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David Mauleon - One of the best experts on this subject based on the ideXlab platform.
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pharmacokinetics of dexketoprofen Trometamol in healthy volunteers after single and repeated oral doses
The Journal of Clinical Pharmacology, 1998Co-Authors: Manuel-josé Barbanoj, Ignasi Gich, Remei Artigas, Digna Tost, Cristina Moros, Luisa M Garcia, Rosa-maría Antonijoan, David MauleonAbstract:The pharmacokinetics of dexketoprofen Trometamol were evaluated in two studies using healthy volunteers. In the first study, the relative bioavailability of a single oral capsule of dexketoprofen free acid 25 mg or dexketoprofen Trometamol 25 mg (given as 37 mg of the Trometamol salt) was compared to ketoprofen 50 mg in 18 healthy volunteers. In the second study, the pharmacokinetics and tolerability of oral dexketoprofen Trometamol in tablet form were evaluated after either a single 25 mg dose (24 volunteers) or a repeated dose of 25 mg twice daily for 7 days (12 volunteers). The absorption of dexketoprofen from dexketoprofen Trometamol capsules was bioequivalent to that of ketoprofen. On the other hand, the extent of absorption of dexketoprofen free acid was significantly lower than that for ketoprofen. Dexketoprofen Trometamol showed the most rapid absorption rate, with highest Cmax and shortest tmax values, whereas dexketoprofen free acid had the slowest absorption rate, and ketoprofen had an intermediate absorption rate. After repeated-dose administration of dexketoprofen Trometamol, the pharmacokinetic parameters were similar to those obtained after single doses, indicating that no drug accumulation occurred. Dexketoprofen Trometamol was well tolerated, with no clinically relevant adverse events reported.
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comparison of dexketoprofen Trometamol and ketoprofen in the treatment of osteoarthritis of the knee
The Journal of Clinical Pharmacology, 1998Co-Authors: Juan Beltran, Remei Artigas, E Martinmola, Manuel Figueroa, Josep Granados, Raimon Sanmarti, Ferran Torres, Monica Forns, David MauleonAbstract:: Dexketoprofen, the active enantiomer of the racemic compound ketoprofen, is a new nonsteroidal antiinflammatory drug (NSAID) of the arylpropionate family. The efficacy and safety of dexketoprofen Trometamol were compared with the equivalent enantiomeric dose of ketoprofen in a multicenter, randomized, double-blind 3-week trial of adult outpatients with pain due to osteoarthritis of the knee. After a washout period of 7-15 days, patients were randomly assigned to receive either dexketoprofen Trometamol 25 mg tid (N = 89) or ketoprofen 50 mg tid (N = 94). Of the 183 patients enrolled, two were lost to follow-up. At the end of treatment (3 weeks), the main efficacy outcome measures were significantly better in the dexketoprofen Trometamol group than in the ketoprofen group. In addition, overall physician assessment indicated that 75% of the dexketoprofen group had improved compared with 50% of the ketoprofen patients. There were fewer adverse events in the dexketoprofen treatment group, but the difference did not reach statistical significance. These results demonstrate that dexketoprofen Trometamol 25 mg tid is more effective than ketoprofen 50 mg tid in short-term symptomatic treatment of knee osteoarthritis and suggest that the tolerability of dexketoprofen Trometamol is more favorable than ketoprofen. Therefore, the substitution of dexketoprofen for racemic ketoprofen may be advantageous in clinical practice.
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clinical comparison of dexketoprofen Trometamol and dipyrone in postoperative dental pain
The Journal of Clinical Pharmacology, 1998Co-Authors: Jose Vicente Bagan, Remei Artigas, Monica Forns, Sebastian Lopez J Arranz, Eduardo Valencia, Joseba Santamaria, Isabel Eguidazu, Manuel Horas, Antonio Zapata, David MauleonAbstract:: A total of 125 outpatients with moderate to severe pain after surgical removal of one impacted third molar were randomly assigned to receive dexketoprofen Trometamol 12.5 or 25 mg or dipyrone 575 mg. For first-dose assessments, patients rated their pain intensity and its relief at regular intervals. From 60 min post dose to the end of the 6-h observation period, both doses of dexketoprofen Trometamol had higher pain relief scores than dipyrone: Between 3 and 6 h the differences were statistically significant. In addition, peak measures (PIDmax and PARmax ) were statistically superior after both doses of dexketoprofen Trometamol compared to dipyrone. The overall efficacy assessed at the end of the first-dose phase was rated as good or excellent by 90%, 83.3%, and 70% of patients receiving dexketoprofen Trometamol 25 mg, dexketoprofen Trometamol 12.5 mg, and dipyrone, respectively. The number of patients who required remedication during the 6-h period was significantly lower in both dexketoprofen groups. Repeated-dose data were also obtained. No significant differences were found in the efficacy after repeated doses, the number of doses taken, or the mean time elapsed between doses. The overall efficacy at the end of the repeated-dose phase was rated as good or excellent by 84.2%, 66.7%, and 70% of patients receiving dexketoprofen Trometamol 25 mg, dexketoprofen Trometamol 12.5 mg, and dipyrone, respectively. The frequency of adverse events was similar for all treatments and no serious adverse events were reported during the study.
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clinical comparison of dexketoprofen Trometamol ketoprofen and placebo in postoperative dental pain
The Journal of Clinical Pharmacology, 1998Co-Authors: Mark Mcgurk, Remei Artigas, Alessandro Casini, P Robinson, V Rajayogeswaran, M De Luca, G Munoz, David MauleonAbstract:: The efficacy and tolerability of single doses of dexketoprofen Trometamol 12.5 mg, 25 mg, and 50 mg and ketoprofen 50 mg were compared in this double-blind, randomized, placebo-controlled study of 210 patients with moderate to severe pain after removal of one mandibular impacted third molar tooth. Pain intensity and pain relief were monitored for 6 h after administration of medication using visual analogue and verbal rating scales. All four active treatments were significantly more effective than placebo (P < 0.001). Dexketoprofen 25 mg and 50 mg produced an analgesic effect within 30 min of administration and their effect persisted for 6 h. Ketoprofen 50 mg produced a level of analgesia similar to those of the higher doses of dexketoprofen Trometamol, but it had a slower onset. The 12.5-mg dose of dexketoprofen Trometamol was significantly superior to placebo but produced a lower level and shorter duration of analgesia compared to the other active treatments. There were no significant differences between 25 and 50 mg of dexketoprofen Trometamol in any measure of analgesic efficacy. No serious adverse events were observed and there were no significant differences in the incidence of adverse events among treatment groups. These results demonstrate that dexketoprofen Trometamol 25 mg is at least as effective as the racemic ketoprofen 50 mg in the treatment of postsurgical dental pain. The more rapid onset of action compared to ketoprofen suggests that dexketoprofen Trometamol is more appropriate for treatment of acute pain.
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clinical comparison of dexketoprofen Trometamol ketoprofen and placebo in dental pain
The Journal of Clinical Pharmacology, 1998Co-Authors: Mark Mcgurk, Remei Artigas, Alessandro Casini, P Robinson, V Rajayogeswaran, G Munoz, Massimo De Luca, David MauleonAbstract:: The efficacy and tolerability of single doses of dexketoprofen Trometamol12.5 mg, 25 mg, and 50 mg and ketoprofen 50 mg were compared in this double-blind, randomized, placebo-controlled study of 210 patients with moderate to severe pain after removal of one mandibular impacted third molar tooth. Pain intensity and pain relief were monitored for 6 h after administration of medication using visual analogue and verbal rating scales. All four active treatments were significantly more effective than placebo (P < 0.001). Dexketoprofen 25 mg and 50 mg produced an analgesic effect within 30 min of administration and their effect persisted for 6 h. Ketoprofen 50 mg produced a level of analgesia similar to those of the higher doses of dexketoprofen Trometamol, but it had a slower onset. The 12.5-mg dose of dexketoprofen Trometamol was significantly superior to placebo but produced a lower level and shorter duration of analgesia compared to the other active treatments. There were no significant differences between 25 and 50 mg of dexketoprofen Trometamol in any measure of analgesic efficacy. No serious adverse events were observed and there were no significant differences in the incidence of adverse events among treatment groups. These results demonstrate that dexketoprofen Trometamol 25 mg is at least as effective as the racemic ketoprofen 50 mg in the treatment of postsurgical dental pain. The more rapid onset of action compared to ketoprofen suggests that dexketoprofen Trometamol is more appropriate for treatment of acute pain.
Paul Coulthard - One of the best experts on this subject based on the ideXlab platform.
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Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain
The Journal of Headache and Pain, 2015Co-Authors: R Andrew Moore, C. Gay-escoda, R. Figueiredo, Z. Tóth-bagi, T. Dietrich, S. Milleri, D. Torres-lagares, C. M. Hill, A. García-garcía, Paul CoulthardAbstract:Background Combination analgesics are effective in acute pain, and a theoretical framework predicts efficacy for combinations. The combination of dexketoprofen and tramadol is untested, but predicted to be highly effective. Methods This was a randomised, double-blind, double-dummy, parallel-group, placebo-controlled, single-dose trial in patients with moderate or severe pain following third molar extraction. There were ten treatment arms, including dexketoprofen Trometamol (12.5 mg and 25 mg) and tramadol hydrochloride (37.5 mg and 75 mg), given as four different fixed combinations and single components, with ibuprofen 400 mg as active control as well as a placebo control. The study objective was to evaluate the superior analgesic efficacy and safety of each combination and each single agent versus placebo. The primary outcome was the proportion of patients with at least 50 % max TOTPAR over six hours. Results 606 patients were randomised and provided at least one post-dose assessment. All combinations were significantly better than placebo. The highest percentage of responders (72 %) was achieved in the dexketoprofen Trometamol 25 mg plus tramadol hydrochloride 75 mg group (NNT 1.6, 95 % confidence interval 1.3 to 2.1). Addition of tramadol to dexketoprofen resulted in greater peak pain relief and greater pain relief over the longer term, particularly at times longer than six hours (median duration of 8.1 h). Adverse events were unremarkable. Conclusions Dexketoprofen Trometamol 25 mg combined with tramadol hydrochloride 75 mg provided good analgesia with rapid onset and long duration in a model of moderate to severe pain. The results of the dose finding study are consistent with pre-trial calculations based on empirical formulae. Trial registration EudraCT (2010-022798-32); Clinicaltrials.gov ( NCT01307020 ).
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dexketoprofen tramadol randomised double blind trial and confirmation of empirical theory of combination analgesics in acute pain
Journal of Headache and Pain, 2015Co-Authors: Andrew R Moore, R. Figueiredo, T. Dietrich, S. Milleri, C. M. Hill, Cosme Gayescoda, Z Tothbagi, Daniel Torreslagares, Abel Garciagarcia, Paul CoulthardAbstract:Combination analgesics are effective in acute pain, and a theoretical framework predicts efficacy for combinations. The combination of dexketoprofen and tramadol is untested, but predicted to be highly effective. This was a randomised, double-blind, double-dummy, parallel-group, placebo-controlled, single-dose trial in patients with moderate or severe pain following third molar extraction. There were ten treatment arms, including dexketoprofen Trometamol (12.5 mg and 25 mg) and tramadol hydrochloride (37.5 mg and 75 mg), given as four different fixed combinations and single components, with ibuprofen 400 mg as active control as well as a placebo control. The study objective was to evaluate the superior analgesic efficacy and safety of each combination and each single agent versus placebo. The primary outcome was the proportion of patients with at least 50 % max TOTPAR over six hours. 606 patients were randomised and provided at least one post-dose assessment. All combinations were significantly better than placebo. The highest percentage of responders (72 %) was achieved in the dexketoprofen Trometamol 25 mg plus tramadol hydrochloride 75 mg group (NNT 1.6, 95 % confidence interval 1.3 to 2.1). Addition of tramadol to dexketoprofen resulted in greater peak pain relief and greater pain relief over the longer term, particularly at times longer than six hours (median duration of 8.1 h). Adverse events were unremarkable. Dexketoprofen Trometamol 25 mg combined with tramadol hydrochloride 75 mg provided good analgesia with rapid onset and long duration in a model of moderate to severe pain. The results of the dose finding study are consistent with pre-trial calculations based on empirical formulae. EudraCT (2010-022798-32); Clinicaltrials.gov ( NCT01307020 ).
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Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain
Journal of Headache and Pain, 2015Co-Authors: R Andrew Moore, C. Gay-escoda, R. Figueiredo, Z. Tóth-bagi, T. Dietrich, S. Milleri, D. Torres-lagares, C. M. Hill, A. García-garcía, Paul CoulthardAbstract:Combination analgesics are effective in acute pain, and a theoretical framework predicts efficacy for combinations. The combination of dexketoprofen and tramadol is untested, but predicted to be highly effective. This was a randomised, double-blind, double-dummy, parallel-group, placebo-controlled, single-dose trial in patients with moderate or severe pain following third molar extraction. There were ten treatment arms, including dexketoprofen Trometamol (12.5 mg and 25 mg) and tramadol hydrochloride (37.5 mg and 75 mg), given as four different fixed combinations and single components, with ibuprofen 400 mg as active control as well as a placebo control. The study objective was to evaluate the superior analgesic efficacy and safety of each combination and each single agent versus placebo. The primary outcome was the proportion of patients with at least 50 % max TOTPAR over six hours. 606 patients were randomised and provided at least one post-dose assessment. All combinations were significantly better than placebo. The highest percentage of responders (72 %) was achieved in the dexketoprofen Trometamol 25 mg plus tramadol hydrochloride 75 mg group (NNT 1.6, 95 % confidence interval 1.3 to 2.1). Addition of tramadol to dexketoprofen resulted in greater peak pain relief and greater pain relief over the longer term, particularly at times longer than six hours (median duration of 8.1 h). Adverse events were unremarkable. Dexketoprofen Trometamol 25 mg combined with tramadol hydrochloride 75 mg provided good analgesia with rapid onset and long duration in a model of moderate to severe pain. The results of the dose finding study are consistent with pre-trial calculations based on empirical formulae. EudraCT (2010-022798-32); Clinicaltrials.gov ( NCT01307020 ).
G C Schito - One of the best experts on this subject based on the ideXlab platform.
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why fosfomycin Trometamol as first line therapy for uncomplicated uti
International Journal of Antimicrobial Agents, 2003Co-Authors: G C SchitoAbstract:Abstract Uncomplicated urinary tract infection (UTI) is one of the most common conditions requiring diagnostic and therapeutic intervention. The aetiology and the treatment of these infectious diseases have changed little during last years of the ‘antibiotic era'. Escherichia coli is the most prevalent uropathogen (85–>90%) and treatment is aimed at eradicating the infection using shorter regimes that typically may employ a 3-day course with once-a-day dosing of a selected drug or a single dose of a particular efficacious antibiotic. Antibiotic resistance to commonly used agents, such as trimethoprim and ampicillin, often now exceeds 30–50%, while fosfomycin Trometamol, despite many years of usage, continues to be characterized by an extremely low incidence of E. coli resistant strains (about 1%) worldwide. Many factors may have contributed to preserve fosfomycin Trometamol antibacterial activity including single dose usage limited to urinary infections, very high and sustained urinary concentrations that rapidly kill bacteria reducing the opportunity for mutant selection. In addition there is no animal feed that contains the drug, resistance is most commonly acquired by chromosomal mutations that do not spread easily and the biological cost of these genetic modifications is high. To these parameters fosfomycin Trometamol adds excellent tolerability and safety. Although nowadays, microbial resistance limits available resources and some drugs can no longer be recommended as reliable agents, fosfomycin Trometamol, because of its properties, remains a drug of choice for the eradication of uncomplicated UTI.
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susceptibility of frequent urinary pathogens to fosfomycin Trometamol and eight other antibiotics results of an italian multicenter survey
Infection, 1992Co-Authors: G C Schito, E Albini, M Moreddu, G Nicoletti, Stefania Stefani, C Chezzi, M C Arcangeletti, G P Del BonoAbstract:In order to assess the resistance profile for fosfomycin Trometamol after several years of clinical use in Italy, this study has explored the susceptibility to fosfomycin and eight other antibacterial drugs of 6,021 strains isolated from 23,816 urines during 1990 in three teaching hospitals located in Genoa, Parma and Catania. Gram-negative strains, notablyEscherichia coli (41.6%), were primarily involved. Amoxicillin was the least active compound with resistance in 41.4% of the isolates. Fosfomycin showed the lowest rate of resistance in both gram-negative (2.8%) and gram-positive (2.1%) pathogens. This was followed by norfloxacin with a resistance rate of 11.8% and netilmicin with 12.2%. These results indicate that fosfomycin-Trometamol may continue to be used in single-dose treatment of urinary tract infections even in the absence of microbiological data since the prevalence of resistance to the drug is, at present, so low that therapeutic failure is highly improbable.
R Yahalom - One of the best experts on this subject based on the ideXlab platform.
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single dose fosfomycin Trometamol versus 5 day cephalexin regimen for treatment of uncomplicated lower urinary tract infections in women
Antimicrobial Agents and Chemotherapy, 1994Co-Authors: Gai Elhanan, H Tabenkin, R YahalomAbstract:A randomized study was conducted to assess the clinical and microbiological efficacies of a single 3-g dose of fosfomycin Trometamol for the treatment of uncomplicated lower urinary tract infections in women compared with a 5-day regimen of cephalexin at 0.5 g four times daily. One hundred twelve women, all of whom had documented infections with bacteria sensitive to both antibiotics, were included. Fifty-eight women received fosfomycin Trometamol, and 54 women received cephalexin. The two groups did not differ in age, severity, or duration of current urinary tract infection, menstrual status, sexual activity, or use of contraceptives. Ninety percent of pathogens in the fosfomycin Trometamol group and 81% in the cephalexin group were Escherichia coli (the difference is not significant [NS]). A clinical evaluation at the 5-day follow-up showed that 91% of the women in each group were free of symptoms, while five women in each group were considered therapy failures and were treated by another antibiotic course. A microbiological evaluation at the 5-day follow-up showed a 91% eradication rate in the fosfomycin Trometamol group and an 83% eradication rate in the cephalexin group (NS). At the 1-month follow-up, a clinical evaluation demonstrated prolonged resolution in 86 and 78%, respectively, of the participating women (NS). A microbiological evaluation at 1 month demonstrated prolonged eradication in 47 (81%) women treated with fosfomycin Trometamol and in 37 (68%) women treated with cephalexin (NS). Three and six women, respectively, had relapsed. No adverse reactions were reported by the fosfomycin Trometamol-treated women, while three women treated with cephalexin reported mild adverse reactions but completed the study period. Fosfomycin Trometamol in a single 3-g dose is as effective as a 5-day regimen of cephalexin for the treatment of uncomplicated lower urinary tract infection in women.
J Vandepitte - One of the best experts on this subject based on the ideXlab platform.
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single dose fosfomycin Trometamol versus multiple dose norfloxacin over three days for uncomplicated uti in general practice
Infection, 1990Co-Authors: Joseph Reynaert, D Van Eyck, J VandepitteAbstract:The aim of this study was to carry out a small-scale bacteriological comparison between a standard therapy with norfloxacin 400 mg twice daily, and fosfomycin Trometamol (3 g) in single dose in uncomplicated urinary tract infections (UTI) in women. Only patients with UTI with cultures showing a bacterial count of 105 or more bacteria/ml were included in the study (n=32; ages 16–75 years). After one week sterile cultures were obtained in 14 of 16 cases in the fosfomycin Trometamol group, and in 14 of 16 cases in the norfloxacin group. After one month eradication was confirmed in 13 of 16 patients in the fosfomycin Trometamol group, and in nine of 16 patients in the norfloxacin group. Recurrence was seen in one case in the fosfomycin Trometamol group, and in five cases in the norfloxacin group. The reinfection and persistence rates were identical (1/16) in both groups. The main clinical symptoms disappeared very rapidly after initiating treatment, and the correlation with the bacteriological data after one week was excellent. Both drugs were well tolerated and the compliance for fosfomycin Trometamol was 100%.