Pharmacy & Therapeutics - March 2009 - (Page 131) NEW DRUGS their last physical therapy session before discharge; had shorter hospital stays; had faster walk times on the fourth rehabilitation day; and were less likely to miss physical therapy sessions. At six months, they were also less likely to report moderate to severe pain when walking (4% vs. 15%), to have pain that interfered with walking (7% vs. 18%), and to be taking analgesics (35% vs. 51%). Source: J Am Geriatr Soc 2009;1:1–10 DRUG NEWS Sales of Efalizumab (Raptiva) Halted in Europe Efalizumab (Raptiva), indicated for treating psoriasis, is being withdrawn from the European market because it has been found to raise the risk of a rare and often fatal brain infection, progressive multifocal leukoencephalopathy (PML). This drug is marketed in Europe by Merck Serono and in the U.S. by Genentech. The FDA is reviewing the situation. Source: The Wall Street Journal, February 20, 2009 Predicting Early Stent Thrombosis About one in 70 high-risk patients with acute coronary syndrome (ACS) eventually experiences early stent thrombosis, whether or not a drug-eluting or bare metal stent is used. In the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial, researchers found that diffuse atherosclerosis, less-than-optimal angiographic results, and inadequate drug therapy raised the risk of ACS. They analyzed coronary angiography in 3,405 patients with moderate-risk and high-risk ACS who received stents. Of those, 3,043 patients had drug-eluting stents. Within 30 days, definite or probable stent thrombosis developed in 48 patients. Results were almost the same in patients receiving either type of stent and heparin plus glycoprotein (GP) IIb/IIIa inhibitors, compared with bivalirudin (Angiomax, The Medicines Company) with or without GPIIb/IIIa inhibitors (1.1% vs. 1.6% and 1.5%, respectively). Patients with stent thrombosis were more likely to have insulin-dependent diabetes and renal insufficiency initially, along with more coronary atherosclerosis and suboptimal final angiographic results. Stent thrombosis was also more common in patients who had not been given thienopyridine before the procedure and who were using antiplatelet drugs inconsistently (fewer than half of the days after hospital discharge). However, the strongest predictors of stent thrombosis were a smaller stent lumen diameter, lack of presurgical thienopyridine, extent of coronary artery disease, and a higher baseline hemoglobin level. Some risk factors are controllable, such as ensuring thienopyridine administration before the procedure, emphasizing the importance of compliance with antiplatelet treatment after stent placement, and not performing percutaneous coronary intervention (PCI) in patients who are likely to be noncompliant. Source: Circulation 2009;119:687–698 Anti-Tumor Necrosis Factor Agents May Raise Risk Of Herpes Zoster Drugs that inhibit tumor necrosis factor–alpha (TNF-α) make patients more vulnerable to bacterial infection, but is the same true of viral infection? Researchers enrolled 5,040 patients in a German biologics register when they began treatment with infliximab (Remicade, Centocor), etanercept (Enbrel, Amgen/Wyeth), adalimumab (Humira, Abbott), or anakinra (Kineret, Bio vitrum, formerly from Amgen) or when they changed conventional disease-modifying antirheumatic drugs (DMARDs). During a three-year follow-up period, 82 patients had 86 episodes of herpes zoster; 39 of these events could be attributed to treatment with anti–TNF-α antibodies, 23 to etanercept, and 24 to conventional DMARDs. After adjusting for age, rheumatoid arthritis severity, and glucocorticoid use, the researchers found a significantly higher risk when patients were treated with monoclonal antibodies. However, the risk was still lower than the threshold for clinical significance. They found no significant associations with etanercept or anti– TNF-α treatment as a class. Source: JAMA 2009;301:737–744 Problems with Clinical Trials Performed Abroad A new study has found that the number of countries conducting drug trials doubled over the past decade. Much of the testing of late-stage drug trials for use in humans is being done outside the U.S. because results can often be obtained more quickly and less expensively. Bureaucracy and regulatory hurdles in the U.S. might also be increasing interest in conducting studies abroad. Concerns exist about the ethical treatment of participants and the integrity of the data produced in developing countries. Patients in those countries tend to be taken advantage of because of poverty and their unfamiliarity with the research process. They may be willing to enroll because of a lack of alternative treatments. Proper research oversight, adequate informed consent, and approval by ethics boards or health officials have been inconsistent abroad. Last year the FDA updated its guidelines for conducting international clinical trials and adopted a standard known as good clinical practices. Critics believe the updated guidelines are less ethically rigorous and more industry-friendly than former guidelines. The new standards protect participants by requiring studies to be reviewed by international ethics committees; each Vol. 34 No. 3 • March 2009 • P&T® 131
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