FDA approves Egrifta to treat Lipodystrophy in HIV patients

The U.S. Food and Drug Administration today approved Egrifta (tesamorelin) to treat HIV patients with lipodystrophy, a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs. The condition is associated with many antiretroviral drugs used to treat HIV.

Egrifta, the first FDA-approved treatment for lipodystrophy, is a growth hormone releasing factor (GRF) drug that is administered in a once-daily injection.

"The FDA recognizes the need for therapies to treat patients with HIV-lipodystrophy," said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “The presence of excess fat with this condition may contribute to other health problems as well as affect a patient’s quality of life, so treatments that demonstrate they are safe and effective at treating these symptoms are important.”

Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied.

Egrifta was evaluated in two clinical trials involving 816 HIV-infected adult men and women with lipodystrophy and excess abdominal fat. Of these, 543 patients received Egrifta during a 26-week, placebo-controlled period. In both studies, patients treated with Egrifta experienced greater reductions in abdominal fat as measured by CT scan, compared with patients receiving another injectable solution (placebo). Some patients reported improvements in their self image.

The most commonly reported side effects in the studies included joint pain (arthralgia), skin redness and rash at the injection site (erythema and pruritis), stomach pain, swelling, and muscle pain (myalgia). Worsening blood sugar control occurred more often in patients treated with Egrifta than with placebo.

Egrifta was developed by Montreal-based Theratechnologies Inc. and marketed in the U.S. by Rockland, Mass.-based EMD Serono.

-----
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG
www.FayetteFrontPage.com
Twitter: @FayetteFP

New Biomarker for Heart Failure Identified

Blood levels of resistin, a hormone produced by fat cells, can independently predict an individual¿s risk of heart failure, cardiologists at Emory University School of Medicine have found.

Their findings were presented Nov. 12 at the American Heart Association Scientific Sessions conference in New Orleans.

"This is one of the strongest predictors of new-onset heart failure we've been able to find, and it holds up even when you control for other biomarkers and risk factors including high blood pressure and diabetes," says Javed Butler, MD, MPH, associate professor of medicine and director of heart failure research at Emory University School of Medicine.

The finding comes out of the Health ABC (Aging and Body Composition) study, sponsored by the National Institute on Aging of the National Institutes of Health. The Health ABC study followed 3000 elderly people in the Pittsburgh and Memphis areas over seven years starting in 1998.

Although scientists don't know the exact function of resistin, it appears to be associated with both inflammation and insulin resistance, says Vasiliki Georgiopoulou, MD, a post-doctoral research fellow with Butler who presented these findings. "Recent laboratory studies have also shown that resistin decreases the ability of rats¿ heart muscles to contract," she adds.

In the Health ABC study, the risk of new onset heart failure increased by 38 percent for every 10 nanograms per milliliter increase in resistin levels in blood. Resistin was a stronger predictor of heart failure risk than other inflammatory markers linked to heart disease, such as C-reactive protein, the researchers found.

"Considering the increasing number of people who are obese or have diabetes, very many of them are going to be at some level of risk for heart failure later in life," Butler says. "The value of a marker such as resistin may be in accurately identifying among this large population of at-risk individuals who is at the highest risk and then targeting interventions to those people."

Investigators from several institutions contributed to the study, including the University of Lausanne, Harvard Medical School, University of California San Francisco, University of Pittsburgh, Wake Forest University, Boston University and the National Institute on Aging.

About Emory Heart & Vascular Center Emory Heart & Vascular Center doctors are committed to providing clinically excellent cardiovascular patient care, pioneering innovative clinical research and training the best heart specialists in the world. A component of Emory Healthcare, the Center is consistently recognized by U.S. News & World Report as one of the top heart centers in the country. Emory Healthcare is the clinical arm of Emory University's Woodruff Health Sciences Center and is the largest, most comprehensive health care system in Georgia.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page