PHARMACY

Study finds extreme glucose levels In diabetic patients who suffer heart failure linked to increase risk of death

BY Alaric DeArment

HOUSTON Patients with diabetes who suffer heart failure and have too high or too low levels of blood glucose may run an increased risk of dying, according to a new study.

The study, conducted by researchers at the Baylor College of Medicine and a Houston-based Dept. of Veteran Affairs hospital, and published in the current issue of the Journal of the American College of Cardiology, compared patients with glucose levels too high or too low to those who had moderately controlled glucose levels over a two- to three-month period by measuring the oxygen-carrying protein in the blood that is bound to the sugar glucose.

“Most doctors try to keep glucose levels of those with diabetes as low as they can to lower the risk of complications such as eye problems, kidney disease or the development of heart disease,” BCM assistant professor of medicine David Aguilar said in a statement. “However, we found that in diabetic patients with heart failure, glucose levels slightly higher than what are normally recommended had the lowest risk of death.”

The researchers, at BCM and the Michael E. DeBakey Veterans Affairs Medical Center, identified 5,815 veterans with heart failure and diabetes who were receiving treatment at VA hospitals across the country, following them for two years and dividing them into five groups depending on their glycosylated hemoglobin levels. Though medical professionals recommend levels of 7 and lower for diabetes patients, the researchers found that those with heart failure who had levels of 7.1 to 7.8 had the lowest death rate.

“This doesn’t mean that diabetic patients with heart failure should change their target goal for glucose levels,” Aguilar said. “The results could simply be telling us that the glycosylated hemoglobin levels are a marker for other risks that are contributing to increased risk of death, but not necessarily the cause of the problem.”

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FDA approves two-in-one blood pressure drug

BY Alaric DeArment

EAST HANOVER, N.J. The Food and Drug Administration has approved a blood pressure pill that combines two drugs in one.

Novartis announced Tuesday that the FDA had approved Tekturna HCT (aliskiren and hydrochlorothiazide), which combines the existing treatment Tekturna with hydrochlorothiazide, a widely used diuretic.

The approval was based on a 2,700-patient clinical trial indicating that the combination of the two drugs reduced blood pressure more than either drug alone.

High blood pressure, also known as hypertension, affects nearly 74 million adults in the United States and is a major risk factor for cardiovascular disease.

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GPhA, generic drug companies release letter regarding biosimilars bill

BY Alaric DeArment

ARLINGTON, Va. An amendment to a health reform bill currently under consideration would preclude the development of a significant biosimilars industry, nearly 30 generic drug companies told three members of the House in a letter released Wednesday.

The Generic Pharmaceutical Association released the letter — written to Reps. Henry Waxman, D-Calif., Frank Pallone, D-N.J., and Nathan Deal, R-Ga. — signed by 27 generic drug makers criticizing the amendment to the House Energy and Commerce Committee’s health reform bill by Reps. Anna Eshoo, D-Calif., and Joe Barton, R-Texas, that would allow 12 years of market exclusivity for biotech drugs before they faced biosimilar competition.

“While safeguarding market protections and intellectual property rights is critical in the pharmaceutical sector, only a healthcare system that balances the interests of innovation and access to lower cost medicine will achieve the greatest success,” the companies wrote in the letter.

Signatories to the letter included generics companies such as Teva, Ranbaxy and Mylan, as well as Paddock Labs, Sovereign Pharmaceuticals and Spear Pharmaceuticals.

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