Drug Topics - May 12, 2008 - (Page HSE8)

8 HSE DRUG TOPICS MAY 12, 2008 Clinical Practice years, 76.5% male, 80% with multivessel disease) undergoing PCIs (percutaneous coronary interventions). All patients were biomarker- (troponin T and CK-MB) negative with stable or unstable angina and had been treated with aspirin >325 mg and clopidogrel 600 mg for ≥ two hours before the procedure. “The hypothesis,” stated Adnan Kastrati, M.D., Deutsches Herzzentrum, Munich, Germany, “is that bivalirudin is superior to UFH for biomarker-negative patients undergoing PCI after optimal pretreatment with clopidogrel.” Participants received bivalirudin as an intravenous bolus at 0.75 mg/kg prior to PCI, followed by continuous IV infusion during the procedure at 1.75 mg/kg/hour. Patients in the UFH arm received UFH as an IV bolus of 140 units/kg followed by a continuous infusion of placebo for the duration of the procedure. All received clopidogrel at 75-150 mg/d until discharge or for the first three days after procedure, then 75 mg/d for at least six months and aspirin 80-325 mg indefinitely. The primary endpoint, a composite of death, myocardial infarction (MI), urgent target vessel revascularization (UTVR) and major bleeding (REPLACE-2 criteria, JAMA ’03), was assessed in terms of net clinical benefit at 30 days, a measure balancing clinical gains and adverse events. It occurred similarly for the two groups at a rate of 8.7% in the UFH group and at 8.3% in the bivalirudin group. Bleeding was higher in the UFH group than in the bivalirudin group. Kastrati commented at an ACC press conference that for some subgroups, for example, older patients, bleeding risk might make bivalirudin the better choice. Cost could make UFH the preferred agent overall, he said. In an interview, Marc Cohen, M.D., professor of medicine at Mt. Sinai School of Medicine in New York City, underscored the extra cost of bivalirudin compared with UFH (~$450-$500). He pointed out also that UFH bleeding rates in the trial were probably increased by the UFH dose, which was about double the U.S. starting dose. Despite the fact that heart failure (HF) patients are particularly vulnerable to development of venous thromboembolism (VTE) and its complications of pulmonary embolism and right ventricular failure, they receive VTE prophylaxis “at an unacceptably low rate,” according to Gregory Piazza, M.D., Harvard Medical School, Boston. Piazza compared 685 patients with HF histories with 3,890 patients without HF in a prospective registry of 5,451 consecutive patients with deep vein thrombosis (DVT) confirmed by ultrasound. Piazza found that HF patients were more likely than non-HF patients to have VTE risk factors of immobilization, acute infection, and chronic obstructive pulmonary disease. Fewer than 12 of patients with HF (46%) who subsequently developed DVT received any VTE prophylaxis. Prophylaxis rates were low among both HF inpatients developing unprovoked VTE and among those who developed VTE in the setting of trauma, surgery, or cancer. THE AUTHOR is a writer based in New York.

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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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