Clinical therapeutics
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Clinical therapeutics · Mar 2009
ReviewVarenicline: a first-line treatment option for smoking cessation.
Varenicline acts as a partial agonist/antagonist with affinity and selectivity for alpha(4) beta(2) nicotinic acetylcholine receptors. This activity at the nicotine-receptor level may help patients achieve smoking cessation by reducing cravings/withdrawal symptoms and smoking satisfaction. ⋯ Varenicline has a unique mechanism of action compared with other first-line options for smoking cessation. Available clinical-trial data support its use as an effective and generally well-tolerated therapy for smoking cessation in healthy adult smokers, although there is a need for further efficacy and safety evaluation in the general population, particularly those with comorbid conditions.
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Clinical therapeutics · Mar 2009
Randomized Controlled Trial Comparative StudyA single-dose, randomized, two-way crossover study comparing two olanzapine tablet products in healthy adult male volunteers under fasting conditions.
Olanzapine is a psychotropic agent that belongs to the thienobenzodiazepine class. ⋯ In this small study in healthy male volunteers, there were no statistically significant differences in any of the calculated pharmacokinetic parameters between the 10-mg test and reference tablets of olanzapine. The 90% CIs for the ratios of mean C(max), AUC(0-72), and AUC(0-infinity) were within the range of 80% to 125% (using log-transformed data), meeting the FDA regulatory criterion for bioequivalence. Both formulations were well tolerated.
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Clinical therapeutics · Mar 2009
Randomized Controlled Trial Multicenter Study Comparative StudyTopiramate versus amitriptyline in migraine prevention: a 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority trial in adult migraineurs.
The primary objective of this study was to compare the efficacy and tolerability of topiramate and amitriptyline in the prophylaxis of episodic migraine headache. ⋯ In this noninferiority study, topiramate was at least as effective as amitriptyline in terms of reducing the rate of mean monthly migraine episodes and all prespecified secondary efficacy end points. Topiramate was associated with improvement in some quality-of-life indicators compared with amitriptyline and was associated with weight loss and improved weight satisfaction.
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Clinical therapeutics · Mar 2009
Randomized Controlled Trial Comparative StudyEffects of intravenous patient-controlled analgesia with buprenorphine and morphine alone and in combination during the first 12 postoperative hours: a randomized, double-blind, four-arm trial in adults undergoing abdominal surgery.
Intense pain in the first 12 hours after major abdominal surgery requires the use of large amounts of analgesics, mainly opioids, which may produce undesirable effects. Buprenorphine (BUP) is not typically used intravenously in this setting, particularly in combination with morphine (MO), due to concerns that BUP might inhibit the analgesic effect of MO. ⋯ In these patients undergoing abdominal surgery, the BUP-i + BUP-b regimen controlled postoperative pain as well as did MO-i + MO-b or the combinations of BUP and MO. BUP neither inhibited the analgesia provided by MO nor induced undesired sedation or hemodynamic or respiratory effects.
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Clinical therapeutics · Mar 2009
Randomized Controlled Trial Multicenter StudyEfficacy and safety of low-dose transdermal buprenorphine patches (5, 10, and 20 microg/h) versus prolonged-release tramadol tablets (75, 100, 150, and 200 mg) in patients with chronic osteoarthritis pain: a 12-week, randomized, open-label, controlled, parallel-group noninferiority study.
This study compared the efficacy and safety of low-dose 7-day buprenorphine patches and prolonged-release tramadol tablets in patients with chronic, moderate to severe osteoarthritis (OA) pain of the hip and/or knee. ⋯ In these patients with chronic, moderate to severe OA pain of the hip and/or knee, 7-day low-dose buprenorphine patches were an effective and well-tolerated analgesic. The buprenorphine patches were noninferior to prolonged-release tramadol tablets. European Union Drug Regulating Authorities Clinical Trials number: 2006-003233-32.