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Significant cardiovascular risk with low carbohydrate-high protein diets, experts warn

Posted: June 28, 2012 at 11:23 am

ScienceDaily (June 27, 2012) Women who regularly eat a low carbohydrate, high protein diet are at greater risk of cardiovascular disease (such as heart disease and stroke) than those who do not, a study just published on the British Medical Journal website suggests.

Although the actual numbers are small (an extra 4-5 cases of cardiovascular disease per 10,000 women per year) the authors say that this is a 28% increase in the number of cases and that these results are worrying in a population of young women who may be exposed to these dietary patterns and face the excess risk for many years.

Low carbohydrate-high protein diets are frequently used for body weight control. Although they may be nutritionally acceptable if the protein is mainly of plant origin (e.g. nuts) and the reduction of carbohydrates applies mainly to simple and refined ones (i.e. unhealthy sweeteners, drinks and snacks), the general public do not always recognise and act on this guidance.

Studies on the long term consequences of these diets on cardiovascular health have generated inconsistent results. So a team of international authors carried out a study on just under 44,000 Swedish women aged between 30 and 49 years from 1991-92 (with an average follow-up of 15 years).

Women completed an extensive dietary and lifestyle questionnaire and diet was measured on the low carbohydrate-high protein (LCHP) score where a score of two would equal very high carbohydrate and low protein consumption through to 20 which would equal very low carbohydrate and high protein consumption.

Factors likely to influence the results were taken into account including smoking, alcohol use, diagnosis of hypertension, overall level of activity and saturated / unsaturated fat intake.

After these variables were included, results showed that 1270 cardiovascular events took place in the 43,396 women (55% ischaemic heart disease, 23% ischaemic stroke, 6% haemorrhagic stroke, 10% subarachnoid haemorrhage and 6% peripheral arterial disease) over 15 years.

The incidence of cardiovascular outcomes increased with an increasing LCHP score.

Unadjusted figures show that, compared with an LCHP score of six or less, cardiovascular diseases increased by 13% for women with a score from 7 to 9, to 23% for those with a score from 10 to 12, to 54% for those with a score from 13 to 15, and to 60% for those with a score of 16 or higher.

After adjusting for other cardiovascular risk factors, there was still a significant 5% increase in the likelihood of a cardiovascular event or death with every two point increase in the LCHP score. The 5% increase resulted from a daily decrease of 20g of carbohydrates (equivalent to a small bread roll) and a daily increase of 5g of protein (equivalent to one boiled egg).

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Significant cardiovascular risk with low carbohydrate-high protein diets, experts warn

Diets suggested for overweight pregnant women

Posted: June 28, 2012 at 11:23 am

By Meredith Cohn

June 28, 2012 12:00 AM

Before Aiesha Eddins got pregnant, she didn't give much thought to her diet.

"I ate whatever," said the 27-year-old Owings Mills, Md., woman. "We ordered take-out."

But when she weighed in at 220 pounds during her initial prenatal visit, she quickly earned a spot at the Johns Hopkins Hospital's Nutrition in Pregnancy Clinic, launched in December to counsel and treat obese women. The clinic has around a dozen patients but already is expanding.

An estimated one in five pregnant women are obese, according to the U.S. Centers for Disease Control and Prevention, an epidemic according to some doctors who have begun to buck conventional ideas about "eating for two." They now recommend healthy diets, little or no weight gain and even bariatric surgery for obese women before they get pregnant.

Obese pregnant women are at increased risk of miscarriage, high blood pressure, diabetes, pre-term delivery, stillbirth, cesarean section and other problems. Their babies, which are harder to see on ultrasounds, are more likely to be obese and diabetic and have other maladies.

Conventional advice for these women since 2009 has been to gain 11 to 20 pounds, reflecting guidance from the Institute of Medicine, the influential federal advisory panel. Normal weight women are told to gain 25 to 35 pounds.

Most doctors generally stick to the guidance and treat obesity complications, said Dr. Janice Henderson, an obstetrician for high-risk pregnancies at Johns Hopkins Bayview Medical Center and Eddins' doctor. But she said some doctors have begun to see that as a "missed opportunity" to teach patients about nutritional and lifestyle changes that can improve their and their babies' health.

Eddins was counseled to eat more fruits, vegetables and whole grains. Now seven months pregnant, she's lost 20 pounds.

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Diets suggested for overweight pregnant women

Diet rich in vegetables may help stave off acute pancreatitis

Posted: June 28, 2012 at 11:23 am

Public release date: 27-Jun-2012 [ | E-mail | Share ]

Contact: Stephanie Burns sburns@bmjgroup.com 44-207-383-6920 BMJ-British Medical Journal

A diet rich in vegetables could help stave off the development of the serious condition acute pancreatitis, suggests a large study published online in the journal Gut.

Pancreatitis refers to inflammation of the pancreas - the gland behind the stomach, which, among other things, releases digestive enzymes to break down food. Occasionally these enzymes become active inside the pancreas, and start to digest the gland itself. In up to one in five of those with acute pancreatitis symptoms are severe and potentially life threatening.

Previous research suggests that excessive production of free radicals, which are by-products of cellular activity, is associated with acute pancreatitis. Furthermore, levels of antioxidant enzymes, which mop up free radicals, are increased during an attack. The authors therefore wanted to know if an imbalance in antioxidant levels, associated with dietary factors, might make the pancreas more sensitive to the effects of free radicals and so increase the risk of acute pancreatitis.

They tracked the health of a population-based sample of 80,000 adults living in central Sweden for an average of 11 years, following the completion of a comprehensive dietary questionnaire in 1997 on how often they had eaten from a range of 96 food items over the preceding year.

Average vegetable and fruit consumption was around 2.5 and just under 2 servings, respectively, every day. In general, those who ate the fewest daily servings of vegetables were men, smokers, and those who had not gone on to higher education.

A similar profile was seen for fruit consumption, although people in this group were more likely to drink alcohol and to have diabetes.

During the monitoring period, 320 people developed acute pancreatitis that was not associated with the complications of gallstones - a relatively common cause of the condition.

The amount of fruit consumed did not seem to influence the risk of developing acute pancreatitis, but this was not the case for vegetables.

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Diet rich in vegetables may help stave off acute pancreatitis

US approves new weight-loss pill

Posted: June 28, 2012 at 11:23 am

27 June 2012 Last updated at 19:43 ET

US health regulators have approved a weight-loss pill for the first time in 13 years.

Belviq, made by Arena Pharmaceutical, can be used by obese or overweight adults with at least one condition.

The drug achieved only modest results in clinical studies, helping people lose on average about 5% of their body weight.

Belviq was rejected in 2010 because of concerns over tumours that developed in animals tested with the drug.

After San Diego-based Arena resubmitted its application with more data, the US Food and Drug Administration (FDA) found little risk of tumours in humans using the drug.

The medication is expected to launch in 2013.

Belviq is designed to block appetite signals in the brain, making patients feel fuller with smaller amounts of food.

It has been approved for use in obese adults with a body mass index of 30 or greater.

The drug can also be used by overweight adults with a BMI of 27 or greater if they have at least one other condition such as high blood pressure, type 2 diabetes or high cholesterol.

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US approves new weight-loss pill

FDA approves lorcaserin, first weight-loss drug since 1999

Posted: June 28, 2012 at 11:23 am

The Food and Drug Administration has approved marketing of the weight-loss drug lorcaserin, the first prescription anti-obesity medication to win the FDA's blessing since the agency approved orlistat in 1999.

Once it is cleared by the Drug Enforcement Administration, the drug will be marketed in the United States under the commercial name Belviq.

The medication won marketing approval as a drug for "chronic weight management in adult patients" with a body mass index greater than 30, or for those with a BMI of 27 or above with a weight-related condition such as high blood pressure, elevated cholesterol or Type 2 diabetes.

The FDA's approval came with a significant warning to consumers likely to flock to a medication that could help boost their weight loss: The safety and effectiveness of Belviq when used alongside other diet medications has not been established.

Nor, the FDA said, has the effect of Belviq on the long-term risk of having, or dying from, a heart attack or stroke.

The approval comes after a lengthy review by an agency under pressure to help Americans lose weight but also to screen out drugs that could prove dangerous once embraced by a large number of patients.

Just over 1 in 3 adult Americans is considered obese, and an additional 36% are overweight, prompting widespread concern that Type 2 diabetes, heart disease and certain cancers linked to obesity will overwhelm the U.S. healthcare system. Already, obesity-related disease is estimated to account for $147 billion in annual healthcare costs.

Belviq, made by San Diego-based Arena Pharmaceuticals, is one of four weight-loss drugs the FDA has anguished over in recent years. Safety concerns have prompted the agency to order the makers of two other candidate drugs to conduct and comb through additional research. A third drug was withdrawn after it was linked to an elevated suicide risk.

In the 28 months since the makers of Belviq submitted the drug for FDA consideration, the agency also demanded the withdrawal of Meridia after studies showed it increased the risk of heart attack and stroke. That left only two FDA-approved weight-loss drugs on the market: orlistat and phentermine.

The result has been to the growing frustration of many obesity experts almost no pharmaceutical aid for a steadily growing population of Americans desperate for help in shedding pounds.

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FDA approves lorcaserin, first weight-loss drug since 1999

Weight Loss Pill Belviq Gets FDA Approval

Posted: June 28, 2012 at 11:23 am

Featured Article Main Category: Obesity / Weight Loss / Fitness Also Included In: Regulatory Affairs / Drug Approvals Article Date: 28 Jun 2012 - 3:00 PDT

Current ratings for: Weight Loss Pill Belviq Gets FDA Approval

Belviq (lorcaserin hydrochloride), made by the Swiss pharma company Arena, is the first prescription diet drug to receive US federal approval in over a decade. It works by activating the serotonin 2C receptor in the brain, an effect that may help the patient feel full after eating smaller amounts of food and thereby eat less.

Dr Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, told the press:

"Obesity threatens the overall well being of patients and is a major public health concern."

FDA says the drug is approved for use in adults who are obese, or adults who are overweight and have at least one weight-related condition, such as type 2 diabetes, high blood pressure, or high cholesterol.

"The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition," said Woodcock.

The agency defines obesity as having a BMI of 30 or over, and overweight as having a BMI under this but no less than 27. BMI stands for Body Mass Index, and equals weight in kilos divided by the square of height in metres.

BMI is used by health authorities and policymakers as a measure of body fat. According to the US Centers for Disease Control and Prevention (CDC), more than one in three of adult Americans is obese.

The approved label for Belviq recommends that patients stop using it if they fail to lose 5% of their body weight after 12 weeks of treatment, as "these patients are unlikely to achieve clinically meaningful weight loss with continued treatment," says the FDA in their announcement.

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Weight Loss Pill Belviq Gets FDA Approval

FDA approves first new weight-loss pill in 13 years

Posted: June 28, 2012 at 11:23 am

Posted: 2:36 pm Wed, June 27, 2012 By Associated Press

WASHINGTON The Food and Drug Administration has approved Arena Pharmaceuticals anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.

Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDAs endorsement, amid calls from doctors for new weight-loss treatments.

The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.

The FDA denied approval for Arenas drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.

The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition, said FDAs drug center director, Dr. Janet Woodcock, in a statement.

With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.

But a long line of prescription weight loss offerings have been associated with safety problems, most notably the fen-phen combination, which was linked to heart valve damage in 1997. The cocktail of phentermine and fenfluramine was a popular weight loss combination prescribed by doctors, though it was never approved by FDA.

In a rare move, the FDA explicitly stated in a press release that Belviq does not appear to activate a chemical pathway that was linked to the heart problems seen with fen-phen.

The FDA said the drug acts on a different chemical pathway in the brain, which is believed to reduce appetite by boosting feelings of satiety and fullness.

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FDA approves first new weight-loss pill in 13 years

FDA clears first new prescription weight-loss pill in 13 years

Posted: June 28, 2012 at 11:23 am

by Associated Press

KING5.com

Posted on June 27, 2012 at 2:33 PM

Updated yesterday at 2:33 PM

WASHINGTON -- The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.

Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.

The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.

The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.

"The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition," said FDA's drug center director, Dr. Janet Woodcock, in a statement.

Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.

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FDA clears first new prescription weight-loss pill in 13 years

FDA clears first new weight-loss pill in 13 years – Wed, 27 Jun 2012 PST

Posted: June 28, 2012 at 11:23 am

June 27, 2012 in Health

MATTHEW PERRONE AP Health Writer

(AP Photo/Food and Drug Administration) photo

This photo provided by Food and Drug Administration shows Arena Pharmaceuticals anti-obesity pill Belviq. The Food and Drug Administration has approved Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade. The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or highcholesterol. (Full-size photo)

WASHINGTON (AP) The Food and Drug Administration has approved Arena Pharmaceuticals anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.

Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDAs endorsement, amid calls from doctors for new weight-loss treatments.

The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.

The FDA denied approval for Arenas drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.

The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition, said FDAs drug center director, Dr. Janet Woodcock, in a statement.

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FDA clears first new weight-loss pill in 13 years - Wed, 27 Jun 2012 PST

FDA Approves First Weight-Loss Drug In 13 Yrs.

Posted: June 28, 2012 at 11:23 am

WASHINGTON (AP) -- The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.

Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.

The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. The drug should be used in combination with a healthy diet and exercise.

Obesity Society President Patrick O'Neil said he's encouraged by the drug's approval because it underscores the notion that lifestyle changes alone are not enough to treat obesity.

"This is good news because it tells us that the FDA is indeed treating obesity seriously," said O'Neil, who teaches at Medical University of South Carolina and was the lead researcher on several studies of Belviq. "On the other hand, it's not the answer to the problem - or even a big part of the answer."

Even if the effects of Belviq are subtle, experts say it could be an important first step in developing new treatments that attack the underlying causes of obesity.

"The way these things tend to work is you have some people who do extremely well and other people don't lose any weight at all. But if we had 10 medicines that were all different and worked like this, we would have a real field," said Dr. Louis Aronne, director of the weight loss program at Weill-Cornell Medical College.

The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.

Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.

With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.

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FDA Approves First Weight-Loss Drug In 13 Yrs.


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