Non-selective, non-steroidal anti-inflammatory drugs (NSAIDs) are associated with an increased risk of congestive heart failure, but little is known about the cardiovascular effects of a newer group of NSAIDS called selective cyclo-oxygenase (COX)-2 inhibitors. We aimed to compare rates of admission for congestive heart failure in elderly patients who were newly dispensed COX-2 inhibitors or non-selective NSAIDs.
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This double-blind clinical study was conducted upon 60 subjects. These patients received 4 tablets of either 100 mg celecocxib or 5 mg prednisolone: one tablet before surgery and the rest for every 8 h post-operation. The subjects were asked to take acetaminophen codeine as rescue dose. Interincisal distance of upper and lower central teeth and pain measurements (according to Visual Analogue Scale) were taken before surgery, 24 h, 48 h and 7 days after surgery.
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The findings of increased retinal expression of VEGF mRNA in the newborn rabbit in response to hyperoxia are most likely due to species differences. Selective targeting of VEGF(121) and Flt-1 mRNA by Cel may represent one regulatory pathway for their anti-inflammatory effects. Further studies are needed to evaluate the therapeutic benefits of cyclooxygenase (COX)-2 inhibitors for the treatment and/or prevention of diseases associated with neovascularization.
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Celecoxib is a hydrophobic and highly permeable drug belonging to class II of biopharmaceutics classification system. Low aqueous solubility of celecoxib leads to high variability in absorption after oral administration. Cohesiveness, low bulk density and compressibility, and poor flow properties of celecoxib impart complications in it's processing into solid dosage forms. To improve the solubility and bioavailability and to get faster onset of action of celecoxib, the self-microemulsifying drug delivery system (SMEDDS) was developed. Composition of SMEDDS was optimized using simplex lattice mixture design. Dissolution efficiency, t(85%), absorbance of diluted SMEDDS formulation and solubility of celecoxib in diluted formulation were chosen as response variables. The SMEDDS formulation optimized via mixture design consisted of 49.5% PEG-8 caprylic/capric glycerides, 40.5% mixture of Tween20 and Propylene glycol monocaprylic ester (3:1) and 10% celecoxib, which showed significantly higher rate and extent of absorption than conventional capsule. The relative bioavailability of the SMEDDS formulation to the conventional capsule was 132%. The present study demonstrated the suitability of mixture design to optimize the compositions for SMEDDS. The developed SMEDDS formulations have the potential to minimize the variability in absorption and to provide rapid onset of action of celecoxib.
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The median size of the dominant liver metastasis was 10 cm (range, 3-19 cm). Twelve patients (71%) had evidence of extrahepatic disease. A median of 2 (range, 0-4) prior chemotherapy regimens had been administered. Median radiation dose was 42 Gy (range, 7.5-72 Gy). Concurrent chemotherapy included celecoxib in 1 (6%), capecitabine in 6 (35%), and both agents in 9 (53%) patients. Frequencies of acute diarrhea, nausea, vomiting, fatigue, hand-foot syndrome, and neutropenia were 29%, 47%, 6%, 29%, 7%, and 0%, respectively (all grade 2 or lower; no grade 3 toxicities). No late toxicities were noted. With a median follow-up time of 9.2 months, the median actuarial overall survival time from RT was 12.6 months (95% confidence interval [CI]: 3.3-40.9 months). The actuarial in-field local control rate was 62% at 6 months. The median actuarial time to in-field, out-of-field hepatic and distant progression were 6.8, 3.9, and 4.1 month, respectively (95% CIs, 3.9-15.8, 1.8-6.3, and 1.8-11.5 months, respectively).
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Our analysis of pooled data from 5 postapproval trials shows that NSAID usage demonstrates a trend towards reduction of depression symptoms in patients with osteoarthritis based upon PHQ-9 scores. Future clinical trials should investigate this association with maximum dosage of drugs, increased treatment duration, and monitoring of social and environmental changes.
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To examine the impact of intravenous acetaminophen on the total quantity of opioids (in morphine equivalents) administered within the first 48 hours postoperatively and perioperatively, while still affording patients adequate analgesia, in women who underwent total abdominal hysterectomies.
Celecoxib is metabolized by enzymes of the cytochrome P450 (CYP450) superfamily, mainly CYP2C9 and CYP3A4. Polymorphisms in the CYP2C9 gene have been associated with decreased enzyme activity and alteration of celecoxib pharmacokinetic parameters. However, literature reports are limited, and some results are contradictory. We enrolled 24 healthy volunteers in a single-dose replicated crossover trial with celecoxib 200 mg. We evaluated the association between single-nucleotide polymorphisms in the CYP2C8 and CYP2C9 genes (CYP2C8*2, CYP2C8*3, CYP2C8*4, CYP2C9*2, and CYP2C9*3) of these individuals and the pharmacokinetic parameters of celecoxib. Subjects carrying CYP2C9*1/*3 and CYP2C9*3/*3 had a higher AUC (2- and 7.7-fold, respectively) and Cmax (1.5- and 1.8-fold, respectively) and lower clearance (2.3- and 10-fold, respectively) than those carrying CYP2C9*1/*1. Half-life was 2.7-fold higher in subjects with CYP2C9*3/*3 than in those with the wild type but not in those with CYP2C9*1/*3. We did not find any significant effect of gender or CYP2C8 polymorphisms on the pharmacokinetics of celecoxib. In conclusion, the recommended dose of celecoxib should be decreased in CYP2C9*3 carriers, especially in homozygous subjects.
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Colonoscopies were performed at year 1 on 88.7 percent of the subjects who had undergone randomization and at year 3 on 79.2 percent. Of the 557 subjects in the placebo group and the 840 subjects in the celecoxib group who were included in the efficacy analysis, 264 and 270, respectively, were found to have at least one adenoma at year 1, at year 3, or both. The cumulative rate of adenomas detected through year 3 was 33.6 percent in the celecoxib group and 49.3 percent in the placebo group (relative risk, 0.64; 95 percent confidence interval, 0.56 to 0.75; P<0.001). The cumulative rate of advanced adenomas detected through year 3 was 5.3 percent in the celecoxib group and 10.4 percent in the placebo group (relative risk, 0.49; 95 percent confidence interval, 0.33 to 0.73; P<0.001). Adjudicated serious cardiovascular events occurred in 2.5 percent of subjects in the celecoxib group and 1.9 percent of those in the placebo group (relative risk, 1.30; 95 percent confidence interval, 0.65 to 2.62).
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A number of case reports and well-controlled clinical trials were identified that provided evidence of the relatively well known drug-drug interactions between prescription/OTC NSAIDs and alcohol, antihypertensive drugs, high-dose methotrexate, and lithium, as well as between frequently prescribed narcotics and other central nervous system depressants. In contrast, the ability of recent alcohol ingestion to exacerbate the hepatotoxic potential of therapeutic doses of acetaminophen is not supported by either case reports or clinical research. Use of ibuprofen according to OTC guidelines in patients taking cardioprotective doses of aspirin does not appear to interfere with aspirin's antiplatelet activity, whereas chronic prescription use of ibuprofen and other NSAIDs may interfere. Low-dose aspirin intake appears to abolish the gastroprotective effects of cyclooxygenase-2-selective inhibitors, including celecoxib. There is evidence of other less well known and potentially clinically significant drug-drug interactions, including the ability of selective serotonin reuptake inhibitors to inhibit the analgesic activity of tramadol and codeine through inhibition of their metabolic activation, to induce serotonin syndrome when used chronically in the presence of high doses of tramadol through synergistic serotonergic action, and to increase the potential for gastrointestinal bleeding associated with NSAID therapy through additive or supra-additive antiplatelet activity.
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Thirty-six male rats were divided into six equal groups; celecoxib was administered after creating PBOO for 1 and 4 weeks in groups 1 and 2, respectively. Two further obstructed groups (3 and 4, PBOO for 1 and 4 weeks, respectively) received no treatment. Sham-operated animals served as controls (group 5 and 6, assessed at 1 and 4 weeks, respectively). After 1 and 4 weeks of PBOO or a sham procedure the bladder weight was recorded before sampling the bladder for Western blotting and immunohistological analysis, to assess the expressions of COX-2 and adherens proteins, E-cadherin and alpha-catenin. Urothelial cell-to-cell interactions were evaluated using electron microscopy.
Enamel matrix proteins are involved in the development and regeneration of root cementum and in its attachment to dentin; however, the mechanisms through which this occurs have yet to be elucidated. The present study was therefore carried out to evaluate the mitogenic and proliferative responses of human periodontal fibroblast (HPLF) cells to Emdogain (EMD), and the potential role of cyclooxygenase 2 (COX-2) in this process.
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Assessments over days 1 to 6 and over 6 weeks included pain on walking, night pain, pain at rest, and morning stiffness as measured on a Western Ontario McMaster Universities Osteoarthritis Index (100-mm visual analog scale [VAS]) and global response to therapy compared among 4 treatment groups.
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Of 443 patients screened, 402 were randomized and 400 received treatment. Baseline demographics were comparable among treatments. Patients receiving high-dose celecoxib (800/400 mg) experienced a significantly greater reduction in pain intensity on Day 2 compared with low-dose celecoxib 50 mg bid [least squares (LS) mean difference -0.46; p=0.0014]. For high-dose celecoxib 800/400 mg, the change in pain scores from baseline to Day 2 was comparable with indomethacin 50 mg tid (LS mean difference 0.11; p=0.4331). There were significant differences in adverse events when the combined celecoxib groups (29.5%) were compared with patients taking indomethacin (43.1%; p=0.0116). There was no change in median serum creatinine levels for any treatment. There were more discontinuations due to adverse events (8.8% vs 3%; p=0.0147) with indomethacin than with the combined celecoxib groups.
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These data strongly suggest that tumor-shed PGE2 is an important factor leading to CD4+ T cell apoptosis during cancer and raise the possibility that theaflavins may have the potential as an effective immunorestorer in cancer-bearer.
The consensus diagnostic criteria established by the American Thoracic Society/European Respiratory Society were followed. The study included 16 patients, 10 men (65%) and 6 women (35%), all diagnosed with NSIP by open lung biopsy. Patients were questioned on pathological history, occupational or environmental exposure, medicinal drug use, contact with birds, and relationship with smoking. In addition, were recorded symptoms and physical signs, laboratory and respiratory function results, chest X-ray and computerized tomography scan features, fiberbronchoscopy findings and open lung biopsy findings.
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RIAA selectively inhibited the NF-kappaB pathway while having no effect on ERK1/2, p38 and JNK phosphorylation in LPS-stimulated RAW 264.7 cells. RIAA also inhibited GSK-3alpha/beta kinase activity and GSK-3beta dependent phosphorylation of beta-catenin in RAW 264.7 cells. In addition, RIAA inhibited NF-kappaB-mediated inflammatory markers in various cell models, including nitric oxide in LPS-stimulated RAW 264.7 cells, RANKL-mediated TRAP activity in transformed osteoclasts, and TNF-alpha/IL-1beta-mediated MMP-13 expression in SW1353 human chondrosarcoma cells. Finally, in a mouse model of collagen-induced arthritis, RIAA ameliorated joint damage as evidenced by significant reduction of the arthritis index and histology score; at 250 mg/kg-body weight, RIAA had efficacy similar to that of 20 mg/kg-body weight of celecoxib.
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Here, we assessed CFA-induced reduction of exploratory activity in a novel environment (CRANE) as an objective nociceptive endpoint in rats. CFA (50%) was subcutaneously injected into the plantar aspect of the hind paw either unilaterally or bilaterally (150 μL/paw). Exploratory activity was recorded using an automated locomotor activity system.
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This study has confirmed that selective and nonselective COX inhibition can induce significant inhibition of free water clearance, indicating that these acute changes are regulated predominantly via COX-2. Acute cerebral edema with hyponatremia has been reported after major endurance sporting events. Identifiable risk factors include excessive hydration and use of NSAID. Impaired free water clearance during exercise potentiated by COX inhibition provides a pathophysiological explanation for these observations.
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Several studies have shown that tumour necrosis factor (TNF)-alpha levels are increased in the peritoneal fluid of women with endometriosis, with correlation between TNF-alpha concentrations and the degree of disease. It is also likely that elevation of peritoneal fluids' TNF-alpha levels may play a role in the pathogenesis of infertility associated with endometriosis. Use of drugs such as etanercept, a TNF-alpha receptor immunoglobulin fusion protein which inhibits TNF-alpha activity, showed in an animal study to reduce the severity of the disease, and the size of endometriotic foci. TNF-alpha blockers were recommended as a possible new line of therapy for endometriosis. Our case involved a 35-year-old Para 0, with rheumatic arthritis and stage 4 endometriosis. After 6 years of constant use of etanercept, she showed no improvement of endometriosis as demonstrated at laparoscopy. However, she underwent a successful IVF after the first attempt. TNF-alpha-blocker medications might not be beneficial for patients with advanced endometriosis. However, we cannot exclude the possible effect of these medications on early-stage endometriosis, and further study is required. Some of the immunologic abnormalities in the pelvis of patients with endometriosis could be the consequence of the disease and not the cause, and possibly suppression of immune cells and their products may not have a major effect on endometriotic lesions at an advanced stage. This also could explain why suppression of TNF-alpha showed no effect on infertility. However, use of TNF-alpha-blockers before IVF might increase the success rate in advanced endometriosis.
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There is combined evidence from three randomized trials that aspirin significantly reduced the recurrence of sporadic adenomatous polyps. There was evidence from short-term trials to support regression, but not elimination or prevention, of colorectal polyps in familial adenomatous polyposis.
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Given that PWD is a well-accepted noninvasive marker of atrial electrophysiology, our results suggest that these patients demonstrate adverse atrial remodeling predisposing to atrial arrhythmia.
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Celecoxib and rofecoxib were associated with different odds of MI. Cardiovascular effects among the COX-2 inhibitors seem different, but further studies, preferably randomized trials, are needed to fully understand the spectrum of effects of COX-2 inhibitors and potential differences among them.
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To investigate the effects of cyclooxygenase (COX) inhibitors including celecoxib, indomethacin, and nimesulide on postoperative adhesion formation.
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A xenograft tumor model of gastric cancer was established subcutaneously in nude mice. After the largest diameter of tumor reached about 5 mm, the nude mice were randomly divided into 4 groups: the control group, the celecoxib group, the tegafur gimeracil oteracil potassium group, and the combination group; the drug was administered respectively for 21 days. Thereafter, tumor tissues were collected, tumor volume was measured, and tumor inhibition rate was calculated. Apoptosis was determined by TUNEL assay and the expression levels of PCNA, Bcl-2 and caspase-3 by immunohistochemistry.
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Mean AUC and t1/2 for aliskiren were not significantly changed by lovastatin, atenolol or celecoxib (< 10% difference between treatments). Aliskiren mean Cmax was not affected by either lovastatin or atenolol, although a non-significant 36% increase was observed with celecoxib. Modest, non-significant increases in aliskiren systemic availability followed coadministration with cimetidine (aliskiren mean AUC, Cmax and t1/2 increased by 17%, 19% and 15%, respectively). Aliskiren coadministration had no significant effect on the disposition of lovastatin, atenolol or celecoxib.