Clinical therapeutics
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Clinical therapeutics · Apr 2013
Randomized Controlled Trial Comparative StudyComparative pharmacokinetic, pharmacodynamic, safety, and tolerability profiles of 3 different formulations of epoprostenol sodium for injection in healthy men.
Epoprostenol sodium for injection is approved for the treatment of severe cases of primary pulmonary arterial hypertension. Currently, there are 3 approved formulations of this drug containing the same active ingredient (epoprostenol sodium) but differing with regard to excipients. When compared with epoprostenol sodium formulated with glycine-mannitol (epoprostenol GM), 2 new formulations of epoprostenol sodium, one formulated with arginine-mannitol (epoprostenol AM) and one formulated with arginine-sucrose (epoprostenol AS), have improved stability after reconstitution and dilution. The biocomparability of epoprostenol AM and epoprostenol GM, with regard to pharmacokinetic (PK), pharmacodynamic (PD), safety, and tolerability profiles, has been shown previously. ⋯ Overall, the PK, PD, safety, and tolerability profiles of the 3 formulations of epoprostenol sodium for injection are comparable and meet the criteria of bioequivalence. Australian New Zealand Clinical Trials Registry identifier: ACTRN12612001086853.
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Clinical therapeutics · Apr 2013
ReviewEffect of azithromycin on anticoagulation-related outcomes in geriatric patients receiving warfarin.
Warfarin is known to have multiple pharmacokinetic and pharmacodynamic interactions. Of the macrolide family, erythromycin and clarithromycin have been shown to interact with warfarin, leading to an elevated international normalized ratio (INR). The incidence of overanticoagulation in patients prescribed azithromycin stabilized on a warfarin regimen is controversial. ⋯ The addition of azithromycin to a stable warfarin regimen resulted in a significant change in the INR and warfarin dosage alteration without an increase in bleeding.
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Clinical therapeutics · Apr 2013
Randomized Controlled Trial Comparative StudyComparison of the efficacy and safety of dual-opioid treatment with morphine plus oxycodone versus oxycodone/acetaminophen for moderate to severe acute pain after total knee arthroplasty.
In acute pain models, coadministration of low doses of morphine and oxycodone markedly enhanced analgesia relative to either opioid given alone. Enhanced analgesia with coadministration of morphine and oxycodone has also been reported in acute and chronic moderate to severe pain conditions during double-blind studies. ⋯ Flexible dose morphine/oxycodone was superior to low-dose morphine/oxycodone and comparable to oxycodone/acetaminophen. Flexible dose morphine/oxycodone-treated patients had a lower rate of moderate to severe nausea or vomiting than equianalgesic oxycodone/acetaminophen-treated patients. Thus, morphine/oxycodone offers an attractive alternative to oxycodone/acetaminophen for the management of moderate to severe postoperative pain.