Lack of efficacy of ridogrel, a thromboxane synthase inhibitor, in a placebo-controlled, double-blind, multi-centre clinical trial in active Crohn's disease

Citation
E. Carty et al., Lack of efficacy of ridogrel, a thromboxane synthase inhibitor, in a placebo-controlled, double-blind, multi-centre clinical trial in active Crohn's disease, ALIM PHARM, 15(9), 2001, pp. 1323-1329
Citations number
34
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Pharmacology,"da verificare
Journal title
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
ISSN journal
0269-2813 → ACNP
Volume
15
Issue
9
Year of publication
2001
Pages
1323 - 1329
Database
ISI
SICI code
0269-2813(200109)15:9<1323:LOEORA>2.0.ZU;2-L
Abstract
Background: Thromboxanes are produced in excess and platelets are activated in active Crohn's disease. Preliminary reports have suggested that ridogre l, a dual thromboxane synthase inhibitor and receptor antagonist, may have therapeutic benefit in patients with inflammatory bowel disease. Aims: To investigate the efficacy of ridogrel in patients with active Crohn 's disease. Patients and methods: This was an international, multicentre, randomized, d ouble-blind, placebo-controlled trial of 5 mg/day oral ridogrel for 12 week s in 85 patients with moderately active Crohn's disease. Sixty patients wer e randomized to receive ridogrel, and 25 to placebo. The Crohn's disease ac tivity index (CDAI) was used to assess disease activity: remission was defi ned as a CDAI < 150. Changes in clinical condition, as assessed by the Harv ey-Bradshaw index, global evaluation by the investigator and the patient, a nd blood measures of inflammation, were used as secondary outcomes. Results: The patients' mean (s.d.) CDAI at recruitment was 277 (68) in the ridogrel treated group and 265 (70) in the placebo group. At their final as sessment, 20 out of 60 (35%) patients who had been given ridogrel in an int ention-to-treat analysis and seven out of 25 (28%) patients given placebo w ere in remission (no significant difference). No significant differences in Harvey-Bradshaw index or global evaluation were noted between patients giv en ridogrel and those given placebo. Adverse events were similar in both gr oups. Conclusion: A 5-mg dose of oral ridogrel was not more effective than placeb o in inducing remission in patients with moderately active Crohn's disease. If thromboxane synthesis and platelet function are to be targeted for the treatment of Crohn's disease, more potent agents require development and as sessment.