Objective: To evaluate the efficacy and safety of an encapsulated, highly viscous formulation of extended-release oxycodone designed to resist common physical manipulation and chemical challenges (Remoxy; King Pharmaceuticals, Inc., Bristol, TV, which was acquired by Pfizer Inc. in March 2011).
Design: An enriched enrollment randomized withdrawal trial design was used whereby patients entered a double-blind, multicenter, placebo-controlled trial after completing an open-label titration phase.
Setting: Sixty-one US clinics.
Patients: All patients (40-75 years) had experienced moderate to severe chronic osteoarthritic pain in the hip or knee for > or = 3 months.
Interventions: During 2 weeks of open-label treatment (N = 558), patients were titrated from Remoxy 5 mg twice daily (bid) to 20 mg bid. Patients who tolerated the drug were randomly assigned to Remoxy or placebo bid for 12 weeks. Dose titration was permitted during weeks 1-4 (range, 10-80 mg/d) and fixed thereafter.
Main Outcome Measures: The area under the curve (AUC) for change in pain intensity (PI) scores from prerandomization to the end of the 12-week period was the primary endpoint. Patient assessment of quality of analgesia, global assessment of study medication, quality of life, and safety were also evaluated.
Results: The mean AUC for change in PI score was significantly greater for Remoxy than for placebo (p = 0.007). Patients receiving Remoxy reported significantly better scores on quality of analgesia (p = 0.004) and global assessment of study medication (p = 0.007) when compared with patients receiving placebo. Remoxy had a safety profile consistent with other opioids.
Conclusions: Remoxy significantly improved analgesia among patients with moderate to severe chronic osteoarthritic pain with an adverse event profile similar to other opioids.
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http://dx.doi.org/10.5055/jom.2011.0062 | DOI Listing |
J Nephrol
January 2025
School of Life and Medical Sciences, University of Hertfordshire, College Lane Campus, Hatfield, UK.
Little is known about the impact of environmental pollution on thyroid function in the non-occupationally exposed population of Kazakhstan. This study aimed to investigate serum levels of thyroxine (T4), thyroid-stimulating hormone (TSH), and anti-thyroid peroxidase (TPO) antibodies in the environmentally exposed population of Kazakhstan in relation to symptoms of anxiety. A total of 1,388 nominally healthy individuals residing in areas exposed to three major types of environmental pollution prevalent in Kazakhstan-non-ferrous metallurgy, condensate gas extraction, and activities of the Semipalatinsk Nuclear Test Site (SNTS)-were enrolled.
View Article and Find Full Text PDFInt J Geriatr Psychiatry
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Precision Neuroscience & Neuromodulation Program, Gordon Center for Medical Imaging, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Background: Alzheimer's disease (AD) is characterized by impaired inhibitory circuitry and GABAergic dysfunction, which is associated with reduced fast brain oscillations in the gamma band (γ, 30-90 Hz) in several animal models. Investigating such activity in human patients could lead to the identification of novel biomarkers of diagnostic and prognostic value. The current study aimed to test a multimodal "Perturbation-based" transcranial Alternating Current Stimulation-Electroencephalography (tACS)-EEG protocol to detect how responses to tACS in AD patients correlate with patients' clinical phenotype.
View Article and Find Full Text PDFJ Cell Mol Med
January 2025
Department of Nephrology, Yi Ji Shan Hospital Affiliated to Wan Nan Medical College, Wuhu, Anhui, China.
Renal fibrosis (RF) is a crucial pathological factor in the progression of chronic kidney disease (CKD) to end-stage renal failure, and accurate and noninvasive assays to monitor the progression of renal fibrosis are needed. Circular RNAs (circRNAs) are noncoding RNAs that can be used as diagnostic biomarkers and therapeutic targets for human diseases. In this study, we analysed the expression of hsa_circ_0008925 in human urinary renal tubular cells and investigated its role in renal fibrosis.
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January 2025
Department of Cardiology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China.
Background: Continuous Positive Airway Pressure (CPAP) treatment brings more benefits than risks to most coronary heart disease (CHD) patients with obstructive sleep apnea (OSA). However, the pathophysiological mechanism by which CPAP treatment improves the prognosis of patients with CHD and OSA remains unclear. The purpose of this study was to clarify whether CPAP can improve arterial stiffness and inflammatory factor levels in CHD patients with OSA, and to further improve prognosis.
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