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We obtained spontaneous reports of these adverse events for diclofenac, nabumetone, naproxen, and piroxicam. Published epidemiologic studies of these events were reviewed.
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1 Fifty-seven elderly patients with primary osteoarthritis of the hip and knee were entered into a double-blind, randomized, controlled parallel group trail to compare the efficacy and tolerability of isoxicam (maximum = 200 mg day-1) and piroxicam (maximum = 20 mg day-1). 2 Clinical assessments were made following a 1 week NSAID-free washout period and at biweekly intervals during the next 6 weeks of active treatment. 3 The majority of patients in both groups experienced a clinically important and statistically significant therapeutic response. 4 No statistically significant between-group differences were noted with respect to drug efficacy. 5 One patient was withdrawn from the piroxicam group because of lack of effect, but there were no such withdrawals from the isoxicam group. 6 Five patients were withdrawn from the piroxicam group because of adverse reactions compared to only one withdrawal from the isoxicam group. 7 This study indicates that isoxicam is an efficacious and well-tolerated once-daily NSAID for elderly patients with osteoarthritis.
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Strychnos pseudoquina ST. HIL. (Loganiaceae) was investigated for its ability to protect the gastric mucosa against injuries caused by non-steroidal anti-inflammatory drugs (piroxicam) and a necrotizing agent (HCl/EtOH) in mice. The MeOH extract and enriched alkaloidic fraction (EAF) provided significant protection in experimental models wheer used at doses of 250 and 1000 mg/kg. In vivo tests were carried out to evaluate for possible toxic effects and no mortality was observed up to the 5 g/kg dose level. Phytochemical investigation led to the isolation of a new indole alkaloid, which elucidated the observed pharmacological effects.
Nonsteroidal anti-inflammatory drugs (NSAIDs) vary in their degree of gastrointestinal (GI) toxicity. NSAIDs with longer half-lives are of particular concern as they may be more toxic in the elderly.
Colonic tumors in mice carrying the Min allele of Apc were followed over several weeks using mCTC and OC. A total of 146 colonic tumors were monitored: 62 in 32 untreated Min mice, 53 in 43 Min mice treated with 5-fluorouracil (5-FU), and 31 in 17 Min mice treated with piroxicam.
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The theoretical charge density of the active pharmaceutical ingredient piroxicam (PXM) was evaluated through density functional theory with a localized basis set. To understand the electronic nature of the sulfur atom within the sulfonamide group, a highly ubiquitous functional group in pharmaceutical molecules, a theoretical charge density study was performed on PXM within the framework of Bader theory. Focus is on developing a topological description of the sulfur atom and its bonds within the sulfonamide group. It was found that sulfur d-orbitals do not participate in bonding. Instead, the existence of a strongly polarized ("ionic") bonding structure is found through a combined topological and natural bonding orbital analysis. This finding is in stark contrast to long-held theories of the bonding structure of organic sulfonamide and has important implications for the parametrization of calculations using classical approaches.
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Comparative assessment of analgesics, by employing 2 PCA apparatuses in one patient, allows evaluation of the efficacy of analgesics added to the conventional methods.
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Tenoxicam 20 mg OD was compared with piroxicam 20 mg OD for patients with rheumatoid arthritis (RA). One hundred and two patients from 5 centers were enrolled: 51 in the tenoxicam group and 51 in the piroxicam group. Evaluation of the primary efficacy variables demonstrated no difference in efficacy between treatment groups. The overall incidence of adverse clinical/laboratory experiences was similar between treatment groups. Six patients discontinued the study because of gastrointestinal intolerance, 3 from each treatment group. Our study demonstrates that tenoxicam 20 mg OD and piroxicam 20 mg OD have similar efficacy and safety in patients with active RA.
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The purpose of this review was to investigate evidence for the relationship between NSAID dose, efficacy, and the occurrence of AEs from clinical trials of RA and OA of the hip and knee.
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The present data suggests that the anti-proliferative effect of NSAIDs may not be entirely attributed to changes in the production of PGE2 and/or LTB4 in the two colon cancer cell lines. These NSAIDs may inhibit cell proliferation largely independent of their ability to modulate eicosanoid synthesis.
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Isoxicam a new nonsteroidal antiinflammatory agent was radiolabeled with 14C at the 3-position of the benzothiazine nucleus. It was well absorbed following peroral administration to man, monkey, dog, and rat, reaching peak plasma concentrations in 4-8 hr. Over 90% of the plasma radioactivity was due to unchanged drug. Plasma elimination half-lives were 22-45 hr in man and 49-53 hr in dogs and 20-35 hr in rats and monkeys. Isoxicam was distributed to most tissues in rats, but the tissue-plasma ratio did not exceed unity, indicating a small volume of distribution. It was extensively metabolized with only a few per cent of the dose appearing as unchanged drug in the urine. The principal urinary metabolite in man was formed by hydroxylation of the methyl group on the isoxozole ring and accounted for 30-35% of an isoxicam dose. In the rat, oxoacetic acid, the major urinary metabolite, was formed by opening of the benzothiazine ring followed by hydrolytic cleavage of the C-3 to N-2 bond. In addition to the hydroxymethyl and oxoacetic acid, two unknown metabolites, accounting for only a small percentage of dose, were detected in the urine of all four species. Urinary excretion of 14C activity accounted for about 60% of a dose in man and rats, 31% in monkeys, and 17% in dogs. These results indicate that there is only a quantitative rather than a qualitative species difference in the metabolic disposition of isoxicam.
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Three hours after intraplantar carrageenan (6 mg/150 microl of saline), we assessed the effects of pre-administered lornoxicam (0.1, 0.3, 1, 3 and 9 mg/kg i.v., n=10 rats for each group) on both the peripheral oedema and number of c-Fos-protein-like immunoreactive (c-Fos-LI) neurons in the lumbar L4-L5 segments, in the awake rat.
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Only randomised or quasi randomised studies were included. Other inclusion criteria included adult patients with a clinical diagnosis of renal colic due to urolithiasis, at least one treatment arm included a non-narcotic analgesic compared to placebo or another non-narcotic drug, and reporting of pain outcome or medication adverse effect. Patient-rated pain by a validated tool, time to relief, need for rescue medication and pain recurrence constituted the outcomes of interest. Any adverse effects (minor or major) reported in the studies were included.
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Cultured rat synovial cells generate PGE2 upon stimulation with a factor derived from rate polymorphonuclear cells (Prostaglandins 27, 697, 1984). E-5110 inhibited PGE2 generation by the synovial cells. The IC50 values (microM) for inhibition of PGE2 generation were 0.026 for E-5110, 0.008 for indomethacin, 0.112 for piroxicam, 0.003 for R-830, 0.667 for BW-755C and 2.05 for benoxaprofen. Calcium ionophore A-23187-stimulated LTB4 generation by human neutrophils was inhibited by E-5110 with an IC50 value of 0.20 microM, which was similar to NDGA. The inhibition of LTB4 by E-5110 was more potent than that of R-830, BW-755C or benoxaprofen. E-5110 also inhibited superoxide generation by human neutrophils stimulated with opsonized zymosan, f-Met-Leu-Phe and phorbol myristate acetate. These results indicate that E-5110 is a potent dual inhibitor that suppresses superoxide generation.
To determine whether knockout or inhibition of sEH would attenuate the development of inflammatory bowel disease (IBD) in a mouse model of IBD in IL-10(-/-) mice.
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Solid dispersion systems of water-insoluble piroxicam in polyethylene glycol (PEG) 4000 and in urea were prepared by fusion and solvent methods and were characterized in this study. The in vitro dissolution studies showed that the dispersion systems containing piroxicam and PEG4000 or urea gave faster dissolution than the corresponding simple mixtures. The differential scanning calorimetry (DSC) study indicated that the piroxicam-PEG system prepared by the fusion method is a solid dispersion, while the piroxicam-urea system prepared by the solvent method is likely to be a solid solution of piroxicam in urea. The storage testings showed that all dispersions were stable, except that uptake of water during storage may occur in the PEG system. A single-dose study with rabbits showed that the dispersion systems provided statistically significant to a higher extent and rate of bioavailability than the corresponding physical mixture (p < 0.05).
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Etoricoxib, piroxicam, and indomethacin dose-dependently inhibited incapacitation and edema. However, only etoricoxib inhibited both mononuclear and polymorphonuclear leukocyte migration. Piroxicam inhibited only mononuclear migration, while indomethacin even increased polymorphonuclear content in inflamed synovia. Associating etoricoxib with either subeffective doses of piroxicam or indomethacin did not enhance the hyponociceptive or the antiedematogenic effect, but prevented the anti-leukocyte migration effect and increased gastric damage.
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Solubility of PXM was enhanced 2.5 times with IC. The dissolution release and amount of PXM permeated through rat small intestine was enhanced significantly with IC. Decreases in the gastric lesion index values of IC were observed than physical mixture (PM) and free PXM. The histopathological studies revealed significant reduction in ulceration in rat stomach after treatment with IC.
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The anti-inflammatory drug piroxicam has been reported to affect the production of reactive oxygen species in phagocytes. This anti-inflammatory effect is thought to be mediated through inhibition of cyclooxygenase (COX), an enzyme important for prostaglandin synthesis. We have compared the effects of piroxicam on superoxide production mediated by two closely related G-protein coupled receptors expressed on neutrophils, the formyl peptide receptor (FPR) and the formyl peptide receptor like 1 (FPRL1). Neutrophils were stimulated with agonists that bind specifically to FPR (the peptide ligand N-formyl-Met-Leu-Phe, fMLF) or FPRL1 (the peptide ligand Trp-Lys-Tyr-Met-Val-L-Met-NH(2), WKYMVM) or both of these receptors (the peptide ligand Trp-Lys-Tyr-Met-Val-D-Met-NH(2), WKYMVm). Piroxicam reduced the neutrophil superoxide production induced by the FPR agonist but had no significant effect on the FPRL1 induced response. Neutrophil intracellular calcium changes induced by the agonist WKYMVm (that triggers both FPR and FPRL1) were only inhibited by piroxicam when the drug was combined with the FPRL1 specific antagonist, Trp-Arg-Trp-Trp-Trp-Trp (WRW(4)), and this was true also for the inhibition of superoxide anion release. Receptor-binding analysis showed that the fluorescently labelled FPR specific ligand N-formyl-Nle-Leu-Phe-Nle-Tyr-Lys (fNLFNYK), was competed for in a dose-dependent manner, by the FPR ligand fMLF and as well as by piroxicam. We show that piroxicam inhibits the neutrophil responses triggered through FPR, but not through FPRL1 and this inhibition is due to a reduced binding of the activating ligand to its cell surface receptor.
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A scanning electron microscopy (SEM) study was performed on the gastric and duodenal mucosa of 14 patients treated with Aspirin or Piroxicam. Six patients with normal mucosal morphology were treated with either 1.5 g/day of Aspirin (3 patients) or 20 mg/day or Piroxicam (3 patients) for one month. In addition, 8 rheumatic patients were treated with a similar dose of Aspirin (4 patients) or Piroxicam (4 patients) for at least 4 months. SEM was used to evaluate the following parameters: mucosal structure, cellular exfoliation and anisocytosis, alteration of the microvilli (blebs). The mucosa showed various aspects of alterations ranging from minimal changes (microvillar alteration) to a completely subverted structure both in the stomach and in the duodenum. Mucosal changes, both on the edge of the macroscopic lesions and at a distance from these, were visible with SEM even when endoscopy was normal. Piroxicam appeared slightly less damaging than Aspirin, and no difference was observed between short-term and long-term treated patients, either with Aspirin or with Piroxicam.
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The leukotriene-dependent component of C5adesArg-induced contractile activity on guinea pig lung parenchymal strips is inhibited by cyclooxygenase inhibitors. Indomethacin simultaneously increased leukotriene release while inhibiting both cyclooxygenase-dependent mediator release and the contractile force generated. Tissue responses to LTC4 and LTD4 are also inhibited by cyclooxygenase blockade, while contractions induced by the thromboxane A2 analog, U-46619, histamine or acetylcholine are not affected. These data indicate a functional role for cyclooxygenase metabolites in leukotriene-induced contractile responses in lung.
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The effects of sodium nitroprusside (SNP) on intestinal electrolyte transport were studied in rat colon mounted in Ussing chambers. Serosal addition of SNP increases short-circuit current (Isc) in a concentration-dependent manner. The maximal change in Isc was 35.6 +/- 2.3 microA/cm2 at 1 mM SNP (ED50 approximately 81 microM). S-nitroso-N-acetylpenicillamine, a nitrosothiol which can release nitric oxide, also stimulated an increase in Isc of 13.9 +/- 3.1 microA/cm2 at a concentration of 100 microM. The response to SNP was rapid, peaking at about 4 min with partial return to baseline at 20 to 30 min. Isc responses to SNP were significantly less in the cecum and ileum as well as after mucosal addition in the distal colon. Pretreatment with serosal atropine, cimetidine, pyrilamine, ketanserin, and N omega-nitro-L-arginine and mucosal amiloride did not inhibit the SNP-stimulated Isc; iodine, methylene blue, bumetanide, piroxicam, and tetrodotoxin each significantly decreased the response and piroxicam plus tetrodotoxin abolished it. Transmural 22Na+ and 36Cl- flux studies demonstrated that the change in Isc produced by SNP was attributable to anion secretion. SNP also inhibited neutral Na+ and Cl- absorption, with the inhibition of Na+, but not Cl- absorption eliminated by tetrodotoxin and piroxicam pretreatment. In summary, SNP has several effects on intestinal electrolyte transport, suggesting that nitric oxide or other components of nitrovasodilators may be important physiological mediators of salt and water transport and may play a role in stimulated colonic epithelial electrolyte transport in inflamed tissues.
Apoptosis is a process by which external or developmental factors induce a specific series of events leading to cell death. Recently, apoptotic cells have been described in rat amnion membrane at late gestation, suggesting apoptosis may be involved in membrane rupture. Mechanisms controlling amnion cell apoptosis are unknown. The objective of this study was to investigate whether cyclooxygenase and prostaglandins are integral to apoptosis in amnion, as reported in intestinal epithelial cells and renal mesangial cells. Amnion-derived WISH cells underwent apoptosis in a dose- and time-dependent manner after incubation with actinomycin D, cycloheximide, or staurosporine, as determined by cell viability, DNA fragmentation analysis, and fluorescent in situ fragmentation analysis. Cells cultured with increasing doses of these agents also demonstrated concomitant increases in prostaglandin E2 output. WISH cell coincubation with these agents and the cyclooxygenase inhibitors indomethacin or piroxicam resulted in dose-dependent decreases in both prostaglandin E2 and apoptosis. Cultures incubated with 0.5 microgram/mL actinomycin D showed 80.7% cell apoptosis after 12 hours compared with 1.1% in untreated cultures. After 24 hours incubation with actinomycin D, 0.8% of the original cell number remained attached to the plate. In cultures coincubated with 0.5 microgram/mL actinomycin D and 100 mumol/L indomethacin, only 19.2%, 24.7%, and 39.3% of the cells were found to be apoptotic after 12, 24, and 48 hours in culture, respectively. Similar trends were observed after the use of cycloheximide or staurosporine in combination with indomethacin or prioxicam. These data suggest that cyclooxygenase and/or prostaglandins play a role in programmed cell death of amnion-derived WISH cells in culture.
A method was developed for assessing non-steroidal anti-inflammatory compounds for their potency in blocking parturition, and prolonging gestation, in the rat. This consisted of injecting compounds into groups of 10 to 13 rat dams twice daily from Day 18 through Day 22 of pregnancy, and comparing the treated dams with appropriate controls on Day 23. The rate of blocked parturition appeared to be positively related to dose of non-steroidal anti-inflammatory agent and, therefore, this model and end-point appeared to be useful for assessing different non-steroidal anti-inflammatory compounds for potency. Among the twenty-seven non-steroidal anti-inflammatory agents evaluated by this method were: ibuprofen, phenylbutazone, tolmetin, flufenamic acid, 2(p-biphenyl) acetic acid, mefenamic acid, aspirin, fenoprofen calcium, flumazole, ketoprofen, naproxen, isoxicam, indomethacin, 2(p-biphenyl) propionic acid, 2(2'-fluoro-4-biphenyl) propionic acid, flurbiprofen, sudoxicam and piroxicam. Piroxicam, sudoxicam, flurbiprofen, 2(p-biphenyl) propionic acid and 2(2'-fluoro-4-biphenyl) propionic acid showed the greatest potency. The relationship between structure and activity and between the blocking of parturition and the inhibition of prostaglandin synthesis are discussed.
A new post-chemiluminescence (PCL) reaction was observed when piroxicam was injected into the reaction mixture after the CL reaction of N-bromosuccinimide (NBS) and luminol. A possible reaction mechanism was proposed based on the studies of the CL kinetic characteristics, the CL spectra, fluorescence spectra and other experiments. A new flow injection CL method for the determination of piroxicam was established based on the PCL reaction. The relative standard deviation (RSD) for the determination of piroxicam was 1.2% (n = 11, c = 2.0 x 10(-6) g/ml). The CL intensity responded linearly to the concentration of piroxicam in the range 1.0 x 10(-7) - 1.0 x 10(-5) g/ml (r = 0.9991). The detection limit was 4.0 x 10(-8) g/ml. The method had been applied to the determination of piroxicam in tablets with satisfactory results.
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Most of the efficacy parameters showed no significant differences between the NSAIDs, although diclofenac SR was significantly better than nabumetone in one of 18 efficacy parameters. Nabumetone-treated patients experienced significantly fewer ulcer and bleeding events compared to patients treated with the comparator NSAIDs [1.1% (4/348) vs. 4.3% (15/346), P = 0.01]. Bleeding events, including outright upper or lower GI bleeding or a significant decline in haemoglobin, occurred in significantly fewer patients treated with nabumetone than with the comparator NSAIDs [1.1% (4/348) vs. 3.5% (12/346), P < 0.05]. More importantly, complications associated with either ulcers (perforation) or bleeding (leading to hospitalization or withdrawal) occurred in significantly fewer patients receiving nabumetone [0% (0/348)] than with comparator NSAIDs [1.4% (5/346), (P < 0.05)].
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NSAIDs and analgesic drugs are used intra-articularly after knee arthroscopy for pain relief. However, synovial effusion is still a common cause of delayed physical therapy. The aim of this study was to demonstrate the beneficial effect of intra-articular injection of Tenoxicam on knee effusion after arthroscopy.