Drug Topics - May 12, 2008 - (Page HSE6)

6 HSE DRUG TOPICS MAY 12, 2008 www.drugtopics.com > > > Clinical Practice Cholesterol controversy tops billing at cardiology confab Walter Alexander, Ph.D. ven prior to the recent American College of Cardiology (ACC) annual meeting, held in Chicago, previews of the data from the ENHANCE trial had already attracted intense media attention. This was largely because of unexpectedly disappointing results and a congressional investigation into delays in data presentation. At the ACC meeting, the ENHANCE (Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression) study was presented in a special “showcase” plenary session by lead investigator John Kastelein, M.D., Ph.D., Academic Medical Center, Amsterdam, The Netherlands. The study compared ezetimibe 10 mg and simvastatin 80 mg (EZE/SMV) (Vytorin, Merck/Schering-Plough) versus simvastatin 80 mg alone with respect to their ability to reverse atherosclerotic thickening of the carotid artery in 720 patients with familial hypercholesterol- E The American College of Cardiology meeting in Chicago drew a record attendance this year. emia. Kastelein reported that the 16.5% incremental reduction of LDL cholesterol with EZE/SMV as compared with SMV alone failed to produce any benefit in carotid plaque reductions from baseline. Representing a panel appointed to discuss ENHANCE results, Harlan M. Krumholz, M.D., professor of medicine at Yale University, commented: “For clinicians who may have employed this medication [i.e., EZE] before exhausting the options with statins, the strongest recommendation we can make on this panel is, ‘Turn back to statins, especially those with favorable outcomes data.’” Associate professor of medicine Michael Davidson, University of Chicago, speaking at a subsequent Merck/Schering-Plough press briefing, said that the most likely explanation for the lack of plaque regression in ENHANCE was that “…the population was so well treated even before the study started that it was impossible to see an effect.” Outcomes data for Vytorin, considered to be the true test of efficacy (as opposed to the surrogate endpoint of ENHANCE), are expected in 2012 with results of IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial), a trial comparing EZE/SMV with SMV alone among 18,000 patients recovering from acute coronary syndromes. In other news from the meeting, researchers reported that when orthopedic issues or age preclude active exercise testing, adenosine is widely used as a vasodilating stressor in myocardial perfusion imaging (MPI) evaluations (SPECT) of heart disease. Adenosine has the drawback, however, of producing flushing, chest pain, shortness of breath, nausea, and atrio-ventricular block (AVB) in up to 80% of patients, stated James E. Udelson, M.D., Tufts-New England Medical Center, Boston. Also, adenosine requires a cumbersome sixminute pump infusion. Udelson presented what he described as “…significant practice-changing results for binodenoson (BINO), a selective adenosine A2A receptor agonist delivered in a 30-second bolus. BINO was tested in two Phase III trials (VISION 302/VISION 305) among 852 patients referred generally for chest pain to pharmacologic stress MPI. Investigators wished to see if BINO and adenosine detected similar magnitudes of ischemia in the same patients, and compared side effects, particularly second- or third-degree AV block. Patient preference was also evaluated. Udelson reported that no second- or third-degree AV block occurred with BINO. AV block, flushing, chest pain, and dyspnea were all reported at significantly higher rates with adenosine. No side effects were significantly greater with BINO than with adenosine. About 70% of patients preferred BINO. Udelson said, “BINO provides similar clinical information as adenosine, but is associated with a significant reduction in the incidence and intensity of many side effects.” The ISAR REACT3 (Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment) trial compared unfractionated heparin (UFH) and bivalirudin (Angiomax, The Medicines Co.) among 4,570 patients (mean age 67 Photo: Walter Alexander http://www.drugtopics.com

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Drug Topics - May 12, 2008 Contents Latebreakers Letters R.Ph.s Say More Needs to be Done to Prevent Pediatric Drug Errors There's a New School of Thought on Use of Beta-Blockers for Hypertension Cover Story Guest Spot Letters Clinical Practice Special Report Professional Practice Broad Label for New Leukemia Therapy Looks Promising Treating Asthma During Pregnancy Safer than Not, Says New Guide In the Pipeline Clinical Q&A APhA Leader's Plan to Leave Office Takes Center Stage at its Conference Policies Passed at a Glance Giving a Talk to the Community? Check Out These Materials This Foundation has Funds to Spare JP at Large Cover Story: Employers and R.Ph.S: A Win-Win Combo FDA's Ilisa Bernstein Discusses Pharmacy Affairs Legal Q&A Manufacturers Unleash a Rash of Poison Ivy Treatments Are OTC Cold Remedies Safe for Kids? Probiotics are All the Rage: How You Can Capitalize on It CMS' Prices for Round One of DMEPOS Competitive Bidding Raising Concerns CVS Caremark's Mentoring Program Recruits and Retains R.Ph.s Antibiotic Resistance Among Community Pathogens Technology Update New Products Advertisers Index Classified Viewpoint

Drug Topics - May 12, 2008

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