Int J Clin Pharm Th
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Int J Clin Pharm Th · Aug 2008
Randomized Controlled TrialThe hemodynamic and pharmacokinetic interactions between chronic use of oral levosimendan and digoxin in patients with NYHA Classes II-III heart failure.
Levosimendan is a calcium-sensitizing drug for the treatment of heart failure. The aim of this exploratory study was to assess the hemodynamic and pharmacokinetic interactions between digoxin and oral levosimendan as well as the proarrhythmic potential of this combination in patients with chronic heart failure. ⋯ The addition of oral levosimendan to digoxin therapy produced only a modest statistically nonsignificant additive inotropic effect. In contrast to the earlier data with intravenous levosimendan, the results indicate a pharmacokinetic interaction between levosimendan and digoxin. Data obtained from repolarization analyses and ambulatory ECG did not indicate any possible proarrhythmic effects of the combination.
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Int J Clin Pharm Th · Jun 2008
Randomized Controlled TrialTolerability, pharmacokinetics and pharmacodynamics of the once-daily human GLP-1 analog liraglutide in Japanese healthy subjects: a randomized, double-blind, placebo-controlled dose-escalation study.
Liraglutide is a once-daily human GLP-1 analog being developed as a Type 2 diabetes therapy. A dose-finding study in Japanese patients with Type 2 diabetes showed liraglutide to produce dose-dependent decreases in HbA(1C). Studies have also shown that, with stepped dose titration, liraglutide is well tolerated. This double-blind trial in 24 healthy Japanese men assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of once-daily subcutaneous (s.c.) liraglutide using doses exceeding those previously studied, and using the stepped titration approach. ⋯ Liraglutide appears to be well tolerated at doses of up to 25 microg/kg in Japanese subjects. Despite clear pharmacodynamic effects in this euglycemic cohort, a low risk for hypoglycemia was suggested together with good gastrointestinal tolerability.
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Int J Clin Pharm Th · Jun 2007
Randomized Controlled Trial Comparative StudyAssessment of the safety, tolerability, and PK/PD properties of two new formulations of subcutaneously administered IFN-beta1a: a double-blind, placebo-controlled comparison with the currently available formulation.
Application-site disorders are well-known adverse events (AEs) associated with subcutaneous (s.c.) injection. With high-dose, high-frequency interferon (IFN)-beta1a (Rebif) these AEs are generally mild but may lead to the discontinuation of some patients. The objective of this study was to compare the safety, tolerability, and the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of two new formulations of Rebif (Rebif New Formulation: RNF1 and RNF2) with the current formulation (hereafter referred to as R) and placebo. ⋯ The results from this study suggest that RNF2 may offer improved tolerability compared with the current formulation of R, but retains comparable pharmacokinetic and pharmacodynamic characteristics.
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Int J Clin Pharm Th · May 2007
Randomized Controlled TrialKetorolac as a pre-emptive analgesic in retinal detachment surgery: a prospective, randomized clinical trial.
Retinal detachment surgery is associated with a high incidence of post-operative pain, nausea and vomiting. Previous studies demonstrated a beneficial role of pre-emptive analgesia using regional anesthetic blocks for this type of surgery. The aim of the present study was to evaluate the pre-emptive analgesic effect of ketorolac in patients undergoing retinal detachment surgery under general anesthesia. ⋯ The use of ketorolac for pre-emptive analgesia is effective in patients undergoing retinal detachment surgery under general anesthesia.
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Int J Clin Pharm Th · Apr 2007
Randomized Controlled Trial Comparative StudyAntipyretic efficacy and safety of a single intravenous administration of 15 mg/kg paracetamol versus 30 mg/kg propacetamol in children with acute fever due to infection.
An intravenous formulation of paracetamol and an intravenous formulation of propacetamol (prodrug of paracetamol) were compared in children with acute fever due to infection in order to determine the antipyretic efficacy and safety during the 6-hour period after administration. ⋯ This double-blind, randomized, clinical trial demonstrates the non-inferiority of a single administration of 15 mg/kg intravenous paracetamol in comparison to 30 mg/kg propacetamol in terms of body temperature reduction in children aged 1 month to 12 years with acute fever due to infection. It confirms the better local safety of intravenous paracetamol in comparison to propacetamol.