The participants in the study who took the drug combination has lost more weight on average than those who took a placebo. Seventy percent of subjects who took a strong dose of two drugs, phentermine and topiramate, suffered a loss of weight of 5 per cent a year.
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The treatment may provide another option for those who have failed to lose weight with current treatments, said study investigator Dr. Kishore M. Gadde, Director of the programme of clinical trials of obesity at Duke University Medical Center.
“After trying to diet and exercise, you only treat long-term obesity orlistatfor,” Gaddesaid. “And if that help you, you jump to the surgery.”
“This potentially bridges the gap that exists between the changes of lifestyle treatments for obesity? diet and exercise? and surgery, Gadde.
However, others argue the patients in this study were highly selected? few were selected a month out of the many that were eligible? If the researchers do not know if the population of overweight and obésités individuals could lose the same amount of weight, said Dr. Pieter Cohen, assistant professor of medicine at Harvard Medical School and a general internist at Cambridge Health Alliance, which was not involved in the study.
In addition, patients were studied after discontinuation of medication, so it is not clear whether weight loss could be maintained in the long term. Patients may have to be on drugs for the rest of their lives, Cohen said, and the safety of such a scheme is not known.
Although current step in the study, some patients on drugs have experienced serious side effects, including anxiety and depression. Side effects were worse with a higher dose of drugs. There has been concern about the safety of the drugs of loss of weight in recent years. In October, the weight loss drug Meridia was removed from the market after it was linked to an increased risk of heart attack and stroke. And in February, the Food and Drug Administration rejected the Contrave weight loss drug approval, citing concerns with the potential cardiovascular risks of the drug.
“What we need to know, is take these drugs increase or decrease the amount of strokes and heart attacks, that these patients will experience,” said Cohen.
The study is published online today (April 11) in the journal the Lancet.
Combination of drugs
Phentermine is approved by the Food and Drug Administration for the treatment of obesity short term, which means that patients can take approximately 12 weeks. But no rigorously designed studies examined the effects of the drug in the long term. Topiramate is a drug used to treat seizures. It was established to assist in weight loss in previous studies, but often causes psychiatric side effects at high doses. It was thought a combination of drugs using lower doses may be more tolerable.
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The new study involved 2 487 people overweight or obese in 93 centres to the United States. The participants were required to have at least two conditions in addition to their obesity, such as diabetes and hypertension.
Patients were randomly assigned to receive one of three treatments: placebo, phentermine and topiramate, or a higher dose of phentermine and topiramate. Approximately 1,000 patients received placebo, 500 received a low dose and 1,000 taken a high dose of the drug combination. All participants received information on the practices of diet and healthy lifestyle.
After a little more than a year, the participants in the placebo group lost an average of 3 pounds (1.4 kg), the participants in the combination of the drug dose lower group lost an average of 18 pounds (8.1 kg) and the higher dose group lost an average of 22 pounds (10.2 kg).
Twenty and one per cent of the participants taking placebo reaches a weight of 5 per cent loss compared to 62% in the Group of drug over dose low who reached this loss of weight and 70% in the highest drug dose group.
The combination of drugs also have lower blood pressure and insulin.
The combination can be more effective than current treatments of obesity drugs because drugs have many ways they are acting on the body to cause weight loss.
“When you have a drug with several mechanisms of action, there is more chance that it have much more effectively,” said Gadde. “The brain has the ability to find a way to make you eat once more, if we are handling just a small way. If you attack centers of appetite from several different angles, you potentially more successful. ?
Further necessary research
Studies future need to look at the combination of drugs would be more effective than aggressive lifestyle interventions, said Cohen. In this study, participants had materials reading describing healthy habits, but this type of intervention is known not to be effective, he said. Aggressive interventions, help patients develop strategies on their weight loss and include meetings with nutritionists, have demonstrated to cause up to 10 percent weight loss, said the Cohen.
Without these data, the suspects Cohen, it is unlikely that the Food and Drug Administration will approve the combination of drugs for the treatment of obesity, Cohen said.
“In fact, the FDA already examined the results of this test and refused to approval for this combination because the risks that may offset the benefits last year” Cohen said, referring to the decision of the FDA last October, which refused approval to Qnexa, a drug that combines phentermine and topiramate. “” “”. It is a very small select group of patients, comparing drugs against doing nothing at all and it is not the type of data that we need to decide whether a drug is really make a difference in the lives of patients with overweight and obésités. ?
Treatments 2009-2024 anti-obesity provides a detailed analysis of the global market the anti-obesity, with overall sales forecast. With a rigorous study of sources, including commercial databases, the reports of the company, industry news and the first-hand interviews with experts in the area of obesity, this report is a unique opportunity to discover how your business can grow over the next 5 years. The result is a report full-based market and industry with detailed analyses and informed view that you won’t find anywhere else.
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A combination of two drugs generated up to a weight loss of 10 percent in obese people after one year. However, additional research is needed to see whether the results apply to the whole of the population and investigate the safety of the drugs.
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