Trial reportBritish journal of clinical pharmacology2000
Dose loading with delayed-release mesalazine: a study of tissue drug concentrations and standard pharmacokinetic parameters.
Trial report in British journal of clinical pharmacology, 2000. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 45 citations in OpenAlex.
- Impact of Inflammatory Bowel Disease (IBD) and IBD Medications on Risk of Hyperlipidemia andFrontiers in medicine · 2022Article
- Clinical Pharmacokinetic and Pharmacodynamic Considerations in the Treatment of Ulcerative Colitis.Clinical pharmacokinetics · 2019Review
- Bioavailability and swallowability of an age-appropriate, delayed-release mesalamine formulation in healthy volunteers.Clinical pharmacology : advances and applications · 2019Article
- Review article: The pharmacokinetics and pharmacodynamics of drugs used in inflammatory bowel disease treatment.European journal of clinical pharmacology · 2015Review
- 5-ASA colonic mucosal concentrations resulting from different pharmaceutical formulations in ulcerative colitis.World journal of gastroenterology · 2013Article
- Optimization of conventional therapy in patients with IBD.Nature reviews. Gastroenterology & hepatology · 2011Review
- Common misconceptions about 5-aminosalicylates and thiopurines in inflammatory bowel disease.World journal of gastroenterology · 2011Article
- Which 5-ASA?Gut · 2003Article
- Pharmacokinetic considerations in the treatment of inflammatory bowel disease.Clinical pharmacokinetics · 2001Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTissue concentrations of 5-aminosalicylic acid (5ASA) and its metabolites may influence the clinical course of inflammatory bowel disease. Since the factors that determine tissue drug concentrations are unknown we have studied the relationships between the oral dose of delayed-release mesalazine, rectal tissue drug concentrations and standard pharmacokinetic parameters.
methodsTwelve healthy volunteers were studied following 7 days treatment with 1.2, 2.4 and 4.8 g of delayed-release mesalazine daily. 5-aminosalicylic acid and N-acetyl 5-aminosalicylic acid concentrations were measured in serum, urine, stool and rectal tissue biopsies.
resultsSerum concentrations and 24 h urinary excretion of 5ASA and N-acetyl 5ASA increased as the oral dose of mesalazine was increased from 1.2 g through 2.4 g to 4.8 g daily (serum area under curve (AUC):5ASA = 3. 9, 15.4 and 46.8 microg ml-1 h, P < 0.0001; N-acetyl 5ASA = 17.2, 30. 9 and 57.8 microg ml-1 h, P < 0.0001: urinary excretion: 5ASA = 1.8, 85.5 and 445 mg, P < 0.0001; N-acetyl 5ASA = 250, 524 and 1468 mg, P < 0.0001, respectively). Faecal 5ASA excretion increased as the oral dose increased from 1.2 g to 2.4 g but did not increase further with 4.8 g daily dosing whereas faecal N-acetyl 5ASA excretion was similar at all three doses. Rectal tissue concentrations of 5ASA increased markedly, and N-acetyl 5ASA increased modestly, as the dose of oral mesalazine increased from 1.2 g to 2.4 g daily but neither increased further with 4.8 g daily dosing.
conclusionsThe relationship between the ingested dose of delayed-release mesalazine and rectal tissue drug concentrations is complex. Factors other than dose are likely to be important determinants of rectal tissue drug concentrations.
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