Ibuprofen scientific update |
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2010 Jul;83(1):51-55.
Krudsood S, Tangpukdee N, Wilairatana P, Pothipak N, Duangdee C, Warrell DA, Looareesuwan S.
Department of Tropical Hygiene, Department of Clinical Tropical Medicine, Hospital for Tropical Diseases, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand;Nuffield Department of Clinical Medicine, University of Oxford, United Kingd
Intravenous Ibuprofen (IV-ibuprofen) Controls Fever Effectively in Adults with Acute Uncomplicated Plasmodium falciparum Malaria but Prolongs Parasitemia.
Because some febrile patients are unable to swallow or retain oral antipyretic drugs, we carried out a double-blind, placebo-controlled trial in which intravenous ibuprofen (IV-ibuprofen) was given to adults hospitalized with fever associated with acute uncomplicated falciparum malaria treated with oral artesunate plus mefloquine. Thirty patients received IV-ibuprofen 400 mg and 30 received placebo every 6 hours for 72 hours. Reduction in the area above 37.0 degrees C versus time curve was significantly greater for IV-ibuprofen than for placebo during the first 72 hours after first administration. No patients developed severe malaria; parasite clearance was delayed in the patients whose fevers were controlled by IV-ibuprofen (median 37.3 hours versus 23.7 hours in the placebo group [P = 0.0024]). This difference did not appear to be clinically important Adverse events, none considered severe, occurred equally in both groups. IV-ibuprofen was effective and well tolerated in reducing fever in febrile inpatients with malaria.
2010 Jul;160(6):1550-60.
Sciorati C, Buono R, Azzoni E, Casati S, Ciuffreda P, D'Angelo G, Cattaneo D, Brunelli S, Clementi E.
San Raffaele Scientific Institute, Stem Cell Research Institute, Milan, Italy.
Co-administration of ibuprofen and nitric oxide is an effective experimental therapy for muscular dystrophy, with immediate applicability to humans.
Background and purpose: Current therapies for muscular dystrophy are based on corticosteroids. Significant side effects associated with these therapies have prompted several studies aimed at identifying possible alternative strategies. As inflammation and defects of nitric oxide (NO) generation are key pathogenic events in muscular dystrophies, we have studied the effects of combining the NO donor isosorbide dinitrate (ISDN) and the non-steroidal anti-inflammatory drug ibuprofen. Experimental approach: alpha-Sarcoglycan-null mice were treated for up to 8 months with ISDN (30 mg.kg(-1)) plus ibuprofen (50 mg.kg(-1)) administered daily in the diet. Effects of ISDN and ibuprofen alone were assessed in parallel. Drug effects on animal motility and muscle function, muscle damage, inflammatory infiltrates and cytokine levels, as well as muscle regeneration including assessment of endogenous stem cell pool, were measured at selected time points. Key results: Combination of ibuprofen and ISDN stimulated regeneration capacity, of myogenic precursor cells, reduced muscle necrotic damage and inflammation. Muscle function in terms of free voluntary movement and resistance to exercise was maintained throughout the time window analysed. The effects of ISDN and ibuprofen administered separately were transient and significantly lower than those induced by their combination. Conclusions and implications: Co-administration of NO and ibuprofen provided synergistic beneficial effects in a mouse model of muscular dystrophy, leading to an effective therapy. Our results open the possibility of immediate clinical testing of a combination of ISDN and ibuprofen in dystrophic patients, as both components are approved for use in humans, with a good safety profile.
2010 Jun 4. [Epub ahead of print]
Ito S, Yamamoto D.
Department of Physiological Chemistry, Osaka Medical College, 2-7 Daigakucho, Takatsuki 565-8686, Japan.
Identification of two bromocresol purple binding sites on human serum albumin.
BACKGROUND: In clinical settings, human serum albumin (HSA) is widely quantitated on the basis of change in the color of bromocresol purple (BCP) bound to HSA. However, the binding sites of BCP on HSA are hitherto unknown. We have identified these sites by performing binding experiments in which BCP was bound to HSA complexed with warfarin, ibuprofen, propofol, or myristic acid. METHODS: The binding experiment was performed with HSA complexed with a drug in buffers at pH 4.8 and 7.2. The number of BCP binding sites (n) and the association constant (Ka) were obtained by Scatchard analysis using the absorbance data of the BCP-HSA complexes. RESULTS: Two BCP binding sites on native HSA were identified at pH 7.2 and 1.3 sites were identified at pH 4.8. The number of sites for warfarin-HSA binding was approximately half that of native HSA at both pH values. The site numbers for myristate- and ibuprofen-HSA were 0.3 and 0.8 at pH 7.2, and 1.5 and 2.0 at pH 4.8, respectively; their Ka values were also high (18x10(4) and 10x10(4)). The Ka values for all HSA samples, except for the 2 samples, arranged from 1.5x10(4) to 3.3x10(4). The n and Ka values for propofol were equivalent to those for native HSA. CONCLUSION: We postulate that the 2 BCP binding sites include a warfarin-binding site (drug-binding site 1) and 1 of the 2 ibuprofen-binding sites. Copyright © 2010 Elsevier B.V. All rights reserved.
2010 Jun 23. [Epub ahead of print]
Fosbøl EL, Køber L, Torp-Pedersen C, Gislason GH.
Gentofte University Hospital, Department of Cardiology, Hellerup, Denmark +45 26845552 ; +45 39751803 ; ELF@heart.dk.
Cardiovascular safety of non-steroidal anti-inflammatory drugs among healthy individuals.
Importance of the field: Studies have raised concern on the cardiovascular safety of NSAIDs. We studied safety of NSAID therapy in a nationwide cohort of healthy individuals. Areas covered in this review: This is a review of the literature regarding cardiovascular safety of NSAIDs with special focus on the few studies investigating healthy individuals. What the reader will gain: Due to a high frequency of gastrointestinal complications related to NSAID treatment a new generation of NSAID, called the selective COX-2 inhibitors, were developed in order to use the beneficial pain-relieving effect of NSAIDs without the COX-1 related risk of gastrointestinal bleeding. However, the selective COX-2 inhibitor rofecoxib was withdrawn from the market in 2004 after studies had documented an increased risk of myocardial infarction related to this drug. Focus also turned to the traditional NSAIDs and found similar results for some of the older drugs, especially diclofenac and high-dose ibuprofen. Most interventional studies have not been designed specifically to evaluate the cardiovascular safety of NSAIDs and no studies have previously investigated the relationship between NSAID treatment and cardiovascular risk in healthy individuals. Overall, evidence regarding the selective COX-2 inhibitors' cardiovascular risk profile (mostly thrombo-embolic events) is derived from the clinical trials whereas results on the traditional NSAIDs are based on observational studies and meta-analyses. Importantly, some of the randomized trials comparing COX-2 inhibitors with traditional NSAIDs did not show a difference in cardiovascular risk and it cannot be denied that the traditional NSAIDs are characterized by a different cardiovascular risk-profile than the COX-2 inhibitors. A recent cohort study among one million healthy people showed that the selective COX-2 inhibitors as well as diclofenac are associated with an increased risk of death or myocardial infarction. This was further underlined by a dose-response relationship. Take home message: Individual NSAIDs have different cardiovascular safety that needs to be considered when choosing appropriate treatment. In particular, rofecoxib and diclofenac were associated with increased cardiovascular mortality and morbidity and should be used with caution in most individuals. This notion is also valid for healthy individuals and underlines the importance of critical use of NSAID therapy in the general population and also that over-the-counter retail of NSAIDs should be reassessed.
2010 Jun 16;6:CD007402.
Massey T, Derry S, Moore RA, McQuay HJ.
Pain Research and Nuffield Department of Anaesthetics, University of Oxford, West Wing (Level 6), John Radcliffe Hospital, Oxford, Oxfordshire, UK, OX3 9DU.
Topical NSAIDs for acute pain in adults.
BACKGROUND: Use of topical NSAIDs to treat acute musculoskeletal conditions is widely accepted in some parts of the world, but not in others. Their main attraction is their potential to provide pain relief without associated systemic adverse events. OBJECTIVES: To review the evidence from randomised, double-blind, controlled trials on the efficacy and safety of topically applied NSAIDs in acute pain. SEARCH STRATEGY: We searched MEDLINE, EMBASE, The Cochrane Library, and our own in-house database to December 2009. We sought unpublished studies by asking personal contacts and searching on-line clinical trial registers and manufacturers web sites. SELECTION CRITERIA: We included randomised, double-blind, active or placebo (inert carrier)-controlled trials in which treatments were administered to adult patients with acute pain resulting from strains, sprains or sports or overuse-type injuries (twisted ankle, for instance). There had to be at least 10 participants in each treatment arm, with application of treatment at least once daily. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and validity, and extracted data. Numbers of participants achieving each outcome were used to calculate relative risk and numbers needed to treat (NNT) or harm (NNH) compared to placebo or other active treatment. MAIN RESULTS: Forty-seven studies were included; most compared topical NSAIDs in the form of a gel, spray, or cream with a similar placebo, with 3455 participants in the overall analysis of efficacy. For all topical NSAIDs combined, compared with placebo, the number needed to treat to benefit (NNT) for clinical success, equivalent to 50% pain relief, was 4.5 (3.9 to 5.3) for treatment periods of 6 to 14 days. Topical diclofenac, ibuprofen, ketoprofen, and piroxicam were of similar efficacy, but indomethacin and benzydamine were not significantly better than placebo. Local skin reactions were generally mild and transient, and did not differ from placebo. There were very few systemic adverse events or withdrawals due to adverse events. There were insufficient data to reliably compare individual topical NSAIDs with each other or the same oral NSAID. AUTHORS' CONCLUSIONS: Topical NSAIDs can provide good levels of pain relief, without the systemic adverse events associated with oral NSAIDs, when used to treat acute musculoskeletal conditions.
2009 Autumn;2(3):185-99.
Alissa R, Sakka S, Oliver R, Horner K, Esposito M, Worthington HV, Coulthard P.
The University of Manchester, Manchester, UK.
Influence of ibuprofen on bone healing around dental implants: a randomised double-blind placebo-controlled clinical study.
PURPOSE: This randomised double-blind placebo-controlled trial was carried out to investigate the effect of a one-week post-operative course of 600 mg of ibuprofen taken four times a day on marginal bone level around dental implants. MATERIALS AND METHODS: A total of 61 patients were allocated to the ibuprofen (31 patients) or placebo group (30 patients). Overall, 132 implants were inserted, 67 implants in the ibuprofen group and 65 implants in the placebo group. Preparation of the implant sites was carried out with an intermittent drilling sequence adapted to the fixture diameter and the local bone quality according to the Astra Tech implant installation guide. The primary outcome measure was the change in marginal bone level around dental implants from the baseline (2 weeks post-placement) to the 3- and 6-month radiographic examinations. The paralleling technique and a film holder coupled to a beamaiming device were used to take the periapical radiographs. Measurement of changes in bone level was made using a viewing box and x8 magnifier. RESULTS: Two patients from the ibuprofen group were unable to complete the prescribed course of ibuprofen owing to a minor self-reported stomach upset. A patient from the control group did not attend any of the scheduled appointments following implant placement. A total of three patients dropped out. All implants survived in either group during the 6-month observation period. The mean marginal bone level changes from the baseline were (-0.33 mm) at the 3-month and (-0.29 mm) at the 6-month follow-up for the ibuprofen group while the corresponding values for the placebo group were (-0.12 mm) and (-0.30 mm). There were no statistically significant differences between groups for mean marginal bone level changes at 3 months (P = 0.27) or 6 months (P = 0.97). CONCLUSIONS: Administration of a short course of systemic ibuprofen for post-operative pain management subsequent to implant placement may not have a significant effect on the marginal bone around dental implants in the early healing period.
2009 Dec;54(4):355-60.
Lau SL, Chow RL, Yeung RW, Samman N.
Oral and Maxillofacial Surgery, Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.
Pre-emptive ibuprofen arginate in third molar surgery: a double-blind randomized controlled crossover clinical trial.
BACKGROUND: This study evaluated the effectiveness of 400 mg ibuprofen arginate either as a pre-emptive (PRE group) or postoperative (POST group) analgesic using a common dental pain model. METHODS: A randomized double-blind crossover clinical trial involving a series of consecutive patients admitted for bilateral third molar surgery. Results were analysed according to the self-reported pain score and the pattern of rescue medication taken. RESULTS: The mean pain score ranged from 0.73 to 1.60 for the PRE group and 0.47 to 1.41 for the POST group among 30 included subjects. The mean time point when first rescue medication taken was 7.3 hours and 8.3 hours postoperative, respectively. Nine patients (30 per cent) in the PRE group and 12 patients (40 per cent) in the POST group took no rescue medication. There was no statistically significant difference for all parameters between groups, while a majority (53 per cent) found the drug "good" to "excellent" in both groups. CONCLUSIONS: Ibuprofen arginate may be considered effective in reducing surgically induced moderate to severe pain when administered either pre-operatively or postoperatively due to the reported relatively low pain score, less consumption of rescue medication, delayed onset of pain, good number of pain-free patients and a high rating in the global assessment score.
2009 Jun;7(2):193-206. Epub 2009 Aug 13.
Ousehal L, Lakhdar A, Elquars F.
Professeur agrégé, département d'orthodontie, faculté de médecine dentaire, Casablanca, Maroc. lahcen2228@yahoo.fr
[Comparison of the effect of paracetamol and ibuprofen on orthodontic pain] [Article in French]
Patients undergoing orthodontic treatment can experience an unpleasant painful sensation. This has been proven by several studies. Controling pain during orthodontic treatment is in the interest of both practitioner and patient. The aim of this study was to compare the effect of ibuprofen and paracetamol on orthodontic pain. To this end, a sample of 56 patients was divided into two groups: Pain levels were assessed using the visual analog scale at 2h, 6h, 24h, day 2, day 3 and day 7 after insertion of the first archwire. Results show that there is no significant difference between ibuprofen and paracetamol regarding control of orthodontic pain except during the first two hours after archwire insertion when paracetamol was observed to be slightly more effective than ibuprofen. Comparison by age and gender revealed no significant differences. Thus, we can conclude that paracetamol and ibuprofen are painkillers of choice in the relief of orthodontically-related pain.
2009 Nov;10(9):1009-47.
Lai XS, Yang LP, Li XT, Liu JP, Zhou ZW, Zhou SF.
College of Acupuncture and Massage, Guangzhou University of Traditional Chinese Medicine, Guangzhou, China.
Human CYP2C8: structure, substrate specificity, inhibitor selectivity, inducers and polymorphisms.
Human CYP2C8 is a key member of the CYP2C family and metabolizes more than 60 clinical drugs. A number of active site residues in CYP2C8 have been identified based on homology modeling and site-directed mutagenesis studies. In the structure of CYP2C8, the large active site cavity exhibits a trifurcated topology that approximates a T or Y shape, which is consistent with the finding that CYP2C8 can efficiently oxidize relatively large substrates such as paclitaxel and cerivastatin. The active site cavity of CYP2C8 contains at least 48 amino acid residues and many of them are important for substrate binding. The structures of CYP2C8 in complex with distinct ligands have revealed that the enzyme can bind divergent substrates and inhibitors without extensive conformational changes. CYP2C8 is a major catalyst in the metabolism of paclitaxel, amodiaquine, troglitazone, amiodarone, verapamil and ibuprofen, with a secondary role in the biotransformation of cerivastatin and fluvastatin. CYP2C8 also metabolises endogenous compounds such as retinoids and arachidonic acid. Many drugs are inhibitors of CYP2C8 and inhibition of this enzyme may result in clinical drug interactions. The pregnane X receptor, constitutive androstane receptor, and glucocorticoid receptor are likely to involve the regulation of CYP2C8. A number of genetic mutations in the CYP2C8 gene have been identified in humans and some of them have functional impact on the clearance of drugs. Further studies are needed to delineate the role of CYP2C8 in drug development and clinical practice.
2009 Nov;10(9):971-80.
Cornejo-Garcia JA, Blanca-López N, Doña I, Andreu I, Agúndez JA, Carballo M, Blanca M, Canto MG.
Research Group of Allergic Diseases, Research Laboratory, IMABIS Foundation-Carlos Haya Hospital, Málaga, Spain.
Hypersensitivity reactions to non-steroidal anti-inflammatory drugs.
NSAIDs are the most important group of drugs involved in hypersensitivity drug reactions, and include heterogeneous compounds with very different chemical structures. These reactions can be IgE dependent (immediate reactions), T cell-mediated (non-immediate), or induced by a non-specific immunological mechanism related with the blocking of the COX-1 enzyme and the shunting to the lipooxygenase pathway (cross-intolerant reactions). Cutaneous symptoms are the most frequent, with ibuprofen, naproxen and diclofenac being common culprit drugs worldwide, although others can be involved because patterns of consumption and exposure rates vary between countries. A very important proportion of immunological reactions are immediate, with urticaria and anaphylaxis being the typical clinical manifestations. Non-immediate reactions comprise a number of heterogeneous entities ranging from mild exanthema to severe TEN or DRESS syndrome, as well as organ-specific reactions such as hepatitis or pneumonitis. Cross-intolerant reactions appear to non-chemically related drugs, and involve respiratory airways, skin or both. In vivo diagnostic tests are based on the capacity of the skin to respond to the culprit drug, but their sensitivity is in many instances rather low. The approach for in vitro testing consists of either detecting specific IgE antibodies or studying the proliferation of T lymphocytes toward the eliciting drug. No appropriate tests are yet available for the in vitro validation of cross-intolerance reactions, although techniques based on the stimulation of basophils have been proposed. Based on these findings, the diagnostic approach is often based on the controlled administration of the drug to assess tolerance. In this work we review current knowledge on hypersensitivity reactions to NSAIDs, including diagnostic approach and genetic studies.
2008 Sep;106(9):615-8, 622, 624.
Hardikar MS.
Hardikar Hospital, Pune 411005.
Chiral non-steroidal anti-inflammatory drugs--a review.
A chiral centre is noted in majority of the NSAIDs. For NSAIDs the enantiomer with S configuration almost exclusively possesses the ability to inhibit prostaglandin activity. R-enantiomers of NSAIDs have poor COX inhibitory activity. Some R-enantiomers are not inert, and many have different actions. The R- to S- chiral inversion varies with biological factors and property of NSAID. The S- to R- chiral inversion is rare for all the NSAIDs. Various preclinical and clinical studies have demonstrated that chirally pure NSAIDs like dexketoprofen, dexibuprofen and S-etodolac are more potent than their respective R enantiomers. Favourable pharmacokinetic and pharmacodynamic profile of dexketoprofen, dexibuprofen and S-etodolac make them effective and well tolerated drug for the treatment of painful inflammatory conditions at half doses of recemate. Thus chiral switch of NSAIDs is a rational approach for the treatment of painful inflammatory conditions.
2008 Oct;91 Suppl 3:S28-34.
Sangtawesin C, Sangtawesin V, Lertsutthiwong W, Kanjanapattanakul W, Khorana M, Ayudhaya JK.
Cardiology Unit, Department of Pediatrics, Queen Sirikit National Institute of Child Health, Department of Medical Services, Thailand.
Prophylaxis of symptomatic patent ductus arteriosus with oral ibuprofen in very low birth weight infants.
BACKGROUND: Patent ductus arteriosus (PDA) is a common cause of mortality and morbidity among very low birth weight infants. Oral ibuprofen suspension has been shown to have the same efficacy and safety as intravenous indomethacin in the prevention and treatment of symptomatic PDA. With lower dosage, the prevalence of side effects may decrease without changes in efficacy. OBJECTIVE: To evaluate the efficacy and side effects of low dose ibuprofen suspension for prevention of symptomatic PDA in very low birth weight infants. PATIENTS AND METHOD: A prospective, double blind, randomized controlled trial was conducted on premature neonates with gestational ages between 28-32 weeks, birth weight 1500 grams or less, at the Neonatal Unit, Queen Sirikit National Institute of Child Health (QSNICH) during October 2005 to October 2006. Only infants who had PDA on echocardiogram were included in the study. Three doses of ibuprofen suspension or placebo were randomly given at the dosage of 10, 5, 5 mg/kg every 24 hours. Daily physical examination, serial laboratory evaluation and echocardiogram were used to evaluate symptomatic PDA, complications and side effects. RESULTS: Sixty-two infants were recruited in the study and randomly assigned into the study and control group. The gestational age and birthweight of the 2 groups were similar The prevalence of symptomatic PDA was less in the ibuprofen group than in placebo group (9.86% vs. 35.48%; p = 0.015). There were no differences in the prevalence of complications and adverse effects between the two groups. CONCLUSION: Prophylactic oral ibuprofen suspension at lower dosage results in less symptomatic PDA without significant side-effects.
2008;59(4):283-8.
Allegaert K, de Hoon J, Naulaers G, Van De Velde M.
Neonatal Intensive Care Unit, Division of Woman and Child, University Hospitals Leuven, Leuven, Belgium.
Neonatal clinical pharmacology: recent observations of relevance for anaesthesiologists.
Neonatal drug dosing needs to be based on the physiological characteristics of the newborn, the pharmacokinetic parameters of the drug and has to take maturational aspects of drug disposition into account. We would like to provide the reader with some recently published compound-specific observations (paracetamol, ibuprofen, tramadol, propofol) in neonates of relevance for anaesthesiologists. Age-specific dosing regimes of intravenous paracetamol have been evaluated and were well tolerated, independent of the postnatal age. Administration of ibuprofen or acetyl salicylic acid resulted in a transient reduction of 20% of the glomerular filtration rate and should be used cautiously in newborns. Both postmenstrual age and pharmacogenetics (CYP2D6) were covariates of tramadol metabolism in newborns. Tramadol seems to be a potential useful analgesic for term neonates and infants, but has limited indications in (extreme) preterm neonates. Finally, propofol clearance depends on post-menstrual and postnatal age. There is a risk for accumulation in preterms and in the first two weeks of postnatal life.
2008;14(6):411-7.
Ranc V, Havlícek V, Bednar P, Lemr K.
Department of Analytical Chemistry, Palacky University, Svobody 8, 77146, Olomouc, Czech Republic.
Nano-desorption electrospray and kinetic method in chiral analysis of drugs in whole human blood samples.
A home-made nano-desorption electrospray ionization (nano-DESI) device and the kinetic method were tested in chiral analysis of model clinical samples containing enantiomers of one of three pharmaceutically important compounds: dihydroxyphenylalanine (DOPA), ephedrine and ibuprofen. The initial evaluation of chiral systems was carried out by direct infusion of solution mixtures (analyte/central metal/chiral reference ligand) to a standard electrospray ionization (ESI) source. Cu(II) was used as a central metal for all analytes, L-phenylalanine was applied as a chiral reference ligand for DOPA, whereas L-tryptophan was used for the other two analytes. Then, the ESI source was substituted by a nano-DESI source and dried spots of 1 microL samples of whole human blood spiked with individual drugs were successfully analyzed without any pre-treatment. Irrespective of a laborious initial nano-DESI set-up, the combination of the kinetic method with nano-desorption electrospray has, for the first time, been demonstrated as a promising tool for chiral analysis of drugs in blood samples.
2008 Nov;69(5):454-81.
Golombek SG, Sola A, Baquero H, Borbonet D, Cabañas F, Fajardo C, Goldsmit G, Lemus L, Miura E, Pellicer A, Pérez JM, Rogido M, Zambosco G, van Overmeire B; Primer Grupo de Consenso Clínico SIBEN.
SIBEN, Sociedad Iberoamericana de Neonatología, The Regional Neonatal Center, Maria Fareri Children's Hospital at Westchester Medical Center/New York Medical College-Valhalla, Valhalla, New York 10595, USA.
[First SIBEN clinical consensus: diagnostic and therapeutic approach to patent ductus arteriosus in premature newborns] [Article in Spanish]
OBJECTIVE: To report the process and results of the first neonatal clinical consensus of the Ibero-American region. DESIGN AND METHODS: Two recognized experts in the field (Clyman and Van Overmeire) and 45 neonatologists from 23 countries were invited for active participation and collaboration. We developed 46 questions of clinical-physiological relevance in all aspects of patent ductus arteriosus (PDA). Guidelines for consensus process, literature search and future preparation of educational material and authorship were developed, reviewed and agreed by all. Participants from different countries were distributed in groups, and assigned to interact and work together to answer 3-5 questions, reviewing all global literature and local factors. Answers and summaries were received, collated and reviewed by 2 coordinators and the 2 experts. Participants and experts met in Granada, Spain for 4.5 h (lectures by experts, presentations by groups, discussion, all literature available). RESULTS: 31 neonatologists from 16 countries agreed to participate. Presentations by each group and general discussion were used to develop a consensus regarding: general management, availability of drugs (indomethacin vs. ibuprofen), costs, indications for echo/surgery, etc. Many steps were learnt by all present in a collaborative forum. CONCLUSIONS: This first consensus group of Ibero-American neonatologists SIBEN led to active and collaborative participation of neonatologists of 16 countries, improved education of all participants and ended with consensus development on clinical approaches to PDA. Furthermore, it provides recommendations for clinical care reached by consensus. Additionally, it will serve as a useful foundation for future SIBEN Consensus on other topics and it could become valuable as a model to decrease disparity in care and improve outcomes in this and other regions.
2008 Sep-Oct;16(5):615-25.
Gottrup F, Jørgensen B, Karlsmark T, Sibbald RG, Rimdeika R, Harding K, Price P, Venning V, Vowden P, Jünger M, Wortmann S, Sulcaite R, Vilkevicius G, Ahokas TL, Ettler K,Arenbergerova M.
University Centre for Wound Healing, Odense University Hospital, Odense C, Denmark. fgottrup@post4.tele.dk
Reducing wound pain in venous leg ulcers with Biatain Ibu: a randomized, controlled double-blind clinical investigation on the performance and safety.
Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicenter randomized double-blind clinical investigation of 122 patients compared two moist wound healing dressings: a nonadhesive foam dressing with ibuprofen (62 patients randomized to Biatain Ibu Nonadhesive Coloplast A/S) and a nonadhesive foam without ibuprofen (60 patients to Biatain Non-Adhesive-comparator). Patients were recruited from September 2005 to April 2006. The ibuprofen foam was considered successful if the pain relief on a five-point Verbal Rating Scale was higher than the comparator without compromising safety including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1-5 (double blind) and days 43-47 (single blind). The primary response variable, persistent pain relief, was significantly higher in the ibuprofen-foam group, as compared with the comparator on day 1-5, with a quick onset of action (p<0.05). Wound pain intensity was significantly reduced with the ibuprofen foam during day 1-5 with 40% from baseline, compared with 30% with the comparator (p<0.001). At day 43-47, the patients in the ibuprofen-foam group had a significant (p<0.05) reemergence of persistent pain and pain at dressing change (p<0.05) when the active dressing was changed to the comparator. Wound healing was similar in the ibuprofen foam and comparator group. No difference in adverse events between the comparator and the ibuprofen foam with local sustained release of low-dose ibuprofen was observed in this study. It was generally found that women reported less pain intensity than men, and pain intensity decreased with increasing age. In addition, pain intensity increased with initial pain intensity and increasing wound size. This study has demonstrated that the ibuprofen-foam dressing provided pain relief and reduced pain intensity without compromising healing or other safety parameters.
2007 Dec;16(92):223-7.
Etoricoxib: new drug. Avoid using cox-2 inhibitors for pain.
(1) Paracetamol is the first-choice analgesic for joint pain. Nonsteroidal antiinflammatory drugs (NSAIDs), especially ibuprofen, are second-line options. Cox-2 inhibitors are no more effective than traditional NSAIDs and have no tangible advantages in terms of gastrointestinal tolerability. In contrast, they expose patients to an increased risk of cardiovascular adverse effects. (2) Etoricoxib is marketed in some European countries to relieve symptoms of osteoarthritis, rheumatoid arthritis, and gout attacks. (3) Many clinical trials have tested etoricoxib in these indications, as well as in ankylosing spondylitis, low back pain, and various types of acute pain. Etoricoxib was no more effective than other NSAIDs such as ibuprofen, naproxen or diclofenac in these situations. (4) Comparative trials showed a higher overall mortality rate with etoricoxib than with naproxen. A combined analysis of long-term comparative trials including 5441 patients, mainly versus naproxen, showed that etoricoxib does not reduce the risk of perforation, ulcer or severe gastrointestinal haemorrhage. Similarly, it does not reduce the risk of mild gastrointestinal events in at-risk patients: those with a history of gastrointestinal disorders, aspirin use, etc. (5) Three trials including a total of 34 701 patients (MEDAL programme) compared cardiovascular thrombotic events associated with etoricoxib and diclofenac. Overall, the cardiovascular risks appear to be similar but the thrombotic risk may be slightly higher with diclofenac than with other conventional NSAIDs. (6) Etoricoxib provoked arterial hypertension, oedema and heart failure during clinical trials. Serious skin reactions were reported both during clinical trials and after marketing, but their precise incidence is not known. Etoricoxib is partly metabolised by the cytochrome P450 isoenzyme CYP 3A4 and increases the bioavailability of ethinylestradiol. (7) When a NSAID is considered, drugs with which we have the most experience should be chosen, such as ibuprofen, and used at the lowest acceptable dose regimen (daily dose and length of treatment). Etoricoxib should be avoided.
2007 Dec;3(4):410-25.
Sansgiry SS, Chanda S, Shringarpure GS.
Department of Clinical Sciences and Administration, College of Pharmacy, University of Houston, TX 77030, USA.
Impact of bilingual product information labels on Spanish-speaking adults' ability to comprehend OTC information.
BACKGROUND: There is a steady growth in the Spanish-speaking population in the United States. Language may be a barrier in accessing nonprescription medication information for the non-English-speaking population. OBJECTIVE: The objective of this study was to compare consumer-reported ease of use, product knowledge, and intention to purchase over-the-counter (OTC) medications using bilingual Product Information Labels (PILs) and currently available label formats in a sample of Spanish-speaking consumers. METHODS: Participants were randomly selected from Spanish-speaking consumers shopping for OTC medications in pharmacy or grocery stores in Houston, TX. Participants viewed 3 label formats (old, new, and PILs) for acetaminophen, ibuprofen, and aspirin in a random order. Questionnaires in English and in Spanish were provided to consumers after they viewed each label format. Domains measured in the questionnaires included ease of use, product knowledge, and purchase intention. All responses were measured on a 7-point Likert-type scale. Data were recoded and analyzed using SAS (version 9.0) (SAS Institute Inc, Cary, NC) to obtain mean scores for each domain. Participants were classified according to language proficiency into "Spanish only" and bilinguals. Comparative statistics were computed to compare mean scores between label formats in each consumer category. RESULTS: A total of 225 questionnaires were collected. The mean (+/-standard deviation) age of participants was 38.91 (+/-11.95) years. A majority of respondents were Hispanic (97.75%), female (60.54%), and married (62.44%). Mean scores from viewing PILs on ease of use, product knowledge, and purchase intention were higher than those from viewing the other label formats. In the category of consumers who spoke Spanish only, mean scores of PILs were significantly higher as compared to those of old and new label formats (P<.05). CONCLUSION: Information provided in Spanish on PILs may be very helpful to the Spanish-speaking community when selecting nonprescription medications. Policy makers and health care providers should consider PILs as an effective means of reducing language barriers and providing OTC medication information to the Spanish-speaking population in the United States.
2007 Dec 15;3(4):114-22. Epub 2007 Dec 15.
Kidon MI, Kang LW, Chin CW, Hoon LS, Hugo VB.
Rheumatology, Immunology and Allergy Service, Department of Paediatric Medicine, KK Children's Hospital, Singapore.
Nonsteroidal anti-inflammatory drug hypersensitivity in preschool children.
Although extensively studied in adults, nonsteroidal anti-inflammatory drug (NSAID) hypersensitivity in children, especially in young children, remains poorly defined. Pediatricians, prescribing antipyretics for children, rarely encounter significant problems, but the few epidemiologic studies performed show conflicting results. Although it is clear that some patients with acetylsalicylic acid (ASA)-sensitive asthma have their clinical onset of disease in childhood and bronchoconstriction after ASA challenge is seen in 0 to 22% of asthmatic children so challenged, ibuprofen at antipyretic doses may cause acute respiratory problems only in a very small number of mild to moderate asthmatics. The recently elucidated mechanism of action of acetaminophen may explain some occurrences of adverse reactions in patients with cross-reactive NSAID hypersensitivity on the basis of its inhibitory activity on the newly described enzyme, cyclooxygenase (COX)-3. This nonspecific sensitivity to inhibition of COX is most likely genetically determined and shows a remarkable association with atopic disease even in the very young age group and possibly an increased predilection in specific ethnic groups. This review summarizes state-of-the-art published data on NSAID hypersensitivity in preschool children.
2007 Dec;23(12):2985-95.
Brune K.
Department of Experimental and Clinical Pharmacology and Toxicology, FAU Erlangen-Nuremberg, Germany.
Persistence of NSAIDs at effect sites and rapid disappearance from side-effect compartments contributes to tolerability.
BACKGROUND: Non-steroidal, anti-inflammatory drugs (NSAIDs) are still the most widely used drugs worldwide. The introduction of selective cyclooxygenase (COX)-2 inhibitors has led to compounds which appear less damaging to the gastrointestinal tract, but possibly more risky to the cardiovascular system than older drugs. None has as yet reached OTC-status. OBJECTIVE: This situation necessitates an analysis of the characteristics of those older ones which - due to their relative safety - have achieved over-the-counter (OTC) status. DESIGN: The pharmacodynamic and pharmacokinetic characteristics of non-selective COX inhibitors in OTC use were obtained from the literature by systematic search, examined and used to construct a coherent hypothesis why they achieved OTC status, i.e. effectiveness and relative safety at low doses. RESULTS: Pharmacodynamic (COX-2 preferential, but not selective inhibition) and, more importantly, pharmacokinetic characteristics of some of the older compounds may make them particularly safe drugs if used at low (OTC) doses with treatment limited to a few days of intake. The reason why some NSAIDs are particularly active while being relatively free from side-effects may be due to their specific biodistribution and metabolism, leading to drug accumulation and persistence in inflamed tissue (effect compartment) together with fast clearance from the central compartment, including blood, vascular wall, heart and kidney, i.e., possible sideeffect compartments. CONCLUSION: This specific pharmacokinetic behavior of some non-selective COX inhibitors, such as diclofenac and ibuprofen, may explain why these widely used, non-steroidal, anti-inflammatory compounds are relatively well suited for OTC use and why some are more appropriate for the therapy of certain pain conditions than others.
2007 Oct;9(5):399-403.
Fakhraee SH, Badiee Z, Mojtahedzadeh S, Kazemian M, Kelishadi R.
Division of Neonatology, Department of Pediatrics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Comparison of oral ibuprofen and indomethacin therapy for patent ductus arteriosus in preterm infants.
OBJECTIVE: Intravenous indomethacin is the conventional treatment for patent ductus arteriosus (PDA) in preterm infants; however its use is associated with various side effects such as oliguria, gastrointestinal bleeding and reduction of cerebral perfusion. Intravenous ibuprofen has recently been used to treat PDA in preterm infants without reducing cerebral blood flow or affecting intestinal or renal hemodynamics. Intravenous forms of indomethacin and ibuprofen are not available in Iran. This study aimed to examine and compare the efficacy and safety of oral ibuprofen and oral indomethacin for the treatment of PDA in preterm infants. METHODS: Thirty-six infants (gestational age less than 34 weeks) who had echocardiographically confirmed PDA were enrolled in this study. The patients were randomly administered with three oral doses of either indomethacin (0.2 mg/kg, at an interval of 24 hrs) or ibuprofen (a first dose of 10 mg/kg, followed at an interval of 24 hrs by two doses of 5 mg/kg each) (n=18 each group). The rate of ductal closure, side effects, complications, and the infants' clinical course were recorded. RESULTS: The ductus was closed in all of 18 patients (100%) in the ibuprofen group and in 15 (83.3%) patients in the indomethacin group (P > 0.05). There were no significant differences in the levels of serum blood urea nitrogen and creatinine between the two groups before and after treatment. Necrotizing enterocolitis (NEC) occurred in 3 patients in the indomethacin group and none in the ibuprofen group (P < 0.05). The survival rate at 1 month after treatment was 94% (17/18) in both groups. One infant in the ibuprofen group died from sepsis and one in the indomethacin group died as a result of NEC. CONCLUSIONS: Oral ibuprofen is as effective as oral indomethacin for the treatment of PDA in preterm infants. Oral ibuprofen therapy is associated with a lower incidence of NEC.
Cancer. 2009 Oct 13.
Zell JA, Ziogas A, Bernstein L, Clarke CA, Deapen D, Largent JA, Neuhausen SL, Stram DO, Ursin G, Anton-Culver H.
Genetic Epidemiology Research Institute and Department of Epidemiology, University of California at Irvine, Irvine, California.
Nonsteroidal anti-inflammatory drugs: effects on mortality after colorectal cancer diagnosis.
BACKGROUND:: Nonsteroidal anti-inflammatory drug (NSAID) use has been associated with a decreased colorectal cancer (CRC) risk. However, to the best of the authors' knowledge, the effects of NSAID on clinical outcomes after CRC diagnosis are not well defined. The authors investigated the association between prediagnosis NSAID use and mortality after CRC diagnosis among women in the California Teachers Study cohort. METHODS:: Women aged <85 years participating in the California Teachers Study, without a prior CRC diagnosis at baseline (1995-1996), and who were diagnosed with CRC during follow-up through December 2005, were eligible for analysis of the association between prediagnosis NSAID use and mortality. NSAID use (including aspirin and ibuprofen) was collected through a self-administered questionnaire. Cancer occurrence was identified through California Cancer Registry linkage. Multivariate Cox proportional hazards regression models were used to estimate hazards ratios (HR) for death and 95% confidence intervals (95% CIs). RESULTS:: Among 621 CRC patients who were identified, 64% reported no prediagnosis regular NSAID use, 17% reported use of 1 to 6 days/week, and 20% reported daily use. A duration of NSAID use <5 years was reported by 17% of patients and a use of >/=5 years was reported by 18%. Regular prediagnosis NSAID use (1-3 days/week, 4-6 days/week, and daily) versus none was associated with improved overall survival (OS) (HR, 0.71; 95% CI, 0.53-0.95) and CRC-specific survival (HR, 0.58; 95% CI 0.40-0.84) after adjustment for clinically relevant factors. Prediagnosis NSAID use >/=5 years (vs none) was found to be associated with improved OS (HR, 0.55; 95% CI, 0.37-0.84) and CRC-specific survival (HR, 0.40; 95% CI, 0.23-0.71) in adjusted analyses. CONCLUSIONS:: When used regularly or over a prolonged duration before CRC diagnosis, NSAIDs are associated with decreased mortality among female CRC patients.
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