FDA ANNOUNCES RESTRICED ACCESS PROGRAM FOR ZELNORM

Rockvile, MD, July 2007. Restricted use of tegaserod maleate (Zelnorm, Ovaries) will be allowed by the FDA.

Zelnorm was suspended from the US market in March when a safety analysis linked its use to an increased risk for stroke. Now, after careful analysis, the FDA has concluded that the product may still benefit certain patients who have no other treatment options.

Now, the FDA will allow doctors to use the drug but only to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 years. Strict criteria further limits its use to patients in critical need who have no known or preexisting heart problems.

THE CHOICE OF SOFT-DRINK ASSOCITED WITH INCREASED METABOLIC RISK?

Boston, MA, July 23, 2007. Drinking more than one soft drink daily is associated with a higher risk of gaining weight and developing high blood pressure and abnormal cholesterol problems according to a new study. Interestingly, it doesn't matter if the soda consumed is the diet variety, those with zero calories, as investigators showed these also increased the burden of metabolic risk in middle-aged adults.

"That was one of the more striking aspects of this study," lead investigator Dr Ramachandran Vasan (Boston University School of Medicine, MA) told heartwire. "It actually doesn't matter if the soft drink is regular or diet. There was an association of increased risk of developing the metabolic syndrome with both types of drinks."

The consumption of soft drinks has doubled to tripled between 1977 and 2001. During this same time period, soft-drink sizes have also increased to staggering proportions. With evidence that soft-drink consumption is linked with weight gain and obesity as well as an increased risk of diabetes, the investigators questioned whether soft-drink consumption in adults, in amounts that are seemingly innocuous, like one per day, posed any metabolic hazard. Investigators found in an analysis of 6000 subjects that drinking more than one soft drink daily was associated with a 44% greater risk of developing obesity, high triglycerides, low HDL-cholesterol (the good cholesterol), and a tendency toward diabetes. There was also a trend toward an increased risk of developing high blood pressure, but this association did not reach statistical significance.

CONSUMPTION OF SMALL AMOUNTS OF DARK CHOCOLATE ASSOCIATED WITH REDUCTION IN BLOOD PRESSURE

July 3, 2007. Eating about 30 calories a day of dark chocolate was associated with a lowering of blood pressure, without weight gain or other adverse effects, according to a study in the July 4 issue of JAMA.

Previous research has indicated that consumption of high amounts of cocoa-containing foods can lower blood pressure (BP), believed to be due to the action of the cocoa polyphenols (a group of chemical substances found in plants, some of which, such as the flavanols, are believed to be beneficial to health). "A particular concern is that the potential BP reduction contributed by the flavanols could be offset by the high sugar, fat and calorie intake with the cocoa products," the authors write. The effect of low cocoa intake on BP is unclear.

44 adults were randomly assigned to receive for 18 weeks either 6.3 g (30 calories) per day of dark chocolate or matching polyphenol-free white chocolate. Dark chocolate intake reduced average systolic BP by - 2.9 mm Hg and diastolic BP by - 1.9 mm Hg without changes in body weight, plasma cholesterol, or blood sugar. The prevalence of hypertension also declined from 86 percent to 68 percent. Systolic and diastolic BP remained unchanged among those in the white chocolate group.

"Although the magnitude of the BP reduction was small, the effects are clinically noteworthy. On a population basis, it has been estimated that a 3-mm Hg reduction in systolic BP would reduce the risk of stroke mortality by 8 percent, of heart disease mortality by 5 percent, and mortality by 4 percent," the authors write.

JAMA. 2007;298(1):49-60

EXERCISE IN OVERWEIGHT MEN HELPS PREVENT HEART DISEASE

July 26, 2007. MedWire News: Exercise does not significantly reduce cholesterol levels in overweight men, but does make the particles that carry cholesterol in the body less likely to cause heart disease. "These findings indicate that physical activity effectively reduces the abundance of small, dense LDL particles, that otherwise might enter into the arterial wall," the researchers write in the Journal of Internal Medicine.

188 overweight men were randomly assigned to diet plus exercise, diet alone, exercise alone, or no intervention. The exercise comprised of 1 hour of walking or running on a treadmill, three times a week, at 60–80% of the participants' peak heart rate. After 1 year, men assigned to exercise (with or without diet) had

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