PMID: 15230484Jul 3, 2004Paper

Randomized trial of AT-1015 for treatment of intermittent claudication. A novel 5-hydroxytryptamine antagonist with no evidence of efficacy

Vascular Medicine
William R HiattMark A Creager

Abstract

AT-1015 is a novel selective 5-HT2A serotonin receptor antagonist that is known to impair platelet aggregation and vasoconstriction. Serotonin has been hypothesized to contribute to claudication symptoms in individuals with peripheral arterial disease (PAD) via microvascular vasoconstrictor and thrombotic effects. AT-1015 was thus evaluated in 439 patients with claudication who were randomized in a double-blind, placebo-controlled trial comparing 10 mg, 20 mg, and 40 mg BID versus placebo for 24 weeks. Treadmill walking performance was assessed by peak walking time (PWT) and pain-free walking time (PFWT). Quality of life (QoL) was measured by the Walking Impairment Questionnaire (WIQ) and the Health Status Survey SF-36. Limb hemodynamics was assessed with the ankle-brachial index (ABI). The 40 mg arm was terminated prematurely by recommendation of the Data Safety Monitoring Committee due to an excess number of non-fatal myocardial infarctions. At study conclusion, there were no statistically significant differences in the mean change of PWT, PFWT, ABI and QoL between the 10 mg and 20 mg BID treatment groups compared with placebo. The proportion of patients who experienced an adverse event (AE) was similar across all treatment g...Continue Reading

References

May 19, 1998·Life Sciences·O YildizR E Purdy
Sep 10, 1999·European Journal of Vascular and Endovascular Surgery : the Official Journal of the European Society for Vascular Surgery·K H LabsW R Hiatt
May 24, 2001·The New England Journal of Medicine·W R Hiatt
Oct 5, 2001·JAMA : the Journal of the American Medical Association·M M McDermottG J Martin
Jun 8, 2002·Current Topics in Medicinal Chemistry·Wesley K KroezeBryan L Roth
Dec 7, 2002·Journal of Vascular Surgery·William R Hiatt

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Citations

Aug 5, 2006·Vascular Medicine·L NorgrenUNKNOWN European MCI-9042 Study Group
Feb 25, 2014·American Journal of Physiology. Heart and Circulatory Physiology·Kristen A BaltgalvisTodd M Kinsella
Dec 5, 2006·European Journal of Vascular and Endovascular Surgery : the Official Journal of the European Society for Vascular Surgery·L NorgrenKenneth Rosenfield
Jan 16, 2007·Journal of Vascular Surgery·L NorgrenUNKNOWN TASC II Working Group

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