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
ReviewEvidence-based pharmacologic management of pulmonary arterial hypertension.
Pulmonary arterial hypertension (PAH) is a debilitating chronic disorder of the pulmonary vasculature characterized by elevated mean pulmonary arterial pressure, right-sided heart failure, and early mortality. ⋯ Patients who respond to an acute trial of a vasodilator may be treated with an oral calcium channel blocker, whereas oral therapies such as sildenafil and bosentan have been effective in patients with mild to moderate symptoms. Infusions of the prostacyclin analogues epoprostenol and treprostinil appear to be the treatment of choice for moderate to severe PAH, and agents with alternate routes of delivery such as inhaled iloprost may be advantageous in adjunctive roles. Future trials that focus on the long-term effects of currently available agents, as well as on combination therapy, are needed.
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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
Comparative StudyCost-effectiveness analysis of bevacizumab combined with chemotherapy for the treatment of metastatic colorectal cancer in Japan.
Rapid progress has been made in the treatment of metastatic colorectal cancer (mCRC). New treatment regimens for mCRC include not only cytotoxic chemotherapy but also targeted monoclonal antibodies, including bevacizumab. However, bevacizumab is an expensive medication, which costs from 300,000 yen to 400,000 yen (US $2500-$3300) per month. ⋯ In this cost-effectiveness analysis in Japan, the ICERs of bevacizumab + FU/LV combination treatment, IFL, and second-line FOLFOX4 were high compared with other chemotherapies for mCRC. It remains difficult to assess first-line therapies comprising bevacizumab with oxaliplatin-based regimens, especially CAPOX. Further information is needed to assess cost-effectiveness.
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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).