Pharmacy & Therapeutics - September 2008 - (Page 521)

NEW DRUGS continued from page 516 DRUG NEWS levels may indicate severe sepsis and septic shock. After an infection is under control, procalcitonin levels decrease. Purpose: This test enables emergency physicians to determine whether an infection is bacterial or viral, and it indicates the severity of a patient’s condition less than an hour after a blood sample is drawn. Because the progression of severe bacterial infections is affected by how early the patient receives appropriate treatment, measuring PCT levels is valuable in ICUs, where sepsis represents a major health challenge. Benefit: This test can improve critical decisions that ICU physicians have to make, such as whether to administer antibiotics, thus avoiding unnecessary use of these powerful drugs and potentially reducing the length of stay. The PCT test can be an effective tool for aiding physicians in quickly assessing the presence of bacterial infections and sepsis. Sources: www.pharmacyonesource. com; www.brahms-usa.com Name: Talent Abdominal Stent Graft System Manufacturer: Medtronic Vascular, Santa Rosa, Calif. Approval Date: April 15, 2008 Use Classification: This graft system is used to repair abdominal aortic aneurysms (AAAs). Description: The stent graft system is composed of a fabric tube supported by a metal framework. Each endovascular graft is compressed into the end of a long, thin, tube-like delivery catheter. The catheter, which contains the endovascular graft, is inserted into an artery to bridge the site of the AAA. The graft is then released in the aorta, where it expands to the diameter of the aorta to seal off the aneur ysm and reline the arter y wall. This graft goes from the aorta to the arteries that supply blood to to endogenous dendritic cells. These data are not the first to show prevention of small-molecule–based diabetes in animal studies, but they are the first to demonstrate a well-defined microparticle system that can reverse clinical hyperglycemia. (Source: Diabetes 2008;57[6]:1544– 1556.) Studies Focus on Food Allergies It is not clear why certain people are affected by food allergies, which have become a significant public health concern. Twelve investigators have received grants totaling $5 million over a period of two years. The program, called Exploratory Investigations in Food Allergy, is funded by the National Institute of Allergy and Infectious Diseases, part of the NIH, and by two groups, the Food Allergy and Anaphylaxis Network, and the Food Allergy Project. As many as 150 food anaphylaxisassociated deaths occur in the U.S. each year, mostly in adolescents and young adults. Projects will address treatment and prevention, triggers, predicting which food proteins are likely to cause reactions, and the role of other immune disorders in food allergy. (Source: NIH, www3.niaid.nih.gov.) placebo subjects. About 55% of patients without the variant experienced good outcomes with naltrexone or a placebo. Naltrexone blocks brain receptors for endogenous opioids (which promote a sense of well-being), making it easier for patients to abstain or to stop their alcohol intake quickly in case of a slip. Naltrexone has reduced relapses and craving for alcohol in some treated patients. Compared with non-carriers of the variant, white carriers who received naltrexone fared substantially better than other groups. The investigators found no gene–medication interaction in patients receiving specialized alcohol counseling, suggesting that genotyping for the variant might be most useful when naltrexone is used without intensive counseling. Naltrexone was approved in 1994. (Sources: Arch Gen Psychiatry, 2008; 65:135–144; NIH.) NEW MEDICAL DEVICES Marvin M. Goldenberg, PhD, RPh, MS Name: Procalcitonin Kryptor Test Manufacturer: Brahms USA, Annapolis, Md. Approval Date: April 7, 2008 Use Classification: This sensitive automated test is indicated for critically ill patients on the first day of admission to an intensive-care unit (ICU) as an aid to assessing the risk of progression to severe sepsis and septic shock. Description: In healthy people, procalcitonin (PCT) is produced in thyroid cells as a precursor to the hormone calcitonin. Although PCT is not found in human blood, the presence of a bacterial infection causes it to be produced by many organs of the body, resulting in a rapid rise of serum PCT levels (viral infections do not cause this increase). The biomarker level reflects the severity of the infection; slightly elevated levels suggest infections with a minor systemic inflammatory response, and very high Naltrexone (ReVia), Genes, And Alcohol Dependence In a study sponsored by the NIH, patients with a certain genetic variant drank less alcohol and experienced better overall clinical outcomes than patients without the variant while they were taking naltrexone (ReVia, Duramed). About 87% of the patients in the 2001– 2004 COMBINE Study (Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence) with the genetic variant remained abstinent or engaged in moderate drinking without related problems, compared with 49% of Vol. 33 No. 9 • September 2008 • P&T® 521 http://www.pharmacyonesource.com http://www.brahms-usa.com http://www.pharmacyonesource.com http://www3.niaid.nih.gov

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Pharmacy & Therapeutics - September 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Effect of Prescription Copays on Adherence and Treatment Failure with Oral Antidiabetic Medications Vaccine Declinations Present New Challenges for Public Health Universal Health Care in America Digestive Disease Week and American Diabetes Association Pharmaceutical Approval Update

Pharmacy & Therapeutics - September 2008

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