Evaluation of the effect of Noclaud® on maximum walking distance without pain in patients diagnosed with second stage peripheral artery disease according to the Fontaine classification

Abstract

Introduction. Medicinal product Noclaud®, containing cilostazol, was approved in Poland on 19.03.2014 without performing a study on its effectiveness in polish population. The aim of this study was to evaluate the efficacy of Noclaud® in the therapy of intermittent claudication (the second stage according to Fontaine classification) in patients with peripheral artery disease (PAD), in whom lifestyle modifications and supervised exercise programs did not alleviate the symptoms. Material and methods. Non-interventional, multi-center, open, post-registration observational study on Noclaud® effectiveness was conducted on 1680 patients with PAD (second stage according to the Fontaine). The assessment of Noclaud® effectiveness included changes in the initial and total claudication distances and changes in ankle-brachial index (ABI). Adverse effects were recorded. Results. Administration of Noclaud® resulted in an increase in the initial claudication distance by 88 (95% CI: 76–100) and 125 (106–145) m after 3 and 6 months, respectively, and the total claudication distance by 121 (99–142) and 148 (119–177) m after 3 and 6 months, respectively. Also during the six minute walk test, distances increased by 64 (57–72) and 104 (93–114) m after 3 and 6 months, respectively. ABI increased by 0.04 (0.03–0.05), and the percentage of patients with ABI < 0.9 decreased significantly (from 90.3 to 72.5%; p < 0.001). However, the percentage of patients with ABI < 0.4 did not change (1.2 vs. 0.9%). Conclusions. Medicinal product Noclaud® increases claudication distance in patients with second grade peripheral artery disease, according to the Fontaine classification. The administration of this drug has only minor effects on the ankle-brachial index.