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Both nonsteroidal anti-inflammatory drugs, such as ibuprofen, and the prototypical selective cyclooxygenase (Cox)-2 inhibitors DuP-697 and NS-398 block the inhibition of Cox-1 by aspirin in vitro. However, clinical studies have shown that the Cox-2 selective drugs (or coxibs) rofecoxib and etoricoxib, at therapeutic doses, do not interfere with the antiplatelet effect of aspirin, in contrast to ibuprofen. Here, we have evaluated the relative potential of ibuprofen and various coxibs to interfere with the inactivation of Cox-1 by aspirin by using purified enzyme and calcium ionophore-activated human platelets. The irreversible inactivation of Cox-1 by aspirin can be antagonized by ibuprofen and coxibs, albeit with widely different potencies. The rank order of potencies for this process (ibuprofen > celecoxib > valdecoxib > rofecoxib > etoricoxib) parallels that obtained for the inhibition of Cox-1-mediated thromboxane B(2) production by calcium ionophore-stimulated platelets. The antagonism of aspirin therefore likely involves a competition at the enzyme active site. The EC(50) value for the antagonism against 10 microM aspirin for each drug is approximately 10- to 40-fold lower than the corresponding IC(50) value for inhibition of platelet Cox-1 activity, consistent with the much weaker initial binding of aspirin to Cox-1 as compared with arachidonic acid. These results show that a low affinity for Cox-1 and a high degree of Cox-2 selectivity confers a low potential to block aspirin inhibition of platelet Cox-1, consistent with the results of clinical studies.
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Although the causative antibodies were drug dependent usually leading to abrupt and intravascular hemolysis, the patient only gradually developed anemia. These findings together with a positive direct and indirect antiglobulin test may lead to confusion with autoimmune hemolytic anemia of warm type. A nonreactive eluate was the key serologic finding in identifying drug-induced immune hemolytic anemia in this case.
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The aim of this study was to compare the pharmacokinetic properties of two etoricoxib (CAS 202409-33-4) 60 mg formulations, namely Etocox-60 (test product) and reference product, and to evaluate whether these two formulations meet the FDA criteria to assume bioequivalence. Twenty-four healthy volunteers were enrolled into this randomized, single-dose, 2-way crossover, open-label pharmacokinetic study. Subjects were randomly assigned to receive the test formulation followed by the reference formulation or vice versa as a single dose of 60 mg tablets after 12 h overnight fasting, with a washout period of two weeks. Following oral administration, blood samples were collected at 0 (baseline), 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0, and 120.0 h. Serum concentration of etoricoxib was assessed using a high performance liquid chromatographic-UV spectrometry procedure. The pharmacokinetic parameters were determined by the non-compartmental method. After administering a single dose of 60 mg of each etoricoxib formulation, the obtained mean (SD) values for the test and reference products were 1.26 (0.33) and 1.29 (0.35) microg/ml for Cmax; 3.25 (2.64) and 2.63 (1.40) h for t(max); 29.63 (8.31) and 30.40 (5.85) h x microg/ml for AUC0-120; and 31.84 (10.97) and 33.00 (8.10) h x microg/ml for AUC0-infinity, respectively. The mean t1/2 was found 27.99 (7.87) h and 29.84 (7.93) h for test and reference product respectively. From paired t-test, no significant differences were observed (p > 0.05) for any pharmacokinetic parameters. After analysis of variance, no period, sequence or formulation effects were observed for any pharmacokinetic property. The 90% confidence intervals of the test/reference mean ratios of the 1n-transformed AUC0-120, AUC0-infinity and Cmax mean values were 95.90% (85.37%-107.74 %), 94.69% (84.43%-106.20%) and 97.87% (85.54 %-111.98 %), respectively, which fell within the predetermined FDA bioequivalence range of 80%-125%. This single-dose study found that the test and reference formulations of etoricoxib met the regulatory criteria for bioequivalence in terms of both rate and extent of absorption.
We identified 486 076 unique patient-drug pairs in UK and 1 533 239 in USA. In UK population 78 201 (16%) were COX-2 users and in PharMetrics 324 206 (21%) were COX-2 users. Diclofenac and ibuprofen (NSAIDS), and celecoxib and rofecoxib (COX-2) were the agents prescribed most frequently. The duration of therapy was longer among celecoxib and rofecoxib users than among other users. More COX-2 users than NSAIDS users received concomitant gastroprotective agents (GPA), corticosteroids and anti-platelet therapy, and had a history of thromboembolic events and hypertension. PharMetrics patients were prescribed higher doses of NSAIDS and COX-2. The use of any single agent for more than 90 days was uncommon, but more frequent in PharMetrics. Switching was uncommon and was generally to a NSAID.
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In spite of numerous studies demonstrating the serious gastrointestinal (GI) toxicity associated with non-selective non-steroidal anti-inflammatory drugs (NSAIDs), many patients at high GI risk continue to receive prescriptions for these drugs, often without gastroprotective agents. Etoricoxib, a COX-2 specific inhibitor, was developed to provide similar efficacy and less GI toxicity than non-selective NSAIDs. We compared the incidence of upper GI Perforations, symptomatic gastroduodenal Ulcers, and upper GI Bleeding (PUBs) in a combined analysis of all randomized, double-blind, clinical trials of chronic treatment with etoricoxib versus NSAIDs completed by June 2003.
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Postoperative pain and fentanyl consumption were significantly reduced by methylprednisolone, etoricoxib and their combination when compared with placebo (P<0.05). The methylprednisolone + etoricoxib combination caused a significant reduction in postoperative pain and fentanyl consumption as compared to methylprednisolone or etoricoxib alone (P<0.05); however, there was no significant difference between the methylprednisolone and etoricoxib groups (P>0.05). The methylprednisolone and methylprednisolone + etoricoxib combination significantly reduced the incidence and severity of PONV and fatigue as well as the total number of patients requiring an antiemetic treatment compared to the placebo and etoricoxib (P<0.05).
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Assessment of correlation of measures of low back pain (LBP) using data pooled from 2 identical studies.
Double-blind, randomized, placebo and active comparator-controlled, 12-week study conducted at 67 sites in 28 countries. Eligible patients were chronic NSAID users who demonstrated a clinical worsening of arthritis upon withdrawal of prestudy NSAIDs. Patients received either placebo, etoricoxib 90 mg once daily, or naproxen 500 mg twice daily (2:2:1 allocation ratio). Primary efficacy measures included direct assessment of arthritis by counts of tender and swollen joints, and patient and investigator global assessments of disease activity. Key secondary measures included the Stanford Health Assessment Questionnaire, patient global assessment of pain, and the percentage of patients who achieved ACR20 responder criteria response (a composite of pain, inflammation, function, and global assessments). Tolerability was assessed by adverse events and routine laboratory evaluations.
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In both groups we found a significant reduction of pain in the days following surgery. At 30 days the VAS score was similar in between the two groups. Few and mild side effects were reported (1 case).
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The results show that analgesics and lasers are effective in the management of orthodontic pain at its peak intensity. Further research is required to improve the quality of evidence, especially for analgesic interventions.
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Etoricoxib at doses of 90 mg and 120 mg demonstrated superior efficacy compared with placebo over 6 weeks, and compared with naproxen over 1 year. These study results demonstrate that etoricoxib is generally safe, well-tolerated, and efficacious for the treatment of AS.
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To assess the gastrointestinal safety of the cyclo-oxygenase-2-selective inhibitor etoricoxib vs. non-selective non-steroidal anti-inflammatory drugs.
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All anaesthesia and surgery was uneventful, no complications or adverse events were noticed. The mean end-tidal sevoflurane concentration intra-operatively was 1.25 (SD 0.2) and 0.91 (SD 0.2) for the pre and post-operative administered group of patients respectively (p < 0.0001). No other intra-operative differences could be noted. Emergence and recovery was rapid and no difference was noticed in time to discharge-eligible mean 52 minutes in both groups studied. In all 6 patients, 5 in the group receiving etoricoxib post-operatively, after surgery, and one in the pre-operative group required rescue analgesia before discharge from hospital. No difference was seen in pain or need for rescue analgesia, nausea or patients satisfaction during the first 24 postoperative hours.
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This study explored the role of intrinsic mitochondrial membrane potential (DeltaPsiM) in etoricoxib-mediated apoptosis in 1,2-dimethylhydrazine dihydrochloride (DMH) induced colon cancer. Male Sprague--Dawley rats were divided into four groups: control, DMH, DMH+etoricoxib and etoricoxib. After 6 weeks of treatment period, animals were killed and colons were analyzed for morphological and histopathological features. Well-characterized preneoplastic aberrations such as multiple plaque lesions, hyperplasia and dysplasia were found in the DMH-treated group whereas these features were reduced with coadministration of etoricoxib and DMH. DeltaPsiM was assessed by 5,5',6,6'-tetrachloro-1,1',3,3' tetraethylbenzimidazol carbocyanine iodide (JC-1) fluorescent staining of the isolated colonocytes. DMH treatment led to a significant increase in DeltaPsiM which was found to be low in the DMH+etoricoxib group. The expression of important proapoptotic proteins, cytochrome C and Bax, were analyzed by western blot and immunohistochemistry. DMH treatment reduced the expression of Bax and cytochrome C whereas etoricoxib promoted the expression of the same. Protein expression of antiapoptotic protein Bcl-2 was also studied in colonic mucosa and was found high in the DMH-treated group and low in DMH+etoricoxib treated animals. Etoricoxib treatment may exert its chemopreventive action in colon carcinogenesis by modulating the DeltaPsiM.
Treatment with non-steroidal anti-inflammatory drugs (NSAID) is a common component of treatment regimens for rheumatoid arthritis (RA). Etoricoxib is a COX-2 selective NSAID that has demonstrated efficacy in the treatment of RA at a dose of 90 mg. The current study further evaluated the efficacy of etoricoxib 60 mg and 90 mg in RA patients with active disease.
The effect of administering etoricoxib was not superior to placebo in reducing the morphine dose required for postoperative analgesia. The lack of changes in peripheral nociception suggests that central algetic mechanisms are of higher impact in the development of postoperative pain following abdominal or thoracic surgery.
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The patients were randomised into one of three groups: the ETORICOX-PREOP group received etoricoxib 120 mg orally 1 h before surgery, one placebo pill at the end of surgery and a further 120 mg etoricoxib after 24 h; the ETORICOX-POSTOP group received one placebo pill 1 h before surgery and etoricoxib 120 mg at the end of surgery and after 24 h. The PLACEBO group received one placebo pill 1 h before surgery, one at end of surgery and a third after 24 h.
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In total, 1015 subjects were randomized to receive etoricoxib 60 mg (N = 702), etoricoxib 90 mg (N = 156), and naproxen 1000 mg (N = 157); 70.9 % were male and the mean age was 45.2 years. There were 919 subjects who completed Part I and all continued to Part II. In Part I, SPI change was non-inferior for both etoricoxib doses vs. naproxen. In both Part I and II, the incidence of adverse events (AEs), drug-related AEs, and serious adverse events (SAEs) were similar between the 3 treatment groups.
Coxib premedication before elective day surgery has an anaesthetic sparing potential.
Management guidelines for drug-drug interactions between non-steroidal anti-inflammatory drugs (NSAIDs) and antihypertensives recommend blood pressure monitoring in hypertensive patients. We measured the short-term effect of initiating NSAIDs on systolic blood pressure (SBP) in users of antihypertensives, aiming to investigate which outpatients are at risk for an increase in SBP in daily clinical practice.
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The objective of this study was to evaluate the efficacy and safety associated with treatment available to prevent an acute attack of gout when initiating a urate-lowering therapy (ULT). We retrospectively reviewed patients who were diagnosed with gout and treated with ULT during the period from January 2000 to January 2014. They were divided into three groups, 75 patients without prophylaxis treatment, 103 patients treated with etoricoxib, and 129 patients with colchicine treatment. Both demographic and clinical characteristics associated with gout were analyzed. At baseline, demographic and clinical characteristics were generally similar in three groups. SU target level was achieved in 49.3% of the patients without prophylaxis treatment, 66.4% in the etoricoxib group and 65.1% in colchicine group, respectively. During the first 16 weeks, patients without prophylaxis treatment exhibited higher flare rates than patients in other two groups. However, no statistically significant difference was observed between patients in etoricoxib group and colchicine group. In the 16-24 weeks, the proportion of patients who reported flares were all decreased similarly in three groups. The mean number of acute gout flares per patient and gout flare days per patient was significantly higher in patients without prophylaxis treatment than patients in other groups. The mean number of acute gout flares was lower (4.2±2.3 vs 3.2±1.8) in patients with etoricoxib treatment than that in patients with colchicine treatment. Gout flare days per patient were significantly higher in patients without prophylaxis treatment. Compared to colchicine group, gout flare days per patient in etoricoxib were lower (1.2±0.5 vs 2.6±0.6). In term of AEs, patients receiving colchicine had higher rates of gastrointestinal AEs than those who received etoricoxib. In summary, our survey revealed that etoricoxib was more effective and safe than colchicine in preventing acute attack during ULT.
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Etoricoxib, a selective inhibitor of cyclooxygenase 2, is increasingly used in pain relief. Here, we report the first case of etoricoxib-induced immune hemolytic anemia.
A total of 74 patients (mean age 37; range: 16-72 years) underwent provocation tests to etoricoxib. Of these, 59% were female. Majority were Chinese (69%), followed by Malay (12%), Caucasian (8%), Indian (5%) and various other races (6%). Forty-six percent of the study population had atopic comorbidities, and 4% had concomitant chronic urticaria. Eighty percent of patients had a history of intolerance to 1 NSAID, while the rest (20%) had intolerance to multiple NSAIDS. Forty-one percent of patients had concomitant acetaminophen intolerance. Some of the patients had multiple symptoms on presentation, the most common of which were periorbital and facial edema (90%), breathing difficulties (26%) and urticaria (25%), with the onset of reaction occurring mostly within 30 minutes to 1 hour. Etoricoxib was tolerated in 95% of the patients. Subjects who reacted to the challenge all had mild reactions which resolved with antihistamines.
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A cohort study with a nested case-control design in Dutch community pharmacies.