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PLGA microspheres were prepared as a sustained release system for the intra-articular administration of celecoxib (CCB). The microspheres were prepared in the presence of different concentrations of dimethyl-β-cyclodextrin (DM-β-Cyd), by the simple oil-in-water emulsion/evaporation solvent method. The microspheres were evaluated as to surface morphology, size and technological properties (such as encapsulation efficiency, drug loading capacity and drug release). Ex vivo studies on cultures of human chondrocytes were performed in order to evaluate the influence of the polymeric carriers on the pharmacological activity of CCB. All systems ranged from about 1 to 5 μm in size and had a high encapsulation efficiency percentage ranging from about 80% to 90% (w/w), except for CCB-loaded-PLGA microspheres containing the highest amount of DM-β-Cyd, in which a dramatic drop in the encapsulation efficiency was observed (about 54%, w/w). FIB images evidenced the fact that the microspheres had a porous structure in the presence of the highest amount of DM-β-Cyd. The macrocycle modulated the release profiles of CCB from the microspheres, producing in some cases a zero-order kinetic release. Ex vivo biological studies demonstrated that DM-β-Cyd improved the drug's anti-inflammatory activity. Thus, CCB-loaded PLGA/cyclodextrin microspheres may have a potential therapeutic application in the treatment of osteo- and rheumatoid arthritis.
We assessed the effectiveness of celecoxib in the prevention of heterotopic ossification (HO) following primary total hip replacement (THR). We studied 170 consecutive THRs. Sixty-three patients received celecoxib after surgery (200mg twice/daily) for 28 days and 84 did not. HO was more common in non-celecoxib patients than in the celecoxib-group at 3, 6, and 12 months (P =0.005, 0.004 and 0.01, respectively). At 1 year, fewer celecoxib recipients had Brooker classes II or III. None of the celecoxib patients developed HO Brooker class IV, while 2% in the non-celecoxib group did. No patient discontinued treatment or had revision for aseptic loosening. A short course of celecoxib for pain aids in the prevention of HO after primary THR, and could be a useful and safe option that does not interfere with anticoagulation.
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A new and simple high-performance liquid chromatography assay was developed and validated for the simultaneous determination of the above-mentioned drugs in small samples of human plasma (0.25 mL). After protein precipitation with acetonitrile, satisfactory separation was achieved on a Hypersil BDS C18 column (250 × 4.6 mm, 5 m) using a mobile phase comprising 20 mmol/L ammonium phosphate buffer (pH = 3) and acetonitrile at a ratio of 35:65, vol/vol; the elution was isocratic at ambient temperature with a flow rate of 1 mL/min. The UV detector was set at 265 nm.
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In patients at high risk of NSAID-associated serious upper gastrointestinal complications, gastroprotection with misoprostol or a proton pump inhibitor should be considered. Only misoprostol, 800 micro g/day, has been shown to reduce serious upper gastrointestinal complications in a large clinical outcome trial. The benefit of Helicobacter pylori eradication in reducing NSAID-associated gastrointestinal toxicity is controversial, and routine testing for and eradication of H. pylori in NSAID users are not currently advised. The gastrointestinal safety of rofecoxib and celecoxib has been assessed in large clinical outcome trials which, on first analysis, show benefits over non-selective NSAIDs in the incidence of serious upper gastrointestinal complications. However, longer term gastrointestinal data from the celecoxib study (CLASS) and cardiovascular adverse event data from the rofecoxib study (VIGOR) have questioned the risk-benefit profile of these new drugs and, until they are better understood, it seems sensible not to use them routinely in large numbers of individuals. The gastrointestinal safety of meloxicam and etodolac has not been adequately assessed in such trials. Therefore, evidence for their use instead of non-selective NSAIDs, or instead of celecoxib or rofecoxib, is not robust.
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Adult female cynomolgus monkeys (Macaca fascicularis).
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The findings of this observational study, along with recent clinical trial results, suggest that prolonged exposure to selective COX-2 inhibitors may be associated with an increased risk of adverse cardiovascular outcomes.
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Pre- and post-treatment serum was collected from patients enrolled in CALGB 30203. Serum VEGF levels were determined using enzyme-linked immunosorbent assay methodology. Statistical analyses were performed to determine the correlation between pretreatment serum VEGF levels and time of overall survival. Pretreatment formalin fixed tissue was stained for 5-LOX and COX-2 by immunohistochemistry.
This analysis suggests that COX-2 inhibitors may be cost-effective from the perspective of the VA. However, cost-effectiveness appears to depend less on the specific characteristics of the high-risk target population considered but more on the agent evaluated. Celecoxib appears to be an alternative to traditional NSAIDs in the patient populations studied.
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The study showed statistically significant improvements in the symptoms of osteoarthristis following the administration of Celecoxib 200mg daily for six weeks.
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Several new drugs have recently been introduced for the treatment of rheumatoid arthritis (RA). These include the cyclooxygenase-2 inhibitor, celecoxib, the anti-tumour necrosis factor agents, etanercept and infliximab, and the new disease-modifying anti-rheumatic drug (DMARD), leflunomide. In clinical trials, celecoxib has been shown to be effective for palliation of the signs and symptoms of RA and to have fewer gastrointestinal side-effects than conventional non-steroidal anti-inflammatory drugs. Etanercept and infliximab are indicated for reduction of the signs and symptoms of RA in patients who have failed to respond adequately to previous DMARDs. The clinical success rate in etanercept-treated patients is significantly better than in placebo-treated patients for up to 18 months. Leflunomide is a DMARD with a novel mechanism of action that has been approved as a first-line treatment for RA. Treatment with leflunomide results in significantly greater improvement of the signs and symptoms of RA than placebo for up to 2 yr and slows radiographically assessed disease progression. Agents are currently in development that will be targeted against components of the immune activation and co-stimulatory pathways. These include antibodies directed against the interleukin-2 receptor and blockers of the CD28 and CD40 co-stimulatory pathways. Continuing research into the pathogenesis of RA will undoubtedly identify even more effective therapeutic approaches for the management of this disease in the future.
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Injection of carrageenan (CG) into one hind paw induced a dose-related hyperalgesia (decreased time for paw withdrawal) to thermal stimuli (infra-red light beam), over 6h.