open access

Vol 23, No 4 (2017)
Original papers
Published online: 2017-12-28
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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

Jerzy Chudek
DOI: 10.5603/AA.2017.0015
·
Acta Angiologica 2017;23(4):151-157.

open access

Vol 23, No 4 (2017)
Original papers
Published online: 2017-12-28

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.

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.
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Keywords

cilostazol, peripheral artery disease, intermittent claudication, ankle-brachial index

About this article
Title

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

Journal

Acta Angiologica

Issue

Vol 23, No 4 (2017)

Pages

151-157

Published online

2017-12-28

DOI

10.5603/AA.2017.0015

Bibliographic record

Acta Angiologica 2017;23(4):151-157.

Keywords

cilostazol
peripheral artery disease
intermittent claudication
ankle-brachial index

Authors

Jerzy Chudek

References (9)
  1. Chudek J, Ziaja D. Cilostazol w leczeniu niedokrwienia kończyn dolnych. Chirurgia Polska. 2014; 16: 6–11.
  2. Bedenis R, Stewart M, Cleanthis M, et al. Cilostazol for intermittent claudication. Cochrane Database Syst Rev. 2014(10): CD003748.
  3. Pande RL, Hiatt WR, Zhang P, et al. A pooled analysis of the durability and predictors of treatment response of cilostazol in patients with intermittent claudication. Vasc Med. 2010; 15(3): 181–188.
  4. http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Cilostazol_31/WC500148973.pdf.
  5. Robless P, Mikhailidis DP, Stansby GP, et al. Cilostazol for peripheral arterial disease. Cochrane Database Syst Rev. 2007(1): CD003748.
  6. Mohler E, Beebe H, Salles-Cuhna S, et al. Effects of cilostazol on resting ankle pressures and exercise-induced ischemia in patients with intermittent claudication. Vasc Med. 2016; 6(3): 151–156.
  7. Dawson DL, Cutler BS, Hiatt WR, et al. A comparison of cilostazol and pentoxifylline for treating intermittent claudication. Am J Med. 2000; 109(7): 523–530.
  8. Elam MB, Heckman J, Crouse JR, et al. Effect of the novel antiplatelet agent cilostazol on plasma lipoproteins in patients with intermittent claudication. Arterioscler Thromb Vasc Biol. 1998; 18(12): 1942–1947.
  9. Money SR, Herd JA, Isaacsohn JL, et al. Effect of cilostazol on walking distances in patients with intermittent claudication caused by peripheral vascular disease. J Vasc Surg. 1998; 27(2): 267–274.

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