A Little Belly Fat Can Double the Risk of Death in Coronary Artery Disease Patients

(BUSINESS WIRE)--One of the largest studies of its kind has found that people with coronary artery disease who have even a modest beer belly or muffin top are at higher risk for death than people whose fat collects elsewhere. The effect was observed even in patients with a normal Body Mass Index (BMI). The findings of this Mayo Clinic analysis are published in the May 10 issue of the Journal of the American College of Cardiology.

Researchers analyzed data from 15,923 people with coronary artery disease involved in five studies from around the world. They found that those with coronary artery disease and central obesity, measured by waist circumference and waist-to-hip ratio, have up to twice the risk of dying. That is equivalent to the risk of smoking a pack of cigarettes per day or having very high cholesterol, particularly for men.

The findings refute the obesity paradox, a puzzling finding in many studies that shows that patients with a higher BMI and chronic diseases such as coronary artery disease have better survival odds than normal-weight individuals.

“We suspected that the obesity paradox was happening because BMI is not a good measure of body fatness and gives no insight into the distribution of fat,” says Thais Coutinho, M.D., the study’s lead author and a cardiology fellow at Mayo Clinic. “BMI is just a measure of weight in proportion to height. What seems to be more important is how the fat is distributed on the body,’’ she says.

Francisco Lopez-Jimenez, M.D., the project’s lead investigator and director of the Cardiometabolic Program at Mayo Clinic, explains why this type of fat may be more harmful: “Visceral fat has been found to be more metabolically active. It produces more changes in cholesterol, blood pressure and blood sugar. However, people who have fat mostly in other locations in the body, specifically, the legs and buttocks, don’t show this increased risk.”

The researchers say physicians should counsel coronary artery disease patients who have normal BMIs to lose weight if they have a large waist circumference or a high waist-to-hip ratio. The measure is very easy to use, Dr. Coutinho says: “All it takes is a tape measure and one minute of a physician’s time to measure the perimeter of a patient’s waist and hip.”

The research subjects were diverse, coming from studies in the U.S. (Rochester, Minn. and San Francisco, Calif.), Denmark, France and Korea. The inclusion of different ethnic groups makes the study more applicable to the real world, Dr. Coutinho says.

Other members of the research team are Kashish Goel, M.D.; Daniel Correa de Sa, M.D.; Randal Thomas, M.D.; Veronique Roger, M.D., MPH; and Virend Somers, M.D., Ph.D., of Mayo Clinic; Charlotte Kragelund, M.D., Ph.D.; Lars Kober, M.D., Ph.D.; and Christian Torp-Pedersen, M.D., Ph.D., from Rigshaspitalet, Copenhagen, Denmark; Alka Kanaya, M.D. of the University of California, San Francisco, California; Jong-Seon Park, M.D.; Sang-Hee Lee, M.D.; and Young-Jo Kim, M.D., of Yeungnam University Hospital, Daegu, Korea; and Yves Cottin, M.D., Ph.D.; and Luc Lorgis, M.D., from CHU Bocage, Dijon, France.

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American Heart Association Meeting Report- Metabolic Abnormalities in Obese Teens May Relate to Poor Diets

/PRNewswire/ -- Obese teens may feel healthy, but blood tests show they have inflammation, insulin resistance, and high homocysteine levels, researchers report at the American Heart Association's Nutrition, Physical Activity and Metabolism/Cardiovascular Disease Epidemiology and Prevention 2011 Scientific Sessions.

"The metabolic abnormalities suggest that the process of developing heart disease has already started in these children, making it critical for them to make definitive lifestyle and diet changes," said Ashutosh Lal, M.D., senior author of the study and a pediatric hematologist at the Children's Hospital and Research Center Oakland in California.

Researchers compared the diets and blood test results of 33 obese youths (ages 11 to 19) with 19 age-matched youths of normal weight. Obesity in youths is a body mass index (BMI) higher than the 95th percentile of children the same age. Normal weight youths had a BMI below the 85th percentile. Body mass index is a measure of weight related to height. Two thirds of the participants in both groups were girls. All of the participants were receiving regular health maintenance care at an inner city clinic in Oakland.

Blood tests revealed that the obese teens had:

* C-reactive protein levels almost ten times higher than controls, indicating more inflammation in the body.
* Insulin resistance, a precursor to type 2 diabetes, with greater amounts of insulin needed to keep blood sugar levels normal.
* Homocysteine levels 62 percent higher than controls. High levels of the amino acid homocysteine are related to greater heart disease risk.
* Total glutathione levels 27.9 percent lower than controls, with oxidized glutathione levels 125 percent higher. A higher ratio of oxidized to non-oxidized glutathione indicates oxidative stress, an imbalance in the production of cell-damaging free radicals and the body's ability to neutralize them. Oxidative stress leads to more inflammation and an increase in blood vessel damage and stiffening.


"Looking at the numbers you would think these children might feel sick, but they did not," Lal said. "They are apparently feeling well, but there is a lot going on beneath the surface."

Dietary quality was poor in all the children – low in fresh produce, fiber, and dairy products. On questionnaires, obese and normal-weight children reported consuming similar amounts of grains, proteins, fats and total calories. However, the obese children reported significantly fewer servings of dairy products and tended towards fewer fruit servings. The obese children's diets were lower in potassium, vitamin C, vitamin D, and vitamin A, found in fortified dairy products and as well as in deeply colored fruits and vegetables.

With such poor dietary quality in both the obese and control groups, clinicians should pay more attention to what their young patients are eating, researchers said.

"Obese teens were consuming too few of the natural sources of anti-oxidants, fruits and vegetables, and may have increased antioxidant needs based on the inflammation associated with their extra adiposity," Lal said. "For their heart health, obese teens need to eat better, not just eat less."

Though the study's participants attended an inner city health clinic, researchers said the metabolic differences between obese and normal-weight teens would be found in all socioeconomic groups.

The children in the study were racially diverse. The obese group was 39 percent African-American, 30 percent non-African-American Hispanic, 18 percent Caucasian and 6 percent Asian and 7 percent other. The control group was 21 percent African-American, 5 percent Hispanic, 42 percent Caucasian, 21 percent Asian and 11 percent other.

This study was funded by the Clinical and Translational Science Institute, University of California, San Francisco, and the Bruce and Giovanna Ames Foundation.

Co-authors are: Michele Mietus-Snyder, M.D.; Jung H. Suh, Ph.D.; Bruce N. Ames, Ph.D.; and Betty Flores, P.N.P. Author disclosures are on the abstract.

Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing science content. Revenues from pharmaceutical and device corporations are available at www.heart.org/corporatefunding. 

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FDA Approves 1st Pacemaker Designed to Work Safely During Some MRI Exams

/PRNewswire/ -- The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams.

Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats. MRIs use a powerful magnetic field, radio frequency pulses and an internal computer to produce detailed images of organs, soft tissues, bone, and other internal body structures not available with other imaging methods.

About half of all patients with pacemakers may require an MRI, but are advised not to have one because an MRI's magnetic and radiofrequency fields can disrupt the pacemaker's setting or cause wires to overheat, resulting in unintended heart stimulation, device electrical failure, or tissue damage.

The Revo MRI SureScan Pacing System includes a function that is turned on before a scan to prepare patients for the MRI. The pacemaker's use in MRIs is limited to certain patients, certain parts of the body, and certain scanning parameters. The FDA also is requiring training for cardiologists and radiologists who use the system.

"FDA's approval of the Revo pacemaker represents an important step forward toward greater device innovation," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. "Those patients who meet the parameters for the device will be able to maintain their critical cardiac therapy while benefiting from the precise diagnostic capability of an MRI."

The FDA reviewed results from one clinical trial of 484 patients. Of those, 464 were successfully implanted with the device and then randomized to receive or not receive an MRI. None of the 211 who underwent an MRI experienced an MRI-related complication. The clinical results confirmed earlier data from animal studies, computational modeling, and other nonclinical research.

Revo is manufactured by Medtronic Inc. of Mounds View, Minn.

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Cost to Treat Heart Disease in United States Will Triple by 2030

/PRNewswire/ -- The cost to treat heart disease in the United States will triple by 2030, according to a policy statement published in Circulation: Journal of the American Heart Association.

"Despite the successes in reducing and treating heart disease over the last half century, even if we just maintain our current rates, we will have an enormous financial burden on top of the disease itself," said Paul Heidenreich, M.D., chair of the American Heart Association expert panel issuing the statement.

The panel estimated future medical costs based on the current rates of disease and used Census data to adjust for anticipated population shifts in age and race. The rigorous methods they devised didn't double count costs for patients with multiple heart conditions.

"These estimates don't assume that we will continue to make new discoveries to reduce heart disease," Heidenreich said. "If our ability to prevent and treat heart disease stays where we are right now, costs will triple in 20 years just through demographic changes in the population."

The panel said effective prevention strategies are needed to limit the growing burden of cardiovascular disease -- the leading cause of death in the United States that accounts for 17 percent of overall national health expenditures.

"Unhealthy behaviors and unhealthy environments have contributed to a tidal wave of risk factors among many Americans," said Nancy Brown, American Heart Association CEO. "Early intervention and evidence-based public policies are absolute musts to significantly reduce alarming rates of obesity, hypertension, tobacco use and cholesterol levels."

Currently, 1 in 3 Americans (36.9 percent) have some form of heart disease, including high blood pressure, coronary heart disease, heart failure, stroke and other conditions. By 2030, approximately 116 million people in the United States (40.5 percent) will have some form of cardiovascular disease, the panel said. The largest increases are anticipated in stroke (up 24.9 percent) and heart failure (up 25 percent).

Between 2010-30, the cost of medical care for heart disease (in 2008 dollar values) will rise from $273 billion to $818 billion, the authors predicted. "We were all surprised at the remarkable increase in costs that are expected in the next two decades," Heidenreich said. "We need to continue to invest resources in the prevention of disease, the treatment of risk factors and early treatment of existing disease to reduce that burden."

Heart disease will also cost the nation billions more in lost productivity, increasing from an estimated $172 billion in 2010 to $276 billion in 2030. Productivity losses include days missed from home or work tasks because of illness and potential lost earnings due to premature death.

Co-authors writing on behalf of the various councils are: Justin G. Trogdon, Ph.D.; Olga A. Khavjou, M.A.; Javed Butler, M.D.; Kathleen Dracup, R.N., D.N.Sc.; Michael D. Ezekowitz, M.B.Ch.B., D.Phil.; Eric Andrew Finkelstein, Ph.D.; Yuling Hong, M.D., Ph.D.; S. Claiborne Johnston, M.D., Ph.D.; Amit Khera, M.D.; Donald M. Lloyd-Jones, M.D.; Sue A. Nelson, M.P.A.; Graham Nichol, M.D.; Diane Orenstein, Ph.D.; Peter W.F. Wilson M.D. and Y. Joseph Woo, M.D.

Author disclosures are on the manuscript.


The American Heart Association/American Stroke Association receives funding mostly from individuals. Foundations and corporations donate as well, and fund specific programs and events. Strict policies are enforced to prevent these relationships from influencing the association’s science content. Financial information for the American Heart Association, including a list of contributions from pharmaceutical companies and device manufacturers, is available at www.heart.org/corporatefunding .

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Xanodyne agrees to withdraw propoxyphene from the U.S. market

Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne’s decision and requested that they voluntarily remove their products as well.

The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.

“The FDA is pleased by Xanodyne’s decision to voluntarily remove its products from the U.S. market,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER). “These new heart data significantly alter propoxyphene’s risk-benefit profile. The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”

The FDA is advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.

Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxophene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).

Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.

In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug’s cardiac effects would be relevant in weighing its risks and benefits.

In June 2009, the European Medicines Agency (EMEA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union. A phased withdrawal of propoxyphene is underway.

In July 2009, the FDA decided to permit continued marketing, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. In addition, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.

The agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (EKG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.

“With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER. “However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away.”

Xanodyne is based in Newport, Ky.

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FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

Atrial fibrillation, which affects more than 2 million Americans, involves very fast and uncoordinated contractions of the heart's two upper heart chambers (atria) and is one of the most common types of abnormal heart rhythm.

"People with atrial fibrillation are at a higher risk of developing blood clots, which can cause a disabling stroke if the clots travel to the brain," said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research.

Pradaxa is an anticoagulant that acts by inhibiting thrombin, an enzyme in the blood that is involved in blood clotting. The safety and efficacy of Pradaxa were studied in a clinical trial comparing Pradaxa with the anticoagulant warfarin. In the trial, patients taking Pradaxa had fewer strokes than those who took warfarin.

"Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa," Stockbridge says.

As with other approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, was among the most common adverse reactions reported by patients treated with Pradaxa. Gastrointestinal symptoms, including an uncomfortable feeling in the stomach (dyspepsia), stomach pain, nausea, heartburn, and bloating also were reported.

Pradaxa was approved with a Medication Guide that informs patients of the risk of serious bleeding. The guide will be distributed each time a patient fills a prescription for the medication.

Pradaxa, manufactured by Boehringer Ingelheim Pharmaceuticals Inc. of Ridgefield, Conn., will be available in 75 milligram and 150 milligram capsules.

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Piedmont Fayette Hospital and Piedmont Heart Institute Physicians Partner with US AGAINST ATHERO to Educate on Heart Disease

Piedmont Fayette Hospital and Piedmont Heart Institute Physicians have teamed up with US AGAINST ATHERO, to bring the Artery Explorer experience to Piedmont Fayette Hospital at 1255 Highway 54 West in Fayetteville, Ga. In addition to this unique educational experience, visitors will have a chance to have their blood pressure checked and learn their body mass index (BMI). The event is Tuesday, October 26 from 11 a.m. to 5 p.m. and Wednesday, October 27 from 1 p.m. to 6 p.m.

As part of US AGAINST ATHERO, the Artery Explorer is touring the country to increase awareness of atherosclerosis—the dangerous buildup of plaque in the arteries. This incredible virtual experience allows viewers to surf through arteries on a journey deep inside the body. The movie demonstrates how risk factors like high levels of bad cholesterol, smoking and high blood pressure can contribute to the buildup of plaque in arteries.

Coronary heart disease and stroke kill more Americans every year than all cancers combined. Atherosclerosis, or athero for short, is often the leading cause. It is the progressive buildup of plaque in the arteries linked to about one in four deaths in the United States each year. For more information, call 770.719.6060 or visit athero.com.
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American Red Cross and American Heart Association Jointly Announce Revised First Aid Guidelines

/PRNewswire/ -- The American Red Cross and American Heart Association today announced changes to guidelines for administering first aid. Among the revisions are updated recommendations for the treatment of snake bites, anaphylaxis (shock), jellyfish stings and severe bleeding. The First Aid Guidelines are being published in Circulation: Journal of the American Heart Association.

Volunteer experts from more than 30 national and international organizations joined the Red Cross and the American Heart Association in reviewing 38 separate first aid questions. Experts analyzed the science behind them and worked to reach consensus on the treatment recommendations. Last revised in 2005, these recommendations form the recognized scientific basis for most first aid training around the world.

"It is vital that the first aid community come to consensus and speak in a clear voice on these life and death issues," said David Markenson, M.D., first aid science advisor to the American Red Cross. "We are proud to help set the standard for first aid training around the globe."

"Prompt and effective first aid can save lives and prevent many medical situations from worsening, so it's important that everyone learn about the changes the American Heart Association and American Red Cross have made to the first aid guidelines," said Jeff Ferguson, M.D., American Heart Association volunteer co-chair of the first aid guidelines writing group.

In looking at the treatment of jellyfish stings, the revised guidelines reaffirm the recommendation to use vinegar to treat the sting. The vinegar neutralizes the venom and may prevent it from spreading. After the vinegar deactivates the venom, immersing the area in hot water for about 20 minutes is effective for reducing pain. The treatment for snake bites has been amended slightly to recommend applying a pressure immobilization bandage to any venomous snake bite, with pressure being applied around the entire length of the bitten extremity.

Under the revised guidelines for treating anaphylaxis, if symptoms persist after a few minutes of giving the patient an epinephrine injection from a prescribed auto-injector and medical help is delayed, the first aid provider can give a second epinephrine injection from a prescribed auto-injector. The guidelines also recommend that the general public not routinely use hemostatic agents (substances used to help stop bleeding) to control bleeding because of significant variability in effectiveness and the potential for adverse effects. Tourniquets and hemostatic agents should be considered alternatives for professional rescuers when direct pressure is not possible or fails to control bleeding.

The expert panel also reaffirmed some key first aid recommendations, including use of aspirin when helping someone experiencing persistent chest pain or discomfort associated with a cardiac emergency. Bystanders should call 9-1-1 and activate the emergency medical services (EMS) system for anyone with chest discomfort. While waiting for EMS personnel to arrive, the person being treated may be advised to chew two low dose baby aspirin or one adult (non-enteric-coated) aspirin, if they are not allergic to aspirin or have had a stroke or recent bleeding.

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Abbott Laboratories Agrees to Withdraw Its Obesity Drug Meridia

/PRNewswire/ -- Abbott Laboratories has agreed to voluntarily withdraw its obesity drug Meridia (sibutramine) from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke, the U.S. Food and Drug Administration announced today.

"Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke," said John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research (CDER). "Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs."

Meridia was approved by the FDA in November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone.

The FDA requested the market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT was initiated as part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of this drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared to another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.

"The patients in the European SCOUT trial did not have the same characteristics as the patients for the approved indication in the United States; however, these results, combined with other available safety data raised serious questions about Meridia's safety for all patient groups," said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology in CDER.

The agency's analysis of SCOUT was the subject of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee meeting on Sept. 15.

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FDA approves devices for heart failure patients

The U.S. Food and Drug Administration today approved a new indication for three cardiac resynchronization therapy defibrillators (CRT-D) used to treat certain heart failure patients. The new use is for patients with an abnormality known as left bundle branch block, which occurs when there is delayed activation and contraction of the left ventricle. The three devices, all manufactured by Boston Scientific Corp., are intended to treat patients with left bundle branch block who have either mild heart failure or heart failure with no apparent symptoms.

The CRT-D device combines two functions. As an implantable cardioverter defibrillator (ICD) it senses dangerous abnormal heart rhythms and then attempts to shock the heart back into a normal rhythm. As cardiac resynchronization therapy, it generates small electrical impulses to coordinate the beating of the left and right ventricles so that they work together more effectively to pump blood throughout the body.

CRT-Ds are to be used as an addition to, not a replacement for, heart failure drug therapy.

“This approval allows heart failure patients with left bundle branch block to benefit from this therapy," said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA is pleased to safely make this new technology available for a greater number of heart failure patients."

The FDA based its approval on the results of the 1,820-patient Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) clinical study. The study which followed 1,820 patients for an average of nearly three years at 110 centers in the United States, Europe, Canada, and Israel. It compared CRT-D therapy to ICD-only therapy in specific heart failure patients to determine whether it reduced the risk of death and heart failure. In patients with left bundle branch block, who represented 70 percent of the study group, CRT-D showed a reduction in the risk of death and heart failure by 57 percent, as compared to ICD alone.

The rate of complications was considered to be acceptable by the FDA for this device, however, physicians should adequately inform patients about potential complications.

As a condition of FDA approval, Boston Scientific must conduct two post-approval studies. One study will evaluate complications and long-term mortality benefits of CRT-D in patients with left bundle branch block identified through the National Cardiovascular Data Registry. The other will follow patients from the original MADIT-CRT clinical study every six months for five years to assess long-term mortality benefits of CRT-D vs. ICD.

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Gene Therapy Proves Effective in Treating Severe Heart Failure; Holds Potential to Drastically Reduce Healthcare Costs for Heart Failure Patients

/PRNewswire/ -- The 14th Annual Scientific Meeting of the Heart Failure Society of America (HFSA) will feature a discussion titled "Latest Developments in Stem Cell and Gene Therapy in Heart Failure" which includes a presentation by Dr. Roger Hajjar, Director of the Cardiovascular Research Institute, one of the 12 translational science institutes at The Mount Sinai Medical Center in New York. Dr. Hajjar's discussion will focus on the injection of a gene into patients with advanced heart failure to reverse the debilitating and life-threatening condition.

Over ten years, Dr. Hajjar and his team have validated the cardiac sarcoplasmic reticulum calcium ATPase pump, SERCA2a, as a target in heart failure and developed methodologies for cardiac-directed gene transfer. This work has led to the initiation and recent completion of phase 1 and phase 2 First-in-Man clinical trials of SERCA2a gene transfer in patients with advanced heart failure.

Patients treated with high dose therapy have shown 90 percent risk reduction for heart failure-related cardiovascular events such as significantly worsening health, the need for a transplant or cardiovascular device support, intravenous treatment or death.

"The patients receiving this gene therapy have shown marked improvements," said Dr. Hajjar. "Through our tests we've observed heart failure patients' quality of life improves greatly for significantly less cost than traditional therapies."

Patients treated with the gene therapy treatment may result in a large decrease in personal health care costs across their trial period. In nine months, individuals treated with the trial's placebo spent an average of $27,118 on health care, paying for expenses such as hospital stays, emergency medicine, and home care. Comparatively, in the same period of time, individuals treated with gene therapy spent an average of $329 on health care.

"Gene Therapy is a breakthrough in the treatment of heart failure patients that holds the potential to reverse the disease while also making treatment and recovery more affordable than ever," said Dr. Douglas Mann, HFSA President. "It is critical for the medical community to continue to integrate science and clinical medicine so biomedical research can improve patient care."

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Study Compares Risk With Two Diabetes Drugs

/PRNewswire/ -- In contrast to previous reports, the risks of the composite endpoint of heart attack, heart failure, both, or death were the same - about 4 percent - for patients taking the diabetes drugs rosiglitazone or pioglitazone, according to a study published in the American Heart Association journal Circulation: Cardiovascular Quality and Outcomes.

"This study provides patients and their doctors with another source of information about rosiglitazone and pioglitazone (sold as Avandia and Actos, respectively) as they determine the best therapy for diabetes patients," said Debra Wertz, Pharm.D., lead author and outcomes research manager at HealthCore, Inc., the research subsidiary of health insurance company WellPoint, Inc.

This study evaluated more than 36,000 diabetes patients. Of the 28,938 patients who were propensity-score matched, a methodology used to provide an estimation of treatment-effects that is as unbiased as possible, 602 patients taking rosiglitazone and 599 taking pioglitazone over a 33-month period suffered either a heart attack, heart failure, both, or died. This translates to about 4 percent of all patients taking either medication. The individual specific adverse events were also not significantly different between the two groups, and were:

-- Heart attack - 96 patients on rosiglitazone and 121 patients on
pioglitazone;
-- Heart failure - 265 patients taking rosiglitazone and 243 taking
pioglitazone;
-- Heart attack and heart failure - 24 patients on rosiglitazone and 18
on pioglitazone; and
-- Death - 217 patients taking rosiglitazone and 217 taking pioglitazone.


The study included 36,628 patients who had submitted insurance claims to WellPoint affiliates for either of the two diabetes medications between 2001 and 2005. Patients' average age was 54, and 58 percent were male. Wertz and her team obtained death records from the National Death Index, a central database administered by the National Center for Health Statistics.

The investigators divided patients into two equal groups, one receiving rosiglitazone and the other, pioglitazone. After adjusting the data for (removing/minimizing the effect of) age, gender, prior heart and blood vessel diseases and diabetes-related complications and severity indicators, they compared the incidence of heart attack, heart failure and death for an average 14 months of treatment and 19 months of post-treatment follow-up.

Diabetes is a disease in which the body cannot adequately produce the hormone insulin or uses it improperly. The disease can cause a potentially dangerous buildup of sugar in the blood and also increases the risk of heart and blood vessel diseases, which are the main causes of death for people with diabetes.

Rosiglitazone, sold under the trade name Avandia by GlaxoSmithKline, and pioglitazone, sold as Actos by Takeda Pharmaceuticals, belong to the same class of drugs, called TZDs or thiazolidinediones. They help the body use insulin more effectively by boosting the body's sensitivity to the hormone and thus help control blood sugar.

This study has results different from earlier ones that found a greater risk of heart attack among rosiglitazone users compared to patients on other treatments or placebo. In 2007, the Food and Drug Administration decided that the benefits of rosiglitazone outweighed the risks, and it remained on the market although its use decreased significantly. In July 2010, an FDA advisory committee again reviewed numerous studies, including this study, and recommended that rosiglitazone remain on the market, although with additional warnings or restrictions. The FDA has not yet ruled on this latest recommendation.

"Besides its findings that rosiglitazone and pioglitazone have comparable risks, what distinguishes this latest study from other claims-based analyses is its analysis of death records, which include out-of-hospital deaths," Wertz said. The study also followed patients for a longer period of time than some of the earlier research, according to the investigators.

"One of the reasons we embarked on this analysis was to see if there were any differences in effect that we could identify between these two agents," said Mark J. Cziraky, Pharm.D., study co-author, and vice president of research development and operations at HealthCore. "We did not find that with the approach and methods we took within this population."

Other co-authors are Chun-Lan Chang, Ph.D.; Chaitanya A Sarawate, M.S.; Vincent J. Willey, Pharm.D.; and Rhonda L. Bohn, M.P.H., Sc.D.

Author disclosures are on the manuscript. WellPoint, Inc. funded this research.


An accompanying editorial, "Improving Surveillance for Drug Safety: Lessons from Rosiglitazone," by Frederick A Masoudi, M.D., M.S.P.H., is available.


Statements and conclusions of study authors published in American
Heart Association scientific journals are solely those of the study
authors and do not necessarily reflect the association's policy or
position. The association makes no representation or guarantee as to
their accuracy or reliability. The association receives funding
primarily from individuals; foundations and corporations (including
pharmaceutical, device manufacturers and other companies) also make
donations and fund specific association programs and events. The
association has strict policies to prevent these relationships from
influencing the science content. Revenues from pharmaceutical and
device corporations are available at http://www.americanheart.org/
corporatefunding.

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Mayo’s “Smart” Adult Stem Cells Repair Hearts

(BUSINESS WIRE)--Mayo Clinic investigators, with Belgian collaborators, have demonstrated that rationally “guided” human adult stem cells can effectively heal, repair and regenerate damaged heart tissue. The findings — called “landmark work” in an accompanying editorial — appear in today’s Journal of the American College of Cardiology.

Stem cells isolated from patients have normally a limited capacity to repair the heart. This innovative technology boosts the regenerative benefit by programming adult stem cells to acquire a cardiac-like profile. Primed by a cocktail of recombinant cardiogenic growth factors, mesenchymal stem cells (MSCs) harvested from the bone marrow of a cohort of patients with coronary artery disease showed “superior functional and structural benefit without adverse side effects” over a 1-year follow-up in a model of heart failure according to the study.

Significance of the Findings

“These findings provide proof-of-principle that “smart” adult stem cells have added benefit in repairing the heart, providing the foundation for further clinical evaluation,” says Andre Terzic, M.D., Ph.D., Mayo Clinic researcher and senior investigator of the study. “The successful use of guided “lineage specified” human stem cells is based on natural cardiogenic cues” adds Atta Behfar, M.D., Ph.D. first author of the study. The pre-clinical data reported in this seminal paper have cleared the way for safety and feasibility trials in humans, which were recently conducted in Europe.

In their editorial, Eduardo Marban, M.D., Ph.D., and Konstantinos Malliaras, M.D., of Cedars-Sinai Heart Institute, in Los Angeles describe the Mayo approach as a “boot camp” for stem cells and also write that the study “… provides the first convincing evidence that MSCs, at least in vitro, can in fact become functional cardiomyocytes (heart cells)...”

The long-term potential of the findings include development of an effective regenerative medicine therapy for patients with chronic heart failure.

How It Was Done

Researchers obtained bone marrow-derived stem cells from heart disease patients undergoing coronary bypass surgery. Testing of these stem cells revealed that cells from two of 11 individuals showed an unusual capacity for heart repair. These rare cells demonstrated upregulated genetic transcription factors that helped identify a molecular signature identifying highly regenerative stem cells. The cardiogenic cocktail was then used to induce this signature in non-reparative patient stem cells to program their capacity to repair the heart. Mouse models with heart failure, injected with these cells, demonstrated significant heart function recovery along with improved survival rate after a year, compared to those treated with unguided stem cells or saline.

Specifically, researchers found that the heart tissue healed more effectively; that human cardiac and vascular cells were found participating in the regeneration, repair and strengthening of heart structures within the area of injury; and that scars and vestiges of heart damage appeared to fade away.

Authors include Atta Behfar, M.D., Ph.D.; Satsuki Yamada, M.D., Ph.D.; Ruben Crespo-Diaz; Jonathan Nesbitt; Lois Rowe; Carmen Perez-Terzic, M.D., Ph.D.; Andre Terzic, M.D., Ph.D. of Mayo Clinic; Vinciane Gaussin, Ph.D. and Christian Homsy, M.D., Cardio3 Biosciences, Mont-Saint-Guibert, Belgium; and Jozef Bartunek, M.D., Cardiovascular Center, Aalst, Belgium.

The research was supported by the National Institutes of Health, the American Heart Association, the Marriott Heart Disease Research Program, Cardio 3 Biosciences, the Ted Nash Long Life Foundation, the Ralph Wilson Medical Research Foundation, the Mayo Clinic General Mills Clinician-Investigator Fellowship, and Mayo Clinic.

Mayo Clinic and Drs. Andre Terzic and Atta Behfar have a financial interest associated with technology related to this research program. In accordance with the Bayh-Dole Act, Mayo Clinic has licensed that technology to Cardio 3 Biosciences in exchange for equity. No royalties have accrued to date to the institution or the inventors.

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FDA Announces Possible Safety Concern for HIV Drug Combination

The U.S. Food and Drug Administration today announced preliminary data suggesting that Invirase (saquinavir) in combination with Norvir (ritonavir) may have potentially important adverse effects on the heart.

When used together, the drugs may cause prolongation of the QT and PR intervals on an electrocardiogram. Prolongation of the QT interval may lead to a condition known as torsades de pointes, an abnormal heart rhythm. Prolongation of the PR interval may also lead to an abnormal heart rhythm known as heart block. With torsades de pointes or with heart block, patients may experience lightheadedness, fainting, or abnormal heart beats. In some cases, torsades de pointes may progress to a life-threatening irregular heart beat known as ventricular fibrillation.

Review of the data is ongoing. Preliminary findings suggest that some patients using Invirase and Norvir may be at an increased risk for heart abnormalities leading to irregular heart rhythms. For example, the risk for torsades de pointes may be increased in patients who are also using medications known to cause a heart disturbance called QT interval prolongation. The risk may also be increased in patients who have a history of QT interval prolongation.

Patients using Invirase should talk to their health care professional about any questions or concerns they have about Invirase. Patients and health care professionals should report any side effects from the use of Invirase to the FDA’s MedWatch program:
http://www.fda.gov/safety/MedWatch/default.htm1

Invirase is an antiretroviral medication that was first approved in 1995. Invirase is used in combination with Norvir and other antiretroviral medicines to treat HIV in adults. Invirase does not cure HIV infection, may not prevent you from developing HIV-related illnesses, and may not prevent you from spreading HIV to other people.

This early communication is in keeping with FDA’s commitment to inform the public about ongoing safety reviews of drugs. FDA will communicate its findings to the public as soon as the review is complete.

Invirase is marketed by San Francisco-based Genentech, a subsidiary of the Roche Group. Norvir is marketed by Abbott Park, Ill.-based Abbott Laboratories.

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FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients

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.

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Pediatric Cancer Survivors at Risk for Chronic Illnesses that May Cause Heart Disease

Survivors of pediatric cancer are at greater risk for high cholesterol, diabetes and high blood pressure, all of which predispose them to heart disease.

These risk factors for heart disease are being found at an earlier age than in the general population, according to research published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.

Lillian R. Meacham, MD, professor of pediatrics at Emory University and medical director of the Aflac Cancer Center of Children's Healthcare of Atlanta Cancer Survivor Program, used data from the Childhood Cancer Survivor Study, which included 8,599 cancer survivors and 2,936 of their siblings.

"In data previously published from the Childhood Cancer Survivor Study, pediatric cancer survivors were found to be at almost 10-fold greater risk for cardiovascular disease than their non-survivor counterparts," says Meacham. "In this study we identified whether the predisposing risk factors for cardiovascular disease - obesity, hypertension, hyperlipidemea and diabetes - were present at higher rates compared to siblings. If the risk factors could be recognized and treated early it is hoped some of the long-term cardiac side effects could be averted."

Meacham found that cancer survivors were nearly twice as likely as their siblings to take medication for high blood pressure, 60 percent more likely to take cholesterol medication and 70 percent more likely to have diabetes.

Radiation treatment may be playing a role in the development of risk factors for cardiovascular disease, Meacham says. Total body irradiation was linked with a 5.5-fold increased risk and chest and abdomen radiation a 2.2-fold increased risk of cardiovascular risk factor clustering, which when present is associated with subsequent cardiovascular disease.

"Mechanistically, we are not yet sure why this is, but the association is definitely there," says Meacham.

Researchers examined the presence of cardiovascular risk factors and found that physical inactivity among cancer survivors was linked with a 70 percent increased risk for cardiovascular risk factor clustering. Older age at the time of the study was linked to a 8.2-fold increased risk for cardiovascular risk factor clustering among survivors compared with children who had never had cancer.

"These risk factors are manifesting at about age 32, which is much younger than a non-cancer survivor would exhibit signs of cardiovascular risk factors," says Meacham. "Some have suggested that when you are a cancer survivor there are parts of you that wear out early, so we need to be vigilant about our follow-up of these patients in order to find these late effects early and intervene."

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Drug for Erectile Dysfunction and Pulmonary Hypertension Improves Heart Function in Children and Young Adults With Single Ventricle Heart Disease

/PRNewswire/ -- Heart function significantly improved in children and young adults with single ventricle congenital heart disease who have had the Fontan operation following treatment with sildenafil, a drug used to treat erectile dysfunction and pulmonary hypertension, say researchers from The Children's Hospital of Philadelphia.

Single ventricle defects are a collection of cardiac malformations that impair the heart's ability to pump blood. Examples include: tricuspid atresia, pulmonary atresia/intact ventricular septum and hypoplastic left heart syndrome.

The Fontan operation is a procedure that redirects systemic venous blood directly to the pulmonary arteries, bypassing the heart. It is the third surgery in a staged palliation for single ventricle heart defects.

Researchers hypothesized that sildenafil may help cardiac performance by directly improving the squeeze of the heart muscle and by allowing for better filling of the heart.

In this study, researchers randomized 28 children and young adults who had undergone the Fontan operation to receive placebo or sildenafil three times a day for 6 weeks. After a 6 week break, subjects were switched to the opposite treatment course. The researchers found significant improvement in heart performance during treatment with sildenafil.

"The enhanced heart performance may improve exercise performance and quality of life in these children and young adults," said David J. Goldberg, M.D., pediatric cardiologist at The Children's Hospital of Philadelphia, who presented the abstract today at the American Heart Association Scientific Sessions in Orlando, Fla.

Grants from The Mark H. and Blanche M. Harrington Foundation and from Big Hearts to Little Hearts provided funding for this study.

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Statins May Worsen Symptoms in Some Cardiac Patients

/PRNewswire/ -- Although statins are widely used to prevent heart attacks, strokes, and other cardiovascular disorders, new research shows that the class of drugs may actually have negative effects on some cardiac patients. A new study presented at CHEST 2009, the 75th annual international scientific assembly of the American College of Chest Physicians (ACCP), found that statins have beneficial effects on patients with systolic heart failure (SHF), but those with diastolic heart failure (DHF) experienced the opposite effect, including increased dyspnea, fatigue, and decreased exercise tolerance.

"Systolic heart failure is most often due to coronary artery disease and appears to have more of an inflammatory component than diastolic heart failure," said Lawrence P. Cahalin, PhD, PT, Northeastern University, Boston, MA. "It is possible that statins would help patients with systolic heart failure more than patients with diastolic heart failure due to the cholesterol-lowering and anti-inflammatory effects of statins."

Researchers from Northeastern University and Massachusetts General Hospital, Boston, MA, retrospectively reviewed the charts of 136 patients with heart failure in order to examine the effect of statins on pulmonary function (PF) and exercise tolerance (ET) in patients with DHF vs. SHF. A non-statin group (82 percent of patients had DHF) of 75 patients was compared with a statin group (72 percent of patients had DHF) of 61 patients. Atorvastatin was prescribed in 75 percent of the patients on statins.

Results of the analysis showed that overall PF and ET of patients in the statin group were significantly lower than patients in the non-statin group. Further subgroup analyses revealed that PF measures in the DHF statin group were 12 percent lower than PF measures in the DHF non-statin group. Furthermore, the amount of exercise performed by patients with DHF who were on a statin was almost 50 percent less than patients with DHF not on a statin.

"Some patients with diastolic heart failure may be more prone to the adverse effect of statins on muscle. It may be that patients with particular preexisting factors will experience unfavorable results from statin therapy, including exercise intolerance, dyspnea, and fatigue," said Dr. Cahalin.

Although the PF and ET measures in the SHF statin group were not significantly greater than in the SHF non-statin group, the PF measures were 11 percent to 14 percent higher, and the peak ET measures were 2 percent to 7 percent higher than the PF and ET measures of the SHF non-statin group, suggesting that statins did benefit patients with SHF.

"Not all statins are alike and not all patients are alike. Some statins are stronger than others and are likely to act differently, given particular patient characteristics, and produce different degrees of wanted and unwanted effects," said Dr. Cahalin. "In our continuing study, we hope to identify patient characteristics that are associated with favorable and less than favorable results from statin therapy."

Although the new data suggest that statins may actually worsen symptoms in patients with DHF, researchers feel that the benefits of using statins in patients with SHF and DHF outweigh the risks.

"Due to beneficial effects on lipids and other cardiovascular factors, statins are becoming a standard treatment for many patients with or without systolic or diastolic heart failure. It is likely that the use of statins for these conditions will continue to increase," said Dr. Cahalin. "However, if patients taking a statin are short of breath, fatigued, and unable to exercise or perform functional tasks, then exams of muscle strength and endurance, as well as pulmonary function and exercise tolerance, are warranted."

"Statins provide significant benefits for patients with cardiovascular disease," said Kalpalatha Guntupalli, MD, FCCP, President of the American College of Chest Physicians. "However, as for any new medication prescribed, clinicians should closely monitor the effects that different types of statins have on individual patients."

CHEST 2009 is the 75th annual international scientific assembly of the American College of Chest Physicians, held October 31-November 5 in San Diego, CA. The ACCP represents 17,400 members who provide patient care in the areas of pulmonary, critical care, and sleep medicine in the United States and throughout the world. The ACCP's mission is to promote the prevention and treatment of diseases of the chest through leadership, education, research, and communication. For more information about the ACCP, please visit the ACCP Web site at www.chestnet.org.

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FDA Approves New Cholesterol-Lowering Drug

The U.S. Food and Drug Administration today approved the 4 milligram maximum dose of Livalo (pitavastatin), a drug intended to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels.

Like other statins, Livalo is intended for patients when diet and exercise fail to lower their cholesterol levels. Statins improve elevated blood cholesterol levels primarily by inhibiting a liver enzyme called HMG Co-A reductase, thus reducing the liver's ability to make cholesterol.

"Elevated or abnormal cholesterol levels are associated with an increased risk for heart disease and stroke," said Eric C. Colman, M.D., deputy director, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. “Today’s approval offers patients and their health care professionals another alternative way to treat high cholesterol.”

Livalo was approved on the basis of five clinical trials comparing its efficacy and safety to that of three currently marketed statins.

The most frequently reported adverse reactions from taking Livalo were muscle pain, back pain, joint pain and constipation.

Livalo is manufactured by Kowa Pharmaceuticals America Inc. of Montgomery, Ala.

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Piedmont Fayette Hospital Now Offers Weekend Heart Disease Screening

Saturday Morning Appointments Available for CT Coronary Calcium Scans

Cardiovascular disease remains the number one killer of Americans according to the Centers for Disease Control (CDC). The American Heart Association’s 2008 Heart Disease and Stroke Statistics Report estimates that one in three American adults suffers from one or more types of cardiovascular disease. In order to increase awareness and promote early detection and education, Piedmont Fayette Hospital (PFH) is now offering CT Coronary Calcium Scans, a quick and painless method for the detection and risk assessment of coronary artery disease, on Saturday mornings.

“To better accommodate our community, we are happy to now offer this service on Saturdays,” says Dr. David Bodne of PFH. “CT Coronary Calcium Scans help physicians determine patients’ risk for heart disease, even if they do not currently have symptoms. Early detection can make an enormous difference in treating heart disease.”

A 64-slice CT (computed tomography) scanner is used for cardiac scoring, a statistical estimate of your likelihood of getting heart disease. The multi-slice scanner takes pictures of your heart and determines how much calcium build-up is in your arteries, a direct indication of heart disease. Calcium build-up is associated with atherosclerosis, which can harden the arteries and restrict the blood flow to the heart, potentially leading to a heart attack.

This simple non-invasive procedure only takes 15 minutes. The multi-slice CT scanner provides multiple images of the heart. The “slices” are actual pictures taken in tiny increments, one at a time, to get the sharpest image of the human heart.

Based on the amount of calcium build up, each patient is given a score. Typical scores range from zero to a high of 3,000. A “zero” calcium score is great news and indicates a reduced chance that a heart attack will occur. A score of 125 in any of the three coronary arteries suggests a more than 50 percent chance that there will be narrowing of at least 50 percent of the artery. After the CT scan your results and score are forwarded to your physician who will use them to assess your risk of heart disease.

PFH has a variety of cardiac and preventative health services available to patients in order to help them to lower their risk for heart disease and continue to lead healthy and active lives. These include a cardiac rehabilitation program, regular health screenings and the PFH Rehabilitation and Fitness Center.

A doctor’s referral is required for the CT Coronary Calcium Scan. Patients should consult with their physician in order to learn more about this screening. Appointments are required, as a limited number of spaces are available per Saturday. The cost of this procedure is $125 and must be paid at the time of registration. Please call 770-719-7007 to schedule an appointment, or for more information visit www.fayettehospital.org.
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