Clinical therapeutics
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Clinical therapeutics · Mar 2010
Randomized Controlled TrialPharmacokinetics of rosuvastatin in healthy Chinese volunteers living in China: a randomized, open-label, ascending single- and multiple-dose study.
Cross-study comparisons suggest that systemic exposure (AUC) to rosuvastatin calcium, a 3-hydroxy-3-methylglutaryl coenzyme A-reductase inhibitor, may be approximately 2-fold higher in Asian subjects living in Asian countries than in white subjects living in Western countries. ⋯ Increases in C(max), AUC(0-t), C(max,ss), and AUC(ss) were observed with increasing single and multiple doses of rosuvastatin 5, 10, and 20 mg. The increase in exposure with increasing doses was lower than would be expected under conditions of strict proportionality. Rosuvastatin exhibited little accumulation on repeated administration. All rosuvastatin doses were well tolerated in these Chinese subjects.
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Clinical therapeutics · Mar 2010
ReviewReview of the cardiovascular safety of zoledronic acid and other bisphosphonates for the treatment of osteoporosis.
In 2 large, randomized, placebocontrolled trials, yearly 5-mg infusions of the bisphosphonate zoledronic acid were associated with increased bone mineral density and reduced fracture incidence in patients with osteoporosis, previous fracture, or both. ⋯ Despite the greater incidence of AF SAEs among zoledronic acid recipients versus placebo recipients in one study (not observed in other trials of this agent), clinical data for zoledronic acid, risedronate, and alendronate indicate no significant differences from placebo in overall incidence of AF AEs.
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Clinical therapeutics · Mar 2010
Prediction of vancomycin pharmacodynamics in children with invasive methicillin-resistant Staphylococcus aureus infections: a Monte Carlo simulation.
Due to the emergence of community-associated strains, the prevalence of invasive methicillin-resistant Staphylococcus aureus (MRSA) infections has increased substantially in pediatric patients. A vancomycin AUC(0-24)/MIC index >400 best predicts treatment outcomes for invasive MRSA infection in adults. Data on whether recommended vancomycin doses in children achieve this break point are lacking. ⋯ Recommended empiric vancomycin dosing in children (40 mg/kg/d) was not predicted to consistently achieve the pharmacodynamic target of AUC(0-24)/MIC >400 for invasive MRSA infections. A vancomycin dosage of 60 mg/kg/d was predicted to optimize achievement of this target in children.
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Clinical therapeutics · Mar 2010
Randomized Controlled Trial Comparative StudyPharmacokinetics and bioequivalence study of three oral formulations of valsartan 160 mg: a single-dose, randomized, open-label, three-period crossover comparison in healthy Indian male volunteers.
Valsartan is a selective angiotensin II type 1 receptor blocker indicated for the treatment of hypertension. Although the bioavailability and pharmacokinetic properties of valsartan have been well characterized, a literature search did not identify any reports concerning the bioavailability of valsartan in the Indian population. ⋯ In this single-dose study in a small sample of healthy Indian male subjects, test formulation B of valsartan 160 mg was considered bioequivalent to the reference formulation as per predetermined regulatory criteria, whereas test formulation A was not. All 3 formulations were well tolerated.
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Clinical therapeutics · Mar 2010
Review Case ReportsAnaphylactoid reaction considered ciprofloxacin related: a case report and literature review.
Although ciprofloxacin is a generally well-tolerated fluoroquinolone antibiotic, serious and life-threatening adverse events such as anaphylaxis and pulmonary edema have been described with its use. However, there is a lack of data in the scientific literature regarding these events. ⋯ The patient described in this case report experienced an anaphylactoid reaction likely associated with ciprofloxacin use. Although anaphylactoid/ anaphylactic reactions are uncommon (<5% of cases) adverse events associated with ciprofloxacin and other fluoroquinolones, clinicians should be aware of this potentially life-threatening event, which might also lead to pulmonary edema even in the setting of normal renal function.