Clinical therapeutics
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Clinical therapeutics · Oct 2004
Randomized Controlled Trial Multicenter Study Clinical TrialEfficacy, tolerability, and effect on asthma-related quality of life of formoterol bid via multidose dry powder inhaler and albuterol QID via metered dose inhaler in patients with persistent asthma: a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study.
Inhaled beta(2)-agonists are widely used in asthma treatment. The design limitations of pressurized metered dose inhalers (pMDIs) have prompted the development of dry powder inhalers (DPIs) for the delivery of asthma medications. ⋯ In this study of adolescents and adults with persistent asthma, 12 weeks of treatment with formoterol 10 microg BID delivered via a multidose DPI provided significantly greater 24-hour bronchodilation compared with albuterol and placebo and resulted in significant improvements in asthma-related QOL compared with placebo. Formoterol was well tolerated in these patients.
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Clinical therapeutics · Aug 2004
Randomized Controlled Trial Multicenter Study Clinical TrialEffects of valdecoxib in the treatment of chronic low back pain: results of a randomized, placebo-controlled trial.
Valdecoxib, a cyclooxygenase (COX)-2 specific inhibitor, is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and primary dysmenorrhea. Therapeutic doses of COX-2 specific inhibitors are as effective as nonspecific nonsteroidal anti-inflammatory drugs in reducing inflammatory pain while sparing the gastrointestinal and platelet toxicity associated with nonspecific COX-1 inhibition. ⋯ In this study of patients with chronic low back pain, valdecoxib 40 mg/d provided rapid relief (within 1 week) and consistent relief (over 4 weeks). In addition, significant improvement in function and decreased disability were found with valdecoxib compared with placebo.
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Clinical therapeutics · Aug 2004
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialComparison of topical tobramycin-dexamethasone with dexamethasone-neomycin-polymyxin and neomycin-polymyxin-gramicidin for control of inflammation after cataract surgery: results of a multicenter, prospective, three-arm, randomized, double-masked, controlled, parallel-group study.
Intraocular inflammation is typically treated with a combination of anti-inflammatory and anti-infective drugs. Tobramycin-dexamethasone (TD) has not been associated with any serious adverse events, indicating good tolerability. ⋯ In this study of patients undergoing cataract surgery combination therapy with TD was noninferior to DNP and was well tolerated.
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Clinical therapeutics · Aug 2004
Randomized Controlled Trial Multicenter Study Clinical TrialDose-ranging analgesic study of Prosorb diclofenac potassium in postsurgical dental pain.
ProSorb diclofenac potassium (K) is a novel, liquid-filled rapid-dispersion formulation of the nonsteroidal anti-inflammatory drug diclofenac, placed into soft gelatin capsules. Its time to maximal plasma drug concentration has been shown to be approximately half, and its maximal plasma drug concentration nearly twice, that of immediate-release diclofenac K tablets. ⋯ In this study of patients treated for pain following dental impaction surgery, single doses of ProSorb diclofenac K 25, 50, and 100 mg were more efficacious than placebo with respect to reduction of pain. All 3 doses provided a rapid analgesic onset and were well tolerated.
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Clinical therapeutics · Jul 2004
Randomized Controlled Trial Multicenter Study Clinical TrialEvaluation of a low-dose lidocaine iontophoresis system for topical anesthesia in adults and children: a randomized, controlled trial.
Commonly used classes of topical anesthetics require 30 to 60 minutes to provide effective anesthesia. A new low-dose lidocaine iontophoresis system (LDLIS) may provide topical anesthesia in 10 minutes at a lower dose than previous systems, thereby limiting adverse events. ⋯ In this study of adults and children, the LDLIS provided effective topical anesthesia for venipuncture and venous cannulation within 10 minutes.