Once- on par with twice-daily cilostazol–Ginkgo biloba combo in peripheral arterial disease

In the treatment of ischemic symptoms associated with peripheral arterial disease (PAD), the use of once-daily SID142 appears to be as good as twice-daily Renexin while having a favourable safety profile, as shown in a phase III study.

Renexin is a pill that contains a combination of cilostazol and Ginkgo biloba leaf extract. On the other hand, SID142 is a controlled-release tablet that contains the same combination (cilostazol 200 mg, Ginkgo biloba leaf extract 160 mg) developed to address the limitation of twice-daily administration with the reference drug.

In the study, 170 patients with PAD were randomized to treatment with SID142 once daily (n=86) or Renexin twice a day (n=84) for 12 weeks. The primary outcome was the patient assessment of lower leg pain intensity with the use of a visual analogue scale (VAS) after 12 weeks of treatment. The lower limit of the two-sided 95 percent confidence interval (CI) of greater than –10 was the noninferiority margin.

Analysis of the change in the primary outcome at 12 weeks compared with baseline showed that SID142 was not inferior to Renexin (21.44 vs 22.30; 95 percent CI, –7.70 to 5.97; p=0.5942).

Likewise, there were no significant between-group differences observed in the secondary efficacy endpoints (ie, cold sensation, ankle-brachial index, ankle systolic pressure, maximum walking distance, pain-free walking distance, and investigator's global assessment).

In terms of safety, significantly fewer adverse reactions occurred with SID142 vs the reference drug (22.35 percent vs 39.29 percent; p=0.0171).