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A total of 601 patients received SoluMatrix diclofenac; 373 of 601 patients (62.1%) received treatment for ≥11 months. The most frequent AEs included upper respiratory tract infection, headache, urinary tract infection, diarrhea, nasopharyngitis, and nausea. Serious gastrointestinal, cardiovascular, renal, and hepatic AEs were uncommon. A small proportion (99 patients, 16.5%) of patients discontinued participation in the study due to AEs. Clinically meaningful improvements from baseline in Physical Component Summary Scores of the SF-36 were noted at week 12 and were sustained through week 52. Improvements in six of the eight individual physical and mental SF-36 domains were also noted.
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Although various single-concentration measurements of the pharmaceutical diclofenac are available in literature, detailed information on the mass flux in the aquatic environment is often missing. Therefore, the overall load of diclofenac was obtained by recording each concentration in nine effluents of sewage treatment plants (STP) and at three river sites located in the area of the river Main (Germany) over a time period of six weeks. In STP effluents, concentrations of up to 2200 ng/L were obtained. In combination with flow rates and connected population an average specific load per capita and day of 0.28 mg (+/-0.11 mg) diclofenac reaches the receiving water course. This average specific load per capita is an expressive parameter to assess main diclofenac exposure to the aquatic environment avoiding uncertainties of estimated data commonly used in exposure assessment. Accordingly, predicted environmental concentrations (PEC) of 140 ng/L for a realistic worst case scenario and 2 to 52 ng/L based on water quality modeling were derived. Since concentrations of up to 140 ng/L were observed in surface water, the obtained PEC is in perfect agreement with measured concentrations. Hence, comparing the PEC with published predicted no effect concentrations (PNEC), chronic adverse effects in fish populations may occur.
Renal failure is a threatening side-effect of NSAID administration, consequent to NSAID-mediated abrogation of prostaglandin synthesis and resultant renal ischaemia. N-acetylcysteine (NAC) has renoprotective properties. We examined effects of NAC in a rat model of NSAID-induced renal failure.
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All randomised trials of drugs (excluding desmopressin or tricyclics) for treating nocturnal enuresis in children up to the age of 16 years were included in the review. Trials were eligible for inclusion if children were randomised to receive drugs compared with placebo, other drugs or behavioral interventions for nocturnal enuresis. Studies which included children with daytime urinary incontinence or children with organic conditions were also included in this review if the focus of the study was on nocturnal enuresis. Trials focused solely on daytime wetting and trials of adults with nocturnal enuresis were excluded.
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The degree of inflammatory response with cytokine release is associated with poor outcomes after aneurysmal subarachnoid hemorrhage (SAH). Previously, we reported on an association between systemic IL-6 levels and clinical outcome in patients with aneurysmal SAH. The intention was to assess the impact of nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen on the inflammatory response after SAH.
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An in vitro Caco-2 cell model and a single-pass intestinal perfusion in situ model in SD rats were used.
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A randomized, double blind, controlled animal trial.
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The objective of the study was to compare the efficacy and safety of topical dexamethasone sodium phosphate 0.1% (Sterodex) to diclofenac sodium 0.1% (Voltaren Ophthalmic) after combined phacotrabeculectomy with mitomycin C.
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Topical diclofenac solution was significantly more effective than the vehicle-control solution for all outcome measures; pain, P = .001; physical function, P = .002; patient global assessment, P = .003; stiffness, P = .005; and pain on walking, P = .004. Among patients receiving topical diclofenac, self-limiting minor skin irritation occurred in 68 (41.5%) of 164 patients, including dryness in 60 (36.6%), rash in 18 (11.0%), and paresthesia, pruritus, and vesiculobullous rash in 1 (0.6%) each. There was no significant difference between groups in NSAID-related gastrointestinal tract complaints or in dropouts due to study-related adverse effects.
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Eighteen New Zealand White rabbits were randomly allocated into three groups (each n = 6): Control group with no postoperative pain killers (Group A), diclofenac group (Group B) and parecoxib group (Group C). In each animal, one dental implant was placed into the calvarial bone (total n = 18). Three rabbits from each group were sacrificed in Week 4. The other three rabbits from each group were sacrificed in Week 12 postoperatively. The implant together with the calvarial bone and dura mater was harvested and subjected to micro-computed tomography (micro-CT) and histomorphometric analysis.
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The values (95% confidence interval) of PASS were 33.5 (29.2-38.6) for pain, 28.0 (23.1-34.1) for night pain, 35.7 (31.3-41.1) for patient's global disease assessment, 31.4 (26.9-37.0) for BASFI, and 34.5 (30.9-38.9) for BASDAI. The PASS estimates were stable over time for all criteria during followup.
A Box-Behnken design was used for evaluation of Eudragit coated diclofenac pellets. The purpose of this work was to optimize diclofenac pellets to improve the physicochemical properties using experimental design.
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In the current study, we used 56 female BALB/c mice with induced dry eye syndrome to evaluate the therapeutic effects of formal saline (FS), sodium hyaluronate (SH), diclofenac sodium (DS), olopatadine (OP), retinoic acid (RA), fluoromethanole (FML), cyclosporine A (CsA), and doxycycline hyclate (DH). All subjects were kept in an evaporative 'dry eye cabinet' for the assessment of blink rate, tear production, tear break-up time, and impression cytology prior to (baseline) and during weeks 2, 4, and 6 of the study. The right eyes of all subjects were treated topically with 5 μL of the test agent twice daily during weeks 2 through 6. Impression cytology and tear break-up time differed between time points in all groups and differed between groups at weeks 4 and 6. Blink rate differed by time point only in the FS, FML, and DH groups. Tear production according to the phenol red cotton thread test differed by time point for all groups except RA, CsA, and DH and differed between groups only at week 6. Among the compounds tested in the present study, DS and CsA were the most effective therapeutic agents in our mouse model of dry eye syndrome; these agents likely exert their therapeutic effect through their antiinflammatory activity.
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The effects of a series of polyol fatty acid esters (sefsols) on diclofenac permeation through rat skin were investigated using in vitro and in vivo methods. Four monoesters and one diester of sefsol were selected as a vehicle components. The effects of each sefsol on in vitro diclofenac permeation were compared at a concentration of 5% sefsol in water. Monoesters of sefsol, except the glyceryl monoester, enhanced the percutaneous permeation of diclofenac. The highest enhancement was observed in propylene glycol monocaprylate. The plasma concentration of diclofenac was increased dramatically by the addition of 10% propylene glycol monocaprylate when applying the diclofenac sodium suspension to abdominal rat skin in vivo. These results suggest that the monoesters of polyol fatty acid are potential candidates to enhance the transdermal absorption of diclofenac sodium.
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To examine the expression of transforming growth factor family members bone morphogenic proteins 2 and 4 (BMP2, BMP4), their receptor mRNAs, and BMP2 and BMP4 proteins in the cells of the human cornea. The effects of BMP2 and BMP4 on corneal fibroblast proliferation and apoptosis were also examined.
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The cyclooxygenase isoforms, COX-1 and COX-2, are the rate limiting enzymes in the biosynthesis of prostaglandin E(2), a major prostaglandin involved in epidermal homeostasis and repair. Epidermal injury results in transient hyperplasia and induction of COX-2 expression. The role of COX-2 in this hyperplasia is unknown, however. In this study, we characterized the epidermal expression of COX isozymes following wounding by abrasion in SKH-1 mice using immunohistochemistry, in situ hybridization, and Western analysis. In addition, we evaluated pivotal keratinocyte functions necessary for the reparative hyperplasia, including proliferation by 5-bromo-2'deoxy-uridine labeling and differentiation by the expression of involucrin, keratin 1, and keratin 6. Although COX-1 expression in keratinocytes remained unchanged during wound healing, COX-2 expression was induced coincidentally with keratinocyte proliferation and keratin 6 expression, suggesting a role for COX-2 in epidermal repair. The role of COX-2 was also evaluated using the selective COX-2 inhibitor SC-791 and the traditional COX inhibitors indomethacin and diclofenac. Neither inhibitor altered keratinocyte proliferation or differentiation following abrasion, in contrast to dexamethasone, which delayed these responses. Our results indicated that, although COX-2 expression was coincident with transient epidermal hyperplasia and keratinocyte proliferation/differentiation during the healing of epidermal injury, it does not play a pivotal role in this repair process.
A series of 4-(methylsulfonyl)aniline derivatives were synthesized in order to obtain new compounds as a potential anti-inflammatory agents with expected selectivity against COX-2 enzyme. In vivo acute anti-inflammatory activity of the final compounds 11-14 was evaluated in rat using an egg-white induced edema model of inflammation in a dose equivalent to 3 mg/Kg of diclofenac sodium. All tested compounds produced significant reduction of paw edema with respect to the effect of propylene glycol 50% v/v (control group). Moreover, the activity of compounds 11 and 14 was significantly higher than that of diclofenac sodium (at 3 mg/Kg) in the 120-300 minute time interval, while compound 12 expressed a comparable effect to that of diclofenac sodium in the 60-240 minute time interval time, and compound 13 showed a comparable effect to that of diclofenac sodium at all experimental times. The result of this study indicates that the incorporation of the 4-(methylsulfonyl)aniline pharamacophore into naproxen, indomethacine, diclofenac and mefanamic acid maintained their anti-inflammatory activity and may increase selectivity towards the COX-2 enzyme which will be confirmed in the future by assessing COX-2: COX-1 inhibitory ratios using a whole blood assay.
A total of 90 female patients (American Society of Anesthesiologists I and II), aged 20-50 years, scheduled for elective total abdominal hysterectomy with or without bilateral salpingo-oophorectomy were randomized to receive 75 mg diclofenac IM 8 hourly (Group D) or 1 g paracetamol IV 8 hourly (Group P) or a combination of both 8 hourly (Group PD) for 24 h post-operative period from the start of surgery. The primary outcome measured was the requirement of rescue analgesic (tramadol), the secondary outcomes measured included visual analog score (VAS) for pain, time until first rescue analgesic administration, patient satisfaction score and any side effects.
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Sucrose esters (SEs) have a wide range of hydrophilic-lipophilic balance (HLB) values (1-16), and hence can be applied as surfactants, or as solubility or penetration enhancers. In general, SEs are used in hot-melt technology, because of their low melting points, but literature data are not available on the effects of active agents on the structures of SEs and the possible solid-state interactions. In this study, drug-SE products were prepared by melt technology and investigated by differential scanning calorimetry (DSC), X-ray powder diffraction (XRPD), rheological measurements and dissolution tests. The model drugs meloxicam and diclofenac sodium and three SEs with different polarities (P1670, S970 and B370) were chosen for the preparation of the products. The DSC and XRPD results revealed that the structures of the SEs were rearranged, with a decrease in the degree of crystallinity. The dissolved drug molecules broke down the structures of the SEs, but were not built into the crystalline phase of the carrier. The dissolution of the drugs was influenced by the different HLB values and gel-forming behaviour of the SEs, and also by the polarity of the drug and the interactions between the drug and the SEs.
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The present study indicates the antiarthritic activity of ESBCI and ESCI, however its mechanism of action has to be studied in the future.