Anabolic steroid users may face heart trouble

Bulking up with anabolic steroids appears to damage and weaken the heart, a new study shows, in principle increasing the odds of heart failure.

While it's nothing new that steroids have bad health effects, the new findings show they may be more harmful than previously thought. In heart failure, a weakened heart can't pump enough blood around the body.

The study did not find heart failure itself, just the signs of it, but in severe cases, the condition creates a backlog of blood in the lungs that makes breathing difficult, and may be fatal.

"What makes this scary is that the full magnitude of the problem may not declare itself until after 20 or 30 years," said Dr. Harrison G. Pope of Harvard University, who worked on the new study, published in the journal Circulation.

Pope, who has studied anabolic steroids for over 20 years, said the drugs began to crop up in gyms around the country in the 1980s, and quickly flourished. Today, as many as two million Americans may have abused the controlled substances at one point or another.

"We may be seeing just the beginning of something that could become a huge public health problem," Pope said.

With his colleagues, he advertised for weightlifters who could bench more than 275 pounds. That way, he got both steroid users and "clean" bodybuilders without having to disclose the study's purpose, which could have biased the results.

The researchers measured the recruits' heart function using ultrasound. Among the 12 steroid users, 10 turned out to have hearts that pumped less blood into the body than they should. In contrast, only one of the seven non-users had this problem.

"That is a stunning statistical difference, far greater that could possibly be explained by chance," Pope told Reuters Health. "The heart becomes more flappy and cannot contract with the same force as it usually does, and it also becomes less flexible."

"There have been case reports of athletes collapsing on the floor," Dr. Nora Volkow, director of the National Institute on Drug Abuse in Bethesda, Maryland, told Reuters Health. "If I was a cardiologist, I would be very concerned."

But she added that because the study is small, it is still too early to predict what will happen to the large group of steroid users now moving into middle age.

In addition to boosting muscle growth, anabolic steroids -- which mimic testosterone, the male sexual hormone -- also affect the brain in unpredictable ways: In some people, they produce aggression, in others depression.

With prolonged use, steroids also limit natural testosterone production in the testicles, which can make men more feminine.

While law enforcement has cracked down on illegal production of steroids in the U.S., the drugs are sold over-the-counter in some countries and can be purchased easily on the internet.

Pope, himself a psychiatrist, said the behavioral effects are worrisome, but that his biggest concern is the heart. Heart failure is already a major killer in developed nations. How much steroids will be adding to that death toll is still unclear.

"It is very hard for the (Drug Enforcement Administration) to intercept this stuff, it just pours into the country," said Pope. "We need to get more data and we need it fast."

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New Technique Prevents Major Cause For Heart-related Stroke

Physicians at The Mount Sinai Medical Center were the first in the country to perform a non-surgical procedure using sutures to tie off a left atrial appendage (LAA), which is the source of blood clots leading to stroke in patients with atrial fibrillation (AFib). AFib is the most common sustained heart-rhythm disorder in the United States.

The procedure was performed Wednesday by Vivek Y. Reddy, MD, Professor of Medicine and Director of the Cardiac Arrhythmia Service at Mount Sinai Heart, and his colleague, Srinivas R. Dukkipati, MD, Director of Mount Sinai's Experimental Electrophysiology Laboratory. With the patient under general anesthesia, the physicians guided two catheters into the patient's heart to seal the LAA with a pre-tied suture loop. The technique is a safe alternative to drug therapies such as the blood thinner warfarin (Coumadin) that can have serious side effects, as well as open-heart surgery, and more invasive implant surgery.

"People who take Coumadin because of atrial fibrillation include active and otherwise healthy people, as well as elderly people for whom the drug may be contraindicated," said Valentin Fuster, MD, PhD, Director of Mount Sinai Heart and Chair of the American/European Guidelines of Atrial Fibrillation.

Drs. Reddy and Dukkipati joined Mount Sinai this month to focus on building the institution's services for heart-rhythm disorders. They had been performing pre-clinical testing of the non-surgical LAA device, and this procedure represents its first application in people in the United States.

"We are very proud of the recruitment of Dr. Reddy and his exceptionally talented team," said Wayne Keathley, President and Chief Operating Officer of The Mount Sinai Hospital. "Their pioneering work has the potential to redirect the field of cardiac rhythm disorders."

"Compared to a lifetime of medication therapy, or other surgical modalities, a one-time, non-surgical procedure to relieve the complications of AFib offers a whole new paradigm," said Dennis S. Charney, MD, Anne and Joel Ehrenkranz Dean, Mount Sinai School of Medicine, and Executive Vice President for Academic Affairs, The Mount Sinai Medical Center. "Drs. Reddy and Dukkipati have ushered in a new standard of care for people with this serious cardiac condition."

Approximately 6 million U.S. adults have been diagnosed with AFib, a condition characterized by a rapid and irregular heart beat that can cause serious complications, including stroke and early death. The majority of these patients take warfarin because left untreated, AFib can cause life-threatening blood clots. Approximately 25-30 percent of patients with AFib have contraindications to the drug—such as concerns of falling or imbalance in elderly patients—and, even for the remainder, only about 55-60 percent receive warfarin.

AFib-related deaths have increased over the past two decades and now account for one-quarter of all strokes in the elderly. Those who do take warfarin must rigorously manage the drug's level in their blood. High levels can cause excessive or internal bleeding, even after minor falls, bruises, or cuts. For some, this management regime can mean monthly tests over the course of many years. In eliminating the need to take warfarin, the LAA procedure can reduce the need for frequent medical visits.

"This procedure demonstrates what translational medicine can do for society," said Kenneth L. Davis, MD, President and Chief Executive Officer, The Mount Sinai Medical Center. "Novel therapeutics that can immediately impact health, while minimally impacting the health care system, are our research priority."

"This non-surgical procedure could lead to a permanent means of protecting against stroke in patients with AFib who are ineligible for long-term warfarin anticoagulation therapy," said Dr. Reddy. "The suture delivery system allows us to place a pre-tied suture loop on the outside of the LAA using a pericardial approach, similar to what is used in surgery. But instead of surgery, which can involve spreading the ribcage or cutting through bone to access the LAA, this procedure does not require surgical incisions and is instead performed percutaneously; that is, using needle punctures to introduce catheters to the heart."

In addition to open-heart surgery, which is rarely performed as a stand-alone surgical procedure because of the associated morbidity, non-pharmaceutical treatment options involve occlusion of the LAA via an implant, a technique that is not yet approved by the U.S. Food & Drug Administration (FDA), commented Samin K. Sharma, MD, Director of Mount Sinai's Cardiac Catheterization Laboratory.

The patient, a 78-year-old woman from Miami, presented with a history of stroke and a fall. Her physicians prescribed Coumadin but had difficulty titrating the medication for her. She initially sought an implant but traveled to Mount Sinai for the non-surgical, catheter-based suture delivery system. Following the procedure, the patient is recovering safely and no longer needs to take the drug for stroke prevention. Patients receiving non-invasive procedures usually return to normal activities in about a week.

The procedure—aided by the LARIAT Suture Delivery Device, which was developed by SentreHEART, Inc., and approved by the FDA in May—was performed in a cardiac catheterization laboratory and did not require cardiopulmonary bypass.

Source : www.sciencedaily.com

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Avandia Study Spurs New Heart Risk Debate

A company-sponsored clinical trial shows that the diabetes drug Avandia causes no more heart deaths than standard treatment, but critics say the study is flawed.

Avandia, made by GlaxoSmithKline, is an oral drug that makes the body more sensitive to insulin.

But concerns that Avandia causes heart problems has led the American Diabetes Association's treatment guidelines committee to advise against prescribing Avandia in favor of Actos, another drug in the same class with fewer heart-safety concerns -- although both drugs increase a patient's risk of heart failure.

GlaxoSmithKline's RECORD study was supposed to answer these concerns. And according to study leader Philip D. Home, DPhil, of the U.K.'s Newcastle University, it did. Home presented the study findings at this week's meeting of the American Diabetes Association in New Orleans.

"The findings are essentially that in overall cardiovascular terms the drug is safe," Home said at a news conference. "There is no increased or decreased risk of death from heart disease, and that includes the heart failure data."

David Nathan, MD, chairman of the American Diabetes Association guideline committee, said the group would reconsider its recommendations in light of the study findings.

However, the study was unable to determine whether Avandia increases a patient's risk of heart attack. That concern was raised by several experts, including Steven Nissen, MD, chairman of cardiovascular medicine at the Cleveland Clinic.

Nissen remains unconvinced by the final report from Home and colleagues.

"The RECORD trial is seriously flawed," Nissen tells WebMD. "The authors don't reveal the number of patients who were still taking Avandia by the end of the study, but I would estimate this number to approach 50%. Obviously, it is impossible to assess the safety of a drug when patients are not actually taking it."

Home says patients assigned to Avandia treatment took the drug for 88% of the study time. But Nissen says Home's own previously published interim findings do not support this calculation.

Indeed, Home agrees that the study does not answer the question of whether patients taking Avandia have an increased risk of heart attack.

"But what we do know is that this is not associated with cardiovascular death," he said. "There were actually fewer deaths in the [Avandia] group."

In the study, all patients received standard treatment with metformin and/or a sulfonylurea. Half added Avandia to this treatment. The study was not blinded, meaning that study investigators and patients knew which treatment they were getting.

Nissen doubts that this unblinded study will convince experts to change their minds about Avandia. That, he says, will happen only if a new study -- the just-started TIDE study -- shows Avandia is truly safe. The TIDE study is a double-blind trial. And even though it is sponsored by GlaxoSmithKline, there will be a direct comparison of Avandia to Actos, made by Takeda Pharmaceuticals.

Home disagrees, and expects the American Diabetes Association committee to give serious consideration to the new findings, which appear in the June 5 early online edition of The Lancet.

In an editorial accompanying the study, Ravi Retnakaran and Bernard Zinman of Toronto's Mt. Sinai Hospital agree with Nissen that the study's open-label design -- and it's much lower-than-expected rate of cardiovascular deaths -- are problematic.

"Definitive conclusions about the relation between [Avandia] and cardiovascular risk remain elusive, owing to study limitations," Retnakaran and Zinman write. "Furthermore, the findings are inconclusive for [heart attack], for which a non-statistically-significant increased risk was noted in the [Avandia] group."

Unfortunately, a definitive answer isn't soon forthcoming. The TIDE trial isn't scheduled to end until October 2015.

Meanwhile, Retnakaran and Zinman suggest that doctors consider prescribing half doses of Avandia, noting that a half dose offers more than half the benefit of a full dose -- and fewer risks.

Source : diabetes.webmd.com

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