Current medical research and opinion
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To evaluate the effectiveness of select biologics, methotrexate (MTX), and other disease-modifying anti-rheumatic drugs (DMARDs) in the management of adult rheumatoid arthritis (RA) in routine clinical practice. ⋯ These data from routine rheumatology clinical practice settings highlight the effectiveness of common biologic and DMARD therapies, and provide additional data beyond those of randomized, controlled trials.
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The addition of recombinant human bone morphogenetic protein (rhBMP-2) to the standard of care, consisting of soft tissue management and intramedullary nailing, in the BMP-2 Evaluation in Surgery for Tibial Trauma (BESTT) study led to a significantly better outcome for the patient. Reductions in fracture healing time, secondary interventions for delayed fracture healing and infection rates were observed with 1.50 mg/mL rhBMP-2 compared with the standard of care alone. In Germany the approximate cost of applying one dose of recombinant human bone morphogenetic protein-2 (rhBMP-2) to an open tibial fracture is euro2970. ⋯ A sound economic model to assess the cost-effectiveness and budget impact of rhBMP-2 is required. Using medical data from the BESTT study the differences in fracture healing time, in reduction of secondary interventions for fracture healing and infection treatment can be transferred into economic savings. It is anticipated that the overall savings that can be achieved by rhBMP-2 treatment in open tibia fractures, offset the upfront price of rhBMP-2 and lead to net savings for health insurance companies.
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Randomized Controlled Trial Comparative Study
Efficacy and safety of rofecoxib 12.5 mg and celecoxib 200 mg in two similarly designed osteoarthritis studies.
To compare the lower osteoarthritis (OA) dose of rofecoxib to the recommended dose of celecoxib in two identically designed studies. ⋯ Rofecoxib 12.5 mg and celecoxib 200 mg provided comparable efficacy over 6 weeks, and both were significantly more efficacious than placebo. The medications demonstrated similar safety compared to one another and placebo. The primary limitations of these studies were that they were only 6 weeks long and were powered for efficacy. Therefore, conclusions about long-term safety cannot be inferred.
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Randomized Controlled Trial Comparative Study
Pharmacodynamic effects on alertness of single doses of armodafinil in healthy subjects during a nocturnal period of acute sleep loss.
To assess the pharmacodynamics of armodafinil compared with modafinil and placebo on measures of alertness in healthy volunteers undergoing sleep loss. ⋯ Armodafinil improved alertness at all doses studied. Relative to modafinil 200 mg, armodafinil 200 mg showed a comparable peak plasma concentration with higher concentrations 6-14 hours post-drug, and improved wakefulness and sustained attention for a longer time post-dose. Both drugs were well tolerated; however, further research on the efficacy, safety, and tolerability of armodafinil in patients with disorders of excessive sleepiness (ES) is required.
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Multicenter Study Comparative Study
Real-world utilization of DMARDs and biologics in rheumatoid arthritis: the RADIUS (Rheumatoid Arthritis Disease-Modifying Anti-Rheumatic Drug Intervention and Utilization Study) study.
Rheumatoid Arthritis (RA) Disease-Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS) is a unique, real-world, prospective, 5-year, observational study of over 10 000 patients with RA. RADIUS provides a snapshot of use patterns, effectiveness, and safety of DMARDs, biologics, and combination therapies used to manage RA in clinical practice. ⋯ These real-world data provide evidence of the prescribing practices of rheumatologists in 2001-2003. Future analyses will allow evidence-based comparisons of the long-term safety and effectiveness of DMARDs, biologics, and combination therapies to assist physicians in clinical decision-making.