Clinical therapeutics
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Clinical therapeutics · Dec 2010
ReviewAntiplatelet therapy after placement of a drug-eluting stent: a review of efficacy and safety studies.
Dual antiplatelet therapy with a thienopyridine (ticlopidine or clopidogrel) and aspirin is used to reduce the risk of late stent thrombosis and complications (myocardial infarction [MI] and death) after placement of a drug-eluting stent (DES). ⋯ The combination of clopidogrel (loading dose, 300-600 mg; maintenance dose, 75 mg/d) and low-dose aspirin (75-162 mg/d) for 12 months is the preferred regimen for the prevention of stent thrombosis and cardiac complications after DES placement. The combination of prasugrel and aspirin may be appropriate in patients with ACS, although it was associated with a significantly increased risk for bleeding. Triple antiplatelet therapy may be beneficial in certain high-risk patients.
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Clinical therapeutics · Dec 2010
Randomized Controlled TrialEfficacy of standard doses of Ibuprofen alone, alternating, and combined with acetaminophen for the treatment of febrile children.
Many pediatricians recommend, and many parents administer, alternating or combined doses of ibuprofen and acetaminophen for fever. Limited data support this practice with standard US doses. ⋯ During a single 6-hour observation period for these participating children, combined and alternating doses of ibuprofen and acetaminophen provided greater antipyresis than ibuprofen alone at 4 to 6 hours. ClinicalTrials.gov identifier: NCT00267293.
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Clinical therapeutics · Dec 2010
Randomized Controlled TrialA phase III, randomized, open-label study to assess the tolerability and immunogenicity of an H5N1 influenza vaccine administered to healthy adults with a 1-, 2-, 3-, or 6-week interval between first and second doses.
Preparedness for an H5N1 influenza pre-pandemic requires effective and well-tolerated emergency vaccination strategies that provide both pandemic strain-specific and heterologous protection. ⋯ Two 7.5-μg doses of MF59-adjuvanted H5N1 influenza vaccine given 2, 3, or 6 weeks apart afforded H5N1-specific immunity and met the CHMP licensure criterion for seroprotection in these healthy volunteers. Clinically relevant levels of heterologous immunity were observed when the 2 doses of vaccine were administered either 2 or 3 weeks apart; however, the licensure criterion for seroprotection was not met in this case.
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Clinical therapeutics · Dec 2010
Tolerability and outcomes of kinetically guided therapy with gentamicin in critically ill neonates during the first week of life: an open-label, prospective study.
Aminoglycosides are bactericidal antibiotics used worldwide for the treatment of serious infections in critically ill patients, including neonates. Critically ill neonates constitute a unique challenge in dosing owing to the pathologic alterations that accompany severe illness and the rapidly changing conditions of these patients. ⋯ The initial dose of gentamicin 4 mg/kg for these critically ill premature and mature neonates with sepsis during the first week of life was high enough to reach bactericidal C(max,1) within 6-10 mg/L. C(max,1) <6 mg/L occurred in 13% of neonates. The interdose interval modified according to the recommendation resulted in C(trough) values within the target range of 0.5-2.0 mg/L in all but 2 neonates. The kinetically guided maintenance dosing of gentamicin based on plasma concentrations after the first dose should be optimized, taking into account actual body weight. (EudraCT number: 2005-002723-13).
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Clinical therapeutics · Dec 2010
Economic analysis of decitabine versus best supportive care in the treatment of intermediate- and high-risk myelodysplastic syndromes from a US payer perspective.
Myelodysplastic syndromes (MDS) are blood and bone marrow disorders that occur primarily in the elderly population, with 30% of all cases progressing to acute myeloid leukemia (AML). Red blood cell transfusions--a conventional treatment of MDS--have been associated with high costs and decreased quality of life compared with transfusion independence. Phase III clinical trial data suggest that decitabine may offer an improved AML-free survival versus best supportive care (BSC), which consists of red blood cell transfusions, deferoxamine, erythropoiesis-stimulating agents, platelet transfusions, and colony-stimulating factors. The US Food and Drug Administration has approved a 5-day outpatient decitabine dosing regimen, which might reduce administration costs compared with the standard 3-day inpatient regimen. ⋯ In this study, decitabine administered on a 5-day dosing schedule was likely a cost-effective treatment option in patients with intermediate- and high-risk MDS from a US payer perspective.