PHARMACY

American Diabetes Association revises clinical guidelines for diabetes testing

BY Allison Cerra

ALEXANDRIA, Va. The American Diabetes Association’s new clinical practice recommendations being published as a supplement to the January issue of Diabetes Care call for the addition of the A1C test as a means of diagnosing diabetes and identifying prediabetes. The test has been recommended for years as a measure of how well people are doing to keep their blood glucose levels under control.

“We believe that use of the A1C, because it doesn’t require fasting, will encourage more people to get tested for Type 2 diabetes and help further reduce the number of people who are undiagnosed but living with this chronic and potentially life-threatening disease. Additionally, early detection can make an enormous difference in a person’s quality of life,” said Richard Bergenstal, president-elect, American Diabetes Association’s medicine and science division. “Unlike many chronic diseases, Type 2 diabetes actually can be prevented, as long as lifestyle changes are made while blood glucose levels are still in the prediabetes range.”

The A1C test measures a person’s average blood glucose levels over a period of up to three months and previously had been used only to determine how well people were maintaining control of their diabetes over time.

A person without diabetes would have an A1C of about 5%. Under the new recommendations, which are revised every year to reflect the most current available scientific research, an A1C of 5.7% to 6.4% would indicate that blood glucose levels were in the prediabetic range, meaning higher than normal but not yet high enough for a diagnosis of diabetes. That diagnosis would occur once levels rose to an A1C of 6.5% or higher. The American Diabetes Association also recommends that most people with diabetes maintain a goal of keeping A1C levels at or below 7% in order to properly manage their disease. Research shows that controlling blood glucose levels helps to prevent serious diabetes-related complications, such as kidney disease, nerve damage and problems with the eyes and gums.

The A1C would join two previous diagnostic tests for diabetes, fasting plasma glucose and the oral glucose tolerance test, both of which require overnight fasting. Because the A1C is a simple blood test and does not require fasting, allowing patients this option could increase willingness to get tested, thereby reducing the number of people who have Type 2 diabetes but don’t yet know it. According to the Centers for Disease Control and Prevention, one-fourth of all Americans with diabetes, or 5.7 million people, don’t realize they have it. Another 57 million have pre-diabetes and 1.6 million new diagnoses are made every year.

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Healthcare IT will help seniors stay compliant, report says

BY Rob Eder

OAKLAND, Calif. A new report from the Center for Technology and Aging, based here in Oakland, suggests that information technology will be critical to improving medication adherence and reducing adverse effects among older adults, potentially saving tens of thousands of lives and billions of dollars.

The white paper, which first emerged in October, addresses three opportunities to improve medication compliance and persistence, including:

• Medication reconciliation, comparing medications a patient is taking against new physician orders;• Medication adherence, and• Medication monitoring. Within each area technologies being used or under development are described, along with an assessment of their pros, cons, market stage and economics.

The report identifies examples of cutting edge technology innovations that are addressing these types of opportunities, including:

• Medication kiosks, such as those piloted at the Veterans Health Administration;• Walgreen’s online medication history tool;• Cognitive assessment tests like the Mini-Mental State Exam (MMSE);• “Rex,” the talking pill bottle designed by Pittsburgh-based MedivoxRx for visually, and cognitively impaired patients;• The Med-eMonitor System, the portable electronic medication-dispensing device from Rockville, Md.-based InforMedix;• Mobile phone apps with medication management, reporting and trending features; and• Wireless point-of-care testing devices to monitor medication use.

“Medication nonadherence is responsible for up to 33% to 69% of medication-related hospital admissions and 23% of all nursing home admissions,” said David Lindeman, director, Center for Technology and Aging. “As Congress debates ways to improve our healthcare system and lower costs, it will be critical to put in place incentives that encourage providers to accelerate the use of available ‘med-op’ technologies.”

For a copy of the complete report log onto www.techandaging.org/medop_program_page.html.

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Biopharm maker Vivus submits NDA for new obesity drug

BY Rob Eder

MOUNTAIN VIEW, Calif. Vivus, a biopharmaceutical company focused on unmet needs in obesity, diabetes and sexual health, announced Tuesday that it has filed a New Drug Application to the Food and Drug Administration for approval of Qnexa, a new, investigational drug for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with such co-morbidities as hypertension, Type 2 diabetes, dyslipidemia or central adiposity.

The NDA submission follows the successful completion of the phase 3 program for Qnexa, including the recently announced results from the two, year-long phase 3 studies, EQUIP and CONQUER. In these trials, patients treated with all three doses of Qnexa achieved significant percent and categorical weight loss compared to placebo and met regulatory requirements for weight loss products as defined in the current FDA Guidance for Developing Products for Weight Management, the company stated. Patients treated with Qnexa also had significant dose-related improvements in a variety of secondary endpoints including reductions in cardiovascular and metabolic risk factors, according to the study.

“The weight loss seen in all of the phase 3 trials supports our belief that, if approved, Qnexa could be an effective treatment for patients who are obese or overweight with co-morbidities,” noted Leland Wilson, CEO, Vivus. “The weight loss of up to 14.7% (37 pounds) combined with significant improvements in weight-related medical conditions, such as hypertension, diabetes, and dyslipidemia, demonstrates the importance of treating obesity, which has become a major epidemic in the United States and many developed countries.”

According to Vivus, other highlights from the two 56-week EQUIP and CONQUER studies — which comprised more than 3,750 patients — included:

  • Statistically significant improvements in cardiovascular, metabolic and inflammatory risk factors among patients treated with Qnexa;
  • FDA efficacy benchmarks for weight loss agents were exceeded at all three doses of Qnexa tested in the clinical program;
  • Completion rates up to 69% were statistically significantly higher than placebo at all three doses of Qnexa, indicating favorable tolerability; and
  • Across both 56-week studies, the most commonly reported side effects were dry mouth, tingling and constipation.

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