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Sarpogrelate, a 5-HT2A receptor antagonist in intermittent claudication: a phase II European study

Norgren, L., Jawien, A., Mátyás, L., Rieger, H. and Arita, K. (2006) Sarpogrelate, a 5-HT2A receptor antagonist in intermittent claudication: a phase II European study Vascular Medicine, 11, (2), pp. 75-83. (doi:10.1191/1358863x06vm657oa).

Record type: Article

Abstract

This was a multinational, multicentre, double-blind Phase II study in Europe to evaluate the efficacy and safety of two dose regimens (200 mg bid and 200 mg tid) of sarpogrelate (MCI-9042, 5-HT2A receptor antagonist) compared to placebo in patients with stable, moderately severe intermittent claudication. Following a single-blind placebo run-in period of 6 weeks, 364 (309 male and 55 female) patients (59.2 ± 8.4 years, mean SD) were randomized to receive sarpogrelate 200 mg bid, 200 mg tid or placebo for 24 weeks with a follow-up of 8 weeks. The primary objective was the increase of absolute claudication distance (ACD) at the end of treatment (week 24) compared to placebo. Analysis of covariance (ANCOVA) was performed on the log-transformed percentage of baseline ACD: loge (ACD/baseline). A responder analysis (defined as a 50% improvement in ACD) was also performed. There was a marked training/placebo effect on the ACD which persisted up to 16 weeks. At 24 weeks the primary objective did not reach statistical significance (200 mg bid vs placebo, p = 0.225; 200 mg tid vs placebo, p = 0.580). In the responder analysis, 200 mg bid showed a statistically significant difference vs placebo (p = 0.035). In the exploratory analysis with completers (patients completing all treadmill tests), there was a statistical difference in ACD/baseline change for 200 mg bid (p = 0.035) and in the responder analysis for 200 mg tid (p = 0.044) at 24 weeks compared to placebo. Both treatments showed a carry-over effect for ACD during the 8-week follow-up (weeks 28-32). The treatment was well tolerated and no clinically significant safety concerns were reported. In conclusion, the study results confirm that sarpogrelate is well tolerated and although the primary endpoint failed to reach statistical significance, the responder analysis showed an increased absolute walking distance, which makes a further trial warranted, including a larger population, and possibly also a longer treatment period.

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More information

Published date: 2006
Additional Information: The European MCI-9042 Group
Keywords: intermittent claudication, MCI-9042, sarpogrelate, walking distance

Identifiers

Local EPrints ID: 61401
URI: http://eprints.soton.ac.uk/id/eprint/61401
ISSN: 1358-863X
PURE UUID: cb8b0324-63ac-4de9-86dd-0d655da9faf1

Catalogue record

Date deposited: 07 Apr 2009
Last modified: 17 Jul 2017 14:22

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Contributors

Author: L. Norgren
Author: A. Jawien
Author: L. Mátyás
Author: H. Rieger
Author: K. Arita

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