Efficacy and Safety of Sarpogrelate on Symptom Improvement in Patients with Peripheral Arterial Disease (PAD) and/or Being at Risk of PAD: A Single Arm, Multi-Centered, Open-Label Trial

Abstract

Aims: To assess the efficacy and safety of sarpogrelate (300 mg) for symptom improvement in patients having peripheral arterial disease (PAD) and/or being at risk of PAD in clinical practice using the Peripheral Artery Questionnaire (PAQ). Background: Symptomatic changes with antiplatelets in patients with PAD are limited. Objective: To determine the effect and safety of sarpogrelate on the PAQ at 24 weeks from baseline. Method: A total of 1003 patients having PAD and/or being at risk of PAD from 17 tertiary hospitals in South Korea who were treated with sarpogrelate, were enrolled in this study. PAQs were collected at baseline and at 12 and 24 weeks, together with physical examination and vital signs measurements. Lifestyle pattern was also investigated. Results: The average PAQ Summary Score in the efficacy evaluation analysis group significantly improved from 62.9 +/- 23.7 at baseline to 68.9 +/- 21.7 at 24 weeks (P<0.0001). Physical limitation items significantly improved from 69.5 +/- 30.0 at baseline to 72.9 +/- 28.3 after 24 weeks (P=0.0011). Symptom stability also significantly improved from 52.1 +/- 21.6 at baseline to 63.6 +/- 22.9 after 24 weeks (P<0.0001). Symptoms, treatment satisfaction, quality of life, and social limitation domains all improved after treatment. A total of 201 patients reported adverse events (20.0%), not directly associated with treatment. Conclusion: Treatment with 300 mg (orally) of sarpogrelate demonstrated statistically significant improvements in all domains and for the summary score of the PAQ at 24 weeks, it gave good results in terms of safety. Sarpogrelate may be helpful in reducing symptoms related to PAD.