PHARMACY

Diabetic retinopathy affects nearly 30% of U.S. diabetic adults, study shows

BY Allison Cerra

WASHINGTON The prevalence of diabetic retinopathy, an eye disease caused by diabetes, has increased among diabetic adults in the United States, according to a study published in the Journal of the American Medical Association.

Examining a sample of about 1,006 participants in the National Health and Nutrition Examination survey, ages 40 years and older, which was conducted from 2005 to 2008. Xinzhi Zhang of the Centers of the Disease Control and Prevention and colleagues found that about 28.5% of those surveyed had diabetic retinopathy and vision-threatening diabetic retinopathy.

Of that 28.5%, the study revealed, more men likely would have diabetic retinopathy than women (31.6% vs. 25.7%). What’s more, African-Americans had a higher prevalence of diabetic retinopathy, compared with white adults (38.8% vs. 26.4% of those surveyed).

The rates were about 40% and two and a half times higher, respectively, than estimates dating back to an earlier NHANES study from 1988 to 1994.

"Improved diabetes care, such as effective management of blood glucose levels, blood pressure, and serum lipid levels, is likely to reduce the incidence of diabetic retinopathy. Conversely, it might also lead to increased survival resulting in higher prevalence of diabetic retinopathy," the authors wrote.

"With the aging of the population and the increasing proportion of the population with diverse racial/ethnic heritage, the number of cases of diabetic retinopathy and vision-threatening diabetic retinopathy will likely increase," the authors concluded.

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Curemark gets nod to start late-stage trial for ADHD drug

BY Alaric DeArment

RYE, N.Y. The Food and Drug Administration has approved a late-stage clinical trial of a drug for attention deficit hyperactivity disorder.

Curemark said the FDA cleared its application to run a phase 3 trial of CM-4612 in patients with ADHD. The company is currently conducting a phase 3 trial of CM-AT, a treatment for autism in children.

“We are very excited to have received [clearance] from the FDA so that we can move forward with clinical trials to study CM-4612,” Curemark CEO Joan Fallon said. “Curemark hopes to have the first physiologically based medication to address ADHD, in lieu of the current psychotropic and stimulant treatments.”

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FDA approves additional dosage for NovoSeven RT

BY Alaric DeArment

PRINCETON, N.J. The Food and Drug Administration has approved a new dose of a treatment for hemophilia from Novo Nordisk, the Danish drug maker said.

The FDA approved Novo Nordisk’s NovoSeven RT (coagulation factor VIIa [recombinant], room temperature stable) in 8-mg vials. The treatment, which comes in the form of a powder mixed for injection, was already available in 1, 2 and 5 mg vials. The FDA also approved an extension of shelf life for all vial sizes from 24 months to 36 months at or below 77 degrees.

NovoSeven RT is formulated for patients with hemophilia A or B with inhibitors. The new dosage will shorten the time it takes to prepare the injection, known as reconstitution, compared with current dosages.

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