Pharmacy & Therapeutics - February 2008 - (Page 91)

NEW DRUGS Ezetimibe (Zetia) Shows Little Benefit In Heart Disease A clinical trial of ezetimibe (Zetia), a cholesterol-lowering drug taken by about one million people each week, has not shown medical benefits, according to its manufacturers, Merck and ScheringPlough. About 60% of patients who take Zetia do so by taking Vytorin, which contains Zetia plus simvastatin (Zocor, Merck) in a single tablet. Zetia lowers cholesterol by 15% to 20% in most patients, but no trial has shown that it can reduce heart attacks, strokes, or even fatty plaques in arteries that can cause heart problems. The ENHANCE trial was designed to show that Zetia could reduce the growth of plaques; however, over two years, the plaques grew almost twice as fast in patients taking Vytorin than in those taking Zocor alone. Patients who took Zocor alone reduced their LDL-cholesterol by 41% on average, but patients using Vytorin reduced their cholesterol by 58%. However, the Vytorin patients had more growth in fatty plaques in their carotid arteries than patients taking Zocor. The trial was completed in 2006, and in December 2007, the companies finally agreed that they would release the results. Even before Zetia was introduced in 2002, some cardiologists argued that Zetia lacked the benefits of statins, which had positive cardiovascular effects beyond their ability to reduce cholesterol. The companies are conducting three large trials with Vytorin. No incremental benefit of Vytorin on cardiovascular morbidity and mortality, over and above that shown for Zocor, has been established. In the U.S., Zetia and Vytorin together account for 20% of the overall cholesterollowering drug market. Both drugs cost about $3 a day. (Sources: The New York Times, January 14, 2008; Merck/Schering-Plough.) DRUG NEWS Alert for EDTA blood test that detects cellular immune responses to proteins associated with tuberculosis (TB) infection. Description: A single test is required, and objective and reproducible results are given. The In-tube format enables blood collection at remote sites. The device measures immune responses to peptides that simulate Mycobacterium tuberculosis proteins, which are not present in the bacille Calmette-Guérin (BCG) vaccine or in most non-TB mycobacteria. The test is 99% specific, and a positive result strongly predicts true infection with M. tuberculosis. Because people who are thought to have TB infection are normally recommended for TB therapy, which carries risks of liver toxicity and nerve damage, this test can reduce unnecessary therapy and overtreatment. Purpose: The test provides a reliable screening method of TB control in the U.S. Cost savings are also realized because common false-positive results of the tuberculin skin test are eliminated. Benefit: The new format, used in Europe and Asia, simplifies testing and fits with existing laboratory equipment. Virtually no labor or setup time is required for blood incubation. Sources: www.pharmacyonesource. com; www.cellestis.com; www.rapid microbiology.com Name: Realize Adjustable Gastric Band Manufacturer: Ethicon Endo Surgery, Inc., Cincinnati, Ohio Approval Date: October 20, 2007 Use Classification: This surgical implant is indicated for weight reduction and improvement in obesity- related health conditions, such as type-2 diabetes, in morbidly obese patients. Description: A soft, adjustable silicone band is wrapped around the stomach to create two chambers. After the procedure, the upper stomach can hold continued on page 96 Vol. 33 No. 2 • February 2008 • The FDA is issuing a public health advisory alert about edetate disodium. Patients have died when they mistakenly received this agent instead of edetate calcium disodium (Calcium Disodium Versenate) or when edetate disodium was used for chelation therapy or other nonapproved uses. Both drugs are often called EDTA and are easily mistaken for each other. They bind with heavy metals or minerals in the body and allow them to be eliminated through the urine. The FDA approved edetate disodium as an emergency treatment for hypercalcemia and for arrhythmias resulting from high levels of digitalis. Newer drugs have been approved since then, but edetate disodium is still used to treat severe lead poisoning. The FDA suggests that hospitals: • evaluate whether they need to keep it in stock; if not, it should be removed to prevent confusion. • treat lead poisoning only with edetate calcium disodium. • use the full product name, not EDTA. • include the indication for the product’s use on the prescribing order. • check the prescription and drug label to confirm that the correct drug has been selected. (Sources: FDA, January 17, 2008; Morb Mortal Wkly Rep, www.cdc.gov/mmwr/ preview/mmwrhtml/mm5508a3.htm.) NEW MEDICAL DEVICES Marvin M. Goldenberg, PhD, RPh, MS Name: QuantiFERON-TB Gold In-Tube Method Manufacturer: Cellestis, Inc., Melbourne, Australia, and Valencia, Calif. Approval Date: October 12, 2007 Use Classification: The device is a P&T® 91 http://www.pharmacyonesource.com http://www.pharmacyonesource.com http://www.cellestis.com http://www.rapidmicrobiology.com http://www.rapidmicrobiology.com http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5508a3.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5508a3.htm

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Pharmacy & Therapeutics - February 2008 Contents Editorial Medication Errors Prescription: Washington The Language of (Forgive Us) Change, As P&T Enters the Digital Age New Drugs/Drug News/New Medical Devices Drug Forecast Use and Outcomes of Antifibrinolytic Therapy in Patients Undergoing Cardiothoracic Surgery at 20 Academic Medical Centers in the United States Evaluation of the Management of Acute Venous Thromboembolism and Its Outcomes: One Institution's Experience American Society of Hematology, 49th Annual Meeting Pharmaceutical Approval Update

Pharmacy & Therapeutics - February 2008

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