Diabetes increases the risk of heart disease and stroke¹, with heart disease being the leading cause of death. In addition, many people with Type 2 diabetes have co-existing risk factors, such as high blood pressure and high cholesterol³, further increasing their cardiovascular risk. Diabetes is also associated with long-term complications that affect almost every part of the body including heart and vessel disease, kidney failure, stroke, blindness, nerve damage and amputations. The SphygmoCor^® System non-invasively provides measurements illustrating the progression of macrovascular disease driving the patient’s risk of cardiovascular disease, thus providing a tool for assisting with early identification of high risk patients and subsequent management of the disease.

Prevalence and Survival

In the United States, 20.8 million people are considered to have diabetes – 7% of the population. This consists of 14.6 million that have been diagnosed with diabetes and 6.2 million suspected of having diabetes that has not yet been diagnosed². Each year, approximately 1.3 million people aged 20 years or older are diagnosed with diabetes and more than 60% of diabetics will die from heart disease¹. Patients with Type 2 diabetes have a 2-7 times increased risk of cardiovascular mortality and morbidity⁴ and patients with Type 1 diabetes also have an increased risk of cardiovascular disease⁵. Furthermore, diabetes has been reported to be one of the leading causes of end stage renal disease¹ which also carries an increased risk of cardiovascular disease⁶.

Arterial stiffness

The increased cardiovascular risk of patients with diabetes remains largely unexplained. Part of this increased risk relates to cardiovascular risk factors such as hypertension, dyslipidaemia, hyperglycaemia and obesity, but some of the increased risk appears to be independent of these factors and may be different for Type 1 and Type 2 diabetes.

Peripheral pulse pressure, a surrogate marker for arterial stiffness, has been shown to be associated with Type 1 diabetes and compared with non-diabetics, age related blood pressure increases seem to shift to a 15-20 year younger age in Type 1 diabetes, suggesting accelerated vascular ageing⁵.

Assessment of a cohort of patients in the FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) Study showed a significant association between Augmentation Pressure (AP) and AIx and carotid IMT, an established marker of atherosclerosis, in Type 2 diabetics, suggesting that arterial stiffness may contribute to the accelerated atherosclerosis in Type 2 diabetes and that measures of central blood pressure and large stiffness may be superior to other conventional risk factors in determining the presence of vascular wall thickening in Type 2 diabetes⁴. A Substudy of the FIELD investigation is ongoing and is expected to provide prospective data on the predictive values of AP and AIx for cardiovascular morbidity and mortality in Type 2 diabetic patients.

Children as young as 10 years old with Type 1 diabetes have also been observed to have increased arterial stiffness (AIx) when matched with control subjects¹⁵. This highlights the potential for markers of arterial stiffness such as those available from the SphygmoCor^® system for providing additional information for cardiovascular risk stratification and optimization of therapy in children with conditions such as Type 1 diabetes that have a high risk of developing cardiovascular and non-cardiovascular complications later in life.

Decreases in arterial stiffness in patients with cardiovascular disease, including those with diabetes, have been demonstrated following pharmacological interventions, often independent of changes in cuff BP. Insulin is known to acutely decrease AIx independent of peripheral vascular resistance^{16, 17}, however this action is defective in insulin-resistant obese¹⁸, type 1¹⁸ and type 2¹⁹ diabetic patients. One study, however, has observed an improvement in AIx after 6 months of insulin therapy²⁰. Among a number of pharmacological interventions shown to improve arterial stiffness, supplementation with oral ascorbic acid has been shown to significantly lower AIx over a 4-week period in diabetic patients²¹. The SphygmoCor^® System allows the physician to see the effects of their patient’s treatment regimen through changes in the key central cardiac function parameters.

References

1. National Institute of Diabetes and Digestive and Kidney Diseases. National Diabetes Statistics Fact Sheet: general information and national estimates on diabetes in the United States, 2003.
2. National Institute of Diabetes and Digestive and Kidney Diseases. National Diabetes Statistics. NIH Publication No 06-3892 November 05.
3. Williams B. The unique vulnerability of diabetic subjects to hypertensive injury. J Hum Hypertens 1999;13:S3-S8.
4. Westerbacka J, Leinonen E, Salonen JT, et al. Increased augmentation of central blood pressure is associated with increases in carotid intima-media thickness in type 2 diabetic patients. Diabetologia 2005;48:1654- 1662.
5. Ronnback M, fagerudd J, Forsblom C, et al. Altered age-related blood pressure pattern in Type 1 diabetes. Circulation 2004;110:1076-1082.
6. U.S. Renal Data System, USRDS 2004 Annual Data Report: Atlas of End-stage renal disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2004.
7. Brooks B, Molyneaux L, Yue DK. Augmentation of central arterial pressure in Type 1 diabetes. Diabetes Care 1999;22:1722-1727.
8. Wilkinson IB, MacCallum H, Rooijmans DF, et al. Increased augmentation index and systolic stress in Type 1 diabetes mellitus. QJM 2000;93:441-8.
9. Schram MT, Henry RMA, van Dijk AJM, et al. Increased arterial stiffness in impaired glucose metabolism and Type 2 diabetes. The HOORN study. Hypertension 2003;43:176-181.
10. Cruickshank K, Riste L, Anderson SG, et al. Aortic pulse-wave velocity and it’s relationship to mortality in diabetes and glucose intolerance. Circulation 2002;106:2085-2090.
11. Smith A, Karalliedde J, De Angelis L, Goldsmith D, Viberti G. Aortic pulse wave analysis and albuminuria in patients with Type 2 diabetes.
12. Fukui M, Kitagawa Y, Nakamura N, et al. Augmentation of central arterial pressure as a marker of athersclerosis in patients with Type 2 diabetes. Diab Res Clin Pract 2003;59:153-61.
13. Rema M, Deepa R, Mohan V, Ravikumar R. Association of carotid intima-media thickness and arterial stiffness with diabetic retinopathy. Diabetes Care 2004;27:1962-1967.
14. Weber T, Auer J, O’Rourke MF, et al. Arterial stiffness, wave reflections, and the risk of coronary artery disease. Circulation 2004;109:184-9.
15. Haller MJ, Schwartz RF, Samyn M, et al. Radial artery tonometery demonstrates arterial stiffness in children with Type 1 diabetes. Diabetes Care 2004;27:2911-2917.
16. Westerbacka J, Wilkinson I, Cockcroft J, et al. Diminished wave reflection in the aorta. A novel physiological action of insulin on large blood vessels. Hypertension 1999;33:1118-22.
17. Westerbacka J, Seppala-Lindroos A and Yki-Jarvinen H. Resistance to acute insulin decreases in large artery stiffness accompanies the insulin resistance syndrome. J Clin Endocrinol Metab 2001;86:5262-8.
18. Westerbacka J, Uosukainen A, Makimattila S, et al. Insulin-induced decrease in large artery stiffness is impaired in uncomplicated type 1 diabetes mellitus. Hypertension 2000;35:1043-8.
19. Tamminen M, Westerbacka J, Vehkavaara S, Yki-Jarvinen. Insulin-induced decreases in aortic wave reflection and central systolic pressure are impaired in Type 2 diabetes. Diabetes Care 2002;25:2314-9.
20. Tamminen MK, Westerbacka J, Vehkavaara S, Yki-Jarvinen H. Insulin therapy improves insulin actions on glucose and aortic wave reflection in Type 2 diabetic patients. Eur J Clin Invest 2003;33:855-60.
21. Mullen BA, Young IS, Fee H, McCance DR. Ascorbic acid reduces blood pressure and arterial stiffness in Type 2 diabetes. Hypertension 2002;40:804-9.

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