PHARMACY

Air pollution may be linked to diabetes, study finds

BY Alaric DeArment

BOSTON Diabetes could partially be related to air pollution, according to a new study.

 

The study, conducted by researchers at Children’s Hospital Boston and published in this month’s issue of the journal Diabetes Care, found that diabetes in adults was consistently correlated with particulate air pollution even after adjusting for known risk factors, such as obesity and ethnicity.

 

 

The researchers based the study on fine particulates of between 0.1 and 2.5 nanometers, known as PM2.5, a component of haze, smoke and car exhaust, obtaining county-by-county data from the Environmental Protection Agency for 2004 and 2005. They then combined that data with diabetes data from the Centers for Disease Control and Prevention and the Census Bureau to find the prevalence of adult diabetes and adjust for such risk factors as obesity, exercise, geography, ethnicity and population density.

 

 

In all analyses, the researchers found a strong and consistent association between the prevalence of diabetes and concentrations of PM2.5; for every increase in PM2.5 exposure of 10 micrograms per cubic meter, there was a 1% increase in diabetes prevalence.

 

 

“We didn’t have data on individual exposure, so we can’t prove causality, and we can’t know exactly the mechanism of these people’s diabetes,” researcher John Brownstein said. “But pollution came across as a significant predictor in all our models.”

 

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Teva receives complete response letter for Neutroval

BY Alaric DeArment

JERUSALEM The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker said Thursday.

 

Teva said it received a complete response letter from the FDA concerning Neutroval (filgrastim), for neutropenia in patients receiving chemotherapy for cancer. The FDA issues complete response letters when it needs additional information before it can approve a drug.

 

 

Neutroval is a biosimilar of Amgen’s Neupogen and is marketed in Europe under the name TevaGrastim.

 

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GSK halts Simplirix trial

BY Alaric DeArment

LONDON British drug maker GlaxoSmithKline has stopped a late-stage trial of a vaccine for genital herpes, citing disappointing results, GSK said Thursday.

 

The company said that while the vaccine Simplirix (herpes simplex vaccine) proved to be safe when administered to women as a prevention for genital herpes disease, it did not prevent infection. GSK had been conducting the phase 3 trial in 8,323 women ages 18 to 30 years in the United States and Canada under a partnership with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

 

 

“We would like to express our gratitude toward our partner, [the National Institute of Allergy and Infectious Diseases], for [its] proactive collaboration and substantial contribution in the program, and the volunteers for their participation in the study,” GSK VP and director for late clinical development Gary Dubin said.

 

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