PHARMACY

Study: Treating depression, diabetes at the same time may improve symptoms

BY Allison Cerra

NEW YORK — Patients that are simultaneously treated for Type 2 diabetes and depression are more likely to adhere to their medication and see improvement in their symptoms, compared with those receiving usual primary care, according to a new study.

Researchers from the Perelman School of Medicine at the University of Pennsylvania monitored patients over a 12-week period after randomly assigning them to an integrated care group — which included the combination of a primary care and a brief medication adherence program that was individualized to participants — or a usual primary care group. After 12 weeks of monitoring for medication adherence, 60.9% of patients who received the integrated approach were found to achieve improved blood-sugar test results, compared with only 35.7% patients who only received the usual primary care. What’s more, patients in the integrated care group also were more likely to show signs of remission of depression, compared with their usual care group counterparts (58.7% versus 30.7%, respectively).

The full results of the study are published in the January/February issue of the Annals of Family Medicine.

"Though research demonstrates the link between depression and diabetes, few integrated programs are being implemented in practice," said lead author Hillary Bogner, an assistant professor of Family Medicine and Community Health in the Perelman School of Medicine, and a senior scholar at the Center for Clinical Epidemiology and Biostatistics, both at the University of Pennsylvania. "Our results demonstrate that integrated treatment for both conditions, combined with a brief program focused on adherence for primary care patients with Type 2 diabetes and depression can result in a significant improvement in clinical outcomes. We hope the findings will encourage the adoption of adherence programs aimed at improving outcomes."


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Bristol-Myers Squibb, AstraZeneca diabetes drug hits speed bump at FDA

BY Alaric DeArment

PRINCETON, N.J. — The Food and Drug Administration has declined to approve a drug for Type 2 diabetes made by Bristol-Myers Squibb and AstraZeneca, saying it needs additional clinical data, the companies said Thursday.

AstraZeneca and Bristol announced that they had received a complete response letter from the FDA for dapagliflozin. The agency said it would need more data to better weigh the drug’s benefits against its risks. The FDA issues a complete response letter when it has finished reviewing a regulatory approval application, but questions remain that preclude approval of the application in its present form.

The companies said they would work closely with the agency to determine the next steps and were also communicating with health authorities in other countries.


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Gilead receives FDA approval for lower-dose HIV drug in children

BY Alaric DeArment

FOSTER CITY, Calif. — The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.

Gilead announced the FDA approval of Viread (tenofovir disoproxil fumarate) in the 150-mg, 200-mg and 250-mg strengths combined with other antiretroviral drugs in patients ages 6 to 12 years while also approving an oral powder formulation for children ages 2 to 5 years. The agency approved the drug in the 300-mg strength for adults in 2001 and for patients ages 12 to 17 years in 2010.

"Prenatal HIV testing and antiretroviral interventions during pregnancy have contributed to a dramatic decline in the number of children born with HIV in the United States," Gilead EVP research and development and chief scientific officer Norbert Bischofberger said. "However, there remains an unmet need for heat-stable, taste-neutral pediatric formulations that do not require cold storage, particularly in resource-limited settings, where mother-to-child transmission remains a significant challenge."


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