Effects of Beraprost Sodium Evaluated by Digital Infrared Thermal Imaging in Diabetic Patients with Peripheral Arterial Disease

Hyun Woo Park; Jae Wan Soh; Seong Hyeon Park; Jae Jung Jeong

doi:10.14193/jkfas.2018.22.3.105

Journal List > J Korean Foot Ankle Soc > v.22(3) > 1101925

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Park, Soh, Park, and Jeong: Effects of Beraprost Sodium Evaluated by Digital Infrared Thermal Imaging in Diabetic Patients with Peripheral Arterial Disease

Original Article

J Korean Foot Ankle Soc 2018;22(3):105-110.

Published online: 20 January 2018

DOI: https://doi.org/10.14193/jkfas.2018.22.3.105

Effects of Beraprost Sodium Evaluated by Digital Infrared Thermal Imaging in Diabetic Patients with Peripheral Arterial Disease

Hyun Woo Park, Jae Wan Soh, Seong Hyeon Park, Jae Jung Jeong

Department of Orthopedic Surgery, Dankook University College of Medicine, Cheonan, Korea

^∗Department of Orthopedic Surgery, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea

^†Department of Orthopedic Surgery, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Daejeon, Korea

Corresponding Author: Jae Jung Jeong Department of Orthopedic Surgery, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 64 Daeheung-ro, Jung-gu, Daejeon 34943, Korea Tel: 82-42-220-9530, Fax: 82-42-221-0429, E-mail: jjeong@catholic.ac.kr ORCID: https://orcid.org/0000-0003-2324-4174

Received 10 July 2018 Revised 8 August 2018 Accepted 13 August 2018

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose

This study examined the effects of beraprost sodium on digital infrared thermal images in patients with peripheral arterial disease caused by type 2 diabetes mellitus.

Materials and Methods

Twenty-five diabetic patients with peripheral arterial disease were treated with beraprost sodium in a prospective, multicenter, cohort study from February 2013 to December 2014. Beraprost sodium (40 µg) was administered orally 3 times daily (120 µg/day) for 6 months. The visual analogue scale (VAS) and digital infrared thermal imaging (DITI) were performed to compare the blood flow improvement between before and after dosing.

Results

Among the 25 patients included in the evaluation, 22 patients completed the study. A significant increase in body temperature was observed in the front and left side, particularly in the plantar side in DITI compared to that before and after administration. An increase in body temperature was observed at the frontal part from 28.1°C±2.3°C to 29.1°C±2.1°C (p=0.021), at the left side from 27.8°C±2.4°C to 28.6°C±1.9°C (p=0.028), at the plantar part at 24.0°C±1.5°C, and at the plantar part at 27.1°C±2.4°C (p<0.01). The VAS decreased significantly from 5.4±1.3 to 2.7±2.0 after 6 months of treatment (p<0.01).

Conclusion

Beraprost sodium is a safe and easy-to use oral medication for diabetes peripheral arterial disease. It can be expected to increase the blood flow and decrease the lower extremity pain statistically after being taken for 6 months.

Keywords: Peripheral arterial disease, Prostaglandin I₂, Beraprost sodium, Digital infrared thermal imaging

References

1. Diabetes fact sheet in Korea 2016 [Internet]. Seoul: Korean Diabetes Association;[cited 2018 Jun 2]. Available from:. http://www.diabetes.or.kr/pro/news/.

2. Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005; 293:217–28.

3. Lipsky BA, Weigelt JA, Sun X, Johannes RS, Derby KG, Tabak YP. Developing and validating a risk score for lower-extremity amputation in patients hospitalized for a diabetic foot infection. Diabetes Care. 2011; 34:1695–700.

4. Yoon HS, Choi WJ, Sung IH, Lee HS, Chung HJ, Lee JW. Effects of beraprost sodium on subjective symptoms in diabetic patients with peripheral arterial disease. Clin Orthop Surg. 2013; 5:145–51.

5. Demolis JL, Robert A, Mouren M, Funck-Brentano C, Jaillon P. Pharmacokinetics and platelet antiaggregating effects of beraprost, an oral stable prostacyclin analogue, in healthy volunteers. J Cardiovasc Pharmacol. 1993; 22:711–6.

6. Lièvre M, Morand S, Besse B, Fiessinger JN, Boissel JP. Oral beraprost sodium, a prostaglandin I(2) analogue, for intermittent claudication: a double-blind, randomized, multicenter controlled trial. Beraprost et Claudication Intermettente (BERCI) research group. Circulation. 2000; 102:426–31.

7. Nony P, Ffrench P, Girard P, Delair S, Azoulay S, Girre JP, et al. Platelet-aggregation inhibition and hemodynamic effects of beraprost sodium, a new oral prostacyclin derivative: a study in healthy male subjects. Can J Physiol Pharmacol. 1996; 74:887–93.

8. Uchikawa T, Murakami T, Furukawa H. Effects of the antiplatelet agent cilostazol on peripheral vascular disease in patients with diabetes mellitus. Arzneimittelforschung. 1992; 42:322–4.

9. Beebe HG, Dawson DL, Cutler BS, Herd JA, Strandness DE Jr, Bortey EB, et al. A new pharmacological treatment for intermittent claudication: results of a randomized, multicenter trial. Arch Intern Med. 1999; 159:2041–50.

10. Dawson DL, Cutler BS, Hiatt WR, Hobson RW 2nd, Martin JD, Bortey EB, et al. A comparison of cilostazol and pentoxifylline for treating intermittent claudication. Am J Med. 2000; 109:523–30.

11. Dawson DL, Cutler BS, Meissner MH, Strandness DE Jr. Cilostazol has beneficial effects in treatment of intermittent claudication: results from a multicenter, randomized, prospective, double-blind trial. Circulation. 1998; 98:678–86.

12. Marso SP, Hiatt WR. Peripheral arterial disease in patients with diabetes. J Am Coll Cardiol. 2006; 47:921–9.

13. Belch JJ, Bell PR, Creissen D, Dormandy JA, Kester RC, McCollum RD, et al. Randomized, double-blind, placebocontrolled study evaluating the efficacy and safety of AS-013, a prostaglandin E1 prodrug, in patients with intermittent claudication. Circulation. 1997; 95:2298–302.

14. Müller-Bühl U, Diehm C, Krais T, Zimmermann R, Mörl H, Eckstein HH. Clinical effects of intravenous iloprost in patients with intermittent claudication. Eur J Clin Pharmocol. 1987; 33:127–31.

15. Friedman R, Mears JG, Barst RJ. Continuous infusion of prostacyclin normalizes plasma markers of endothelial cell injury and platelet aggregation in primary pulmonary hypertension. Circulation. 1997; 96:2782–4.

16. Vane JR, Botting RM. Pharmacodynamic profile of prostacyclin. Am J Cardiol. 1995; 75:3A–10A.

17. Goya K, Otsuki M, Xu X, Kasayama S. Effects of the prostaglandin I2 analogue, beraprost sodium, on vascular cell adhesion molecule-1 expression in human vascular endothelial cells and circulating vascular cell adhesion molecule-1 level in patients with type 2 diabetes mellitus. Metabolism. 2003; 52:192–8.

18. Galiè N, Manes A, Branzi A. Prostanoids for pulmonary arterial hypertension. Am J Respir Med. 2003; 2:123–37.

19. Ueno Y, Koike H, Nakamura Y, Ochi Y, Annoh S, Nishio S. Effects of beraprost sodium, a prostacyclin analogue, on diabetic neuropathy in streptozotocininduced diabetic rats. Jpn J Pharmacol. 1996; 70:177–82.

20. Aso Y, Tayama K, Takanashi K, Inukai T, Takemura Y. Changes in skin blood flow in type 2 diabetes induced by prostacyclin: association with ankle brachial index and plasma throbomodu-lin levels. Metabolism. 2001; 50:568–72.

Figure 1.

A schematic diagram of digital infrared thermal imaging (DITI). DITI was performed on each of four photographs of the anterior (Ant), posterior (Post), left (Lt), and right (Rt) sides of the lower limbs.

Figure 2.

A 63-year-old male digital infrared thermal imaging (DITI) before medication. (A) Anterior part (Ant), posterior part (Post), right side (Rt), and left side (Lt). (B) Plantar side.

Figure 3.

A 63-year-old male digital infrared thermal imaging (DITI) after 6 month taking medicine. Compared to Fig. 2, there is an increase in body temperature. (A) Anterior part (Ant), posterior part (Post), right side (Rt), and left side (Lt). (B) Plantar side.

Table 1.

Patients Characteristics

Characteristic	Value
No. of patients	22
Age (yr)	59.3±6.3
Male:female	13:9
Height (cm)	164.4±8.1
Weight (kg)	65.2±10.1
Body mass index (kg/m²)	23.5±3.2
Diabetes duration (yr)	13.3±8.0

Values are presented as number only or mean±standard deviation.

Table 2.

Difference in Laboratory Findings after Beroprost Sodium Administration

Laboratory variable	Before	After	p-value
AST/ALT (IU/L)	24/32	26/28	0.915
BUN/Cr (mg/dL)	24/1.1	25/1.2	0.780
Glucose (mg/dL)	277.7±24.4	283.3±18.8	0.321
HbA1c (%)	7.8±1.6	7.7±1.4	0.930

Values are presented as number only or mean±standard deviation. AST/ALT: aspartate aminotransferase/alanine aminotransferase, BUN/ Cr: blood urea nitrogen/creatinine.

Table 3.

Difference in Thermography and Visual Analogue Scale after Beroprost Sodium Administration

Efficacy variable	Before	After	p-value
Digital infrared thermal imaging (°C)
Anterior	28.1±2.3	29.1±2.1	0.021
Posterior	27.7±2.4	28.3±1.8	0.177
Left	27.2±2.3	28.3±1.8	0.094
Right	27.8±2.4	28.6±1.9	0.028
Plantar	24.0±1.5	27.1±2.4	0.001
Visual analogue scale	5.4±1.3	2.7±2.0	0.001

Values are presented as mean±standard deviation.

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