Clinical therapeutics
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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.
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Immune thrombocytopenic purpura (ITP) is characterized by platelet deficiency due to platelet destruction and/or inadequate production. Initial therapy consists of corticosteroids or intravenous immunoglobulin (IVIg). Patients with chronic refractory disease might undergo splenectomy. Although there is no treatment of choice in those who do not respond to splenectomy, immunosuppressive agents are typically prescribed. Romiplostim is the first available drug in a recently developed class of agents that work through stimulation of the thrombopoietin (TPO) receptor (c-Mpl) to increase platelet production. ⋯ Based on the findings from this review, romiplostim administration has been associated with a durable platelet response in these patients with refractory chronic ITP. Romiplostim has been found to be generally well tolerated.
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Clinical therapeutics · Sep 2009
Comparative StudyA comparison of aspirin and clopidogrel with or without proton pump inhibitors for the secondary prevention of cardiovascular events in patients at high risk for gastrointestinal bleeding.
This study was conducted to compare the risk of recurrent hospitalization for major gastrointestinal (GI) complications (peptic ulcer, bleeding, and perforation) in patients at high GI risk who require ongoing antiplatelet therapy (aspirin [acetylsalicylic acid] or clopidogrel) with or without proton pump inhibitors (PPIs). ⋯ In this analysis in patients at high GI risk who were receiving antiplatelet therapy for the secondary prevention of cardiovascular events, aspirin plus a PPI was associated with a reduced risk of recurrent hospitalization for major GI complications. This was not the case for clopidogrel plus a PPI.