Clinical therapeutics
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Clinical therapeutics · Aug 2013
Randomized Controlled TrialIpragliflozin does not prolong QTc interval in healthy male and female subjects: a phase I study.
Ipragliflozin, a potent, selective sodium glucose cotransporter 2 inhibitor, is in development for the treatment of type 2 diabetes mellitus. The International Conference on Harmonisation recommends that the safety investigation of new drugs include characterization of each agent's effects on the QT/QTc interval. ⋯ No clinically meaningful QTc interval prolongation was observed in these healthy subjects who received ipragliflozin doses up to 600 mg/d for 7 days. ClinicalTrials.gov identifier: NCT01232413.
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Clinical therapeutics · Jul 2013
Randomized Controlled Trial Multicenter Study Comparative StudyFluticasone/Formoterol combination therapy compared with monotherapy in adolescent and adult patients with mild to moderate asthma.
This study investigated the efficacy and tolerability of a new asthma therapy combining fluticasone propionate and formoterol fumarate (fluticasone/formoterol)*, administered twice daily (BID) via a single aerosol inhaler, compared with fluticasone propionate (fluticasone) or formoterol fumarate (formoterol) administered alone, in patients with mild to moderate asthma. ⋯ Fluticasone/formoterol had a good tolerability profile and showed statistically superior efficacy for the two co-primary endpoints compared to fluticasone or formoterol, in adolescents and adults with mild to moderate asthma. ClinicalTrials.gov identifier: NCT00394199.
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Clinical therapeutics · Jul 2013
Randomized Controlled Trial Meta Analysis Comparative StudyMixed treatment comparison meta-analysis of aspirin, warfarin, and new anticoagulants for stroke prevention in patients with nonvalvular atrial fibrillation.
Warfarin and aspirin are used to prevent stroke in patients with atrial fibrillation (AF). There are inherent challenges with both treatments, including variable and inconsistent benefit and increased bleeding risks. The availability of new anticoagulants offers some alternatives. ⋯ This mixed treatment comparison meta-analysis found similarity between warfarin and the new anticoagulants with the exception of one comparison, in which warfarin was associated with more non-major bleeding than apixaban. Thus, the new anticoagulants are therapeutically comparable when warfarin is inappropriate.
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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 · 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.