LIA did not provide any extra analgesic effect after THA over and above that from the multimodal analgesic regimen used in this study.
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.
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The effects of etoricoxib on blood coagulation parameters were evaluated, along with acetylsalicylic acid, in male Wistar rats. Blood samples were collected at the end of the first, second, third and fourth weeks of the administration period and the plasma concentrations of etoricoxib determined by liquid chromatography-tandem mass spectrometry; the samples were also used for the analysis of the hematological parameters. There were no significant changes in the platelet count and fibrinogen levels, and a decrease by 1.9% of the prothrombin time was detected at the third week. The activated partial thromboplastin time assay showed a nonsignificant shortening. The antiactivated factor X and antiactivated factor II activities showed reductions lower than 2.8 and 1.3%, respectively. These findings and the comparison with acetylsalicylic acid can be helpful to support the benefit-to-risk profile, contributing to the safe therapeutic use.
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Therapy with nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) has long been the cornerstone of pharmacologic management of patients with osteoarthritis (OA) and rheumatoid arthritis (RA). Many patients with OA or RA, however, are at increased risk of developing clinically significant adverse events associated with NSAID therapy, particularly upper gastrointestinal (GI) complications including symptomatic and complicated ulcers. The introduction of cyclooxygenase (COX)-2-selective inhibitors (coxibs) represents a major advance in the pharmacologic approach to the signs and symptoms of arthritis. In addition to the first two members of this class, celecoxib and rofecoxib, other coxibs have been introduced or are in development (valdecoxib, etoricoxib). In numerous clinical trials, coxibs have been shown to be as effective as nonselective NSAIDs in relieving pain and inflammation associated with OA and RA, and notably, with a significantly lower risk of NSAID-type adverse events. The use of coxibs to treat OA and RA is recommended as first-line therapy when symptoms of pain and inflammation are present in patients vulnerable to potential NSAID-associated GI toxicity.
Etoricoxib was well tolerated, without any signs of immediate or delayed hypersensitivity in aspirin- and nonsteroidal anti-inflammatory drug-induced asthmatic patients. None of 77 study patients experienced any symptoms or developed dyspnea, change in nasal examination, significant variation in peak expiratory flow rate greater than 20%, or decline in forced expiratory volume in 1 second greater than 15% during etoricoxib challenge. The exact 1-sided confidence interval for the probability of etoricoxib inducing cross-reactions in patients with AERD was 0% to 2%.
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The present work focuses on the anti-neoplastic role of non steroidal anti-inflammatory drugs (NSAIDs) in modulating the biophysical parameters of the colonic membranes in 1,2-dimethylhydrazine dihydrochloride (DMH) induced carcinogenesis. The steady-state fluorescence polarization technique was applied to assess membrane fluidity, membrane polarity and lipid phase states. The decline in cholesterol content, biosynthesis and cholesterol: phospholipids ratio with DMH treatment indicates more fluidity associated with carcinogenesis. The DMH group had shown lower order parameter indicating more fluidity whereas NSAIDs resulted in increasing the membrane lipid order. The converging effects of these changes were more in membrane phase separations and membrane phase state. In DMH treatment membrane shows lesser phase separation or high polarity, and more liquid crystalline state while for NSAID groups membranes have higher phase separations or low polarity, and more of the gel phase. Further, NSAIDs induced anti-proliferative effects were evidently observed by apoptosis in the colonocytes by using acridine orange-ethidium bromide fluorescent staining and Terminal de-oxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay. The results suggest that NSAIDs induced alteration in the membrane biophysical parameters may be an important initiating event for the chemopreventive action.
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We identified systematic reviews in the Cochrane Database of Systematic Reviews in The Cochrane Library through a simple search strategy. All reviews were overseen by a single review group, had a standard title, and had as their primary outcome the number of participants with at least 50% pain relief over four to six hours compared with placebo. For individual reviews, we extracted the number needed to treat for an additional beneficial outcome (NNT) for this outcome for each drug/dose combination, and also the percentage of participants achieving at least 50% maximum pain relief, the mean of mean or median time to remedication, and the percentage of participants remedicating by six, eight, 12, or 24 hours. Where there was adequate information for pairs of drug and dose (at least 200 participants, in at least two studies), we defined the addition of four comparisons of typical size (400 participants in total) with zero effect as making the result potentially subject to publication bias and therefore unreliable.
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Six databases including Medline and EMBASE.
The purpose of the present study was to investigate whether paracetamol, ketorolac and etoricoxib can hinder alveolar bone formation, taking the filling of rat extraction socket with newly formed bone as experimental model.
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At the start of the study period, use of coxibs showed no growth. At the date when prior authorization of celecoxib was removed (November 2006), however, DDD/TID of the coxib whose prior authorization had not been removed - namely etoricoxib - remained unchanged, whereas consumption of celecoxib increased significantly (by the end of the study period, celecoxib use displayed a relative increase of 615% in terms of the DDD/TID prescribed before the removal of its prior authorization requirement). Similarly, etoricoxib use remained unchanged until its prior authorization was removed (February 2007), from which time DDD/TID of etoricoxib also underwent a considerable increase (by the end of the study period, etoricoxib use displayed a relative increase of 793% in terms of the DDD/TID prescribed before the removal of its prior authorization). Segmented regression analysis showed a sharp, statistically significant rise and change in slope in both celecoxib and etoricoxib use immediately after removal of their respective prior authorizations.
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These data indicate that both etoricoxib and meloxicam are good alternatives for treatment in older children with hypersensitivity to NSAIDs.
The method is based on baseline manipulation (difference) spectroscopy where the amplitudes at 274 and 351 nm were selected to determine ETR and DRT, respectively, in combined formulation and methanol was used as solvent. Both the drugs obey Beer's law in the concentration ranges of 4-20 μg/mL for DRT and 4.5-22.5 μg/mL for ETR.
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Thermodynamic properties of amorphous pharmaceutical forms are responsible for enhanced solubility as well as poor physical stability. The present study was designed to investigate the differences in thermodynamic parameters arising out of disparate molecular structures and associations for four structurally related pharmaceutical compounds--celecoxib, valdecoxib, rofecoxib, and etoricoxib. Conventional and modulated temperature differential scanning calorimetry were employed to study glass forming ability and thermodynamic behavior of the glassy state of model compounds. Glass transition temperature of four glassy compounds was in a close range of 327.6-331.8 K, however, other thermodynamic parameters varied considerably. Kauzmann temperature, strength parameter and fragility parameter showed rofecoxib glass to be most fragile of the four compounds. Glass forming ability of the compounds fared similar in the critical cooling rate experiments, suggesting that different factors were determining the glass forming ability and subsequent behavior of the compounds in glassy state. A comprehensive understanding of such thermodynamic facets of amorphous form would help in rationalizing the approaches towards development of stable glassy pharmaceuticals.
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The open prospective follow-up by a simple randomization method included 80 patients, including 49 women and 31 men (mean 60.8±4.7 years). The patients were randomized into 4 groups of 20 persons each: 1) etoricoxib 90 mg/day; 2) nimesulide 100 mg/day; 3) diclofenac 100 mg/day; 4) meloxicam 15 mg/day. The investigation lasted 90±4.5 days. The interim evaluation criteria (study points) were pain changes using a visual analog scale (VAS); blood pressure (BP) changes; diurnal BP rhythm; and changes in coagulation hemostatic parameters and blood biochemical markers. The primary evaluation criteria (study endpoints) were the incidence of CVE in the use of nonsteroidal anti-inflammatory drugs (NSAIDs).
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The enzyme cyclooxygenase (COX) was shown to exist as two distinct isoforms about a decade ago. COX-1 is constitutively expressed as a 'housekeeping' enzyme in nearly all tissues, and mediates physiological responses (e.g. cytoprotection of the stomach, and platelet aggregation). On the other hand, COX-2, expressed by cells involved in inflammation (e.g. macrophages, monocytes, synoviocytes), has emerged as the isoform that is primarily responsible for the synthesis of prostanoids involved in acute and chronic inflammatory states. Consequently, the hypothesis that selective inhibition of COX-2 might have therapeutic actions similar to those of non-steroidal anti-inflammatory drugs, but without causing gastrointestinal side effects, was the rationale for the development of selective inhibitors of the COX-2 isoenzyme. Selective COX-2 inhibitors currently used in the clinic are the sulphonamides celecoxib and valdecoxib (parecoxib is a prodrug of valdecoxib), as well as the methylsulphones rofecoxib and etoricoxib. Furthermore, the phenylacetic acid derivative lumiracoxib has gained permission recently to be marketed in Europe. This review discusses the clinically relevant similarities and differences of these substances, with particular emphasis on their diverse pharmacokinetic characteristics.
We performed a national register-based cohort study on patients with AS or SpA (n = 21,872) identified in the Swedish national patient register from 1987-2009. Treatment exposure was assessed time dependently based on the prescription drug register from 2006-2009, adjusting for sociodemographics and comorbidities derived from national population-based registers.
In the 1990s, the pharmaceutical industry developed selective COX-2 inhibitors (coxibs) as alternatives to conventional nonsteroidal anti-inflammatory drugs (NSAIDs), with the expectation of similar analgetic and anti-inflammatory efficacy but a reduced risk of adverse gastrointestinal (GI) effects. Marketing authorisation (MA) was granted for rofecoxib and celecoxib as first representatives of this new pharmacological class at the end of the 1990s in the EU. In the following years MAs were granted for the 'second generation' coxibs etoricoxib, parecoxib/valdecoxib and lumiracoxib. However, data from large clinical 'outcome studies' as well as epidemiological data raised concerns about the cardiovascular (CV) safety of the coxibs. In consequence, two comprehensive review processes (referrals) were initiated by the European Medicines Agency (EMEA). As a result, in the EU the use of coxibs has been contraindicated in patients with established coronary heart disease, cerebrovascular disease and peripheral arterial disease and a number of warning statements concerning CV, GI and skin toxicity have been introduced in the coxib product informations. This article provides a description of the regulatory actions taken and discusses some specific aspects of the past and future regulatory assessment of coxibs.
In the 12-week placebo- and active comparator-controlled period of a randomized, double-blind study, eligible patients were treated with etoricoxib 60 mg once daily (n = 224), naproxen 500 mg twice daily (n = 221), or placebo (n = 56). Western Ontario McMaster's Osteoarthritis Index (WOMAC) pain and physical function subscales and patient's global assessment of disease status were primary end points. Key secondary and other end points were patient's and investigator's global assessment of response to therapy, WOMAC stiffness subscale, investigator's global assessment of disease status, rescue paracetamol use, proportion of patients discontinuing due to lack of efficacy, and study joint tenderness.
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There were 588 patients initially randomized to placebo (n=46), etoricoxib 120 mg once daily (n=97), etoricoxib 90 mg once daily (n=191), ibuprofen 600 mg every 6 hours (n=192), and acetaminophen 600 mg/codeine 60 mg (A/C) every 6 hours (n=62) after third-molar extraction (≥2, ≥1 impacted) in a double-blind controlled trial. Patients were allowed flexible dosing on days 2 and 3; 46, 96, 190, 192, and 56 patients on placebo, etoricoxib 120 mg, etoricoxib 90 mg, ibuprofen, and A/C, respectively, continued to Day 2 of the study. Outcomes included Average and Worst Recall Pain Assessments (0 to 10 scale) and Global Assessments of Study Medication (0 to 4 scale). Rescue medication (acetaminophen 325 mg up to 4 times daily) usage was evaluated. Adverse experiences were collected and evaluated.
This randomized, double-blind, active-control study included sixty patients with clinical pulpal diagnosis of necrosis of the first mandibular molar and an associated periapical radiolucency who experienced severe pain (more than 60 out of 100 in scale of Visual Analog Scale (VAS). The patients were equally randomized into four groups, who received 60 mg etoricoxib (group 1), 90 mg etoricoxib (group 2), 120 mg etoricoxib (group 3), and 400 mg ibuprofen (group 4). All patients randomly received a single dose of the drug after the first session of the root canal therapy. Using VAS, the severity of pain was recorded 2, 4, 6, 12, 24, 48, and 72 hours after the drug was administered.
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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.
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To compare the efficacy of etoricoxib, lumiracoxib, celecoxib, non-selective (ns) NSAIDs and acetaminophen in the treatment of osteoarthritis (OA) METHODS: Randomized placebo controlled trials investigating the effects of acetaminophen 4000mg, diclofenac 150mg, naproxen 1000mg, ibuprofen 2400mg, celecoxib 100-400mg, lumiracoxib 100-400mg, and etoricoxib 30-60mg with treatment duration of at least two weeks were identified with a systematic literature search. The endpoints of interest were pain, physical function and patient global assessment of disease status (PGADS). Pain and physical function reported on different scales (VAS or LIKERT) were translated into effect sizes (ES). An ES 0.2 - 0.5 was defined as a "small" treatment effect, whereas ES of 0.5 - 0.8 and > 0.8 were defined as "moderate" and "large", respectively. A negative effect indicated superior effects of the treatment group compared to the control group. Results of all trials were analyzed simultaneously with a Bayesian mixed treatment comparison.
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Administering cyclooxygenase-2 inhibitors preoperatively appears attractive since these drugs reduce post-operative pain, but do not increase the risk of post-operative bleeds, asthmatic attacks and stress-related gastrointestinal ulcers. In a former investigation, we could show that post-operative administration of etoricoxib reduces prostaglandin production in wound fluid, but the onset of action is variable due to delayed post-operative absorption.
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The model suggests that etoricoxib is cost saving compared with non-selective NSAIDs plus PPIs or non-selective NSAIDs plus misoprostol. The model also suggests that etoricoxib is cost effective in terms of the incremental cost per QALY gained for non-selective NSAIDs alone (pound 19,766) and for non-selective NSAIDs plus H2 antagonists (pound 9350). The incremental cost of etoricoxib per PUB avoided was pound 12,446 versus non-selective NSAIDs alone and pound 6438 versus NSAIDs co-prescribed with H2 antagonists. For patients without the presence of specific GI risk factors (history of GI event, corticosteroid use or disability), etoricoxib may be cost effective for patients over age 56 years, assuming a cost-effectiveness threshold of pound 30,000 per QALY gained. Etoricoxib may also be cost effective in patients of all ages who had at least one specific GI risk factor.
Much information is available on the role of nitric oxide (NO) in osteoarthritis (OA). However, its role has not been studied in the monosodium iodoacetate (MIA)-induced model of osteoarthritic pain. The present study was undertaken in rats to investigate the effect of iNOS inhibitor S-methylisothiourea (SMT) in MIA-induced osteoathritic pain and disease progression in rats. Osteoarthritis was produced by single intra-articular injection of the MIA in the right knee joint on day 0. Treatment groups were orally gavazed with different doses of SMT (10, 30 and 100mg/kg) and etoricoxib (10mg/kg) daily for 21 days. On days 0, 3, 7, 14 and 21, pain was measured and histopathology of right knee joint was done on day 21. SMT produced analgesia in a dose-dependent manner as shown by mechanical, heat hyperalgesia, knee vocalization, knee squeeze test, and spontaneous motor activity test. SMT reduced NO production in synovial fluid. Histopathological findings indicated that SMT reduced disease progression as evident from complete cartilage formation in rats treated with SMT at 30 mg/kg. In conclusion, the results indicate that SMT attenuates the MIA-induced pain and histopathological changes in the knee joint. The antinociceptive and antiarthritic effects of SMT were mediated by inhibiting cartilage damage and suppression of NO in synovial fluid. It is suggested that SMT has potential as a therapeutic modality in the treatment of osteoarthritis.
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For every 2 patients treated with etoricoxib, 1 achieved a clinically meaningful (≥30%) improvement in spine pain and BASDAI beyond that expected from placebo, whereas the corresponding values were approximately 1 in every 3 patients treated with naproxen. Use of NNTs and responder analyses provide additional, complementary information beyond population mean responses when assessing efficacy compared to placebo and amongst active therapies.