HealthDay reporter Steven Reinberg
HealthDay reporter Mon Apr 11, 11:48 pm ET
Sunday, April 10 HealthDay News)-obese patients who a high dose of an investigational weight loss pill called lost Qnexa on average 22 pounds more than a year, and at the same time reduce their cholesterol levels and blood pressure numbers, a new study has found.
Qnexa is a combination of two drugs: phentermine, the most widely used weight loss drug in the United States, currently under various brand names, as well as a generic. and topiramate (Topamax), known as a drug for epilepsy and migraine to facilitate.
Qnexa was recently as a weight loss help from the U.S. food and drug administration, refused because there not enough data on the risk of birth defects and heart problems in relation to the drug. Topiramate has been with women at increased risk for cleft palate, who took the drug born children combined.
The new study by Vivus, Qnexa's maker, suggest that "the combination of topiramate and phentermine if managed some lifestyle advice could be a valuable treatment for obesity,", said lead researcher Dr. Kishore Gadde, Assistant Professor of Psychiatry and Director of the programme obesity clinical studies at Duke University Medical Center.
One reason for the significant weight loss is that these drugs by various mechanisms work, said Gadde. "In a treatment [with] the more mechanisms that you have there is a greater likelihood reach a large proportion of the patients, the type of weight loss, we hope," he said.
Also speculated the combination of drugs the side effect profile for each drug can change it. "The thinking behind the combination of drugs is that some of the side effects could actually raise," said Gadde. "Topiramate a stimulant, so that they negate the side effects of each other could be effects that fatigue and phentermine is."
Topiramate cause also mood swings can phentermine more uplifting, although he added.
The report is published in the April 11 online edition of the Lancet.
In this study multimedia center called cutters, assigned Gadde's team randomly almost 2,500 overweight and obese men and women, diet and exercise to advice alone or in conjunction with daily low - or high-dose Qnexa in pill form advice. During high-dose birth control pills 15 mg phentermine and 92 mg of topiramate include contained 7.5 milligrams (mg) of phentermine and 46 mg of topiramate, low-dose Qnexa.
Lost to 56 weeks patients to either dose of Qnexa significantly more weight than those who only in the consulting program researchers participated found.
Not in the drug combo had compared an average weight loss of 3 pounds, 18 pounds for those on low-dose Qnexa and 22 pounds for those on the high-dose Qnexa.
In addition, while 21 percent of respondents to the consultation alone was at least 5 percent of their weight, the numbers rose 62 percent of those polled on low dosed Qnexa and 70 percent for those with high-dose.
In addition the Qnexa saw reductions in their blood pressure, blood cholesterol, triglycerides (a blood fat) and blood sugar levels, Gadde's group, found.
The ideal candidate for this treatment obese and overweight people weighing their health impact, said Gadde.
"If you are looking for weight loss in patients, it should not for cosmetic reasons," he said. "Someone, obesity is an ideal candidate for weight loss [] has health risks."
Noted Gadde, that the weight loss seen was retained in the first year of study in the second year of the process.
Side effects occur in some patients, and were particularly common in the higher dose. In the high dose Qnexa most common side effects were dry mouth (21%), paresthesia or a feeling of "needles" (21%), constipation (17%), insomnia, nausea and distorted taste (10 percent).
Paresthesia is a common side effect of phentermine, Gadde mentioned, while the other side-effects on the likely topiramate are associated with.
In the taking of the drugs seemed to increase as the dosage given rose was found also an increased risk of depression and anxiety. About twice the number of people in the high-dose drug group consulting broke the researchers get the study when compared to people alone established.
"Side effects such as depression and anxiety is displayed, you must be careful," said Gadde. "These drugs to someone not type, which is clinically depressed," he added.
According to Gadde, there were no birth defects under each of the newborn, the 34 women who became pregnant while taking Qnexa in this study.
Ashley Buford, a spokeswoman for Vivus, said the company hopes to resubmit your application for the approval of Qnexa to the FDA by the end of the year.
The study, obesity expert Dr. David L. Katz, Director of the Prevention Research Center at Yale University School of medicine, commented that "this study shows what had we to believe in cause: that weight loss of Office based consultancy Qnexa alone erleichtertsolange people take the drug."
However, the weight loss can he not be expected to, if use of the drug will stop, said.
"In addition we still white, whether Qnexa for long term or even lifelong use is safe, and can thus not yet say whether it is safe and useful for long term weight management," said Katz. "Other drugs, which have in the short term facilitate weight loss didn't translate, long-term use of safe and effective." This bar, that drug must disable a really useful weight loss, ", he said."
More information
More obesity, visit the U.S. National Library of medicine.
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