Clinical therapeutics
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Clinical therapeutics · Mar 2008
Randomized Controlled Trial Multicenter StudyPharmacokinetic, pharmacodynamic, and tolerability profiles of the dipeptidyl peptidase-4 inhibitor alogliptin: a randomized, double-blind, placebo-controlled, multiple-dose study in adult patients with type 2 diabetes.
Alogliptin is a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor that is under development for the treatment of type 2 diabetes (T2D). ⋯ In these adult patients with T2D, alogliptin inhibited plasma DPP-4 activity and significantly decreased PPG levels. The PK and PD profiles of multiple doses of alogliptin in this study supported use of a once-daily dosing regimen. Alogliptin was generally well tolerated, with no dose-limiting toxicity.
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Clinical therapeutics · Feb 2008
Randomized Controlled Trial Multicenter StudyValidity, reliability, and responsiveness of the work productivity and activity impairment questionnaire in Crohn's disease.
Crohn's disease (CD) is a chronic inflammatory bowel disease usually diagnosed in early adult life and characterized by unpredictable flares and debilitating symptoms such as diarrhea, abdominal pain, and fever, which can interfere with a patient's ability to work and perform daily activities. ⋯ The discriminative validity, reliability, and responsiveness of the WPAI:CD were demonstrated. The WPAI:CD may be useful for evaluating drug impact on CD.
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Clinical therapeutics · Jan 2008
Randomized Controlled Trial Multicenter Study Comparative StudyComparison of levalbuterol and racemic albuterol in hospitalized patients with acute asthma or COPD: a 2-week, multicenter, randomized, open-label study.
The National Heart, Lung, and Blood Institute guideline recommends that dosing racemic albuterol be administered every 1 to 4 hours for treating patients with asthma or chronic obstructive pulmonary disease (COPD) in the hospital. Previously published preliminary and retrospective studies suggested that levalbuterol can be administered every 8 hours for the treatment of bronchoconstriction in hospitalized patients. However, it is unclear how the different dosing regimens affect the total number of nebulizations (scheduled plus as-needed treatments) and the costs of treatment of bronchoconstriction in a hospital setting. Moreover, it is not clear how the different dosing regimens affect symptom outcomes and health status in hospitalized patients with asthma or COPD. ⋯ In these hospitalized patients with acute asthma or COPD treated with levalbuterol every 6 to 8 hours or racemic albuterol every 1 to 4 hours, significantly fewer total nebulizations were required with levalbuterol, without an increased need for rescue nebulizations during 14 days of hospitalization. Both treatments were associated with improvements from baseline in symptoms and health status. The costs of treating bronchoconstriction in hospitalized patients were similar between the levalbuterol and racemic albuterol groups.
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Clinical therapeutics · Jan 2008
Randomized Controlled Trial Multicenter StudyAnalgesic effectiveness of celecoxib and diclofenac in patients with osteoarthritis of the hip requiring joint replacement surgery: a 12-week, multicenter, randomized, double-blind, parallel-group, double-dummy, noninferiority study.
The hip is the second most common large joint that is affected by osteoarthritis (OA), with prevalence ranging from 3% to 11% in patients aged > or = 35 years. OA is often associated with significant pain, disability, and impaired quality of life. Treatment should be tailored according to the level of pain, disability, and handicap. Pharmacologic treatment options for hip OA include acetaminophen (recommended by the European League Against Rheumatism as a first-line treatment), NSAIDs such as diclofenac, and cyclooxygenase-2-selective NSAIDs such as celecoxib. ⋯ This study did not demonstrate noninferiority of celecoxib 200 mg QD to diclofenac 50 mg TID in treating arthritis pain in patients with OA of the hip requiring joint replacement.
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Clinical therapeutics · Nov 2007
Randomized Controlled Trial Multicenter StudyEfficacy and tolerability of escitalopram versus citalopram in major depressive disorder: a 6-week, multicenter, prospective, randomized, double-blind, active-controlled study in adult outpatients.
The S-enantiomer of citalopram (escitalopram) is the active moiety linked to the anti-depressant effects associated with citalopram (the racemate). For escitalopram to be approved for the treatment of depression in Europe, findings from clinical trials of escitalopram are required to match previous results from studies of the racemate, citalopram. ⋯ The results from this study suggest that escitalopram 10 mg was more effective than citalopram 10 and 20 mg at 6 weeks in these adult outpatients with MDD. All treatments were well tolerated.