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Arena weight-loss data expected to underwhelm

Arena weight-loss data expected to underwhelm

Upcoming trial results for lorcaserin, the experimental obesity drug being developed by Arena Pharmaceuticals Inc, will likely show it is about 4 percentage points more effective in promoting weight loss than a dummy pill

But that is well short of the 9.4 percent placebo-adjusted weight loss reported last week by Vivus Inc, which is developing Qnexa — a combination of phentermine and epilepsy treatment topiramate, both now sold as generics, that is designed to minimize side effects from the two drugs.

But Wall Street is not discounting the value of a viable treatment for obesity, a health-damaging condition afflicting more than one-quarter of all Americans. “Right now physicians have pretty much nothing,” said JMP Securities analyst Jason Butler.

Piper Jaffray has forecast lorcaserin sales of $3 billion in 2015.

One-year results from Vivus’ Qnexa trials sent the company’s stock up more than 70 percent on Wednesday.

“There is a lot less opportunity for that to happen with this (Arena) trial,” Butler said. “We’ve seen so much data already.”

Shares of Arena, which ended Nasdaq trading at $5.30 on Friday, closed as low as $2.26 in April and as high as $7.42 in February.

The phentermine used in Vivus’ Qnexa is a stimulant that was part of the fen-phen diet drug cocktail. Other drugs used in the cocktail, flenfluramine and dexfenfluramine, were recalled in 1997 after they were linked to heart valve damage.

SIDESTEPS HEART PROBLEMS

Lorcaserin is a serotonin activator like fenfluramine, but it is designed to selectively target only one variety of the chemical — and thereby sidestep heart-related side effects.

Earlier studies have found no heart problems associated with the drug. “There is no reason to expect anything different safety-wise,” from the new trial results expected this month, said Carol Werther, an analyst at Summer Street Research.

The company earlier this year said a large, year-long trial found that lorcaserin patients, on average, lost 5.8 percent of their body weight, while placebo patients lost 2.2 percent of their weight — a percentage point difference of 3.6 percent.

“No single agent has consistently shown a 5 percentage point difference,” said Werther.

U.S. Food and Drug Administration guidelines for obesity drugs require a 5 percent improvement in weight loss between the test drug and placebo or that the number of subjects who lose at least 5 percent of their body weight be at least 35 percent, and double the proportion in the placebo group, with a statistically significant difference between the groups.

The earlier lorcaserin trial found that 48 percent of patients on the drug lost 5 percent or more of their weight, while 20.3 percent of placebo patients achieved that goal

Dominic Behan, chief scientific officer and co-founder of Arena, said a major advantage of lorcaserin is that it is a single agent, and that doctors do not need to adjust doses for patients.

Moreover, he said lorcaserin improved cholesterol levels in patients. And data from earlier trials suggest it can be safely taken on a chronic basis, Behan said. By contrast, he said phentermine is currently approved only for short-term use.

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beating heart surgery

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beating heart surgery

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Beating heart or “off pump” coronary artery surgery is the latest revolution in the management coronary disease. It is being embraced world-wide by increasing numbers of surgeons. Many of the advantages are subtle but reduced mortality, stroke, and bleeding as well as earlier discharge are well-established benefits. A cardiac stabiliser is mandatory for this surgery, most are single use only and very expensive, this one is multiple use and is saving many healthcare dollars.

Beating-heart surgery is a way to perform surgery without stopping the heart. Surgeons use a special device to stabilize the part of the heart on which they are operating. The heart continues to beat and circulate blood to heart muscle during the operation. Surgery on a beating-heart helps reduce the risk for complications associated with temporarily stopping the heart during surgery.

Surgery on a stopped heart is common, and some heart procedures can only be performed on a motionless heart. Physicians use a special solution called cardioplegia to stop the heart.

If the heart is stopped for surgery, the surgeon must restart it and reintroduce blood into the tissue. This is called reperfusion. Reperfusion can cause impairment of heart function. Sometimes, heart muscle tissue can be damaged at the cellular level during reperfusion, a phenomenon known as reperfusion injury. In some people, reperfusion injury can lead to complications such as arrhythmias and heart attacks. Reperfusion injury is especially a concern in high-risk patients, such as the elderly, people who have had several heart surgeries, patients with severe blockages, and those with complex health problems.

Reperfusion injury can be avoided if the heart is kept beating during surgery.

At the University of Chicago Medical Center, our cardiac surgeons opt to perform beating-heart surgery whenever possible. More than 90 percent of coronary artery bypass surgeries performed here are done on a beating heart.

While not all procedures can be performed on a beating heart, our surgeons have developed many techniques that make beating-heart surgery an option for even complex procedures on the inside of the heart–including valve repair. In fact, our surgeons were among the first in the world to perform beating-heart mitral valve surgery. The University of Chicago Medical Center is one of the only hospitals in the nation where beating-heart surgery is being performed to treat valve disease.

Some of the procedures performed on a beating heart include:

Coronary artery bypass graft surgery (including ThoraCAB, a minimally invasive option performed without cutting the breastbone, as well as open-chest, beating-heart bypass)

Surgery for atrial fibrillation

Treatment of some congenital heart defects, such as closure of atrial septal defect

Valve repair (mitral, pulmonary, or tricuspid)

Valve replacement (mitral or tricuspid)

Ventricular reconstruction

Conventional On Pump Coronary Artery Bypass Surgery

More than 70%² of all bypass surgeries are performed on a stopped heart. Unlike beating heart surgery, during conventional on pump heart bypass, medication is used to stop your heart.

A heart-lung machine takes over the function of your heart and lungs during the surgery.The heart-lung machine is also called a cardiopulmonary bypass machine. It has a pump to function as the heart and a membrane oxygenator to function as the lungs.

Heart-Lung Machine

This mechanical “heart and lungs” keeps oxygen rich blood circulating throughout your body. The heart-lung machine collects the blood. Carbon dioxide and other waste products are removed. The oxygenator adds oxygen, and the oxygenator’s heat exchanger warms (or cools) the blood. The blood is gently circulated back through the body. This process is called perfusion. The person who operates the heart-lung machine is the perfusionist.

Stopping Your Heart

Your heart will usually be stopped for about 30-90 minutes of the 3-6 hour surgery. The heart-lung machine makes it possible for the surgeon to work on a still heart. This technique has been used for many years with excellent results. Once the surgery is over, the surgeon and perfusionist restart your heart.

Medtronic Perfusion Systems

Medtronic creates the dependable perfusion systems that make on pump surgery possible. We are committed to providing doctors, hospitals, and patients with reliable, technically advanced equipment.

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How broccoli can protect your arteries

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How broccoli can protect your arteries

It’s long been thought that broccoli is good for your heart, and now British scientists think they know why.

Researchers at Imperial College London have found evidence a chemical in broccoli and other green leafy vegetables could boost a natural defense mechanism that protects arteries from the clogging that can cause heart attacks.

In a study funded by the British Heart Foundation charity and conducted on mice, the researchers found that sulforaphane — a compound occurring naturally in broccoli and other brassicas — could “switch on” a protective protein which is inactive in parts of the arteries vulnerable to clogging.

“We know that vegetables are clearly good for you, but surprisingly the molecular mechanisms of why they are good for you have remained unknown for many years,” said Paul Evans of the National Heart and Lung Institute at Imperial College.

“This study provides a possible explanation for how green vegetable consumption can promote a healthy heart.”

Scientists already know that arteries don’t clog up in a uniform way, but that there are bends and branches of blood vessels — where blood flow is disrupted or slower — which are much more prone to the build-up of fatty plaques that cause heart disease.

Evans said his research found that in the more vulnerable areas, a normally protective protein known as Nrf2 is inactive.

“What our study showed was that sulforaphane can protect those regions by switching on the Nrf2,” he said.

The research, reported in the journal Arteriosclerosis Thrombosis and Vascular Biology, was conducted using purified sulforaphane, not broccoli. Researchers said the next step was to test the effect of the chemical as it is found in vegetables.

We now need to go and test this with broccoli smoothies, as it were, and compare that with the effect of purified sulforaphane,” Evans said, adding that if the vegetable form proved less effective, there could be an argument for taking sulforaphane in pill form.

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