Clinical therapeutics
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Clinical therapeutics · Jul 2010
Randomized Controlled Trial Multicenter Study Comparative StudyEffectiveness and tolerability of high-dose (23 mg/d) versus standard-dose (10 mg/d) donepezil in moderate to severe Alzheimer's disease: A 24-week, randomized, double-blind study.
Currently approved Alzheimer's disease (AD) treatments have been reported to provide symptomatic benefit, without proven impact on clinical progression. We hypothesized that the loss of initial therapeutic benefit over time may be mitigated by higher doses of a cholinesterase inhibitor. ⋯ In this study in patients with moderate to severe AD, donepezil 23 mg/d was associated with greater benefits in cognition compared with donepezil 10 mg/d. The between-treatment difference in global functioning was not significant in the overall population. Patients with more advanced AD appeared to benefit from donepezil 23 mg/d on the assessment of global functioning, but this observation requires additional studies for confirmation. ClinicalTrials.gov identifier: NCT00478205.
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Clinical therapeutics · Jul 2010
Randomized Controlled Trial Multicenter Study Comparative StudyTriple therapy with olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide in adult patients with hypertension: The TRINITY multicenter, randomized, double-blind, 12-week, parallel-group study.
Patients with hypertension may require a combination of > or =2 antihypertensive agents to achieve blood pressure (BP) control. ⋯ In these adult patients with moderate to severe hypertension, triple combination treatment with OM 40 mg + AML 10 mg + HCTZ 25 mg was associated with significant BP reductions compared with dual combinations of the individual components. All treatments were generally well tolerated. ClinicalTrials. gov identifier: NCT00649389.
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Clinical therapeutics · Jul 2010
Randomized Controlled TrialPharmacokinetics, analgesic effect, and tolerability of a single preprocedural dose of intranasal fentanyl in patients undergoing drain removal after breast reduction or augmentation surgery: A prospective, randomized, double-blind, placebo-controlled study.
Although acetaminophen is used to reduce pain after breast reduction or augmentation surgery, pain during the removal of the surgical drains is typically not specifically treated. Intranasally administered fentanyl may be suitable for pain control during removal of drains. The reported therapeutic window of fentanyl is between 0.2 and 1.2 ng/mL. ⋯ In these women who had undergone breast reduction or augmentation surgery, a single preprocedural dose of intranasal fentanyl was significantly more effective than placebo in reducing pain intensity over the hour after removal of surgical drains. However, there was no significant difference in pain intensity between fentanyl at the time of drain removal and placebo. Intranasal fentanyl was generally well tolerated. At the dose used (0.05 mg), plasma fentanyl concentrations were below the reported therapeutic window.
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Clinical therapeutics · Jul 2010
Randomized Controlled Trial Comparative StudyRelative bioavailability and pharmacokinetic properties of two different enteric formulations of esomeprazole in healthy Bangladeshi male volunteers: An open-label, single-dose, randomized-sequence, two-way crossover study.
In Bangladesh, a number of generic oral formulations of esomeprazole are marketed. Study of the relative bioavailability of these generic formulations has yet to be conducted in a Bangladeshi population. ⋯ This single-dose study found that the test and reference formulations of esomeprazole 40 mg met the FDA regulatory criteria for assuming bioequivalence in these healthy, fasting Bangladeshi male volunteers. A significant difference was found in T(max) between the 2 formulations. Both formulations were well tolerated in the studied population.