Efficacy and Safety of SID142 in Patients With Peripheral Arterial Disease: A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group, Phase III Clinical Trial.

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.

Application of dynamic indocyanine green perfusion imaging for evaluation of vasoactive effect of acupuncture: a preliminary follow-up study on normal healthy volunteers.

BACKGROUND: Even though acupuncture has long been used for alleviating symptoms related to vascular insufficiency, the clinical effect of acupuncture on peripheral circulation has not been fully confirmed. In this study, we investigated whether a near-infrared optical imaging-based method can be used to evaluate the efficacy of the acupuncture procedure to induce changes in peripheral tissue perfusion. METHODS: Two normal, healthy controls were treated with acupuncture on two acupoints (LI-4 and SI-3) three times within 1 week. At the first and third visits, participants were examined using indocyanine green (ICG) perfusion imaging before and 10 minutes after the acupuncture procedure. Blood perfusion of the hands was determined after intravenous bolus injection of ICG and dynamic analysis of the fluorescence signals by near-infrared imaging system. RESULTS: The blood perfusion rates of the hands were markedly increased immediately after acupuncture at the first trial in both cases. The baseline perfusion rates of the hands measured at the third visit were higher compared to the original basal level in one case; there was no difference in baseline perfusion rates of both hands in another case. In both cases, there was no acute effect of acupuncture on hand perfusion at the third trial. CONCLUSIONS: These results collectively suggest a potential of the ICG perfusion imaging as an effective evaluation tool to validate the vasoactive effect of acupuncture.