Clinical therapeutics
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Clinical therapeutics · Sep 2009
Randomized Controlled Trial Multicenter Study Comparative StudyA multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain.
Although opioids are the mainstay of inpatient postoperative pain management, they do not block inflammation. The NSAID ibuprofen has antiinflammatory and analgesic properties, and a multimodal approach may reduce opioid requirements. ⋯ In these patients undergoing postoperative pain management, ibuprofen 800 mg IV q6h was associated with significant reductions in morphine use and pain at rest and with movement compared with placebo. Ibuprofen IV was not associated with significant increases in AEs compared with placebo, with the exception of dizziness with the 800-mg dose. These findings suggest that ibuprofen 800 mg IV q6h was effective for postoperative pain management and was generally well tolerated. ClinicalTrials.gov identifier: NCT00225732.
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Clinical therapeutics · Sep 2009
Comparative StudyEfficacy and tolerability of nebivolol monotherapy by baseline systolic blood pressure: a retrospective analysis of pooled data from two multicenter, 12-week, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging studies in patients with mild to moderate essential hypertension.
In clinical studies, nebivolol at doses of 2.5 to 40 mg once daily was associated with significant decreases in systolic blood pressure (SBP) and diastolic BP (DBP) in patients with hypertension and was well tolerated. ⋯ The present analysis of pooled data from 2 previously published registration studies found that nebivolol was associated with significant reductions in BP compared with placebo in these patients with stage 1 or 2 hypertension, with a tolerability similar to that of placebo.
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Clinical therapeutics · Sep 2009
Prediction of abstinence at 10 weeks based on smoking status at 2 weeks during a quit attempt: secondary analysis of two parallel, 10-week, randomized, double-blind, placebo-controlled clinical trials of 21-mg nicotine patch in adult smokers.
Smoking cessation outcomes are calculated as the probability of abstinence at follow-up among all enrolled smokers, but it is also useful to estimate the probability of success for those who experienced success or failure at earlier time points. ⋯ More than two thirds (71.3%) of subjects who were abstinent 2 weeks into a quit attempt maintained that abstinence through the end of 10 weeks of treatment. Use of a nicotine patch was significantly associated with maintaining abstinence and with recovering abstinence after an early lapse.
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Clinical therapeutics · Sep 2009
Randomized Controlled Trial Comparative StudyResults of a single-center, single-dose, randomized-sequence, open-label, two-way crossover bioequivalence study of two formulations of valsartan 160-mg tablets in healthy volunteers under fasting conditions.
Valsartan is a nonpeptide, orally active angiotensin II type 1 receptor blocker used to treat hypertension alone or in combination with other antihypertensive agents. ⋯ In this open-label study of healthy volunteers, the test and reference formulations of valsartan 160 mg met the European regulatory definition of bioequivalence, based on the rate and extent of absorption of a single dose under fasting conditions. Both formulations were well tolerated.
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Clinical therapeutics · Sep 2009
Randomized Controlled Trial Comparative StudyA single-dose, three-period, six-sequence crossover study comparing the bioavailability of solution, suspension, and enteric-coated tablets of magnesium valproate in healthy Mexican volunteers under fasting conditions.
Valproic acid has been associated with a highly variable intersubject absorptive phase; therefore, magnesium salt (magnesium valproate [MgV]) was developed to diminish variation during enteric absorption. ⋯ This single-dose study found that the 3 formulations (solution, suspension, and enteric-coated tablets) of MgV met the regulatory criteria for bioequivalence in these healthy, fasting, Mexican volunteers.