MOUNTAIN VIEW, CA, USA I February 1, 2013 I VIVUS, Inc. (Nasdaq: VVUS) announced today the publication of a study concluding that weight loss resulting from treatment with QsymiaTM (phentermine and topiramate extended-release) capsules CIV led to significant improvements in cholesterol, blood pressure and triglycerides in obese and overweight patients experiencing one or more of these associated conditions. The improvements were significantly greater among patients who lost 10% or more of their starting weight.
The study was published online in The American Journal of Cardiology and can be accessed via the following link: [http://www.ajconline.org/article/S0002-9149(12)02641-0/abstract].
"This provides clear evidence that patients with hypertension or high cholesterol treated with Qsymia for one year experienced significant weight loss and clinically meaningful improvements in their underlying cardiovascular risk factors," said Suzanne Oparil, M.D., Director of the Vascular Biology and Hypertension Program, University of Alabama at Birmingham, and an investigator in the study. "The ability to improve underlying risk factors is another reason physicians should proactively discuss the medical treatment of obesity with their patients who have failed lifestyle modification alone."
Obesity is a chronic condition defined by having excess body fat. Obesity and smoking are the leading causes of preventable death in the U.S., and obesity contributes directly to numerous life-threatening conditions including diabetes, cardiovascular disease, hypertension and stroke. According to the World Health Organization and CDC, more than 500 million people worldwide and approximately one-third of American adults (more than 78 million people) are obese. In addition to obesity, high cholesterol, blood pressure and triglycerides are significant risk factors for cardiovascular disease.
About the Study
Participants in the study with body mass indexes of 27 to 45 kg/m2 were randomized to placebo, recommended dose (7.5/46mg) or top dose (15/92mg) Qsymia. Participants also received lifestyle modification counseling. Primary end points were percentage weight loss and the proportion of participants achieving at least 5% weight loss. Additional end points were changes in lipid variables in patients with dyslipidemia and changes in blood pressure in patients with hypertension, stratified by treatment assignment and magnitude of weight loss. Qsymia produced significantly greater dose-related mean percentage weight loss compared with placebo in the subgroups of participants with dyslipidemia and those with hypertension.
In the subgroup with dyslipidemia, treatment-emergent adverse events occurred in 75.9%, 86.5%, and 88.3% of the placebo, recommended dose, and top dose groups, respectively. In the subgroup with hypertension, the rates were 77.3%, 85.4%, and 88.8%, respectively. The most common treatment emergent adverse events in the subgroup with dyslipidemia and the subgroup with hypertension were dry mouth, paraesthesia, constipation, upper respiratory tract infection, and nasopharyngitis. Adverse event profiles in these high risk patients were similar to those seen in the study population as a whole.
About Qsymia
Qsymia is approved in the U.S. and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.
Important Safety Information
Qsymia (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.
Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.
The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.
About VIVUS
VIVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health for U.S., Europe and other world markets. Qsymia is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. For more information about the company, please visit www.vivus.com.
SOURCE: VIVUS
Post Views: 137
MOUNTAIN VIEW, CA, USA I February 1, 2013 I VIVUS, Inc. (Nasdaq: VVUS) announced today the publication of a study concluding that weight loss resulting from treatment with QsymiaTM (phentermine and topiramate extended-release) capsules CIV led to significant improvements in cholesterol, blood pressure and triglycerides in obese and overweight patients experiencing one or more of these associated conditions. The improvements were significantly greater among patients who lost 10% or more of their starting weight.
The study was published online in The American Journal of Cardiology and can be accessed via the following link: [http://www.ajconline.org/article/S0002-9149(12)02641-0/abstract].
"This provides clear evidence that patients with hypertension or high cholesterol treated with Qsymia for one year experienced significant weight loss and clinically meaningful improvements in their underlying cardiovascular risk factors," said Suzanne Oparil, M.D., Director of the Vascular Biology and Hypertension Program, University of Alabama at Birmingham, and an investigator in the study. "The ability to improve underlying risk factors is another reason physicians should proactively discuss the medical treatment of obesity with their patients who have failed lifestyle modification alone."
Obesity is a chronic condition defined by having excess body fat. Obesity and smoking are the leading causes of preventable death in the U.S., and obesity contributes directly to numerous life-threatening conditions including diabetes, cardiovascular disease, hypertension and stroke. According to the World Health Organization and CDC, more than 500 million people worldwide and approximately one-third of American adults (more than 78 million people) are obese. In addition to obesity, high cholesterol, blood pressure and triglycerides are significant risk factors for cardiovascular disease.
About the Study
Participants in the study with body mass indexes of 27 to 45 kg/m2 were randomized to placebo, recommended dose (7.5/46mg) or top dose (15/92mg) Qsymia. Participants also received lifestyle modification counseling. Primary end points were percentage weight loss and the proportion of participants achieving at least 5% weight loss. Additional end points were changes in lipid variables in patients with dyslipidemia and changes in blood pressure in patients with hypertension, stratified by treatment assignment and magnitude of weight loss. Qsymia produced significantly greater dose-related mean percentage weight loss compared with placebo in the subgroups of participants with dyslipidemia and those with hypertension.
In the subgroup with dyslipidemia, treatment-emergent adverse events occurred in 75.9%, 86.5%, and 88.3% of the placebo, recommended dose, and top dose groups, respectively. In the subgroup with hypertension, the rates were 77.3%, 85.4%, and 88.8%, respectively. The most common treatment emergent adverse events in the subgroup with dyslipidemia and the subgroup with hypertension were dry mouth, paraesthesia, constipation, upper respiratory tract infection, and nasopharyngitis. Adverse event profiles in these high risk patients were similar to those seen in the study population as a whole.
About Qsymia
Qsymia is approved in the U.S. and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.
Important Safety Information
Qsymia (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.
Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.
The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.
About VIVUS
VIVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health for U.S., Europe and other world markets. Qsymia is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. For more information about the company, please visit www.vivus.com.
SOURCE: VIVUS
Post Views: 137
