PHARMACY

Report: Metformin cost-effective strategy in battling diabetes

BY Michael Johnsen

ALEXANDRIA, Va. — Lifestyle intervention and treatment with metformin provide safe, long-term, cost-effective means of preventing Type 2 diabetes and should be incorporated into prevention strategies for reducing the dramatic rise in incidence of Type 2 diabetes in the United States, according to two new analyses and an editorial published in the April issue of Diabetes Care.

The two reports provide further analyses and follow-up to the landmark Diabetes Prevention Program research first funded a decade ago primarily by the National Institutes of Health’s National Institute of Diabetes and Digestive and Kidney Diseases. The studies are accompanied by an editorial highlighting the American Diabetes Association’s recently revised Strategic Plan, which calls for an increased focus on translating the growing body of research on prevention into primary care and community treatment strategies.

One analysis by the Diabetes Prevention Program Research Group found that over 10 years, investing in lifestyle intervention or treatment with metformin for adults at high risk for Type 2 diabetes provided “good value for the money.” Over the first three years of the clinical trial, lifestyle interventions — losing 5% to 8% of body weight, or 10 to 16 lbs. for a 200-lb. person, plus increasing physical activity to at least 150 minutes per week — reduced the incidence of Type 2 diabetes by 58% and significantly improved quality of life. Metformin reduced diabetes by 31%. This follow-up analysis found that lifestyle intervention came at a cost-effectiveness of about $10,000 per cumulative-quality-adjusted life-year gained. Cost-effectiveness of such commonly used interventions as mammography or blood pressure generally range from $10,000 to $50,000 per QALY.

"This new analysis of costs and outcomes in the DPP and its follow-up study show both metformin and lifestyle change were very cost-effective for prevention or delay of Type 2 diabetes when analyzed from the perspective of healthcare payers," stated Griffin Rodgers, director of the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases. "Metformin treatment led to a small savings in healthcare costs over 10 years. The individual training in lifestyle change, as delivered in the study, was cost-effective and could become cost saving if offered to groups in community settings."

The second analysis found that long-term treatment with metformin safely produced sustained weight loss at 10 years and prevented or delayed the onset of Type 2 diabetes.

Currently, the Centers for Disease Control and Prevention estimated that 35% of U.S. adults aged 20 years or older may have prediabetes, a condition in which blood glucose levels are higher than normal, but not yet high enough for a Type 2 diabetes diagnosis.

 

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Court dismisses AstraZeneca case against FDA

BY Alaric DeArment

NEW YORK — A federal court has dismissed a case that drug maker AstraZeneca filed against regulators regarding a drug used to treat psychotic and bipolar disorders, the company said Monday.

The U.S. District Court for the District of Columbia dismissed AstraZeneca’s lawsuit against the Food and Drug Administration over generic formulations of Seroquel (quetiapine fumarate) and its extended-release version, Seroquel XR. The roots of the lawsuit go back to September 2011, when the drug maker asked the agency to withhold approval of any generic version of the drug whose labeling didn’t include warning language about risks of elevated blood sugar and suicide that it had required AstraZeneca to include.

The FDA turned down AstraZeneca’s request on March 7, prompting the company to sue the agency five days later. The company had requested an injunction against the FDA’s approval of any generic version of Seroquel until the Dec. 2, 2012 expiration of clinical trial data.

"Notwithstanding the court’s decision, the company continues to believe strongly in the merits of its position and is evaluating its options," a statement by AstraZeneca read.


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Supreme Court hears arguments surrounding healthcare law

BY Allison Cerra

WASHINGTON — The U.S. Supreme Court justices have gathered this week to discuss a potential legal issue surrounding President Obama’s healthcare law.

This week, the Supreme Court justices heard arguments for 90 minutes surrounding a legal issue pertaining to the Patient Protection and Affordable Care Act. The issue at hand is that "taxpayers who don’t purchase health insurance will have to report that omission on tax returns for 2014 and will pay a penalty along with federal income tax. At issue is whether that penalty is a tax," according to the Associated Press.

Meanwhile, last Friday marked the two-year anniversary of the enactment of the Patient Protection and Affordable Care Act. In line with the anniversary, the White House issued a report that aimed to highlight the benefits of the healthcare law. According to the Department of Health and Human Services secretary Kathleen Sebelius, new data found that seniors saved more than $3.2 billion on prescription drugs under the new healthcare law, while savings for seniors included a one-time $250 rebate check to those who hit the "donut hole" coverage gap in 2010 and a 50% discount on covered brand-name drugs in the donut hole in 2011.

Click here for the full report from AP.


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