Clinical drug investigation
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Randomized Controlled Trial Multicenter Study
Early non-response in patients with severe depression: escitalopram up-titration versus switch to duloxetine.
Comparative evidence for second-step treatment strategies in severe depression is scarce. Up-titrating a well tolerated selective serotonin reuptake inhibitor (SSRI) versus switching to a serotonin norepinephrine reuptake inhibitor (SNRI) after initial SSRI non-response are possible treatment options. It is often unclear whether relevant tolerability and efficacy differences exist between SSRI up-titration versus switch to an SNRI. ⋯ Registered at ClinicalTrials.gov as NCT00384436.
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Randomized Controlled Trial Comparative Study
Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study.
The International Conference of Harmonisation (ICH) E14 guideline for thorough QT studies requires assessing the propensity of new non-antiarrhythmic drugs to affect cardiac repolarization. The present study investigates whether a composite ECG measure of T-wave morphology (Morphology Combination Score [MCS]) can be used together with the heart rate corrected QT interval (QTc) in a fully ICH E14-compliant thorough QT study to exclude clinically relevant repolarization effects of bilastine, a novel antihistamine. ⋯ This study shows that bilastine, at therapeutic and supratherapeutic dosages, does not induce any effects on T-wave morphology or QTcF. These results confirm the absence of an effect for bilastine on cardiac repolarization.
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Randomized Controlled Trial
Flucloxacillin and diclofenac do not cause recurrence of neuromuscular blockade after reversal with sugammadex.
Sugammadex, a modified γ-cyclodextrin, facilitates rapid reversal of rocuronium- and vecuronium-induced neuromuscular blockade (NMB). Cyclodextrins are known for their ability to form inclusion complexes with various drugs. Theoretically, molecules with a high affinity for sugammadex could interact and displace sugammadex from the sugammadex-rocuronium or sugammadex-vecuronium complex, potentially resulting in the recurrence of NMB due to recirculation of free rocuronium or vecuronium. ⋯ Administration of flucloxacillin or diclofenac does not result in recurrence of NMB through displacement of sugammadex from the sugammadex-rocuronium or sugammadex-vecuronium complex.
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Randomized Controlled Trial
Reduction in healthcare and societal resource utilization associated with cladribine tablets in patients with relapsing-remitting multiple sclerosis: analysis of economic data from the CLARITY Study.
Multiple sclerosis (MS) is a common, chronic, neurodegenerative condition associated with substantial healthcare and societal economic burden. Disease-modifying MS treatments have the potential to reduce health resource utilization (HRU), thereby reducing the attendant socioeconomic burden. ⋯ This study provides evidence that the efficacy of cladribine tablets observed during the CLARITY study was associated with a reduced consumption of healthcare resources and a decreased need for medical and societal support.
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Randomized Controlled Trial
Therapeutic efficacy and tolerability of the topical treatment of inflammatory conditions of the oral cavity with a mouthwash containing diclofenac epolamine: a randomized, investigator-blind, parallel-group, controlled, phase III study.
Non-steroidal anti-inflammatory drugs (NSAIDs), including diclofenac, are the mainstay of analgesic and anti-inflammatory treatment in dentistry. Diclofenac epolamine [diclofenac N-(2-hydroxyethyl)pyrrolidine; DHEP] is a diclofenac salt with greater water solubility and better cutaneous absorption properties than other commonly used forms of the drug. IBSA has recently developed a mouthwash formulation of DHEP for the topical treatment of inflammatory conditions of the oral cavity. ⋯ DHEP mouthwash was at least as effective as diclofenac mouthwash at alleviating pain and inflammation symptoms and is well tolerated in patients with painful inflammatory conditions of the oral cavity. The potential of DHEP mouthwash deserves to be investigated in a larger patient population.