Clinical therapeutics
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Clinical therapeutics · Oct 2007
Randomized Controlled Trial Multicenter StudyBuprenorphine transdermal delivery system in adults with persistent noncancer-related pain syndromes who require opioid therapy: a multicenter, 5-week run-in and randomized, double-blind maintenance-of-analgesia study.
This study compared the efficacy and safety profile of buprenorphine transdermal delivery system (BTDS) and placebo in subjects with persistent noncancer-related pain who required opioid analgesics. ⋯ In this population of adult subjects with persistent noncancer-related pain who required opioid therapy, BTDS use was associated with analgesic efficacy and was generally well tolerated. Results of this study were presented in part at the annual meeting of the American Pain Society, March 30-April 2, 2005, Boston, Massachusetts.
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Clinical therapeutics · Oct 2007
Randomized Controlled Trial Clinical TrialPharmacokinetic properties of rosuvastatin after single-dose, oral administration in Chinese volunteers: a randomized, open-label, three-way crossover study.
Rosuvastatin, a 3-hydroxy-3-methyl glutaryl coenzyme A reductase inhibitor ("statin"), has been marketed for the treatment of patients with dyslipidemia. ⋯ The PK properties of rosuvastatin are based on first-order kinetics in the dose range tested. In this small, selected group of healthy Chinese volunteers, no clinically significant differences in PK properties between doses or sexes were found. The absorption of rosuvastatin was significantly decreased in the fed state compared with the fasting state, which suggests that rosuvastatin should be administered on an empty stomach. All rosuvastatin doses tested were well tolerated.
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Clinical therapeutics · Oct 2007
Randomized Controlled Trial Multicenter StudyIdentification and pretherapy susceptibility of pathogens in patients with complicated urinary tract infection or acute pyelonephritis enrolled in a clinical study in the United States from November 2004 through April 2006.
The purpose of this study was to assess the pretherapy microbiology and fluoroquinolone susceptibility of pathogens from 650 patients with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP) as part of a multicenter, randomized, controlled clinical trial. ⋯ In this study, the level of fluoroquinolone susceptibility of urinary pathogens was high (90.6% in cUTI; 98.1% in AP).
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Clinical therapeutics · Oct 2007
Randomized Controlled Trial Multicenter StudyCardiac safety profile of nebulized formoterol in adults with COPD: a 12-week, multicenter, randomized, double- blind, double-dummy, placebo- and active-controlled trial.
Recently, there have been concerns about the tolerability of long-acting (2)-agonists, including possible adverse cardiovascular effects-a particular concern in patients with chronic obstructive pulmonary disease (COPD), who are at elevated risk for cardiovascular disease. ⋯ In this COPD population, no clinically significant cardiac effects were found with twicedaily treatment with nebulized formoterol fumarate inhalation solution.
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Clinical therapeutics · Oct 2007
Randomized Controlled TrialEfficacy of multivitamin supplementation containing vitamins B6 and B12 and folic acid as adjunctive treatment with a cholinesterase inhibitor in Alzheimer's disease: a 26-week, randomized, double-blind, placebo-controlled study in Taiwanese patients.
Elevated serum homocysteine levels have been associated with the development of Alzheimer's dementia (AD). The combined use of a mecobalamin capsule preparation, which contains vitamin B12 0.5 mg with an active methyl base, and an over-the-counter nutritional supplement that contains folic acid 1 mg and pyridoxine hyperchloride 5 mg may be effective as a homocysteine-lowering vitamin regimen. ⋯ In this population of patients with mild to moderate AD in Taiwan, a multivitamin supplement containing vitamins B(6) and B(12) and folic acid for 26 weeks decreased homocysteine concentrations. No statistically significant beneficial effects on cognition or ADL function were found between multivitamin and placebo at 26 weeks.