Raising “Good” Cholesterol Levels Fails Again to Reduce Heart Disease Risks

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped a clinical trial studying a blood lipid treatment 18 months earlier than planned. The trial found that adding high dose, extended-release niacin to statin treatment in people with heart and vascular disease, did not reduce the risk of cardiovascular events, including heart attacks and stroke. So far, studies have found no evidence that drugs that have been shown to increase levels of high-density lipoprotein cholesterol—the so-called good cholesterol—actually help protect against cardiovascular events such as a heart attack or stroke.

The latest setback for this approach came today when the US National Heart, Lung, and Blood Institute (NHLBI) announced that it was stopping a clinical trial evaluating the use of high-dose extended-release niacin in patients with heart and vascular disease who were also taking a statin to lower their level of low-density lipoprotein cholesterol, the “bad” cholesterol. The reason: study participants taking the niacin along with the statin were just as likely as those taking only the statin to experience a cardiovascular event such as a heart attack or stroke. In the AIM-HIGH trial, which enrolled 3414 patients beginning in 2006, about half of the patients received extended-release niacin (Niaspan) plus simvastatin (Zocor) and the other half received a placebo plus simvastatin. Although the trial was intended to follow-up the participants into 2012, the study’s independent data and safety monitoring board concluded in April that the extended-release niacin offered no benefits beyond statin therapy alone in reducing cardiovascular-related problems.

Physicians often recommend a prescription form of niacin, or vitamin B3, to patients with low blood levels of high-density lipoprotein cholesterol (HDL-C), the “good” cholesterol, based on the presumption that doing so protects against heart disease. But rigorous research proving that such increases are protective has been lacking.

The safety board also noted a small and unexplained increase in stroke rate in the group of patients taking the niacin, which added to the NHLBI’s decision to stop the trial. The US Food and Drug Administration issued a statement saying that it will look at the complete details of the AIM-HIGH study, which are expected to be made available this fall, before it offers any new conclusions or recommendations regarding the use of extended-release niacin alone or in combination with statins.

Based on the AIM-HIGH trial’s findings, extended-release niacin joins a list of other drugs such as fenofibrate and torcetrapib that raise HDL-C levels but do not decrease heart disease risk.

- Adapted from News@ JAMA.org original article at: http://www.nih.gov/news/health/may2011/nhlbi-26.htm

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm256841.htm
 

FDA issues warning for Use of High-Dose (80 mg) Simvastatin

The US Food and Drug Administration says that a high-dose version of simvastatin (Brand name: Zocor by Merck), which lowers levels of low-density lipoprotein cholesterol, should not be prescribed to new patients because of potential safety risks. As far back as  2004  an editorial in  in the Journal of the American Medical Association (JAMA) commented  that high-dose simvastatin, while increasing the risk of myopathy, was no better than low-dose simvastatin in reducing major cardiovascular events such as heart attack or stroke in patients with acute coronary syndrome. The FDA announcement does not recommend that patients who are stable on this dose for a long time be changed.  It allowed doctors to continue prescribe the medication to patients at the highest dose as long as they had taken it for at least a year without ill effects. The FDA announced June 8 that it is recommending that no new patients be started on an 80 mg Zocor (simvastatin) regimen, due to the risk of myopathy (muscle injury) , rhabdomyolysis (muscle cell breakdown), and possible secondary kidney damage.

Study Links Heavy Drinking With Pancreatic Cancer

Heavy drinking is associated with an increased risk of pancreatic cancer, according to results from a study by Susan M. Gapstur, PhD, MPH, of the American Cancer Society and her colleagues.

Daily consumption of 3 to 4 drinks of hard (distilled) liquor is associated with an increased risk of pancreatic cancer, even for those individuals who have never smoked, according to results from a massive prospective study published recently in the Archives of Internal Medicine

 More than 1 million people were followed for more than 20 years to complete this study. The fact that alcohol consumption alone increased pancreatic cancer rates is news. Tobacco consumption has long been known to be a risk factor for pancreatic cancer.

  These results strengthen the evidence that alcohol consumption, specifically liquor consumption of 3 or more drinks per day, increases pancreatic cancer mortality independent of smoking.

Sleep Loss May Lower Testosterone

Lack of Sleep Lowers Testosterone Levels in Young Men, Study Finds

By Jennifer Warner
WebMD Health News

Reviewed by Laura J. Martin, MD

June 3, 2011 -- Cutting back on sleep, even for a little while, may have a dramatic effect on men's testosterone levels.

A preliminary new study shows a week of sleep loss lowered testosterone levels by up to 15% in group of healthy young men.

Researchers say low testosterone levels can negatively affect men's health in a variety of ways, in addition to affecting sexual behavior.

For example, very low testosterone levels or testosterone deficiency is associated with low energy, reduced libido, poor concentration, and fatigue.

Testosterone is also critical to building muscle mass and strength and bone density. Testosterone levels naturally decline in men aged 40 and over by about 1% to 2% per year.

Here’s a link to a slide show to improve sleep.  http://www.webmd.com/sleep-disorders/sleep-benefits-10/slideshow-sleep-tips

'Food Pyramid' Out, ‘My Plate’ in for  Healthy Eating

By Lisa Maroun, Registered Dietitian

1. 

Few nutritionists will mourn the passing of the pyramid, which, while instantly recognized by millions of American school kids, parents and consumers, was derided by nutritionists as too confusing and deeply flawed because it did not distinguish clearly between healthy foods like whole grains and fish and less healthy choices like white bread and bacon. A version of the pyramid currently appearing on cereal boxes, frozen dinners and other foods has been so streamlined and stripped of information that many people have no idea what it represents.

Dr. Post said the U.S.D.A. had spent about $2 million to develop and promote the logo, including conducting research and focus groups and creating a Web site. Some of that money will also be used for the first year of a campaign to publicize the image. He said the agency would use the plate to get across several basic nutritional messages, including urging consumers to eat smaller portions, switch to low-fat or fat-free milk and drink water instead of sugary drinks.

The food pyramid has a long and tangled history. Its original version showed a hierarchy of foods, with those that made up the largest portions of a recommended diet, like grains, fruit and vegetables, closest to the wide base. Foods that were to be eaten in smaller quantities, like dairy and meat, were closer to the pyramid’s tapering top. But the pyramid’s original release was held back over complaints from the meat and dairy industry that their products were being stigmatized. It was released with minor changes in 1992.

A revised pyramid was released in 2005. Called MyPyramid, it turned the old hierarchy on its side, with vertical brightly colored strips standing in for the different food groups. It also showed a stick figure running up the side to emphasize the need for exercise.

But the new pyramid was widely viewed as hard to understand. The Obama administration began talking about getting rid of it as early as last summer. At that time, a group of public health experts, nutritionists, food industry representatives and design professionals were invited to a meeting in Washington where they were asked to discuss possible alternative symbols. One option was a plate.