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Long-Term Effects of Beraprost Sodium on Arteriosclerosis Obliterans: a Single-Center Retrospective Study of Japanese Patients

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Abstract

Introduction

Arteriosclerosis obliterans (ASO) causes ischemic symptoms of the lower limbs, reducing quality of life (QOL), and has a poor prognosis. Early diagnosis and treatment are necessary. In this study, the effects of long-term administration of beraprost sodium (beraprost) to treat ASO were investigated.

Methods

One hundred and eighty eight patients treated with beraprost for ≥1 year were retrospectively identified. Outcomes were lower limb ischemic symptoms, carotid intima/media thickness (IMT), and cardiovascular events. Patients reported visual analog scale scores for major symptoms at baseline and after 3, 6, and 12 months of treatment.

Results

Overall, 188 patients (mean age 70.8 ± 10.15 years, Fontaine classification: grade I 14.4%, grade II 85.6%) treated with beraprost for 2.4–10.7 years (mean 6.5 years) were included in this study. Administration of beraprost significantly reduced patient-reported severity of lower limb ischemic symptoms in all patients at 12 months, including those with diabetes, hypertension, or dyslipidemia. IMT decreased from 1.09 ± 0.09 mm at baseline to 1.04 ± 0.11 mm at 12 months (P < 0.001). Decreases in IMT were similar in patients with diabetes, hypertension, or dyslipidemia. Overall, 26 (13.8%) events occurred during a mean follow-up of 6.5 years, including 23 cardiovascular events (unstable angina in three patients, myocardial infarction in six patients, cerebral infarction in eight patients, and transient cerebral ischemic attack in six patients) and non-cardiovascular death in three patients. Beraprost at 120 μg/day significantly reduced the risk of ischemic symptoms compared with <120 μg/day (adjusted hazard ratio: 0.17; 95% confidence interval: 0.06, 0.45; P < 0.001). No severe adverse events or adverse events requiring dose reductions/discontinuation occurred during long-term administration of beraprost.

Conclusion

Beraprost reduced lower limb ischemic symptoms, IMT, and the incidence of cardiovascular events in patients with ASO.

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Acknowledgments

The author did not receive any financial support for conduct of this study. Editorial assistance in the preparation of this manuscript was provided by Nicholas D. Smith, PhD. Funding for his assistance was provided by Toray Industries, Inc.. The manuscript is a combination of two articles published in Japanese (Pharma Medica 2009; 27:97–108; Therapeutic Research 2011; 32:71–77) resulting from a single study, as well as new data that were derived from extending the data collection period for each patient by an average of 1.9 years. The publishers of both journals gave permission for the translation and combination of the results for publication in Advances in Therapy. Dr. Tadashi Arai is the guarantor for this article, and takes responsibility for the integrity of the work as a whole.

Conflict of interest

Dr. Tadashi Arai declares no conflict of interest.

Ethical standards statement

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000.

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Authors and Affiliations

  1. Arai Clinic, Yamagata, Gifu, Japan

    Tadashi Arai

  2. Second Department of Internal Medicine, Gifu University Graduate School of Medicine, Gifu, Japan

    Tadashi Arai

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  1. Tadashi Arai
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Correspondence to Tadashi Arai.

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Arai, T. Long-Term Effects of Beraprost Sodium on Arteriosclerosis Obliterans: a Single-Center Retrospective Study of Japanese Patients. Adv Ther 30, 528–540 (2013). https://doi.org/10.1007/s12325-013-0030-7

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  • DOI: https://doi.org/10.1007/s12325-013-0030-7

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