HealthDay Reporter by Steven Reinberg
HealthDay Reporter - LUNS on 11 April, 11: 48 pm EST
(Sunday, 10 April HealthDay News) - obese patients taking a high dose of a called Qnexa experimental weight loss pill an average of 22 books has lost more than a year, while reducing the rate of cholesterol and blood pressure numbersa new study has found.
Qnexa is a combination of two drugs: phentermine drug for weight loss used more widely to the United States, currently available in a variety of brand names, but also a generic; and topiramate (Topamax), better known as a drug used to relieve epilepsy, and migraine.
Qnexa was recently shot down as a weight loss aid, by the Food and Drug Administration because no there was not enough data on the risk of birth defects and problems related to the drug. TOPIRAMATE has been associated with an increased risk of cleft lip / palate in babies born to mothers who took the drug.
The results of the study, which was funded by vivos, creator of Qnexa, suggest that "the combination of topiramate and phentermine when administered with some lifestyle tips could be a valuable treatment for obesity", said principal investigator Dr. Kishore GaddeProfessor of Psychiatry and Director of the programme of clinical trials of obesity at Duke University Medical Center.
One of the important weight loss reasons are that these drugs work by different mechanisms, said Gadde. "In treatment, [by] the mechanisms you have it y a greater likelihood of achieving the kind of weight loss, we expect, a significant proportion of patients," he said.
In addition, the combination of drugs may modify profile of side effects for each drug, he speculated. "The thinking behind the combination of drugs is that some of the secondary effects may actually cancel," said Gadde. "Topiramate causes fatigue and phentermine is a stimulant, so that they may be negating the side effects of each other."
TOPIRAMATE may also cause changes in mood, while phentermine is more exciting, he added.
The report is published in the online edition of The Lancet on April 11.
In this multicenter trial, called CONQUER, the team of the Gadde randomly about 2500 overweight and obésités of men and women in the diet and the consultation exercise alone or alongside counselling once per day low or high-dose Qnexa as pills. Low dose Qnexa contained 7.5 milligrams (mg) of topiramate phentermine and 46 mg, pill contained high dose phentermine 15 mg and 92 mg of topiramate.
After 56 weeks, patients in each dose of Qnexa had lost a lot more weight that those who participated in the programme of counselling, the researchers found.
Those who take the drug combo had an average weight loss of 3 pounds, compared to 18 pounds for those low-dose Qnexa and 22 pounds for those on the high-dose Qnexa.
In addition, while 21% of people in the programme of counselling alone lost at least 5% of their weight, this number rose to 62% of those with low-dose Qnexa and 70% for those on the scheme of high dose.
In addition, people taking of Qnexa have reductions in blood pressure, blood cholesterol, triglycerides (a blood fat) and sugar levels in the blood, Gadde Group found.
The ideal candidates for this treatment are obese and whose weight is affecting their State of health of people overweight, Gadde said.
"When you are looking for weight loss in patients, should not be for aesthetic reasons," he said. "An ideal candidate for weight loss is someone who has the [health] obesity risk."
Gadde stressed that weight loss in the first year of the trial was continued in the second year of the trial.
Side effects occurred in some patients and have been particularly common in the high dose. To those who take high doses Qnexa side effects most often are dry mouth (21%), paresthesia or a sensation of "pins and needles" (21%), constipation (17%), insomnia, dizziness and distorted taste (10%).
Paresthesia is a common side effect of phentermine, Gadde, pointed, while the other side effects are likely associated with topiramate.
An increased risk of depression and anxiety also noted in those taking drugs, seeming to increase as the dosage given pink. On twice the number of people in the high dose drug groups dropped trial against people who receive a single counselling, researchers noted.
"If you see side-effects such as depression and anxiety, you need to pay more attention", said Gadde. You don ' t give the drugs to someone who is clinically depressed ", he added.
According to Gadde, there is no congenital malformations in babies born to 34 women who are fallen pregnant while taking Qnexa in this trial.
Ashley Buford, a spokesman for vivos, said that the company is in the hope to resubmit his application for approval of Qnexa to FDA at the end of the year.
Commenting on the study, obesity expert Dr. David l. Katz, Director of the Yale University School of Medicine Prevention Research Centre, said that "" this study shows that we cause to believe before: that Qnexa facilitates beyond weight loss consultation seultant Office that people are taking the drug-based. ""
However, weight loss may likely not persist if the drug use is stopped, he said.
"In addition, we is not yet known if Qnexa is safe for use in the long term, or even life and therefore cannot yet say if it is safe and useful for weight control in the long term.""," said Katz. "Other drugs that have facilitated short-term weight loss have failed to be translated for use in the long term safe and effective." This is the bar of what a really useful weight loss drug must clearly, "says.
More information
For more information on obesity, visit the U.S. National Library of Medicine.
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