Clinical characteristics and outcomes in familial adenomatous polyposis patients with a long-term treatment of celecoxib: a matched cohort study
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To investigate the validity and safety of different doses of non-steroidal anti-inflammatory drugs (NSAID) in attempting to maintain the regression of colorectal adenomas in patients with familial adenomatous polyposis (FAP) and hereditary nonpolyposis colorectal cancer (HNPCC).Twenty-two FAP patients who were willing to receive celecoxib were randomly divided into 2 groups 400 mg/d group (n = 8, taking celecoxib 400 mg/d) and 200 mg/d group (n = 10, taking celecoxib 200 mg/d). Four FAP patients who refused celecoxib and selected aspirin 80 mg/d instead. Six HNPCC patients were given celecoxib 400 mg daily. The treatment lasted for 24 months in all groups. The efficacy was evaluated respectively by the number and grade of polyps by coloscopy every 3 months in the first year and every 6 months in the second year.Either dose of celecoxib could reduce polyps in the FAP patients, with a polyps reduction rate of 86.6% (280/323) in the 400 mg group, significantly higher than that in the 200 mg group [51.81% (129/249) of the aspirin group]. In 5 of the 6 HNPCC patients the polyps completely vanished after 9 months of treatment. Side effects, such as arrhythmia, angina pectoris, and nervous headache, were observed in the celecoxib 400 mg/d group. The side effects could be reversed by decreasing the dose of celecoxib or using aspirin instead. Only one patient in the celecoxib 200 mg/d group showed side effects.Celecoxib 400 mg daily is more effective but has more side effects. At first the patients should be treated with celecoxib 200 mg daily for a long time, or 400 mg/d in the first 6 months and then with a daily dose of 200 mg/d to maintain the treatment effects. Soluble aspirin has similar effects.
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AIM:To compare the therapeutic effects and safety of celecoxib and ibuprofen in treating osteoarthritis. METHODS: Sixty-six patients with osteoarthritis were divided into two groups.Celecoxib group of thirty-four patients received celecoxib 100 mg, po, bid, for 4 wk. Ibuprofen group of thirty-two patients received ibuprofen 300 mg, po, bid, for 4 wk. RESULTS: The total effective rates were 85 % in celecoxib group and 81 % in ibuprofen group(P 0.05). The adverse reaction rates were 18 % in celecoxib group and 34 % in ibuprofen group(P 0.05). CONCLUSION: Celecoxib is an effective and safe drug in treating osteoarthritis.
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Objective To investigate the validity and safety of different doses of non-steroidal anti-inflammatory drugs (NSAID) in attempting to maintain the regression of colorectal adenomas in patients with familial adenomatous polyposis (FAP) and hereditary nonpolyposis colorectal cancer (HNPCC). Methods Twenty-two FAP patients who were willing to receive celecoxib were randomly divided into 2 groups 400 mg/d group (n=8, taking celecoxib 400 mg/d) and 200 mg/d group (n=10, taking celecoxib 200 mg/d). Four FAP patients who refused celecoxib and selected aspirin 80 mg/d instead. Six HNPCC patients were given celecoxib 400 mg daily. The treatment lasted for 24 months in all groups. The efficacy was evaluated respectively by the number and grade of polyps by coloscopy every 3 months in the first year and every 6 months in the second year. Results Either dose of celecoxib could reduce polyps in the FAP patients,with a polyps reduction rate of 86.6%(280/323)in the 400 mg group, significantly higher than that in the 200 mg group 51.81%(129/249)of the aspirin group . In 5 of the 6 HNPCC patients the polyps completely vanished after 9 months of treatment .Side effects, such as arrhythmia, angina pectoris, and nervous headache, were observed in the celecoxib 400 mg/d group. The side effects could be reversed by decreasing the dose of celecoxib or using aspirin instead. Only one patient in the celecoxib 200 mg/d group showed side effects. Conclusion Celecoxib 400 mg daily is more effective but has more side effects. At first the patients should be treated with celecoxib 200 mg daily for a long time, or 400 mg/d in the first 6 months and then with a daily dose of 200 mg/d to maintain the treatment effects. Soluble aspirin has similar effects.
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Although celecoxib is quite effective in the management of inflammation-related diseases, especially arthritis, its use is limited by concerns including low bioavailability (BA), non-linear pharmacokinetic (PK) profile, and peak concentration-related toxicity. To overcome these issues, we designed and prepared hydrophilic celecoxib prodrugs, namely N-glycyl-aspart-1yl celecoxib (N-GA1C), glutam-1-yl celecoxib (G1C), and aspart-1yl celecoxib (A1C), for the sustained release of celecoxib in the intestine with limited systemic absorption. The celecoxib derivatives were converted to celecoxib in the intestinal contents. The conversion rates were in order of N-GA1C > G1C > A1C. Oral administration of the celecoxib derivatives (oral celecoxib derivatives) sustained the plasma concentration of celecoxib for 24 h, improving the BA and linearity of the PK profile of celecoxib. The peak concentrations (Cmax) of celecoxib after oral celecoxib derivatives were lower than that after oral celecoxib. In a carrageenan-induced rat paw edema model, oral N-GA1C exhibited greater anti-inflammatory activity for a longer duration compared with oral celecoxib. The order of efficacy of the celecoxib derivatives was N-GA1C > G1C > A1C. Taken together, the prodrug approach is a feasible strategy to improve the PK and therapeutic properties of celecoxib, and among the celecoxib derivatives, N-GA1C may be the most promising prodrug of celecoxib.
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Do proton‐pump inhibitors confer additional gastrointestinal protection in patients given celecoxib?
Abstract Objective Celecoxib has a superior upper‐gastrointestinal (GI) safety profile compared with nonselective nonsteroidal antiinflammatory drugs (NS‐NSAIDs). It is unclear whether the utilization of a proton‐pump inhibitor (PPI) with celecoxib confers additional protection in elderly patients. We assessed the association between GI hospitalizations and use of celecoxib with a PPI versus celecoxib alone, and NS‐NSAIDs with a PPI or NS‐NSAIDs alone in elderly patients. Methods We conducted a population‐based retrospective cohort study using the government of Quebec health services administrative databases. Elderly patients were included at their first dispensing date for celecoxib or an NS‐NSAID between April 1999 and December 2002. Prescriptions were separated into 4 groups: celecoxib, celecoxib plus PPI, NS‐NSAIDs, and NS‐NSAIDs plus PPI. Cox regression models with time‐dependent exposure were used to compare the hazard rates of GI hospitalization between the 4 groups adjusting for patient characteristics at baseline. Results There were 1,161,508 prescriptions for celecoxib, 360,799 for celecoxib plus PPI, 715,176 for NS‐NSAIDs, and 148,470 for NS‐NSAIDs plus PPI. The adjusted hazard ratios (HRs; 95% confidence intervals [95% CIs]) were 0.69 (0.52–0.93) for celecoxib plus PPI versus celecoxib, 0.98 (0.67–1.45) for NS‐NSAIDs plus PPI versus celecoxib, and 2.18 (1.82–2.61) for NS‐NSAIDs versus celecoxib. Subgroup analyses showed that use of a PPI with celecoxib may be beneficial in patients ages ≥75 years but was not better than celecoxib alone among those ages 66–74 years (HR 0.98, 95% CI 0.63–1.52). Conclusion Addition of a PPI to celecoxib conferred extra protection for patients ages ≥75 years. PPI did not seem necessary with celecoxib for patients ages 66–74 years.
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ABSTRACT The chemopreventive activity of celecoxib against colorectal cancer is limited to a proportion of familial adenomatous polyposis (FAP) patients who experience a response. The cause of this response variability and the potential mechanisms underlying these responses remain poorly understood. Preclinical studies showed that celecoxib increases the production of main oxidative metabolism product of linoleic acid, 13-S-hydroxyoctadecadienoic acid (13-S-HODE), to suppress colorectal tumorigenesis. We conducted a phase II clinical study to determine whether celecoxib increases 13-S-HODE production in colonic adenomas from FAP patients. Twenty seven FAP patients completed a 6-month oral course of 400 mg of celecoxib twice a day and had colonoscopies before and after celecoxib treatment to assess colorectal polyp tumor burden and obtain colorectal normal and polyp biopsies to measure celecoxib, 13-HODE, 15-HETE, 12-HETE, and LTB4 levels by LC/MS. Celecoxib levels in sera from those patients were also measured before treatment and 2, 4, and 6 months of treatment. Seventeen of the 27 patients experienced a response to celecoxib, with a more than 30% reduction of colonic polyp burden on the basis of a reproducible quantitative assessment of colonoscopy results. Celecoxib levels were significantly lower in polyp tissues than in normal colorectal tissues. Celecoxib levels in sera and normal colorectal tissues were correlated in patients who experienced a response to celecoxib but not in those who did not. Among the measured lipoxygenase products, only 13-HODE levels were significantly lower in polyp tissues than in normal tissues. Our findings demonstrate the differential bioavailability of celecoxib between normal and polyp tissues and its potential effects on clinical response in FAP patients.
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