ABSTRACT
Purpose
Renexin® is a combination pill of cilostazol and Ginkgo biloba leaf extract that is used for the improvement of ischemic symptoms associated with
peripheral arterial disease (PAD). SID142 is a controlled-release tablet of cilostazol
(200 mg) and G biloba leaf extract (160 mg) that was developed to address the limitation of BID administration
with Renexin. This study aimed to verify that SID142 was not inferior to Renexin in
the treatment of patients with PAD.
Methods
This was a multicenter, randomized, double-blind, active-controlled, parallel-group,
Phase III clinical trial. Study subjects were randomized to receive SID142 once daily
or Renexin twice a day for 12 weeks. The primary end point was a change in the patient
assessment of lower leg pain intensity with the use of a visual analog scale (VAS)
after 12 weeks of treatment. If the lower limit of the two-sided 95% CI was greater
than –10, the study drug was declared noninferior to the reference drug. Secondary
efficacy end points included cold sensation, ankle-brachial index, ankle systolic
pressure, maximum walking distance, pain-free walking distance, and investigator's
global assessment. Study group results were compared 4, 8, and 12 weeks after treatment.
Adverse events were assessed as a safety end point.
Findings
In total, 344 subjects from 19 medical centers were screened, and a total of 170 subjects
were randomly assigned to either the SID142 (n = 86) or the Renexin (n = 84) group.
Analysis of the change in lower extremity pain at 12 weeks compared with baseline
revealed that SID142 was not inferior to Renexin (21.44 [19.23] vs 22.30 [17.75];
95% CI, –7.70 to 5.97; P = 0.5942). No significant differences were found between groups in any secondary
efficacy end point. However, the incidence of adverse reactions was significantly
lower in the SID142 group (22.35% vs 39.29%; P = 0.0171).
Implications
SID142 once daily was not inferior to Renexin twice a day for efficacy in patients
with PAD. SID142 had a favorable safety profile. ClinicalTrials.gov identifier: NCT03318276.
Key words
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Article info
Publication history
Published online: April 09, 2022
Accepted:
January 27,
2022
Identification
Copyright
© 2022 Published by Elsevier Inc.
