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  • 1
    Electronic Resource
    Electronic Resource
    A phenylbutazone dose-finding study in rheumatoid arthritis (1983)
    Springer
    European journal of clinical pharmacology 24 (1983), S. 773-776 
    Details
    ISSN: 1432-1041
    Keywords: phenylbutazone ; rheumatoid arthritis ; dose ; oxyphenbutazone ; side effects
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Different doses of phenylbutazone have been compared in a double blind study on 32 patients with rheumatoid arthritis in order to determine the minimum effective dose. Of 8 different dose levels studied (90 mg, 150 mg, 180 mg, 240 mg, 270 mg, 300 mg, 360 mg and 450 mg/day) the most efficacious was found to be 300 mg/day. Doses below this did not produce full benefit; no further improvement occurs with higher doses. Although 7/32 patients developed adverse reactions there was no relationship between these and the plasma levels of either phenylbutazone or oxyphenbutazone. An attempt was made to distinguish ‘responders’ from ‘non-responders’. We found no relationship between response and plasma levels of phenylbutazone or oxyphenbutazone.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00607086
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  • 2
    Electronic Resource
    Electronic Resource
    Osmosin: its effect on plasma and synovial fluid kinetics of indomethacin (1985)
    Springer
    European journal of clinical pharmacology 27 (1985), S. 689-691 
    Details
    ISSN: 1432-1041
    Keywords: indomethacin ; Osmosin ; plasma and synovial fluid ; polyarthritis ; inflammation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary ‘Osmosin’ (sodium indomethacin trihydrate, now withdrawn) produced a constant rate of release of indomethacin into the gut. Paired plasma and synovial fluid samples were obtained at regular intervals following a single dose of ‘Osmosin’ (19 patients) and after continuous daily dosing (15 patients). Indomethacin is rapidly absorbed and plasma concentrations maintained in the range 0.3 to 0.6 µg/ml after the first 4 h. Equilibrium between plasma and synovial fluid occurs, with SF/plasma ratios 0.74 to 0.82 12–24 h after a single dose and up to 0.96 thereafter. The indomethacin synovial fluid/plasma profile is changed by Osmosin from the pattern of a short half-life drug to the pattern typical of a long half-life drug. Results from serial samples obtained by use of indwelling cannulae (in vein and knee joint) show close agreement with our single paired sampling technique. Our method may have theoretical disadvantages but it has many practical advantages.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00547050
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  • 3
    Electronic Resource
    Electronic Resource
    Plasma and synovial fluid concentrations of diclofenac sodium and its hydroxylated metabolites during once-daily administration of a 100 mg slow-release formulation (1986)
    Springer
    European journal of clinical pharmacology 31 (1986), S. 469-472 
    Details
    ISSN: 1432-1041
    Keywords: diclofenac sodium ; slow-release formulation ; plasma and synovial fluid concentrations
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Plasma and knee joint synovial fluid (SF) concentration of diclofenac sodium and its hydroxylated metabolites were measured after chronic dosing with the 100 mg polymer matrix formulation. Peak concentrations were reached in plasma and SF roughly after administration. Plasma concentrations then fell rapidly, but concentrations in SF were maintained for up to 25 h. The active metabolite was present in both fluids throughout the study period. The slow-release form showed a longer plasma/SF equilibration time than the conventional tablet had in a previous study. Prostaglandin E1 and F2a concentrations were lower in the early post-dose period but did not correlate with drug concentrations.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00613526
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  • 4
    Electronic Resource
    Electronic Resource
    The pharmacokinetics of diclofenac sodium in patients with active rheumatoid disease (1982)
    Springer
    European journal of clinical pharmacology 21 (1982), S. 331-334 
    Details
    ISSN: 1432-1041
    Keywords: diclofenac sodium ; rheumatoid disease ; healthy subjects ; serum albumin ; pharmacokinetics
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Pharmacokinetic data for diclofenac sodium has been well established in healthy volunteers, whereas in patients with rheumatoid arthritis very little information is available in the literature. A single oral dose of enteric-coated diclofenac sodium was given to 10 patients with active rheumatoid disease, adopting the same procedures used for a group of 10 healthy volunteers in whom pharmacokinetic data was already available. Plasma specimens were collected over a period of 8h following administration and concentrations of diclofenac determined by GLC. Resulting plasma concentration curves were similar to those obtained in the healthy subjects in that areas under curves and terminal half-lives were comparable. However, peak concentrations of diclofenac were significantly reduced in the rheumatoid patients. The lower peak concentrations were correlated with the lower serum albumin levels in the patients which are associated with active rheumatoid disease.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00637622
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  • 5
    Electronic Resource
    Electronic Resource
    Plasma and synovial fluid concentrations of diclofenac sodium and its major hydroxylated metabolites during long-term treatment of rheumatoid arthritis (1983)
    Springer
    European journal of clinical pharmacology 25 (1983), S. 389-394 
    Details
    ISSN: 1432-1041
    Keywords: diclofenac sodium ; synovial fluid levels ; hydroxylated metabolites ; rheumatoid patients
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Plasma and synovial fluid concentrations of diclofenac sodium and its principal hydroxylated metabolites have been measured in sixteen rheumatoid patients on chronic therapy to investigate possible reasons for the drug's extended duration of action despite its apparent short elimination half-life in plasma. Diclofenac was detected in synovial fluid 2 h after dosing but at a lower level than in plasma. Thereafter synovial fluid concentrations remained relatively constant through to 11 h post-dosing whereas plasma levels in the same period declined rapidly from an initially high peak to near the sensitivity limit of the assay. Hydroxylated metabolites (free + conjugated) were rapidly formed with measurable concentrations of the 4′ and 5 mono and dihydroxy derivatives being detected in plasma 2 h after dosing; levels of the 3′ hydroxy metabolite were negligible at this time. Initially plasma levels of all metabolites were higher than those in synovial fluid but after 4 h synovial fluid levels were equal to or slightly higher than those in plasma. The significance of these findings is discussed in relation to the drug's overall clinical effect.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01037953
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  • 6
    Electronic Resource
    Electronic Resource
    Intra-articular steroids: Confounder of clinical trials (1991)
    Springer
    Clinical rheumatology 10 (1991), S. 38-42 
    Details
    ISSN: 1434-9949
    Keywords: Intra-Articular Steroids ; ESR ; C-Reactive Protein ; Rheumatoid Arthritis ; Drug Efficacy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary The effect of intra-articular (i-a) steroid injection on ESR and C-reactive protein (CRP) in rheumatoid arthritis (RA) was investigated. One week following injection of 1 or 2 knees there was a significant fall in ESR (p〈0.0001) and CRP (p〈0.01) in a cohort of 20 RA patients. The mean drop for both ESR and CRP was 46%. This effect lasted over a variable period up to 6 months. A survey of 50 published drug efficacy studies in RA revealed that, while 44 used ESR and 20 CRP as efficacy measures, 37 neither excluded nor recorded i-a steroid injections during the study. Steroid injections were excluded in 8 studies and recorded in 5, being used as an outcome measure in 2 of these. It is recommended that the frequency with which i-a injections are used in drug efficacy studies is reported and that they are avoided in the 3 months preceding an outcome measurement if ESR or CRP are being used as outcome measures.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF02208031
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  • 7
    Electronic Resource
    Electronic Resource
    The run-in period in trial design: A comparison of two non-steroidal anti-inflammatory agents in psoriatic arthropathy (1982)
    Springer
    Inflammation research 12 (1982), S. 221-224 
    Details
    ISSN: 1420-908X
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Psoriatic arthropathy is a relatively uncommon arthritis that exists in a wide variety of clinical forms. These two features of the disease cause problems in the design of clinical trials. In a comparison of two non-steroidal anti-inflammatory agents in this condition we attempted to overcome the difficulties by using a run-in period during which the dosage of one of the trial drugs was adjusted to suit the individual patient. After two weeks on indomethacin (75 mg or 150 mg/day) patients were allocated to four-week periods of indomethacin in the chosen dosage or diclofenac (75 mg or 150 mg/day) in a double-blind randomized crossover trial that used double dummy packaging. Of the 35 patients that entered the study, 19 completed both study groups. No significant differences were observed between the clinical improvements due to both drugs during the course of the study. In general more side-effects were seen during indomethacin treatment, though the study design precluded exact comparison. In a study biased against diclofenac, patient preference was 9/19 for indomethacin, 4/19 for diclofenac and 7/19 expressing no choice. Advantages and disadvantages of the study design are discussed.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01965150
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  • 8
    Electronic Resource
    Electronic Resource
    An assessment of tenoxicam, a nonsteroidal anti-inflammatory drug of long half-life, in patients with impaired renal function suffering from osteoarthritis or rheumatoid arthritis (1989)
    Springer
    Clinical rheumatology 8 (1989), S. 453-460 
    Details
    ISSN: 1434-9949
    Keywords: Kidney ; NSAID ; Tenoxicam ; Osteoarthritis ; Rheumatoid Arthritis
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Fifty-eight patients, aged 48–87 years, with impaired renal function and mean initial creatinine clearance of 52.1 mls/min were recruited to a 12-week open study of tenoxicam 20 mg/day for osteoarthrosis or rheumatoid arthritis. Renal function was mea sured before and after a brief run-in period when patients discontinued all nonsteroidal anti-inflammatory drugs, taking paracetamol alone, prior to monthly monitoring thereafter. Fifty-four% of patients completed the study, the others being withdrawn from lack of efficacy (17%), adverse events (24%) or both (5%). During the run-in period the mean creatinine clearance of 28 patients completing the trial improved to 64.7 mls/min and then dropped to 57.9 mls/min during the course of 12 weeks treatment with tenoxicam. Serial analysis of haematological and biochemical safety parameters showed no drug-induced change of significance. Twenty-three% of patients felt worse and 45% better at the end of treatment. Seventeen patients withdrew because of adverse events. These were normally gastrointestinal and always unrelated to further deterioration in renal function. Tenoxicam, 20 mg/day, can be given safely for a period of at least three months in patients with mild or moderate renal impairment.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF02032096
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