Archive for April, 2010

Experts Push 7 Steps to Heart Health

Thursday, April 29th, 2010

Assessing whether you are in poor, moderate or ideal cardiovascular health takes just seconds, thanks to a new American Heart Association measure of health factors and behaviors.

The seven-point checklist is part of a heart association program designed to improve U.S. cardiovascular health by 20 percent and reduce deaths from cardiovascular disease and stroke by 20 percent.

The program for children and adults, published online Jan. 20 in Circulation, includes well-known recommendations on diet, exercise, smoking and other risk factors, but there’s more, said Dr. Clyde W. Yancy, medical director of the Baylor Heart and Vascular Institute and president of the heart association.

“Collectively, when these health factors and healthy behaviors are found in aggregate in one person, the effect on markers of health and healthy outcome are remarkable,” Yancy said. “Your chance for meaningful longevity with good quality of life is substantially increased.”

The U.S. death rate from heart attack, stroke and other cardiovascular conditions has been reduced by 35 percent, with half of that improvement because of better preventive measures, Yancy said.

“By packaging these seven components together, it is possible to see a further 20 percent reduction in deaths from heart attack and stroke and also improve cardiovascular health,” he said.

In a recent survey, 39 percent of Americans said they had ideal heart health, yet 54 percent of those folks said they had been told by a health professional that they had at least one risk factor for heart disease and/or needed to make a lifestyle change. This suggests that many people don’t connect lifestyle behaviors like inactivity and poor diet with cardiovascular disease, the association said.

For adults, the seven goals for achieving ideal cardiovascular health are:
Never smoked or quit more than a year ago.
Body mass index, a measure based on weight and height, less than 25.
Physical exercise — at least 150 minutes of moderate intensity or 75 minutes of vigorous intensity each week.
At least four key components of a healthy diet, such as fewer calories, more fruits and vegetables, and oily fish, such as salmon, four times a week.
Total cholesterol lower than 200.
Blood pressure below 120/80.
Fasting blood sugar below 100.

Cardiovascular health is graded as poor, intermediate or ideal depending on how an individual scores in the seven areas, dubbed “Life’s Simple 7.”

“This strategy of seven simple steps makes it a lifestyle-worthy approach,” Yancy said.

The goals and assessment chart can be accessed online at www.heart.org/MyLifeCheck. The Web site also tells how to improve your status and track your progress toward better health.

“What’s exciting about this is that the American Heart Association is dedicated not only to preventing the ravages of heart disease but also to promoting cardiovascular health in general,” said Dr. Donald M. Lloyd-Jones, associate professor of medicine and chair of preventive medicine at Northwestern University Feinberg School of Medicine, and lead author of the scientific statement.

“Very strong scientific evidence shows us that the package of all seven is the fountain of youth for your life,” Lloyd-Jones added.

Is any one factor more important than the others?

“Since we’re talking about not just heart disease but also stroke, heart failure and peripheral arterial disease, much of what is driving cardiovascular disease today is obesity,” Lloyd-Jones stated.

SOURCES: Clyde W. Yancy, M.D., medical director, Baylor Heart and Vascular Institute, Dallas, and president, American Heart Association; Donald M. Lloyd-Jones, M.D., associate professor, medicine, and chair, preventive medicine, Northwestern University Feinberg School of Medicine, Chicago;

FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients

Saturday, April 24th, 2010

The U.S. Food and Drug Administration today approved the HeartMate II, a continuous-flow, left ventricular assist system as a support for severe heart failure patients who are not acceptable candidates for heart transplantation.

The HeartMate II is already FDA-approved for use in patients awaiting further, perhaps more complex treatment, such as transplants.

Heart assist devices are surgically implanted mechanical pumps that help the heart’s ventricle pump blood to the rest of the body. HeartMate II consists of a small, lightweight blood pump implanted in a patient’s chest just below the heart. An electrical cable that powers the blood pump passes through the patient’s skin to an external controller worn around the patient’s waist.

A physician designates the pump’s speed based upon clinical need. The device is designed to sound an alarm upon malfunction or other potentially drastic changes that could impact the pump’s operation.

“The approval of HeartMate II provides an option for heart failure patients who cannot receive a transplant,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Its smaller size and mobility should allow more patients, including women and men of smaller stature, access to treatment.”

In a randomized clinical study of 200 participants at 38 centers, 46 percent of 134 participants with the HeartMate II were still living after two years with no disabling stroke or need for a reoperation for device replacement or repair compared with 11 percent of 66 participants in the control group. In addition, data collected in a separate registry of smaller stature women and men indicated that the device worked well in this specific population.

As a condition of the FDA’s approval, the company will conduct a post-approval study to further evaluate the device’s performance. The data will be recorded in the Interagency Registry of Mechanical Assisted Circulatory Support (INTERMACS) and made available when the post-approval study is concluded. The INTERMACS is a clinical outcomes registry managed by the FDA, the National Heart, Lung and Blood Institute at the National Institutes of Health, the Centers for Medicare & Medicaid Services and participating hospitals and companies.

HeartMate II is manufactured by Thoratec Corp. based in Pleasanton, Calif.

First Oral Medications For MS Show Promise

Saturday, April 17th, 2010

Two new drugs — both oral, rather than injected — may soon be available to combat multiple sclerosis.

Three studies, all being published early online Jan. 20 in the New England Journal of Medicine, find that the new drugs — fingolimod and cladribine — reduce relapse rates in people with relapsing-remitting multiple sclerosis (MS). Both drugs work by altering the immune system response.

However, as is often the case with immune-suppressing medications, there are concerns about side effects, including an increased risk of serious infections and possibly, cancer.

“Oral drugs are what people with MS have been wishing for a long time. This is wonderful news for people with MS,” said Dr. John Richert, executive vice president of research and clinical programs for the National Multiple Sclerosis Society (NMSS). “The drugs appear to be quite effective, and at the moment, appear to have a reasonable risk-benefit ratio. However, it will be very important for people with MS and their physicians to remain vigilant and be on the lookout for side effects.”

All three studies were funded by the drug’s manufacturers — Novartis for fingolimod and Merck Serono for cladribine. Both manufacturers are currently pursuing U.S. Food and Drug Administration approval for their medications.

Multiple sclerosis is a chronic, potentially disabling illness that’s believed to be an autoimmune disorder. In MS, the body’s natural defense system mistakenly attacks the fatty substance that protects the nerves (myelin). About 400,000 Americans have multiple sclerosis, according to the NMSS.

The current treatments for MS are all injectable medications, which Richert said is sometimes a barrier for people to start early treatment. He said that treatments may be more successful if they’re started early in the course of the disease, so he’s hoping that having oral medications will help people start treatment sooner.

Two of the new studies focused on the oral medication called fingolimod. Both were phase 3 studies. One study included more than 1,000 people with relapsing-remitting MS. The study participants were randomly selected to receive a daily dose of 0.5 milligrams (mg), 1.25 mg or a placebo.

Annual relapse rates were less than 1 percent each year, but were 54 percent less for the lower dose of fingolimod and 60 percent for the higher dose. The study also found slower disease activity and progression.

In the second study on fingolimod, 1,153 people with relapsing-remitting MS were randomly assigned to receive a daily dose of 0.5 mg or 1.25 mg of fingolimod or a weekly dose of 30 micrograms of interferon beta-1a (Avonex) for one year. The annual relapse rate on either drug was less than 1 percent in this study as well. However, the people on fingolimod had up to a 52 percent lower relapse rate. This study found no significant differences in disease progression between the two treatments.

Both studies found that the lower dose of the drug was better tolerated. A small number of serious infections occurred, including two deaths from herpes infections in these studies. And, there appeared to be a higher incidence of cancer in people taking fingolimod.

Still, “the fact that fingolimod is given orally is a huge advantage,” said the lead author of the yearlong study, Dr. Jeffrey Cohen, director of experimental therapeutics at the Mellen MS Center at the Cleveland Clinic in Ohio. “It appears to be effective and is generally well-tolerated.”

The third study, also a phase 3 study, looked at the oral medication cladribine in comparison to placebo. In this study, more than 1,300 people with relapsing-remitting MS were randomly assigned to receive a cladribine dose of either 3.5 mg or 5.25 mg per kilogram of body weight or a placebo. During the second year of the study, those on cladribine were all given the lower dose.

As in the fingolimod studies, annual relapse rates were less than 1 percent. However, those on cladribine had relapse rates that were up to 58 percent lower. Disease activity and disability scores were also lower in the treatment groups.

Although the drug appeared to be generally well-tolerated, there were some serious side effects with cladribine as well, including serious herpes zoster infections. Herpes zoster is the virus that causes shingles, and there is a vaccine available for this virus. Whether getting the vaccine prior to treatment would lessen the risk of infection isn’t clear because it hasn’t been studied, said Richert. Cladribine was also associated with a potentially increased risk of cancer.

Another question that remains to be answered for both medications is whether or not they will increase the risk of a very serious brain infection known as progressive multifocal leukoencephalopathy (PML). It wasn’t discovered that the MS medication, natalizumab (Tysabri), caused a slight increase in the rate of these infections until the drug came to market. That’s because it’s such a rare side effect.

SOURCES: Jeffrey Cohen, M.D., director, experimental therapeutics, Mellen MS Center, Cleveland Clinic, Ohio; John Richert, M.D., executive vice president, research and clinical programs, National Multiple Sclerosis Society, New York City;