Multicentre Study of Piroxicam Versus Naproxen in Juvenile Chronic Arthritis, With Special Reference to Problem Areas in Clinical Trials of Nonsteroidal Anti-Inflammatory Drugs in Childhood

Williams, Peter; Ansell, B. M.; Bell, Andrew; Cain, Agnieszka; Chamberlain, M A; Clarke, Antony; Craft, A. W.; Hollingworth, P.; Keegan, D. A. J.; Roberts, Sonia; Rooney, Mary R.; Smith, Pamela Alethea

doi:10.1093/rheumatology/25.1.67

Cited by 19 publications

(11 citation statements)

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“…This indicates that the toxicity index may be clinically important in the assessment of drug toxicity in children over time, but the implications of our results are hard to assess because of the difficulty of statistical comparison. Exposure to ibuprofen, naproxen, antimalarials and methotrexate has previously resulted in 5-24% side-effects in controlled randomised trials of children treated with these drugs [7,9,[24][25][26], but in contrast to the tendency in our study, an equal tolerance of piroxicam and naproxen has been found in short-term randomised trials [8,27].…”

Section: Discussioncontrasting

confidence: 97%

“…Data on drug toxicity during long-lasting juvenile rheumatic diseases are scarce. Thus toxicity during 2 or more years of treatment has previously been reported in retrospective studies for some antirheumatic drugs [4][5][6], and drug tolerance has been assessed in prospective randomised trials, but these latter studies have, to our knowledge, only lasted for 2-12 months [7][8][9].…”

Section: Introductionmentioning

confidence: 99%

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Toxicity of antirheumatic and anti-inflammatory drugs in children

Flatø¹,

Vinje²,

Førre³

1998

Clin Rheumatol

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The aim of the study was to describe the long-term toxicity of antirheumatic and anti-inflammatory drugs in a paediatric rheumatology clinic population. One hundred and seventeen children were studied on first admission to a paediatric rheumatology clinic and after a mean of 8.6 +/- 0.4 years of follow-up. Medical records from the intermediate period were reviewed. The patients had 155 exposures to non-steroidal anti-inflammatory drugs (NSAIDs), 88 exposures to disease-modifying antirheumatic drugs (DMARDs) and 12 exposures of prednisolone during a total of 682 patient years. Drug toxicity was measured in terms of the number of toxic events, number of drug discontinuations due to toxicity, number of side-effects per patient year of drug exposure and as a toxicity index. Side-effects were seen in 69 (27%) of the drug exposures, corresponding to 0.10 toxic events per patient year of exposure. Abdominal pain was the most common side-effect, and was reported in 21 (14%) of the exposures to NSAIDs. Five severely toxic events, all leading to hospitalisation, occurred. The toxicity of NSAIDs was not significantly different from that of DMARDs with regard to the number of toxic events (21% and 31%, respectively, NS) and drug discontinuations due to toxicity (17% and 14%, respectively, NS). Piroxicam tended to be more toxic than ibuprofen (46% versus 18% toxic events, p <0.05; 36% versus 16% discontinuations due to toxicity, NS; 0.33 versus 0.05 side-effects per patient year and a toxicity index of 1.45 versus 0.20 units per patient year). Gold tended to be more toxic than antimalarials (41% versus 15% toxic events, p<0.05; 24% versus 12% discontinuations, NS; 0.37 versus 0.08 side-effects per patient year and a toxicity index of 1.56 versus 0.23 units per patient year). It was concluded that antirheumatic and anti-inflammatory drugs led to side-effects in 27% of the exposed children during 9 years of follow-up. There was an overlap of the toxicity of certain NSAIDs and the most commonly employed DMARDs.

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Section: Discussioncontrasting

confidence: 97%

Section: Introductionmentioning

confidence: 99%

Toxicity of antirheumatic and anti-inflammatory drugs in children

Flatø¹,

Vinje²,

Førre³

1998

Clin Rheumatol

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“…GI AE have been observed in a number of clinical trials in children with JRA using NSAID 4,[9][10][11][15][16][17][18][19][20][21][22][23] . A number of clinical trials and observational studies have also been conducted to determine the prevalence of GI complications of NSAID therapies over time, in a real-world clinical setting.…”

Section: Rheumatologymentioning

confidence: 99%

A Prospective Study Comparing Celecoxib with Naproxen in Children with Juvenile Rheumatoid Arthritis

Foeldvari¹,

Szer²,

Zemel³

et al. 2009

J Rheumatol

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“…Piroxicam, an oxicam derivative, which is known for its long t'l2 (""36h) has been found effective in juvenile arthritis patients (Garcia- Morteo et al 1987;Tyndall & Ansell 1980;Williams et al 1986). Dosage recommendations are not available, but an average dose of piroxicam 0.33 mg/kg/day given once daily was used in most of the above trials.…”

Section: Other Nsaidsmentioning

confidence: 99%

Clinical Pharmacokinetics of Drugs Used in Juvenile Arthritis

Skeith

Jamali

1991

Clinical Pharmacokinetics

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Juvenile arthritis is defined as the occurrence of objective evidence of arthritis for a minimum of 6 weeks, in a child 16 years of age or younger. With a reported incidence of 9 to 19.6 per 100,000 children, juvenile arthritis is considered to be a rare disease. There is no known cure; however, up to 75% of patients will undergo remission by late adolescence. Drugs used in the treatment of juvenile arthritis are divided into 2 major classes: (a) the nonsteroidal anti-inflammatory drugs (NSAIDs) including salicylates, naproxen, ibuprofen, fenoprofen, ketoprofen, flurbiprofen, indomethacin, sulindac, tolmetin and diclofenac, and (b) disease modifying agents which encompass drugs such as antimalarial agents, gold, methotrexate, penicillamine and sulfasalazine. In almost all the reports dealing with the pharmacokinetics of NSAIDs, the level of disease activity has not been noted. The level of activity is important since, during a flare, the plasma albumin may fall to the point that it causes a substantial and clinically significant increase in the unbound serum concentration of highly bound drugs. The relationship between the concentration of these drugs in the systemic circulation and their efficacy is not clear. However, for many of them, therapeutic drug monitoring is recommended as a means of reducing the possibility of toxic reactions. Further pharmacokinetic and -dynamic evaluations are needed for many of these drugs in juvenile arthritis.

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Multicentre Study of Piroxicam Versus Naproxen in Juvenile Chronic Arthritis, With Special Reference to Problem Areas in Clinical Trials of Nonsteroidal Anti-Inflammatory Drugs in Childhood

Cited by 19 publications

References 0 publications

Toxicity of antirheumatic and anti-inflammatory drugs in children

Toxicity of antirheumatic and anti-inflammatory drugs in children

A Prospective Study Comparing Celecoxib with Naproxen in Children with Juvenile Rheumatoid Arthritis

Clinical Pharmacokinetics of Drugs Used in Juvenile Arthritis

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