Clinical therapeutics
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Clinical therapeutics · Jun 2013
Randomized Controlled TrialPsychometric performance of the incontinence quality-of-life questionnaire among patients with overactive bladder and urinary incontinence.
The Incontinence Quality-of-Life Instrument (I-QOL) is a condition-specific questionnaire that assesses the health-related QOL impact of urinary incontinence, but it has not been validated in patients with overactive bladder (OAB) who have been inadequately managed by anticholinergic therapy. ⋯ This study demonstrated that OAB with urinary incontinence affects health-related QOL and that the I-QOL reliably and validly measures these impacts.
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Clinical therapeutics · Jun 2013
A stewardship program's retrospective evaluation of vancomycin AUC24/MIC and time to microbiological clearance in patients with methicillin-resistant Staphylococcus aureus bacteremia and osteomyelitis.
Current guidelines for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) bacteremia recommend targeting a vancomycin AUC24/MIC ≥400. Data on the association between AUC24/MIC and microbiological clearance in patients with concomitant MRSA bacteremia and MRSA osteomyelitis are limited. ⋯ We observed a >2.5-fold increase in time to microbiological clearance in patients with concomitant MRSA bacteremia and MRSA osteomyelitis unable to achieve a vancomycin AUC24/MIC >293. A 5-day increase in hospital and infection-related length of stay was observed when this target was not achieved. Recurrence of bacteremia and hospital readmissions were higher in the cohort who did not achieve an AUC24/MIC >293. Only 9% of patients were able to achieve an AUC24/MIC >293 if the isolate MIC was >1 μg/mL. Trough concentration did not correlate with AUC24/MIC. In patients with concomitant MRSA bacteremia and MRSA osteomyelitis treated with vancomycin, stewardship programs should optimize pharmacodynamic parameters, specifically AUC24/MIC, or alternative therapies should be considered.
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Clinical therapeutics · Jun 2013
Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.
Much of the literature on trends and factors affecting biopharmaceutical innovation has focused overwhelmingly on the development and approval of never-before approved drugs and biologics. Little attention has been paid to new uses for already-approved compounds, which can be an important form of innovation. ⋯ Development of and regulatory approval for new uses of already-approved drugs and biologics is an important source of innovation by biopharmaceutical firms. Despite rising development costs, the output of new-use approvals has remained stable in recent years, driven largely by the pursuit of new pediatric indications. FDA approval-phase times have generally declined substantially for all types of applications since the mid-1990s following legislation that provided a new source of income for the agency. However, while the resources needed to review supplemental applications are likely lower in general than for original-use approvals, the approval-phase times for important new uses are no lower than for important original-use applications.
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Clinical therapeutics · May 2013
Meta AnalysisRelationship between pain relief and improvements in patient function/quality of life in patients with painful diabetic peripheral neuropathy or postherpetic neuralgia treated with pregabalin.
In patients with chronic pain due to diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN), pregabalin treatment results in pain relief and improved patient function/quality of life (QoL). Few studies, however, have examined the exact relationship between pain relief and improvements in patient function/QoL. It is unclear, for example, whether pregabalin has a direct independent effect on patient function/QoL or whether improvements in function/QoL are an indirect consequent of pain relief. ⋯ In patients with chronic pain due to DPN or PHN, improvements in patient function/QoL in response to pregabalin treatment are correlated with the extent of pain relief. However, such improvements in function/QoL are not mediated entirely through pain relief but are the result of a combination of pregabalin's effects on pain and sleep disturbance and a direct effect on patient function itself.
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Clinical therapeutics · May 2013
Randomized Controlled Trial Comparative StudyEffects of injectable HPβCD-diclofenac on the human delayed rectifier potassium channel current in vitro and on proarrhythmic QTc in vivo.
Novel formulations and administration routes of established drugs may result in higher maximum concentrations or total exposures and potentially cause previously unrecognized adverse events. ⋯ The findings from the present study suggest that HPβCD-diclofenac does not have a dose-dependent effect in the in vitro hERG assay system and does not produce proarrhythmic QTc prolongation in vivo. ClinicalTrials.gov identifier: NCT01812538.