "Obviously the suicides are tragedies," said Eric Topol, director of Scripps Translational Science Institute and the study's lead author. "But we accept trade-offs in medicine and the psychiatric side effects might have been acceptable if we had found greater cardiovascular benefits later," he said.

He said rimonabant might still have been useful for fighting obesity, and that measures like stomach stapling surgeries also come with significant risk. Other experts disagreed. "Any mortality associated with cardiovascular preventive therapy is generally viewed as unacceptable," wrote Matthijs Boekholdt and Ron Peters of the department of cardiology in the Academic Medical Center in Amsterdam, in an accompanying commentary.
Source: MSNBC

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New anti-obesity drug Liraglutide significantly reduce weight

The drug, liraglutide, is the first of a new class of anti-obesity agents which mimic the action of a hormone that occurs naturally in the gut, reducing hunger. Experts said it had "great potential" because it also reduced the risk factors for Type 2 diabetes and heart disease. Diabetes already affects more than two million people in Britain and is rising so fast it threatens to overwhelm the National Health Service (NHS). "It tells the body to produce more insulin and the brain to stop eating. It is a naturally occurring satiety hormone.



"The problem is that it is eliminated from the blood stream within minutes. The company (Novo Nordisk) has added a molecule to make it more resistant to elimination, so it lasts for a full day."





Read more: NZHerald

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Users of one of the drugs, Alli, can lose 3lb a week

Users of one of the drugs, Alli, can lose 3lb a week, according to its manufacturer GlaxoSmithKline. This equates to more than three stones over four months.
The drug, which is a £1.60-a-day diluted version of the prescription-only drug Xenical, works by reducing the body's ability to process fat by about 25 per cent.


The undigested fat passes straight through the body, creating what is described as "an urgent need to go to the bathroom".
Professor Gareth Williams, professor of medicine at the University of Bristol and the author of Obesity: Science To Practice, said that the side-effects are so severe that "possibly few users will even finish their first pack of Alli, let alone buy a second".

Read more on: Telegraph.co.uk

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New Weight Loss products on the FDA alert list


Herbal Xenicol, Slimbionic and Xsvelten are now on the FDA alert list.
Also the undeclared pharmaceutical ingredients added to the warning are fenproporex, fluoxetine, furosemide and cetilistat. The FDA warned consumers late last year not to purchase or consume 28 different products marketed for weight loss. The latest warning is the second update to that list, which now includes 72 products, and the agency said it would continue to update the list as needed.




"These tainted weight-loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed maximum recommended dosages," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a news release. "Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health."

The products included in the alert, some of which are marketed as dietary supplements are promoted and sold on various Web sites and in some retail stores and beauty salons, the FDA said. The products have not been approved by the FDA and are illegal, the agency said.


Source: Honnews

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Acai Berry Blast

Acai Berry Blast is a dietary and weight loss supplement that is to help you shed unwanted pounds, boost your energy, detoxify your body and feel better. Containing the wonder fruit, the acai berry which hails from the Amazon Rain Forest, Acai Berry Blast captures the powerful antioxidant properties of this tiny berry and delivers it to you in a capsule form.
Acai berries are known for their comprehensive nutrition profile and have been celebrated as one of nature’s most complete foods by many health and nutrition experts.





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FDA said consumers shouldn't take the weight-loss pill Venom Hyperdrive 3.0

Venom Hyperdrive 3.0, marketed by California-based Applied Lifescience Research Industries Inc., contains sibutramine, a chemical that can put people at risk for addiction and can increase peoples blood pressure and heart rate, according to a press release issued Tuesday by the FDA. Consumers who have the product should stop taking it immediately and contact their doctor if they are experiencing any adverse health effects, the agency said. Applied Lifescience Research initiated a recall of the product in late December after the FDA said the dietary supplement contained sibutramine, according to the agency's press release.


The FDA's announcement comes about a month after the agency said more than 60 weight-loss products were tainted with powerful ingredients, including those used in antiseizure medications and some chemicals suspected to cause cancer.

Venom Hyperdrive 3.0 comes in red plastic bottles and can be found in retail stores in the U.S., as well as in Canada, Poland, Sweden, Hungary, South Africa, the Netherlands, Australia, France and the United Kingdom.

Applied Lifescience Research's Web site says only "trace" amounts of sibutramine can be found in the product, the FDA said, but the agency's analysis showed Venom Hyperdrive contains a significant amount.

"Nowhere do we state that Venom Hyperdrive contained trace amounts of subutramine," said Charles Weller, general counsel for Applied Lifescience Research. He added that the company's Web site only mentioned that trace amounts of sibutramine weren't harmful, not that trace amounts were in the product.

Mr. Weller said the company had begun replacing Venom Hyperdrive 3.0 about six months ago with a newer version. He said the company isn't certain how the sibutramine got into the original product, but said he believes it was contaminated by raw-material suppliers in China.

Source: The Wall Street Journal

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Appesat (seaweed) could help in the battle against obesity

An expanding pill that tricks the brain into thinking the stomach is full.
The pill is taken at least half an hour before meals and works by reducing appetite so that smaller portions are eaten. As it swells, the pill, called Appesat, stretches the stomach wall, stimulating receptors that send a signal to the brain to say that the stomach is full.

The effects are similar to those of a gastric balloon, an inflatable implant surgically inserted into the stomach and then filled with saline solution. The new pill simply needs to be swallowed with water. After a few hours, it gets broken down by acid in the stomach and is flushed out of the body as waste.


It has been approved as a medical device by the Medicines and Healthcare Products Regulatory Authority, the government body that vets new treatments.
Recent research predicted one in three adults in the UK will be obese by the time London stages the Olympic Games in 2012.

Source: DailyMail.co.uk

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Weight-loss pill Lorcaserin passes early test

In recently released phase 2 trials, the drug, known as lorcaserin, resulted in substantial weight loss in obese men and women. "Lorcaserin is a completely novel mechanism and we think it can bring very robust weight loss. But, also, the safety profile of the compound is excellent," said Dominic P. Behan, co-founder and chief scientific officer of Arena Pharmaceuticals in San Diego, which makes the drug and sponsored a study published in the Dec. 4 issue of the journal Obesity.

"We demonstrated a highly statistically significant, progressive weight loss. This study involved no diet or exercise and the weight loss was rapid and we saw the weight loss in as little as two weeks," he added. A phase 3 trial is under way and, if all goes well, Arena Pharmaceuticals may file a new drug application with the U.S. Food and Drug Administration at the end of 2009, Behan said.

With some two-thirds of Americans either overweight or obese, the need for an effective weight loss tool is tremendous. Excess weight can lead to a variety of health problems, including heart disease, stroke, cancer, arthritis and type 2 diabetes. "Obesity is an epidemic," said Dr. Stuart Weiss, a clinical assistant professor of medicine at New York University's Langone Medical Center in New York City. "Diabetes trails behind obesity by a short few years and the numbers of patients that are developing diabetes is staggering."

Diet and exercise are proven antidotes for excess weight, but few people are able to sustain such changes and, even if they lose weight, will regain it.
Some weight-loss drugs are already on the market -- such as Xenical and Meridia -- but have certain side effects. The drug Fen-phen, a combination of fenfluramine and dexfenfluramine, worked for many but was withdrawn from the market in 1997 when it was linked with increased rates of heart valve problems in patients.

Fen-phen acted on serotonin receptors both in the brain and in the heart and therein lay the problem, Behan said.
"The challenge was to design a compound that was purely selective for the receptor involved, namely the 2c receptor [located in the hypothalamus region of the brain and involved in weight loss] and avoiding the 2b receptor [located in the heart]," Behan said.

The result was lorcaserin, which targets the 5-HT2C serotonin receptor only.
For the phase 2 trial, 469 men and women with a body mass index ranging from 30 to 45 were randomly assigned to one of four groups: 10 milligrams (mg) of lorcaserin once a day, 15 mg once a day, 10 mg twice a day, or a placebo.
Participants taking lorcaserin at 10 mg, 15 mg and 20 mg a day lost 4 pounds, 5.7 pounds and 7.9 pounds, respectively, over the 12-week period. Those in the placebo group lost less than a pound.

In the 10 mg, 15 mg and 20 mg groups, respectively, 12.8 percent, 19.5 percent and 31.2 percent of participants lost 5 percent or more of their starting body weight, versus only 2.3 percent of patients on the placebo.
Participants taking the two higher doses of lorcaserin also shaved inches off their waist and dropped their cholesterol levels. Also, their echocardiograms -- ultrasound images of the heart -- were normal.

"It [lorcaserin] certainly looks a bit better [than other weight-loss medications]," Weiss said. "We don't have much out there. They're really just modest medications and they don't do much at all."

Source: iVillage

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FDA warning consumers nationwide not to purchase any of the following tainted weight loss products

- Fatloss Slimming
- 2 Day Diet
- 3x Slimming Power
- Japan Lingzhi 24 Hours Diet
- 5x Imelda Perfect Slimming
- 3 Day Diet
- 7 Day Herbal Slim
- 8 Factor Diet
- 7 Diet Day/Night Formula
- 999 Fitness Essence
- Extrim Plus
- GMP
- Imelda Perfect Slim
- Lida DaiDaihua
- Miaozi Slim Capsules
- Perfect Slim
- Perfect Slim 5x
- Phyto Shape
- ProSlim Plus
- Royal Slimming Formula
- Slim 3 in 1
- Slim Express 360
- Slimtech
- Somotrim
- Superslim
- TripleSlim
- Zhen de Shou
- Venom Hyperdrive 3.0

After analysing these products the FDA found they contained undeclared active pharmaceutical ingredients, in some case in amounts that exceeded FDA-recommended levels, thereby putting consumers' health at risk.

The director of the FDA's Center for Drug Evaluation and Research, Dr Janet Woodcock said: "These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages.""Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public," she added.Among the undeclared ingredients they found were:

Sibutramine: this can cause high blood pressure, palpitations, tachycardia, seizures, heart, attack, and stroke. It can also interact with other medications to cause adverse reactions. Its safety for use by children under 16 or pregnant or breastfeeding women is unknown.

Rimonabant: an appetite suppressant that has been evaluated but not approved by the FDA for sale in the US. This drug is approved for sale in Europe, where is has been implicated in 5 deaths and 720 reported adverse reactions in the last two years. The drug has also been linked to increased risk of depression and suicidal thoughts.

Phenytoin: an anti-seizure drug.
Phenolphthalein: a suspected carcinogen that is used to test for acidity in chemical experiments. Some of the products are advertised as containing only "herbal" or "natural" ingredients, but in reality contain potentially harmful substances that are not listed on product labels or advertisements.

The FDA warns that:"These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers."If you have bought or own any of these products you should stop taking them and talk to your doctor immediately said the FDA, who also advises consumers to talk to a healthcare professional before buying any weight loss products.The federal agency has inspected a number of firms selling or connected with the selling of these illegal products and is seeking to recall the products.

The FDA may proceed with a number of enforcement actions, escalating from warning letters to seizures, injunctions and criminal prosecution. Whether you are a consumer or healthcare professional, you can report serious adverse events or side effects, or problems with product quality to the FDA's MedWatch Adverse Event Reporting program in any of the following ways:

- Going online at http://www.fda.gov/MedWatch/report.htm
- Faxing to the fax number: (800) FDA-0178.-- Calling phone number: (800) FDA-1088.-- Writing to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
- Filling in postage-paid FDA form 3500 available at: http://www.fda.gov/MedWatch/getforms.htm and then mailing to above address.Click here for more information about these weight loss products and consumer-directed questions and answers.

Source: Medical News Today

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The Qnexa phase 3 obesity program

A pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced positive results from the EQUATE study (OB-301), a 28-week, phase 3 obesity trial conducted at 32 sites with Qnexa™, an investigational drug. The EQUATE study met the primary endpoint by demonstrating superior weight loss with both the full-dose and mid-dose of Qnexa, as compared to the individual components and placebo.

Subjects treated with full-dose and mid-dose Qnexa had an average weight loss of 9.2%and 8.5% respectively, as compared to weight loss of 1.7% reported in the placebo group. Average weight loss was 19.8 pounds and 18.2 pounds in the treatment arms as compared to 3.3 pounds in the placebo group. Qnexa was well-tolerated, with no drug-related serious adverse events in the study.

"The results from the EQUATE trial once again confirmed our belief in Qnexa. In addition to hitting the primary endpoints of the study with the full-dose, we were also able to show excellent results with the mid-dose of Qnexa," commented Leland Wilson, president and chief executive officer of VIVUS. "The EQUATE study is the first of three studies in the Qnexa phase 3 obesity program. Data from the EQUIP and CONQUER studies, which combined enrolled over 3,750 subjects, is expected in mid-2009."

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Scientists are trying to understand how Fen-phen behaves in the brain in order to develop safer anti-obesity drugs with fewer side effects

Once hailed as a miracle weight-loss drug, Fen-phen was removed from the market more than a decade ago for inducing life-threatening side effects, including heart valve lesions.

In a study appearing in the Nov. 25 issue of Neuron, the researchers define a circuit in the brain that explains the ways fenfluramine, a component of Fen-phen, suppresses appetite.“Our findings provide evidence that the neural circuit we’ve proposed is sufficient for the neurotransmitter serotonin to regulate food intake and body weight, ” said Dr. Joel Elmquist, professor of internal medicine and pharmacology at UT Southwestern and senior author of the study. “Fen-phen works directly on this pathway. Unfortunately, that drug also adversely affects peripheral tissue such as the heart.”

For the current study, the researchers engineered mice in which the expression of a serotonin receptor called 5-hydroxytryptamine 2C was blocked throughout the entire body. This was previously known to produce obese mice resistant to the anorexic actions of fenfluramine. When activated by serotonin, however, this receptor is also known to suppress appetite. Using this mouse model, the authors engineered another set of mice in which the same serotonin receptor was blocked everywhere in the body except within a group of brain cells called pro-opiomelanocortin, or POMC, neurons. The POMC neurons, which are found in the hypothalamus, are also known to play an important role in suppressing appetite and inducing weight loss.

The researchers found that the animals with no serotonin 2c receptors expectedly developed obesity as well as other metabolism disorders such as increased food intake, hyperactivity and leptin insensitivity. They also were prone to spontaneous seizures, said Dr. Elmquist.In contrast, the mice in which the serotonin receptor was re-expressed and functioning only in the POMC neurons stayed slim and responded to fenfluramine.“The POMC-specific reactivation of the receptor only in POMC neurons normalizes the abnormal metabolism in these mice,” Dr. Elmquist said. “The animals don’t eat excessively.
Their hyperactivity is also gone.”Previous work from the UT Southwestern group led to the hypothesis that Fen-phen worked by activating the serotonin 2c receptor in the POMC neurons in the hypothalamus. The current work provides genetic proof supporting this model.“Conventional wisdom is that fenfluramine increases serotonin release that then activates serotonin receptors in the brain to regulate food intake and body weight, but unfortunately, this drug also causes lesions in heart valves,” he said. “If you could develop a drug that would travel to both the brain and the peripheral tissues, and then give a blocker to protect the heart, it’s possible that you could prevent the harmful side effects and still aid weight loss.

Admittedly, that’s a bit farfetched, but this mouse model could be used to test that theory.”The team’s next step is to determine whether they’ve identified the sole circuit required to suppress appetite and induce weight loss.

Source: UT Southwestern

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Banned drug Fenfluramine has been shown to have serious long-term effects


In a report published in the open access journal BMC Medicine, researchers have shown that people who stopped using fenfluramine eleven years ago had damaged heart valves up to seven years later.

Fenfluramine (and the closely related dexfenfluramine) were widely prescribed as half of a so-called 'fen/phen' drug combination used to combat obesity. Since its withdrawal, there have been reports that tens of thousands of lawsuits have been filed against the drug's manufacturers over damage caused. In this study, Charles Dahl from the Central Utah Clinic led a team of researchers who studied the heart condition of 5743 former fenfluramine users. He said, "Valve problems were common in individuals exposed to fenfluramines, more frequent in females and associated with duration of drug use in all valves assessed".

Heart valves, such as the aortic, mitral and tricuspid valves, ensure that blood flows in the correct direction around the heart. When they fail, blood back-flows (termed regurgitation). If the regurgitation is severe enough, congestive heart failure and/or the need for heart valve surgery may occur. Dahl said, "We found clear evidence for a strong, graded association between duration of exposure to fenfluramines and prevalence of aortic regurgitation and for mild or greater mitral and tricuspid regurgitation".

This is the largest study to examine duration of exposure to the drug and the first to estimate the incidence of valvular surgery among prior users. The authors found that 0.44% of former fenfluramine users in this group had valve surgery as a result of the use of fenfluramines. This risk for valve surgery was increased approximately seven fold. They write, "This is probably a conservative estimate, as another study has shown that there exists a 17- to 34-fold excess of clinically apparent (presumably severe), valvular disease in persons who had used fenfluramines for four months or longer".

Source: Medical News Today

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A chemical cousin of red wine extract resveratrol tricks the body to lose weight

The University of Louis Pasteur team found the drug protected mice against weight gain and insulin resistance. The drug SRT1720 - a chemical cousin of red wine extract resveratrol - targets the protein SIRT1, which is thought to combat ageing, Cell Metabolism reports. UK obesity experts said new drug treatments were needed but should be used alongside lifestyle changes. About a quarter of men and a third of women in the UK are overweight, according to government statistics. A change in diet and an increase in physical exercise can shift excess weight, but can be hard for many to maintain. With the removal of the anti-obesity pill rimonabant, also known as Acomplia, from the market amid safety concerns, fewer drug options exist.

Potent drug
The French team from the University Louis Pasteur became interested in the SIRT1 protein after earlier studies showing resveratrol countered some effects of a high-calorie diet via SIRT1.
But tests in mice suggested gallons of wine would be necessary for humans to stand a chance of getting the same benefits. The scientists turned their attention to creating a more potent drug that would specifically target SIRT1.

They found that a low dose of SRT1720 partially protected mice from gaining weight on a high-fat diet after 10 weeks of treatment. The drug worked by shifting the metabolism to a fat-burning mode that normally takes over only when energy levels are low.

At higher doses, the drug completely prevented weight gain. It also improved the rodents' blood sugar tolerance and insulin sensitivity, which are important for warding off diabetes. The mice showed no sign of side effects. However, the scientists say further studies are needed to test the drug's safety and efficacy before it could be used in humans.

Other scientists are investigating SIRT1 activators similar to SRT1720 developed by Sirtris Pharmaceuticals. Professor Stephen Bloom, who has been researching obesity at Imperial College London, said: "This sounds interesting but is terribly early. "We do need new treatments for obesity, particularly as there are 1,000 deaths a week in the UK from obesity."

Prof Ian Broom, of the Centre for Obesity Research and Epidemiology at The Robert Gordon University, said: "Research in this area is to be welcomed as an additional route of combating the obesity epidemic and associated comorbid disease." He added that any such drug should be used alongside dietary and lifestyle changes to tackle obesity.

Source: BBC News

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The overall profile of taranabant does not support further development for obesity

Merck & Co., Inc. will not seek regulatory approval for taranabant, an investigational medicine, to treat obesity and is discontinuing its Phase III clinical development program for taranabant for obesity.

"Available Phase III data showed that both efficacy and adverse events were dose related, with greater efficacy and more adverse events in the higher doses. Therefore, after careful consideration, we determined that the overall profile of taranabant does not support further development for obesity," said John Amatruda, M.D., senior vice president and research head, diabetes and obesity, Merck Research Laboratories. "We thank the patients and investigators around the world who collaborated with us on the research program for taranabant and look forward to developing new medicines for obesity to address the significant medical need posed by this disease."

Source: FierceBiotec

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The benefits of rimonabant no longer outweigh its risks

The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of rimonabant no longer outweigh its risks and the marketing authorisation should be suspended across the EU.

Following the assessment of the available information on the benefits and risks of rimonabant including data from studies completed since it was granted marketing authorisation, the CHMP confirmed at its October 20-23 meeting, that there is an approximate doubling of the risk of psychiatric disorders in obese or overweight patients taking rimonabant compared with those taking placebo.

The CHMP considered that the new data from post-marketing experience and ongoing clinical trials indicated that serious psychiatric disorders may be more common than in the clinical trials used in the initial assessment of the medicine. The CHMP was also of the opinion that these psychiatric side effects could not be adequately addressed by further risk minimisation measures.

In addition, the CHMP noted, that the effectiveness of rimonabant in clinical practice is more limited than was expected on the basis of the clinical trials, because available data indicate that patients generally take rimonabant only for a short period.

Prescribers should not issue any prescriptions for rimonabant and should review the treatment of patients currently taking the medicine. There is no need for patients to stop treatment with rimonabant immediately, but patients who wish to stop can do so at any time.

The CHMP opinion will now be sent to the European Commission for the adoption of a decision, applicable in all EU countries.

Source: Doc Guide

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Obesity pill Tesofensine shows promise

Tesofensine works by interfering with three brain chemicals -- noradrenline, serotonin and dopamine -- involved in regulating hunger. People who take the pill are less hungry and feel full more quickly.
People taking NeuroSearch A/S's obesity pill tesofensine lost twice as much weight as men and women using approved weight loss drugs, Danish researchers said on Thursday.

The study suggest the experimental drug is safe because it had no effect on blood pressure and only raised heart rate slightly, said Arne Astrup of the University of Copenhagen, who led the study published in the journal Lancet.

"It is quite solid from this study that it seems to produce a weight loss that is twice ... what we see from existing compounds on the market," Astrup said in a telephone interview.

The company hopes to take tesofensine to Phase III clinical trials early next year -- the last stage of human testing before a company can seek regulatory approval for a drug.

Obesity, which raises the risk of diseases like type 2 diabetes and heart problems, is increasingly a problem as more people adopt a Western lifestyle.

The World Health Organization classifies around 400 million people around the world as obese, representing an increasingly lucrative market for drug makers.

Astrup and his team compared tesofensine against the Sanofi-Aventis SA obesity-fighting drug Acomplia and Abbott Laboratories' Reductil, known as Meridia in the United States.

The 203 obese volunteers at five Danish obesity centers were given different doses of tesofensine or placebo. The drug worked twice as well as previously published data on Acomplia and Reductil, known generically as sibutramine, the study showed.

SIDE EFFECTS

After the study ended, the men and women on tesofensine had lost 10 kilograms more than people on placebo, compared with studies which have shown weight loss of 3 kilograms for Reductil and about 5 kilograms for Acomplia over a similar six month period, Astrup said.

Side effects included dry mouth, constipation and insomnia, but importantly the volunteers did not exhibit the suicidal thoughts that have plagued Acomplia, known generically as rimonabant, Astrup said.

Acomplia took a hit last year when a U.S. expert panel recommended against its approval in the world's biggest market after it was linked to rare cases of suicide ideation -- a psychological problem not shown to raise the risk of suicide but one that worries doctors.

"So far there have been no warnings about problematic side effects," Astrup said. "It seems clean so far."

Other researchers not involved in the study cautioned that the results are from a single trial in a relatively small number of patients.

"We should therefore be a little circumspect about accepting these claims as to efficacy and await the results of the more relevant Phase III studies, which the author does say at the end of the paper," Ian Broom, a researcher at Robert Gordon University in Britain said in a statement.

in regulating hunger. People who take the pill are less hungry and feel full more quickly.

The next step are Phase III trials in which doctors will also try to regulate diet, something that Astrup said could lead to the kind of weight loss associated with gastric-bypass surgery.

"Most clinicians are always saying we need more effective drugs that can make surgery not necessary," Astrup said. "This is the first opening we have seen."

Source: Yahoo News

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Using sibutramine or phentermine in tandem with pramlintide can enhance weight loss


Amy Halseth, MD, Amylin Pharmaceuticals, San Diego, California, and colleagues randomised 244 overweight or obese patients after a 1-week placebo run-in period to 24 weeks of subcutaneous injections of placebo or pramlintide 120 mcg TID alone or in combination with sibutramine 10 mg QAM or phentermine 37.5 mg QAM. Participants also received dietary counselling.

Pramlintide combined with sibutramine produced an 11.3 +- 1.2 kg mean weight loss, while pramlintide coupled with phentermine produced an 11.3 +- 0.9 kg mean weight loss. Subjects treated with pramlintide alone lost a mean of 3.6 +- 0.7 kg, and placebo-treated patients lost a mean of 2.1 +- 0.9 kg (P < .0001 combination arms vs pramlintide or placebo).

More patients achieved 5% or greater weight loss and 10% or greater weight loss in the pramlintide-sibutramine (78% and 49%, respectively) and pramlintide plus phentermine (82% and 56%, respectively) groups than pramlintide (36% and 11%) or placebo treatment groups (28% and 3%, respectively).

Three serious events occurred -- 2 with placebo, 1 with pramlintide plus phentermine. None of these events was judged to be related to the study medication. The most frequently observed adverse events were similar to those that have been previously reported with these agents when used individually, and no novel safety or tolerability issues arose with either medication, according to the researchers.

The robust weight loss (about 11% from baseline) with pramlintide plus sibutramine and pramlintide plus phentermine seen in this study confirms the potential for the development of combination treatment for obesity, Dr. Halseth said in a presentation on September 9.

She also noted that the findings corroborate earlier experimental data suggesting that targeting multiple pathways using the combination of pramlintide and other centrally-acting agents may produce robust weight loss.

Finally, she noted that future studies should assess more fully the potential risks of combination therapies in future studies.

Source: Doctor's Guide

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Vigabatrin also led to rapid weight loss


US scientists testing the epilepsy drug vigabatrin (GVG) as a potential treatment for drug addiction, discovered that it also led to rapid weight loss and reduced food intake in genetically bred obese rats.

The discovery by scientists at the US Department of Energy's (DOE) Brookhaven National Laboratory, is published in the 20 August advance online issue of the journal Synapse.

Vigabatrin is currently being tested throughout the US in Food and Drug Administration (FDA) approved Phase II trials for the treatment of cocaine and methamphetamine addiction.

For this latest study, the scientists at the DOE's Brookhaven Laboratory found that rats that were genetically bred to be obese showed a 19 per cent loss of total body weight while rats that were not obese lost 12 to 20 per cent, after less than two months on vigabatrin.

Study leader Amy DeMarco, who works with co-author and senior scientist at the Laboratory, Stephen Dewey, said it appeared that the drug made the animals feel full:

"Our results appear to demonstrate that vigabatrin induced satiety in these animals."

Dewey's team was the first to discover vigabatrin as a potential treatment for addiction. They have been investigating the drug for more than 20 years.

Earlier research at Brookhaven discovered a strong link between obesity and addiction, characterized by similar changes in brain activity of the obese and addicts depedent on drugs like cocaine. This prompted Dewey and colleagues to try and find out if vigabatrin would quench food cravings as it does drug cravings. As Dewey explained:

"Given the growing obesity epidemic, we felt that examining vigabatrin's therapeutic efficacy for obesity was particularly relevant."

For the study, Dewey, DeMarco and colleagues assigned 50 adolescent and adult genetically bred "fat" and normal weight rats either to a control group or to groups that were given varios doses of vigabatrin and monitored them for up to 40 days.

The control group rats were given daily injections of saline, while the drug groups were injected with up to 300 mg of of vigabatrin a day. The injection phases lasted for two periods of 7 to 13 days, with breaks in between.

After 40 days, all the animals treated with vigabatrin weighed significantly less than those that received only the saline injections (the controls).

The biggest weight loss and reduction in food intake was in the group that had the biggest dose, the 300 mg dose of vigabatrin. The obese rats lost an average of 19 per cent of their body weight, and the non obese animals lost between 12 and 20 per cent.

Dewey said that the fact the results occurred in the genetically obese animals "offers hope that this drug could potentially treat severe obesity".

"This would appear to be true even if the obesity results from binge eating, as this disorder is characterized by eating patterns that are similar to drug- taking patterns in those with cocaine dependency," he added.

Source: Medical News Today

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Controversial obesity drug Acomplia gets UK okay

Sanofi-Aventis won a final green light for its obesity drug Acomplia from Britain's cost-effectiveness watchdog NICE on Wednesday, clearing the way for doctors to prescribe it on the state health service. Acomplia was once touted as a multibillion-dollar seller, but hopes for the product dimmed last year when a U.S. expert panel recommended against its approval in the world's biggest market, after it was linked to rare cases of suicidal thoughts.

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Resveratrol, a compound present in grapes and red wine, reduces the number of fat cells


Resveratrol may one day be used to treat or prevent obesity, according to a new study.

Past research found that resveratrol protected laboratory mice that were fed a high-calorie diet from the health problems of obesity, by mimicking the effects of calorie restriction. Researchers at the University of Ulm in Germany wanted to know if resveratrol could mimic the effects of calorie restriction in human fat cells by changing their size or function. The German team used a strain of human fat cell precursors, called preadipocytes. In the body, these cells develop into mature fat cells, according to the study's lead author, Pamela Fischer-Posovszky, PhD, a pediatric endocrinology research fellow in the university's Diabetes and Obesity Unit.

In the cell-based study, they found that resveratrol inhibited the pre-fat cells from increasing and prevented them from converting into mature fat cells. Also, resveratrol hindered fat storage. Most interesting, according to Fischer-Posovszky, was that resveratrol reduced production of certain cytokines (interleukins 6 and 8), substances that may be linked to the development of obesity-related disorders, such as diabetes and clogged coronary arteries. Also, resveratrol stimulated formation of a protein known to decrease the risk of heart attack. Obesity decreases this substance, called adiponectin.

The new finding is consistent with the theory that the resveratrol in red wine explains the French paradox, the observation that French people eat a relatively high-fat diet but have a low death rate from heart disease.

"Resveratrol has anti-obesity properties by exerting its effects directly on the fat cells," Fischer-Posovszky said. "Thus, resveratrol might help to prevent development of obesity or might be suited to treating obesity."

Fischer-Posovszky cautioned that, while the health benefits of resveratrol seem promising, there is not sufficient knowledge about the effects of long-term treatment. One small study found that a single dose of up to 5 grams of resveratrol (much higher than the amount in a bottle of red wine) caused no serious ill effects in healthy volunteers, she pointed out. However, she said another study theorized that resveratrol may stimulate the growth of human breast cancer cells, possibly because resveratrol's chemical structure is similar to a phytoestrogen, an estrogen-like substance found in some plants.

Source: ScienceDaily

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