Multi-country study on the prevalence and clinical features of peripheral arterial disease in asian type 2 diabetes patients at high risk of atherosclerosis

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Abstract

Objective

PAD-SEARCH was the first international study to investigate the prevalence of peripheral arterial disease (PAD) in Asian type 2 diabetic patients and to demonstrate the relationships between putative risk factors and PAD.

Subjects and methods

In total 6625 type 2 diabetic patients aged 50 and older were enrolled and determined ankle-brachial index (ABI) and brachial-ankle pulse wave velocity (baPWV) in Korea, China, Taiwan, Hong Kong, Indonesia, Thailand and the Philippines.

Results

Mean patient age was 63.7 ± 8.2 years and mean duration of diabetes was 10.3 ± 8.0 years. One thousand one hundred and seventy-two (17.7%) subjects were diagnosed as PAD by ABI (≤0.9). PAD subjects had a significantly longer duration of diabetes, hypertension, higher HbA1c, and a significantly lower mean BMI than non-PAD subjects. In terms of lipid profiles, triglyceride was the only significant variable. Notably, mean ABI and baPWV in females were significantly poorer than age matched males in subjects with a normal ABI. However, mean ABI and baPWV in males were significantly poorer than in age matched females in subjects with PAD.

Conclusions

These findings suggest that PAD is a common complication in Asian type 2 diabetic patients. Therefore, PAD screening and treatment should be emphasized for Asian diabetic patients with high risk factors.

Introduction

Due to a general increase in the standard of life, the incidences of chronic diseases such as hypertension, obesity, diabetes, dyslipidemia have increased worldwide [1], [2], [3]. Atherosclerosis is a major complication of these chronic diseases and is a well known direct cause of cerebrovascular and cardiovascular diseases that have become major health problems during recent years in many countries [4].

Peripheral arterial disease (PAD), like cerebrovascular and cardiovascular diseases, is a major arterial disease caused by atherosclerosis. PAD can be characterized as a chronic systemic disease caused by atherosclerotic occlusion and reduced blood flow in the lower extremity arteries. During its early period, PAD shows no remarkable signs and is easily overlooked. However, as it progresses, claudication and ischemia in the lower extremities, ulceration and necrosis of the feet can occur, and this too frequently leads to a severe clinical course where amputation may be the only answer [5], [6]. Also regardless of its clinical symptoms, PAD is known to be a major risk factor of cardiovascular and cerebrovascular diseases [7], [8]. According to Adult treatment panel III of National Cholesterol Education Program, PAD should be regarded as being equivalent to DM as a CHD risk factor [9].

Smoking, DM, old age, dyslipidemia, hypertension, hyperhomocysteinemia, and increase of fibrinogen are some of the proven risk factors of PAD [10], [11], [12], [13]. In particular, since the Framingham study, DM and impaired glucose tolerance have become well recognized major risk factors of PAD [14]. DM itself can aggravate atherosclerosis and PAD, and in DM patients the incidence of PAD is three to four times higher, the region affected is larger, and clinical symptoms are more severe than in patients with normal glucose tolerance [15], [16], [17].

Asian countries that are experiencing rapid industrialization and lifestyle changes are also predicted to experience increase in the incidence of PAD and its complications. However, recent clinical studies on PAD focused on American and European patients and do not reflect lifestyles and ethnicities in the Asian region. In fact, no major clinical study has been undertaken on the relationship between the prevalence of PAD and its risk factors in the Asian peoples or on its relation with unique ethnic characteristics.

For these reasons, we planned this study named PAD-SEARCH (peripheral arterial disease, screening and evaluation of diabetic patients in Asian regions characterized by high risk factors). Patients with type 2 DM at high risk of PAD were selected from seven different Asian regions and the relationships between the prevalence of PAD and ethnicity, gender, and several other PAD associated risk factors were studied.

Section snippets

Subjects

The PAD-SEARCH study was carried out on a study population comprised of patients from 72 hospitals in the following seven major Asian countries; Korea, China, Taiwan, Hong Kong, Indonesia, Thailand, and the Philippines. The numbers of hospitals participating in each country were as follows—China: 15 hospitals followed by Korea: 14 hospitals; Indonesia, Thailand, Philippine: 10 hospitals each; Taiwan: 8; Hong Kong: 5 hospitals. One hundred patients were chosen at random at each hospital and thus

Clinical characteristics of study subjects

Of the 7200 subjects originally recruited, we were able to successfully collect data on 6771 (94.0%). Because 146 (2.2%) subjects were ABI >1.3, total 6625 subjects were enrolled in statistical analysis. Some differences were detected between subjects from different regions, but overall similar tendencies were found (Table 2). Most regions showed a higher proportion of female subjects, and mean age for all regions was 63.7 ± 8.2 years and mean body mass indexes was 24.9 ± 3.7 kg/m2, indicating a

Discussion

The PAD-SEARCH was the first multi-country study carried out to understand the current state of PAD and its characteristics in Asian type 2 diabetes patients with a high risk of atherosclerosis. Moreover, this type of large-scale study has not been done previously in Asia even for other chronic diseases with high prevalence rates. Consequently, the findings of this study are important for Asian type 2 DM patients, because they help us; assess the current state of diseases, understand the

Acknowledgements

The OIAA Co., Ltd. (Otsuka International Asia, Arab Division at Korea Otsuka Pharmaceutical Company) provided financial support for this study. Fukuda Densi Co., Ltd. were responsible for the importation and transportation of VaSera VS-1000™.

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