Current medical research and opinion
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Multicenter Study Clinical Trial
An open-label multicenter study to assess the safety of dextromethorphan/quinidine in patients with pseudobulbar affect associated with a range of underlying neurological conditions.
Pseudobulbar affect (PBA) is associated with neurological disorders or injury affecting the brain, and characterized by frequent, uncontrollable episodes of crying and/or laughing that are exaggerated or unrelated to the patient's emotional state. Clinical trials establishing dextromethorphan and quinidine (DM/Q) as PBA treatment were conducted in patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS). This trial evaluated DM/Q safety in patients with PBA secondary to any neurological condition affecting the brain. ⋯ DM/Q was generally well tolerated over this 52 week trial in patients with PBA associated with a wide range of neurological conditions.
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Randomized Controlled Trial Multicenter Study
Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study.
Safety and efficacy of a once daily controlled-released (CR) formulation of pregabalin was evaluated in patients with fibromyalgia using a placebo-controlled, randomized withdrawal design. ⋯ Time to LTR was significantly longer with pregabalin CR versus placebo in fibromyalgia patients who initially showed improvement with pregabalin CR, indicating maintenance of response. Pregabalin CR was well tolerated in most patients. Generalizability may be limited by study duration and selective population.
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Randomized Controlled Trial Multicenter Study
Impact of fatigue on outcome of selective serotonin reuptake inhibitor treatment: secondary analysis of STAR*D.
To explore relationships between baseline and changes in fatigue during treatment with outcomes in patients with major depressive disorder (MDD) receiving citalopram monotherapy. ⋯ Lower baseline fatigue and remission of fatigue during antidepressant treatment in patients with MDD are associated with higher rates of remission of depressive symptoms and better function and quality of life. Study limitations include use of the STAR*D Level 1 sample (citalopram as only antidepressant), use of a proxy measure of energy/fatigue (item 14 from the QIDS-SR16), and the secondary post-hoc analysis design.
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study.
NSAIDs, such as diclofenac, are the most commonly used medications to treat osteoarthritis (OA), but they are associated with dose-related adverse events (AEs). Low-dose submicron diclofenac was developed using a new, proprietary dry milling process that creates submicron drug particles (SoluMatrix Fine Particle Technology * ), enabling effective treatment at lower doses than other commercially available diclofenac drug products. This phase 3 study evaluated the efficacy and safety of low-dose submicron diclofenac 35 mg three times daily (tid) and twice daily (bid) in patients with OA pain. ⋯ Low-dose submicron diclofenac is an effective therapeutic option for the treatment of OA pain.
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Randomized Controlled Trial Multicenter Study Comparative Study
Efficacy of a triple antiemetic regimen with aprepitant for the prevention of chemotherapy-induced nausea and vomiting: effects of gender, age, and region.
To determine the variability in treatment responses to antiemetic therapy (ondansetron and dexamethasone vs ondansetron and dexamethasone plus aprepitant) given with moderately emetogenic chemotherapy. ⋯ Although we acknowledge that subset numbers in this post hoc analysis may be too small to allow definitive conclusions, the data suggest that aprepitant triple therapy provides a benefit over control therapy for the prevention of CINV in patients receiving anthracycline and cyclophosphamide (AC)- or non-AC-based moderately emetogenic chemotherapy across age, gender, and region. (Original trial results available at ClinicalTrials.gov: NCT00337727.).