Pharmacy & Therapeutics - January 2009 - (Page 30) MEETING HIGHLIGHTS American Heart Association 2008 Scientific Sessions United European Gastroenterology Week American College of Rheumatology Scientific Meeting Walter Alexander American Heart Association 2008 Scientific Sessions At the most recent AHA meeting, from November 8 to 12, 2008, in New Orleans, 1,600 presenters offered roughly 4,000 abstracts. Among the topics discussed were pharmacological agents designed to help prevent cardiovascular events and the optimal use of other agents when such events occur. This article reviews one late-breaking clinical trial on statin use in individuals with normal low-density lipoprotein-cholesterol (LDL-C) levels, two trials seeking to identify optimal therapy for acute coronary syndromes (ACS), and another session on early treatment in children with familial hypercholesterolemia. AHA Studies Show Benefits of Statins, Optimal Dosing for Acute Coronary Syndromes The TMACS Trial • Shamir R. Mehta, MD, McMaster University, Hamilton, Ontario, Canada “Most patients with ACS can be managed safely with either an early or a delayed invasive strategy,” suggested Dr. Mehta. An early invasive strategy, however, is best for those at high risk, he added. He presented results of TIMACS (TIMing of intervention in patients with Acute Coronary Syndromes), a clinical trial that included patients with unstable angina or non–ST-elevation myocardial infarction (NSTEMI) who met two of three criteria: age older than 60 years, ischemic electrocardiographic (ECG) changes or increased biomarkers, and suitability for revascularization. Patients received aspirin, clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis), and glycoprotein (GP IIb/IIIa) antagonists as per routine practice. They were randomly assigned to undergo an early invasive procedure (coronary angiography) as soon as possible and percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at or before 24 hours, or a delayed invasive procedure (angiography) at 36 hours or later, followed by PCI or CABG. Death, new MI, or stroke at six months was the primary outcome, occurring at rates of 9.7% for the early strategy and 11.4% for the delayed strategy (P = 0.15). The difference between strategies for the secondary outcome, adding refractory ischemia to the primar y outcome combination, however, significantly favored the early strategy (9.6% vs. 13.1%; P = 0.002). Looking separately at patients with low-risk or interMr. Alexander is a freelance medical writer living in New York City. mediate-risk scores from the Global Registry of Acute Coronary Events (GRACE) revealed little difference in the primary outcome in terms of the strategies (7.7% early, 6.7% delayed; P = 0.43); however, the difference favoring the early strategy was significant for the group with high GRACE risk scores (14.1% early vs. 21.6% delayed; P = 0.0097). There were no significant differences in major bleeding or other safety concerns between strategies. (The GRACE database tracks outcomes of patients with ACS, including MI and unstable angina.) For all but patients with the highest-risk scores, Dr. Mehta concluded: “The decision regarding timing of intervention can depend on other factors such as cath lab availability and economic considerations.” However, he underscored that an early invasive strategy had a large impact on refractory ischemia, reducing it by 70%. • Robert P. Giugliano, MD, Assistant Professor of Medicine, Brigham and Women’s Hospital, Boston, Mass. While calling the TIMACS conclusions “fair, ” Dr. Giugliano commented: “The results suggest you can perform angiography sooner or later, but there’s no reason not to do it early.” Dr. Giugliano is lead investigator for another ACS timing trial (Early ACS) for which preliminary results are expected in early 2009. Early ACS is comparing front-loaded administration with a GPIIb/IIIa inhibitor (eptifibatide [Integrilin, Millennium]) at initial presentation with administration concurrent with angiography or stenting. The 10,500-patient trial is the largest—and with GPIIb/IIIa inhibitors soon going off-patent, probably the last—to address this issue. Previous studies, he said, have had mixed results. 30 P&T® • January 2009 • Vol. 34 No. 1
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