Clinical therapeutics
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Clinical therapeutics · Mar 2013
Randomized Controlled TrialEffects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults.
Mirabegron is a β3-adrenoceptor agonist used for the treatment of overactive bladder. Mirabegron is formulated as an extended-release tablet using oral controlled-absorption system (OCAS) technology. ⋯ Mirabegron OCAS tablets exhibited a decrease in mirabegron plasma exposure with food that was independent of dose (50 or 100 mg) or gender but dependent on meal composition. A greater reduction in mirabegron exposure was observed after a low-fat breakfast compared with after a high-fat breakfast. Based on findings from previous studies, the effects of food observed in this study do not warrant dose adjustment in clinical practice. ClinicalTrials.gov identifier: NCT00939757.
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Clinical therapeutics · Mar 2013
ReviewImpact of local administration of liposome bupivacaine for postsurgical analgesia on wound healing: a review of data from ten prospective, controlled clinical studies.
Liposome bupivacaine is a liposomal formulation that allows delivery of bupivacaine for 96 hours with a single local administration. It is indicated for the management of postsurgical pain. ⋯ Liposome bupivacaine given locally at the surgical wound site appeared to have no clinically evident impact on wound or bone healing at doses up to 532 mg across different surgical models. The wound-healing profile of liposome bupivacaine was similar to that of bupivacaine HCl.
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Clinical therapeutics · Mar 2013
Randomized Controlled TrialSingle-dose pharmacokinetics of fentanyl sublingual spray and oral transmucosal fentanyl citrate in healthy volunteers: a randomized crossover study.
Fentanyl sublingual spray (FSS) is a novel fentanyl formulation recently developed for the treatment of breakthrough cancer pain, which is characterized by a fast onset and a relatively short duration. ⋯ Absorption of fentanyl in this study was faster and bioavailability was greater with FSS than with OTFC. The pharmacokinetic profile of the sublingual spray closely matches the duration of onset to pain intensity in a breakthrough cancer pain episode. These findings suggest that FSS is appropriate for the treatment of breakthrough cancer pain. ClinicalTrials.gov identifier: NCT01780233.
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Opioid use for the treatment of chronic nonmalignant pain has increased drastically over the past decade. Although no evidence of efficacy exists supporting the treatment of fibromyalgia (FM) with chronic opioid therapy, a large number of patients are receiving this therapy. Geographic variation in the use of opioids has been demonstrated in the past, but there are no studies examining variation of chronic opioid use. ⋯ Geographic variation in chronic opioid use among patients with FM exists at rates similar to those seen in other studies examining opioid use. This large level of geographic variation suggests that the prescribing decision is not based solely on physician-patient interaction but also on contextual and structural factors at the state level. The level of physician and condition prevalence suggest that information dissemination and peer-to-peer interaction may play a key role in adopting evidence-based medicine for the treatment of patients suffering from FM and related conditions. Level of diagnosis prevalence as a predictor of evidence-based practice has not been reported in the literature and is an important contribution to research on geographic variation.