British journal of clinical pharmacology
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Br J Clin Pharmacol · Dec 2007
Randomized Controlled Trial Comparative StudyEffect of dronedarone on renal function in healthy subjects.
To assess the effects of dronedarone on renal function and tubular cation handling. ⋯ Dronedarone reduces renal creatinine and NMN clearance by about 18%, without evidence of an effect on GFR, renal plasma flow or electrolyte exchanges. This suggests a specific partial inhibition of tubular organic cation transporters (OCT). A limited increase in serum creatinine is therefore expected with dronedarone treatment, but does not mean there is a decline in renal function.
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Br J Clin Pharmacol · Dec 2007
Comparative StudyAbsence of tolerance and toxicity to high-dose continuous intravenous furosemide in haemodynamically unstable infants after cardiac surgery.
To evaluate a high-dose continuous furosemide regimen in infants after cardiac surgery. ⋯ High-dose continuous furosemide infusion for 72 h in haemodynamically unstable infants after cardiac surgery appears to be a safe and effective treatment for volume overload. Development of tolerance against the effects of furosemide and ototoxic furosemide concentrations were not observed.
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Br J Clin Pharmacol · Nov 2007
Effective dose of nefopam in 80% of patients (ED80): a study using the continual reassessment method.
The effective dose in 50% of patients (ED(50)) is far from being relevant for clinical purposes. We used the continual reassessment method (CRM) to determine the effective dose of nefopam in 80% of the patients suffering from moderate pain in the postoperative period (ED(80)). ⋯ The ED(80) of nefopam, close to 60 mg is higher than the usual dose of 20 mg. The CRM allowed us to determine the ED(80) of nefopam with reasonable accuracy in a small number of patients as compared with the classical dose-probability curve fitting. We did not observe an increased incidence of side-effects when compared with the literature or to our previous studies.
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Br J Clin Pharmacol · Sep 2007
Randomized Controlled TrialThe pharmacokinetics, pharmacodynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects.
The novel direct thrombin inhibitor (DTI), dabigatran etexilate (Boehringer Ingelheim Pharma GmbH & Co. KG), shows potential as an oral antithrombotic agent. Two double-blind, randomized trials were undertaken to investigate the pharmacokinetics (PK), pharmacodynamics (PD) and tolerability of orally administered dabigatran etexilate in healthy male subjects. ⋯ These data suggest that dabigatran etexilate is a promising novel oral DTI with predictable PK and PD characteristics and good tolerability. Further investigation of dabigatran etexilate for the treatment and prophylaxis of patients with arterial and venous thromboembolic disorders, acute coronary syndromes and other medical conditions is warranted.