Posted on: 10:36 am, September 18, 2012, by Ryan Sullivan, updated on: 09:00pm, September 18, 2012

(CNN) A new diet drug approved by the U.S. Food and Drug Administration in July is now available for obese and at-risk overweight patients. The oral medication Qsymia can only be obtained with a doctors prescription.

Qsymia (pronounced kyoo-SIM-ee-uh) is the second diet drug approved this year. The FDA approved a weight-loss pill called Belviq on June 27.

Patients in clinical trials experienced more dramatic weight loss with Qsymia than with Belviq. On Qsymia, patients went from an average 227 pounds to 204 pounds; on Belviq, the average weight dropped from 220 to 207.

Qsymia had been known as Qnexa until its approval. The FDA asked the company to change the name to avoid confusion with another drug on the market, according to the company.

Some consumer advocates worry that the medications weight loss comes with a price. Some patients in the clinical trial suffered an increased heart rate and a condition called metabolic acidosis, which can lead to hyperventilation, fatigue and anorexia.

Concerns have also been raised about birth defects. One of the ingredients in Qsymia is topiramate, an anti-convulsant that has been linked to birth defects such as cleft lip and cleft palate in babies born to women who have taken it for migraines or seizures. Qsymias other ingredient is phentermine, an appetite suppressant.

Our belief is that women will be invited (through) compelling advertising and marketing messages to experiment on themselves with a drug that has some effectiveness with healthy weight loss but possible serious risks, said Cindy Pearson, executive director of the National Womens Health Network.

Qsymias manufacturer, Vivus Inc., says that the drug helped lower blood pressure and cholesterol levels in obese people and that people taking it were less likely to get type II diabetes.

Obesity is not being adequately addressed by diet and lifestyle changes or currently available therapies, the company said. The need for new options is urgent, particularly nonsurgical options.

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Diet drug Qsymia approved by FDA

Public release date: 19-Sep-2012 [ | E-mail | Share ]

Contact: Eileen Leahy andjrnlmedia@elsevier.com 732-238-3628 Elsevier Health Sciences

Philadelphia, PA, September 19, 2012 The Dietary Approaches to Stop Hypertension (DASH) diet, which promotes consumption of more fruits, vegetables, low-fat dairy products, and whole grain, and less meats and sweets, is a proven effective treatment for hypertension. For some individuals, adherence to the diet can be just as effective in lowering blood pressure as taking antihypertensive medication. A new study has found that greater adherence to the diet can lead to significant reductions in blood pressure, but that African Americans are less likely to adopt the diet compared to whites. The study is published online today in the Journal of the Academy of Nutrition and Dietetics.

"After DASH dietary counseling, African Americans increased their consumption of DASH foods, but continued to lag behind whites in overall adherence to the DASH eating plan, consuming considerably more meat, sweets, and fat, and less fruit," reports lead investigator James A. Blumenthal, PhD, Professor of Behavioral Medicine in the Department of Psychiatry and Behavioral Sciences at Duke University Medical Center in Durham, NC.

The study was a new analysis of the ENCORE study, which evaluated the effectiveness of the DASH diet alone and in combination with exercise training and weight reduction. 144 sedentary, overweight, and obese adults with high blood pressure were randomly assigned to three treatment groups. The first group ate the DASH diet and was engaged in weekly education, support, and feedback in group sessions. The second group also ate the DASH diet and received structured support and feedback, and in addition began a weight management program with caloric restriction, behavior modification, and aerobic exercise three times a week. The third group was instructed to maintain their normal diet and activity, but did not receive in instruction in the DASH diet nor were they encouraged to exercise or lose weight.

Researchers evaluated adherence to the diet, clinic and ambulatory blood pressure, and cardiorespiratory fitness. Participants also underwent a number of psychosocial assessments to evaluate their mental and social wellbeing and to identify potential predictors of dietary adherence including depression, anxiety, level of support from family and friends, and their beliefs about health and exercise. Demographic and background variables, including sex, age, ethnicity, income, education, and baseline body mass index were also examined.

After four months, participants in the DASH plus weight management group lost more weight compared to the DASH diet alone and control groups. There was no difference in dietary compliance between the DASH plus weight maintenance and the Dash alone groups. Participants with higher post-treatment DASH adherence scores had lower blood pressure levels, and the more participants adhered to the daily recommendations in the diet, the more their blood pressure decreased.

While both African-American and white participants in the DASH treatment groups increased their consumption of DASH foods after treatment, African Americans in both treatment groups had lower adherence scores compared to whites. No other demographic, behavioral, or social variable predicted DASH adherence.

"Strong cultural influences on food preferences, food preparation, and perceptions about eating practices might make it more challenging for African Americans to adhere to the DASH diet," Dr. Blumenthal notes. "In light of the considerable role that food plays in African-American culture, greater cultural sensitivity is likely to be needed to achieve greater adoption of the DASH eating pattern when prescribing dietary modification programs. For example, it might be more effective to modify traditional recipes to meet current nutritional guidelines rather than to recommend that such foods be eliminated altogether."

In a video accompanying the article, co-investigator Pao-Hwa Lin, PhD, a nutritionist from the Department of Medicine at Duke University Medical Center, discusses the implications of the study and possible reasons for lower adherence to the DASH diet in African Americans.

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African Americans less likely to adhere to DASH diet for lowering blood pressure

Public release date: 19-Sep-2012 [ | E-mail | Share ]

Contact: Rachel Bloch rachel.bloch@duke.edu 919-419-5069 Duke University Medical Center

DURHAM, N.C. Better adherence to the DASH (Dietary Approaches to Stop Hypertension) diet is associated with significant reductions in blood pressure. However, African-Americans may be less likely than whites to adopt the diet, according to researchers at Duke University Medical Center.

The findings, which appear online September 19 in the Journal of the Academy of Nutrition and Dietetics, suggest that altering traditional recipes to meet nutritional guidelines rather than eliminating certain foods altogether may result in better adherence among African-Americans.

The DASH diet is recognized as the diet of choice for preventing and managing high blood pressure. The diet is rich in fruits, vegetables, and low fat dairy products, and is low in fats and cholesterol.

"Previous research, including results from our ENCORE study, established the DASH diet as an important approach for lowering blood pressure, and for some individuals, it may be an effective alternative to taking medication for hypertension," said James A. Blumenthal, PhD, professor of behavioral medicine in the Department of Psychiatry and Behavioral Science at Duke University Medical Center. "In this study we were interested in whether dietary adherence was related to blood pressure changes and what factors predicted who would adhere to the diet."

The study was a new analysis of data from the ENCORE trial, led by Duke researchers to evaluate the effectiveness of the DASH diet on cardiovascular health. Participants were 144 sedentary, overweight or obese adults, who had high blood pressure and were not taking medication.

Researchers measured a series of clinical and behavioral factors at the start of the study including blood pressure, weight, and physical fitness, as well as dietary habits. Depression, anxiety and social support were also evaluated as potential predictors of adherence to the regimen.

Participants were randomly assigned to one of three treatment groups: the DASH diet alone; the DASH diet in combination with weight-loss counseling and aerobic exercise; or no change in diet and exercise habits.

After four months, participants in the group that got the DASH diet plus weight-loss counseling and exercise lost an average of 19 pounds, while weight remained stable in the other two groups.

Link:
Blood pressure diet works, but adherence drops among African-Americans

Meg Evans, in red, lost 48 pounds her first year on Qsymia and another two pounds the second year.

STORY HIGHLIGHTS

(CNN) -- A new diet drug approved by the U.S. Food and Drug Administration in July is now available for obese and at-risk overweight patients. The oral medication Qsymia can only be obtained with a doctor's prescription.

Qsymia (pronounced kyoo-SIM-ee-uh) is the second diet drug approved this year. The FDA approved a weight-loss pill called Belviq on June 27.

Patients in clinical trials experienced more dramatic weight loss with Qsymia than with Belviq. On Qsymia, patients went from an average 227 pounds to 204 pounds; on Belviq, the average weight dropped from 220 to 207.

Qsymia had been known as Qnexa until its approval. The FDA asked the company to change the name to avoid confusion with another drug on the market, according to the company.

Health care costs to bulge along with U.S. waistlines

Some consumer advocates worry that the medication's weight loss comes with a price. Some patients in the clinical trial suffered an increased heart rate and a condition called metabolic acidosis, which can lead to hyperventilation, fatigue and anorexia.

Concerns have also been raised about birth defects. One of the ingredients in Qsymia is topiramate, an anti-convulsant that has been linked to birth defects such as cleft lip and cleft palate in babies born to women who have taken it for migraines or seizures. Qsymia's other ingredient is phentermine, an appetite suppressant.

"Our belief is that women will be invited (through) compelling advertising and marketing messages to experiment on themselves with a drug that has some effectiveness with healthy weight loss but possible serious risks," said Cindy Pearson, executive director of the National Women's Health Network.

Read more from the original source:
New diet drug Qsymia now available

Meg Evans, in red, lost 48 pounds her first year on Qsymia and another two pounds the second year.

STORY HIGHLIGHTS

(CNN) -- A new diet drug approved by the U.S. Food and Drug Administration in July is now available for obese and at-risk overweight patients. The oral medication Qsymia can only be obtained with a doctor's prescription.

Qsymia (pronounced kyoo-SIM-ee-uh) is the second diet drug approved this year. The FDA approved a weight-loss pill called Belviq on June 27.

Patients in clinical trials experienced more dramatic weight loss with Qsymia than with Belviq. On Qsymia, patients went from an average 227 pounds to 204 pounds; on Belviq, the average weight dropped from 220 to 207.

Qsymia had been known as Qnexa until its approval. The FDA asked the company to change the name to avoid confusion with another drug on the market, according to the company.

Health care costs to bulge along with U.S. waistlines

Some consumer advocates worry that the medication's weight loss comes with a price. Some patients in the clinical trial suffered an increased heart rate and a condition called metabolic acidosis, which can lead to hyperventilation, fatigue and anorexia.

Concerns have also been raised about birth defects. One of the ingredients in Qsymia is topiramate, an anti-convulsant that has been linked to birth defects such as cleft lip and cleft palate in babies born to women who have taken it for migraines or seizures. Qsymia's other ingredient is phentermine, an appetite suppressant.

"Our belief is that women will be invited (through) compelling advertising and marketing messages to experiment on themselves with a drug that has some effectiveness with healthy weight loss but possible serious risks," said Cindy Pearson, executive director of the National Women's Health Network.

See the original post here:
FDA-approved diet drug Qsymia now available with prescription