Data were pooled from two replicate randomized controlled trials of 621 adult menstrual migraineurs with dysmenorrhea who treated migraine with sumatriptan-naproxen or placebo. Along with headache symptoms, nonpain menstrual symptoms (bloating, fatigue, and irritability) and menstrual pain symptoms (abdominal and back pain) were recorded at the time periods of 30 minutes and 1, 2, 4, and 4-24 hours. Relief of menstrual symptoms was compared using a Cochran-Mantel-Haenszel test. Logistic regression was used to determine the odds of a headache response with increasing numbers of moderate to severe dymenorrheic symptoms.
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Naproxen is an anti-inflammatory pharmaceutical that has been detected in natural and engineered aquatic environments. The primary aim of this research was to study chemical transformations of naproxen following chlorine oxidation, which is common in water and wastewater treatment systems. Synthetic waters containing elevated concentrations of naproxen were oxidized by free chlorine at naproxen:chlorine molar ratios of 0.02-3:1 and pH values of 5-9. The formation of naproxen products was dependent on pH, chlorine dosage and contact time. This study demonstrates that naproxen readily reacts with free chlorine and forms disinfection products. The formation of specific reaction products can vary depending on the characteristics of the water or wastewater and treatment operating conditions. More research is needed to identify intermediate and chemical reaction end products and to understand the reaction kinetics of naproxen chlorination for a range of water and wastewater treatment conditions. A secondary aim of this research was to study effects of naproxen and its chlorination products on biofilm processes, which are common in water and wastewater treatment systems and natural aquatic environments. A bioreactor was fed a naproxen solution and then fed a solution at the same naproxen concentration following contact with free chlorine. Results indicate that naproxen was not degraded biologically for the conditions of this study. In contrast, the naproxen solution containing products of chlorination caused an adverse response by discharging biomass from the bioreactor. Results therefore demonstrate that naproxen products of chlorination can adversely affect a biofilm process, which potentially can impact the performance of biofilm processes in natural and engineered aquatic environments. More research is needed to study naproxen chlorination reactions at low concentrations and in complex matrices, and to understand the toxicological relevance of naproxen and its products of chlorination in natural and engineered aquatic environments.
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These results show that misoprostol at 400-600 microg daily is significantly more effective than ranitidine in the short-term prevention of naproxen-induced gastric lesions. The lower dose retained mucosal protective activity that was statistically indistinguishable from that of misoprostol at 200 microg t.i.d.
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Sixty patients with impacted lower third molars were randomly allocated to three single-dose treatment groups--placebo, 50 mg rofecoxib, or 550 mg naproxen--1 h before extraction. Pain intensity was evaluated with categorical and visual analog scales every 30 min from 90 to 240 min after surgery. At these times, PGE2 production in the alveolar socket was also evaluated. Cyclooxygenase-1 and cyclooxygenase-2 mRNA expression was examined by reverse-transcription polymerase chain reaction in gingival specimens collected during tooth removal and 240 min after surgery.
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Antiplatelet effects of common analgesics were assessed in vitro. The Streck Platelet Aggregation Test Kit (Omaha, NE) was used to measure percent platelet aggregation in response to sodium arachidonate, collagen, adenosine diphosphate, and ristocetin in patients on various analgesics. In comparison with the control group, the response to arachidonate and collagen of ibuprofen (86% vs. 33% and 55% vs. 23%), naproxen (86% vs. 43% and 55% vs. 29%), indomethacin (86% vs. 26% and 55% vs. 17%), and aspirin (86 vs. 21% and 55 vs. 23%) all demonstrated a significant yet comparable reduction in platelet aggregation (p < 0.01). Because of the comparable antiplatelet effects of aspirin and NSAIDs, the additional benefits of daily aspirin in those patients on chronic and consistent NSAID therapy must be reconsidered.
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Of 3,189 patients with multiple morbidities aged 65-85 years, 1,170 patients reported to have taken at least one prescription or non-prescription analgesic within the last 3 months (36.7 %). Of these, 289 patients (24.7 % of 1,170) took at least one OTC analgesic. Duplicate prescription was observed in 86 cases; 15 of these cases took the analgesics regularly. In two cases, the maximum daily dose of diclofenac was exceeded due to duplicate prescription. In 235 cases, patients concurrently took a drug with a potentially clinically relevant interaction. In 43 cases (18.3 % of 235) an OTC analgesic, usually ibuprofen, was involved.
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We recently compared the intestinal permeability markers polysucrose (PS) 15,000, 51Cr-ethylenediaminetetraacetic acid (EDTA), and 14C-mannitol in healthy humans. We have now studied the ability of these markers to show non-steroidal anti-inflammatory drug (NSAID)-induced intestinal damage, with special regard to the possibility of improving discrimination versus healthy intestine by using a hyperosmolar test solution, adding a standardized liquid meal, calculating paracellular/ transcellular marker excretion ratios, or correcting excretion values for urinary volume.
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The pharmacokinetics of Naproxen have been studied in 11 patients diagnosed with various hepatic and biliary disorders after oral administration of a single dose of 250 mg of the drug. The drug is seen to follow an open two-compartment model. In relation to the values obtained from healthy volunteers, it may be seen that in these patients there are modifications in the absorption, distribution and elimination of the drug. In certain of the patients with cholestasis, a significant delay in absorption may be observed. In most of the patients studied, elimination is clearly diminished due to a decrease in the capacity to biotransform the drug within the organism. In healthy volunteers, the plasma half-life of the beta-phase has an average value of 14.14 hrs while in patients it reaches a value of 20.36 hrs.
In this paper, the third generation of flow injection analysis, also named the lab-on-valve (LOV) approach, is proposed for the first time as a front end to high-performance liquid chromatography (HPLC) for on-line solid-phase extraction (SPE) sample processing by exploiting the bead injection (BI) concept. The proposed microanalytical system based on discontinuous programmable flow features automated packing (and withdrawal after single use) of a small amount of sorbent (<5 mg) into the microconduits of the flow network and quantitative elution of sorbed species into a narrow band (150 microL of 95% MeOH). The hyphenation of multisyringe flow injection analysis (MSFIA) with BI-LOV prior to HPLC analysis is utilized for on-line postextraction treatment to ensure chemical compatibility between the eluate medium and the initial HPLC gradient conditions. This circumvents the band-broadening effect commonly observed in conventional on-line SPE-based sample processors due to the low eluting strength of the mobile phase. The potential of the novel MSFI-BI-LOV hyphenation for on-line handling of complex environmental and biological samples prior to reversed-phase chromatographic separations was assessed for the expeditious determination of five acidic pharmaceutical residues (viz., ketoprofen, naproxen, bezafibrate, diclofenac, and ibuprofen) and one metabolite (viz., salicylic acid) in surface water, urban wastewater, and urine. To this end, the copolymeric divinylbenzene-co-n-vinylpyrrolidone beads (Oasis HLB) were utilized as renewable sorptive entities in the micromachined unit. The automated analytical method features relative recovery percentages of >88%, limits of detection within the range 0.02-0.67 ng mL(-1), and coefficients of variation <11% for the column renewable mode and gives rise to a drastic reduction in operation costs ( approximately 25-fold) as compared to on-line column switching systems.
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Coxibs are a major advance in the therapy of patients with painful and inflammatory conditions. At present, the theoretical harm that derives from inhibiting vascular COX-2 has not emerged as a significant risk, although more research is needed. What has emerged is that some NSAIDs, particularly naproxen, may have an aspirin-like effect in reducing the risk of vascular disease, although more research is needed. Whether this finding is sufficient to recommend naproxen for the management of patients with arthritis who also require vascular protection is intriguing and worth further evaluation. It is widely believed and maintained that coxibs have the greatest potential value in patients with other risk factors for ulcer disease, and this seems likely to be the case for patients taking corticosteroids or anticoagulants and probably those who are elderly. Dosing should be [figure: see text] cautious in old patients, however, because of the ability of NSAIDs and coxibs to cause fluid retention, heart failure, and hypertension. It is less clear that coxibs reduce risk sufficiently in patients with previous ulceration (particularly recent) to make them a better strategy than acid co-therapy. This possibility requires further evaluation, as does the competing value of the 2 strategies for patients infected with H. pylori. If coxibs are used in patients with H. pylori-associated risks, there are grounds to recommend eradication. For patients taking aspirin or drugs [figure: see text] with an aspirin-like effect, the intrinsic risk of these drugs may mandate use of acid suppression and obviate the use of coxibs (Fig. 8). Available data suggest that the risk reduction in patients with no risk factors who use coxibs may be almost as great as in patients with risk factors, with the added advantage that patients may be taken to a state that is virtually free of any risk of ulcer complications that otherwise might require additional therapy. Contrary to current popular truisms, the greatest value of coxibs may be in patients without risk factors because it is in this unconfounded group that the ability of coxibs to free patients of ulcer risk appears to be delivered in full.
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The JADAS includes 4 measures: physician global assessment of disease activity, parent/patient global assessment of well-being, active joint count, and erythrocyte sedimentation rate. These variables are part of the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30), Pedi 50, and Pedi 70 criteria for improvement. Validation analyses were conducted on >4,500 patients and included assessment of construct validity, discriminant validity, and responsiveness to change. Three versions of the JADAS were tested based on 71-joint (range 0-101), 27-joint (range 0-57), or 10-joint (range 0-40) counts. Statistical performances of the JADAS were compared with those of 2 rheumatoid arthritis composite scores, the Disease Activity Score in 28 joints (DAS28) and the Clinical Disease Activity Index (CDAI).
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We present the results obtained from the largest series of in vitro diagnostic tests ever reported in patients with clinically validated hypersensitivity to acetylsalicylic acid (ASA)/nonsteroidal anti-inflammatory drugs (NSAID) compared with various categories of controls tolerating ASA/NSAIDs. This multicenter study, which was performed within the framework of the European Network for Drug Allergy (ENDA) group, showed that the basophil activation test (BAT), particularly when used with the 3 NSAIDs aspirin (ASA), diclofenac (DIC), and naproxen (NAP), allows us to confirm the diagnosis of NSAID hypersensitivity syndrome. The results of the cellular allergen stimulation test (CAST) frequently correlate with those of the BAT, although not always. An unexpected finding was that basophil activation by NSAIDs is not an all-or-nothing phenomenon restricted to clinically hypersensitive patients, but that it also occurs in a dose-related manner in some NSAID-tolerant control individuals.Therefore, NSAID hypersensitivity appears as a shift in the normal pharmacological response to NSAIDs. These findings allow us to formulate a new rational hypothesis about the mechanism of NSAID hypersensitivity syndrome, a mechanism that most authors continue to describe as "unknown."