Clinical therapeutics
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Clinical therapeutics · Apr 2007
Randomized Controlled Trial Comparative StudyRelative bioavailability of tizanidine 4-mg capsule and tablet formulations after a standardized high-fat meal: a single-dose, randomized, open-label, crossover study in healthy subjects.
An immediate-release, multiparticulate capsule formulation of tizanidine has been developed to modify tizanidine pharmacokinetic characteristics in an attempt to decrease adverse events (AEs) while maintaining effectiveness in the management of spasticity. ⋯ In this small study in healthy volunteers, after a single oral dose was administered following a high-fat meal, the mean C(max) was significantly lower and mean T(max) was significantly longer with the capsule formulation of tizanidine compared with the tablet. The capsule formulation was found not to be bioequivalent to the tablet when given with food. Based on these findings, caution is needed when a patient is switched between the capsule and tablet formulations of tizanidine, or when the timing of administration of either formulation is changed in relation to food ingestion.
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Clinical therapeutics · Apr 2007
Randomized Controlled TrialA phase I, randomized, open-label, crossover study of the single-dose pharmacokinetic properties of guanfacine extended-release 1-, 2-, and 4-mg tablets in healthy adults.
Guanfacine is an alpha(2)-adrenoreceptor agonist used to treat children and adults with attention-deficit/hyperactivity disorder. An extended-release formulation of guanfacine is currently under development. ⋯ In these 49 healthy adult subjects, the single-dose pharmacokinetic properties of GXR 1-, 2-, and 4-mg tablets appeared to be statistically linear; that is, increases in mean C(max), AUC(0-t), and AUC(0-infinity) of guanfacine were proportional to dose, with the exception of the increase in mean C(max) between GXR 1 and 2 mg. All doses appeared to be well tolerated, with no serious AEs or withdrawal or discontinuation from study participation due to AEs reported.
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Clinical therapeutics · Apr 2007
Prevalence and treatment of dyslipidemia in Canadian primary care: a retrospective cohort analysis.
Dyslipidemia is an important modifiable risk factor for cardiovascular disease (CVD). Studies suggest that dyslipidemia is underdiagnosed and undertreated in Canada. ⋯ Based on the results of this retrospective cohort analysis, dyslipidemia prevalence in Canadian primary care is high, and despite clinical evidence and treatment guidelines, dyslipidemia is largely untreated in family practice, suggesting a gap in care.
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Clinical therapeutics · Apr 2007
Antipsychotic use at adult ambulatory care visits by patients with mental health disorders in the United States, 1996-2003: national estimates and associated factors.
This retrospective analysis was conducted to derive national estimates of typical, atypical, and combination (typical-atypical) antipsychotic use and to examine factors associated with their use at adult (age >-18 years) ambulatory care visits by patients with mental health disorders in the United States. ⋯ This retrospective analysis found more atypical than typical or combination antipsychotic use at US ambulatory care visits by adults with mental health disorders other than schizophrenia or psychoses in the period studied. Atypical versus typical antipsychotic use was significantly less likely at visits by adults aged 41 to 64 years and those with public insurance, but significantly more likely at visits by those with depression or bipolar disorder.
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Clinical therapeutics · Mar 2007
Randomized Controlled TrialEffect on the development of ankle edema of adding delapril to manidipine in patients with mild to moderate essential hypertension: a three-way crossover study.
Use of the combination of an angiotensin-converting enzyme inhibitor (ACEI) and a calcium channel blocker (CCB) is considered a rational approach in patients whose hypertension is not controlled by monotherapy, providing better blood pressure (BP) control than the individual components with a lower incidence of adverse effects. In particular, such combinations have been found to reduce the incidence of ankle edema, the most common adverse effect of dihydropyridine annhypertensives. ⋯ In these patients with mild to moderate essential hypertension, the addition of delapril to manidipine partially counteracted the manidipine-induced microcirculatory changes responsible for ankle edema.