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Treatment for 1 week with Etoricoxib attenuated the CGRP-IR fibre depletion, the COX-2-IR increased cell number and the TNF-alpha and COX-2 mRNA increased levels induced by NGI. Two weeks of treatment had no beneficial effect.
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Etoricoxib tolerance was assessed by single-blind-placebo-controlled oral challenges and its subsequent use was checked by a standardized telephone call. The test was performed in 139 subjects (83 single NSAID reactors and 56 multiple NSAID reactors).
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A practicable and selective liquid chromatography-mass spectrometry assay for the determination of two cyclooxygenase-2 inhibitors, etoricoxib and valdecoxib, in human plasma is presented. The analytical technique is based on reversed-phase high-performance liquid chromatography (HPLC) coupled to atmospheric pressure chemical ionisation (APCI) mass spectrometry (Finnigan Mat LCQ ion trap). Mass analysis was performed in the positive ion mode. The ion trap was operated in the tandem MS mode (MS2) and the transitions of etoricoxib (m/z 359.2 --> 280.3) and valdecoxib (m/z 315.1 --> 235.1) were followed by selected reaction monitoring. Retention times of etoricoxib and valdecoxib were 1.05 and 1.08 min, respectively. The method was validated over a linear range 10-2500 and 5-1000 microg/L using the other substrate as internal standard. After validation, the method was used to study the pharmacokinetic pro fi le of etoricoxib or valdecoxib in a healthy volunteer after administration of a single oral dose (valdecoxib, 20 mg; etoricoxib, 90 mg). The presented method was suf fi cient to cover more than 90% of the area under the plasma concentration time curve.
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Diclofenac is commonly associated with aminotransferase elevations, generally in the first 4-6 months of therapy. Clinical liver events requiring hospitalization are relatively rare (23/100,000 patients), but may develop early or late in therapy. The markedly increased rate of aminotransferase elevation with diclofenac may not be paralleled by a proportional marked increase in clinical liver events, although clinical events potentially also may be decreased with regular monitoring in a clinical trial setting.
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Coxib premedication before elective day surgery has an anaesthetic sparing potential.
Ifosfamide (IFS) is often involved in the occurrence of hemorrhagic cystitis due to direct contact of its metabolite acrolein with uroepithelium. It has been shown that COX-2 is involved in this pathogenesis. Thus, we aimed to study the functional changes on the urinary bladder in the putative modifications induced by IFS, as well as the COX-2 role in this process.
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To study the impact of therapy with nonsteroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, meloxicam, etoricoxib, and nimesulide, on systolic and diastolic blood pressure (BP) changes in a short period (3 days), as well as the risk of acute transient ischemic attack, ischemic and hemorrhagic stroke, and acute cardiovascular events within 6 months after NSAID use.
The single- and multiple-dose pharmacokinetics of etoricoxib, a selective inhibitor of cyclooxygenase-2, were examined in two clinical studies. Single-dose pharmacokinetics--including dose proportionality, absolute bioavailability of the highest dose-strength (120-mg) tablet, and the effect of a high-fat meal on the bioavailability of that tablet--were investigated in a two-part, open, balanced crossover study in two panels of healthy subjects (12 per panel). Steady-state pharmacokinetics were investigated in an open-label study in which 24 healthy subjects were administered 120-mg single and multiple (once daily for 10 days) oral doses of etoricoxib tablets. The pharmacokinetics of etoricoxib were found to be consistent with linearity through doses at least twofold greater than the highest anticipated clinical dose of 120 mg. Etoricoxib administered as a tablet was rapidly and completely absorbed and available; the absolute bioavailability was estimated to be 100%. A high-fat meal decreased the rate of absorption without affecting the extent of absorption of etoricoxib; therefore, etoricoxib can be dosed irrespective of food. Steady-state pharmacokinetics of etoricoxib, achieved following 7 days of once-daily dosing, were found to be reasonably predicted from single doses. The accumulation ratio averaged 2.1, and the corresponding accumulation t1/2 averaged 22 hours, supporting once-daily dosing. Etoricoxib was generally well tolerated.
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This thesis is part of the studies of gender bias in health which together with the paradigm of evidence-based medicine shares the empirical assumption that there are inaccuracies in medical practice, in addition to a lack of rigour and transparency. It worked with the distinction between the concepts of sex and gender and between the concepts of sex-related differences and gender inequalities, in terms of applying a gender perspective in the study design and the subsequent analysis. This PhD review presents the research process conducted in Spain, which can provide an example for future research. Study I described a review of 58 clinical trials (CTs) of etoricoxib to assess its compliance with the Recommendations of Evaluation of Gender Differences in the Clinical Evaluation of Drugs. In Study II, key informants from professions related to different areas in drug development and pharmacovigilance held a working meeting to reach a consensus document on recommendations for the study and evaluation of gender differences in CTs in Spain. In Study III, the websites of the eight best-selling hormone replacement therapy drugs in Spain on Google first page of results were analysed. In Study IV, a logistic regression analysis was performed to compare analgesic prescription by sex in regions with a higher or lower Gender Development Index (GDI) than the Spanish average. Gender biases identified in this thesis limited the legitimacy of medicine, which is not based on the best possible evidence. The results also demonstrate the existence of inequalities between men and women that are not due merely to biological differences, but are gender inequalities stemming from the social differences that exist between both sexes.
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The patients with acute back pain were shown to have a high incidence of comorbidities during outpatient care. The administration of NSAIDs resulted in a significant reduction in the magnitude and intensity of pain syndrome according to VAS in all the groups just on day 3 of therapy with a more marked analgesia in patients receiving etoricoxib and diclofenac. All the groups exhibited an increase in average daily systolic and diastolic BP with the most favorable profile in Group 1 patients. The intake of etoricoxib and other NSAIDs provided no evidence for changes in hemostatic parameters and biochemical markers during 10 weeks. The safety of etoricoxib was comparable with that of NSAIDs in its effect on the plasma hemostatic system.
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It was found that a combination of a single dose of prednisolone and Etorikoxib is well-suited for treatment of postoperative pain, trismus, and swelling after third molar surgery and should be used to diminish postoperative swelling of soft tissues.
Conventional NSAIDs may cause clinical relapse in about 20% of patients with quiescent IBD, which may be due to dual inhibition of the COX enzymes. Certain COX-2-selective NSAIDs appear to be safe.
We evaluated whether early response to NSAIDs predicted later response, and when this was established.
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Pachydermoperiostosis (PDP), also named primary hypertrophic osteoarthropathy (PHO: MIM 167100), is a rare genetic disease characterized by 3 major symptoms: pachydermia including cutis verticis gyrata (CVG), periostosis, and digital clubbing. Additional clinical signs and symptoms include seborrheic hyperplasia, hyperhidrosis, and arthropathy. This article is protected by copyright. All rights reserved.
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Pain is the main reason why people decide to see a doctor; hence, the widespread use of anti-inflammatory drugs which were specifically developed to control pain and inflammation. One of the main causes of pain is represented by osteoarticular conditions, the most common one being arthrosis. Paracetamol is universally indicated as the therapy of first choice in degenerative pathologies of the joints, although it is often insufficient to control adequately the clinical picture and less efficacious than anti-inflammatory drugs. These latter, however, especially when taken chronically, exhibit an unfavourable safety profile. The most common side effect of anti-inflammatory drugs is gastric discomfort; coxibs - COX-2 selective inhibitors - were developed to solve this problem. The use of these drugs, relative to conventional NSAIDs, is associated to a significantly lesser gastroduodenal ulcer rate and to fewer clinically relevant complications, as well as to a smaller rate of treatment discontinuation due to gastrointestinal (GI) symptoms. From a clinical and practical standpoint, the use of coxibs is associated to a remarkably reduced risk of gastroduodenal lesions, similar as the one resulting from the combination of a conventional NSAID and a proton-pump inhibitor. By adding a proton-pump inhibitor to a coxib, such risk seems to become virtually non-existent, even in a high risk population and regardless of ASA administration. It is important to stress that the better tolerability of coxibs does not imply an inferior anti-inflammatory and pain-relieving efficacy, especially with regard to etoricoxib, whose efficacy is at least equivalent as other competing NSAIDs, even in quite severe and complex musculoskeletal pain models. This clear-cut advantage of coxibs at gastric level clashed against a documented increased cardiovascular (CV) risk, which led to the much-talked-about withdrawal of rofecoxib from the market. The most credited pathogenetic hypothesis to explain the association between chronic use of coxibs and CV risk seems to be related to a trombophilic effect due to an imbalance of prothrombotic and antithrombotic factors. Several observational and case-control studies, however, led to suspect that conventional NSAIDs share with coxibs an increased cardiovascular risk; such suspicion was experimentally confirmed by the MEDAL trial. In this trial, the cardiovascular risk of thrombosis among patients who were treated on a long-term basis with a coxib (etoricoxib) was shown to be similar as the risk observed in patients receiving a conventional NSAID (diclofenac). In conclusion, coxibs represent a valid therapeutic option in the treatment of patients with osteoarticular conditions. In terms of cardiovascular risk their efficacy is associated to a similar safety profile as conventional NSAIDs, whereas the gastrointestinal risk related to coxibs seems to be significantly lesser.
A total of 52 patients were selected for the study and the data of 44 patients were analyzed. In the control group, the average level of pain in the first session was 7.68 (standard deviation 1.70), dropping to an average of 7.32 (standard deviation 1.39) after ingestion of placebo. Therefore, there was no statistical difference (p = 0.1187). In contrast, the average level of pain without the drug in the group taking etoricoxib 120 mg was 7.95 (standard deviation 1.46) vs 5.18 (standard deviation 1.65) with the drug, a significant statistical difference (p<0.001).
On the basis of the evidence in this review, we recommend the use of ISBs as the most effective analgesic for outpatient arthroscopic shoulder surgery.
The aim of the present study was to improve solubility and dissolution of the poorly aqueous soluble drug, etoricoxib by solvent evaporation technique using various sugar carriers, such as lactose, sucrose, and mannitol. Etoricoxib solid dispersions and their respective physical mixtures using lactose, sucrose, and mannitol were prepared in different ratios by solvent evaporation technique. The percent yield, drug content, saturation solubility, and in vitro dissolution of etoricoxib solid dispersions and physical mixtures were analyzed. Etoricoxib solid dispersions were characterized by FTIR spectroscopy, XRD, and DSC analysis. The FTIR spectroscopic analysis revealed the possibility of intermolecular hydrogen bonding in various solid dispersions. The XRD and DSC studies indicated the transformation of crystalline etoricoxib (in pure drug) to amorphous etoricoxib (in solid dispersions) by the solid dispersion technology. Both the aqueous solubility and dissolution of etoricoxib were observed in all etoricoxib solid dispersions as compared with pure etoricoxib and their physical mixtures. The in vitro dissolution studies exhibited improved dissolution in case of solid dispersion using lactose than the solid dispersions using both sucrose and mannitol. The in vitro dissolution of etoricoxib from these solid dispersions followed Hixson-Crowell model.
Electronic databases were searched up to November 2003. Industry submissions to the National Institute for Health and Clinical Excellence (NICE) in 2003 were also reviewed.
We evaluated etoricoxib, a novel COX-2-specific inhibitor, in 319 patients with chronic low back pain (LBP) in this double-blind, placebo-controlled trial. Patients were randomized to a 60 mg dose (n = 103) or 90 mg dose (n = 107) of etoricoxib, or placebo (n = 109), daily for 12 weeks. The primary endpoint was low back pain intensity scale (Visual Analog Scale of 0- to 100-mm) time-weighted average change from baseline over 4 weeks. Other endpoints included evaluation over 3 months of low back pain intensity scale, Roland-Morris Disability Questionnaire (RMDQ), low back pain bothersomeness scale, patient- and investigator-global assessments, Patient Health Survey (MOS SF-12), rescue acetaminophen use, and discontinuation due to lack of efficacy. Etoricoxib provided significant improvement from baseline versus placebo in pain intensity (4 weeks: 12.9 mm and 10.3 mm for 60-mg and 90-mg doses, P <.001 for each; 12 weeks: 10.5 mm and 7.5 mm for 60-mg and 90-mg doses, P =.001 and.018, respectively). Etoricoxib at either dose led to significant improvement in other endpoints, including RMDQ scores, bothersomeness scores and global assessments. Etoricoxib given once daily provided significant relief of symptoms, and disability associated with chronic LBP that was observed 1 week after initiating therapy, was maximal at 4 weeks, and was maintained over 3 months.
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We investigated the role of prostaglandin E2 in reptilian regeneration. Prostaglandin E2 is known to play a vital role during wound healing and cell proliferation. A significant delay in the rate of growth of regenerate after autotomy was observed when the production of prostaglandin E2 was blocked by usage of specific cyclooxygenase inhibitors as compared to control animals and this delay continued to all the defined stages of regeneration. Therefore, prostaglandin E2 could be one of the essential requirements for a successful process of regeneration.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most commonly prescribed analgesics for treatment of variety of pain and inflammatory conditions. Their effects on the gastrointestinal tract are well described, but their possible propensity to cause clinical relapse in patients with inflammatory bowel disease (IBD) remains somewhat unclear.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Oxford Pain Database, ClinicalTrials.gov, and reference lists of articles. The date of the most recent search was 3 January 2012.
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To summarise the efficacy of pharmaceutical interventions for acute pain in adults with at least moderate pain following surgery who have been given a single dose of oral analgesic.