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Real-World Safety and Effectiveness of Controlled-Release Cilostazol in Patients with Symptomatic Peripheral Artery Disease

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Abstract

Background

Cilostazol is the only first-line medication for treating intermittent claudication, and the controlled-release (CR) formulation is associated with a lower prevalence of adverse events (AEs).

Objective

The objective of the study was to assess the safety and effectiveness of cilostazol CR in patients with symptomatic peripheral artery disease (PAD).

Methods

In this multicentre (113 sites), open-label, prospective observational study, we evaluated the real-world safety and effectiveness of cilostazol CR 200 mg once daily in patients with symptomatic PAD treated in routine clinical settings. The primary endpoint was the incidence and severity of AEs, and their causal relationship with cilostazol CR. The secondary endpoint was the effectiveness of the drug, as assessed by each patient’s physician, for improving intermittent claudication.

Results

Among 2063 participants who received cilostazol CR for a mean duration of 88.6 days, 99 (4.80 %) experienced adverse drug reactions (ADRs), although no unexpected adverse reactions were observed. There was no significant difference in the incidence of ADRs according to patient demographics and comorbidities (all p > 0.05). The treatment was ‘effective’ in 1600 patients (78.93 %), although effectiveness significantly differed according to the patients’ sex and the presence of comorbidities, including diabetes mellitus, hypertension, and coronary artery disease (all p < 0.01).

Conclusions

This study demonstrated the tolerability and effectiveness of cilostazol CR treatment in patients with symptomatic PAD.

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Acknowledgements

We thank all the research nurses, study coordinators, and sub-investigators for their contributions to this study; Ju Cheol Jeong of Korea United Pharm. Inc. for the study-related discussions; and Jin Yeong Ko of Korea United Pharm. Inc. for support with the statistical analyses.

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Authors and Affiliations

  1. Department of Family Medicine, Chung-Ang University College of Medicine, Heukseok-ro 102, Dongjak-gu, Seoul, 06973, Republic of Korea

    Woo-young Shin, Hye Jun Lee & Jung-ha Kim

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Corresponding author

Correspondence to Jung-ha Kim.

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Funding

This work was supported by Korea United Pharm. Inc.

Conflicts of interest

The authors declare that they have no conflict of interest.

Ethics approval

The study was approved by the institutional review board of Seoul National University Hospital and Soon Chun Hyang University Bucheon Hospital (ref: 2015-085-665 and SCHBC 2014-07-036, 31 Oct 2013) and was conducted in accordance with the Good Clinical Practice guidelines as well as the principles evinced in the Declaration of Helsinki and its later amendments.

Consent to participate

Written informed consent was obtained from all individual participants for their inclusion in the study.

Consent for publication

The participants provided written informed consent for the publication of their data.

Availability of data and material

The datasets generated and analysed during the current study are not publicly available due to privacy concerns for subjects but are available from the corresponding author on reasonable request.

Code availability

Not applicable

Author contributions

Conceptualisation, Methodology, Visualization: J.H.K. Writing-Original draft preparation: W.Y.S. and H.J.L. Validation, Formal analysis, Investigation, Resources, Data curation, Writing-Review & editing, Supervision, Project administration: W.Y.S., H.J.L. and J.H.K. All authors read and approved the final version.

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Shin, Wy., Lee, H.J. & Kim, Jh. Real-World Safety and Effectiveness of Controlled-Release Cilostazol in Patients with Symptomatic Peripheral Artery Disease. Clin Drug Investig 43, 729–738 (2023). https://doi.org/10.1007/s40261-023-01302-6

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