Pharmacotherapy
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In a large phase III study of patients with unstable angina treated with percutaneous transluminal coronary angioplasty (PTCA), the thrombin-specific anticoagulant bivalirudin produced relative risk reductions of 22% (p = 0.039) for ischemic complications and 62% (p < 0.001) for bleeding complications compared with heparin. Subsequent reports have shown that between-treatment differences favoring fewer complications with bivalirudin also extend to high-risk patients. Early heparinization promotes heparin resistance and decreases activated clotting time achieved during PTCA. ⋯ An ongoing trial is aimed at determining the efficacy and safety of heparin with planned glycoprotein IIb/IIIa therapy versus bivalirudin with provisional glycoprotein IIb/IIIa therapy. The use of bivalirudin in patients with heparin-induced thrombocytopenia also is being evaluated after favorable findings in early compassionate-use studies. The fact that between-treatment differences favoring bivalirudin were especially outstanding among the high-risk patients considered in this review reinforces the impression that bivalirudin is a promising and unprecedented alternative to heparin in PCI.
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Comparative Study Clinical Trial
Point-of-care versus laboratory monitoring of patients receiving different anticoagulant therapies.
To compare point-of-care and standard hospital laboratory assays for monitoring patients receiving single or combination anticoagulant regimens. ⋯ Point-of-care methods showed limited agreement with standard hospital laboratory assays of coagulation for all treatment groups. For INR values, significantly greater disagreement was noted between the assay methods for the warfarin plus heparin group compared with the warfarin group, but the agreement was similar for the warfarin and warfarin plus enoxaparin groups. Our data indicate that the point-of-care assays should not be considered interchangeable with standard laboratory assays.
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Recent attention has been called to the interpretation of studies of antiinfective agents demonstrating effects on the QTc interval. It seems that the effects of many of these agents on the QTc interval are small, but in some patient populations, these drugs may cause morbidity and mortality related to TdP. It would be beneficial to researchers and clinicians alike for the FDA to standardize the types of studies designed to assess the QTc interval prolongation potential of a drug, methodologies, and interpretation criteria. ⋯ One message that must not be lost in this discussion over the use of this reporting system to calculate incidences to incriminate certain agents is its overall importance, over time, in assisting governing bodies and clinicians alike in identifying compounds that may place certain patient populations at risk. It is imperative that clinicians not only submit adverse event reports to the FDA, but provide complete and accurate information. For moxifloxacin, levofloxacin, and gatifloxacin, the point must be clear that these agents should not be used in patients with risk factors predisposing them to TdP.
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Randomized Controlled Trial Clinical Trial
Pharmacokinetic and pharmacodynamic evaluation of two dosing regimens for piperacillin-tazobactam.
To compare the pharmacokinetic and pharmacodynamic profiles of two dosing regimens for piperacillin-tazobactam against commonly encountered pathogens. The regimens compared were piperacillin 4.0 g-tazobactam 0.5 g administered every 8 hours, and piperacillin 3.0 g-tazobactam 0.375 g administered every 6 hours. ⋯ Although statistically significant differences in the pharmacodynamic profile were noted for the regimens, both provide adequate T>MIC against commonly encountered pathogens considered susceptible to piperacillin-tazobactam. However, for treatment of Pseudomonas aeruginosa infection, combination therapy or higher-dosage regimens (e.g., piperacillin 3.0 g-tazobactam 0.375 g every 4 hours, piperacillin 4.0 g-tazobactam 0.5 g every 6 hours, or continuous-infusion piperacillin 12 g-tazobactam 1.5 g/day) may be a prudent option when full MIC data are unavailable.
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To review our experience with etomidate in nonintubated patients in the emergency department. ⋯ Although controversial, etomidate holds promise as a potent sedative agent for patients undergoing painful procedures in the emergency department. A large prospective evaluation is needed to document the performance and complications of this agent.