Unmet needs of diabetic patients

Diabetes mellitus is a major risk factor for coronary heart disease. According to the National Cholesterol Education Program (NCEP) and Adult Treatment Panel III (ATPIII) recommendations, diabetes can be considered to be equivalent to coronary heart disease.¹ In the United Kingdom Prospective Diabetes Study (UKPDS), low-density-lipoprotein cholesterol (LDL-C) is the most important risk factor for coronary heart disease in diabetes.² A meta-analysis of 14 statin trials (which included 18,686 diabetic participants) showed that with an average 39 mg/dL reduction in LDL-C over 4.3 years, all-cause mortality was decreased by 9% and major cardiovascular events by 21%.³ These results suggest that statins have become the most important medication for decreasing cardiovascular events in patients with diabetes, especially those who also suffer from coronary heart disease. The clinical practice recommendation from the American Diabetes Association suggests that statin therapy should be added to lifestyle therapy, regardless of baseline lipid levels, for diabetic patients with overt cardiovascular disease.⁴ The treatment target for LDL-C for such patients is <70 mg/dL.⁵

Clinical trial results indicate that patients with high triacylglycerol levels cannot be effectively treated with fibrates to reduce cardiovascular outcomes. In the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, the use of fenofibrate did not significantly change the primary end-point of nonfatal myocardial infarction or death related to coronary heart disease.⁶ Similarly, in the Action to Control CardiOvascular Risk in Diabetes (ACCORD) trial, the addition of fenofibrate to simvastatin vs. simvastatin plus placebo did not reduce the risk of cardiovascular events.⁷ Therefore, fibrate therapy was not strongly recommended as a clinical practice tool by the American Diabetes Association.⁴ Regarding antiplatelet therapy, the American Diabetes Association has recommended aspirin therapy (75–162 mg/d) as a primary strategy in those patients with type 1 or type 2 diabetes who are at increased cardiovascular risk (10-year risk >10%), and as a secondary prevention strategy in those with diabetes and a history of cardiovascular disease.⁴

Despite tremendous evidence supporting the efficacy of these evidence-based therapies, including statin and aspirin therapy, their utilization has been suboptimal in daily practice. For instance, in the recent CEPHEUS Pan-Asian survey (2012), the goal attainment for LDL-C was only 34.9% (70 mg/dL) in patients with a very high cardiovascular risk, which included patients with concomitant diabetes and coronary heart disease.⁸ In the Return on Expenditure Achieved for Lipid Therapy in Asia (REALITY-Asia, 2008) survey, which enrolled 2622 patients in six Asian countries, the overall rate of attainment of the target (LDL-C < 100 mg/dL) for patients with diabetes and coronary heart disease was only 38%.⁹ Furthermore, the goal attainment rate was only 16% for these patients in Taiwan, the lowest among all six countries involved in the REALITY-Asia survey. The frequency of use of aspirin in patients with diabetes and coronary heart disease was reported to be substantially reduced in Asian countries.

In the current issue of the Journal of the Chinese Medical Association, Yi-Chun Lin et al report on the utilization of statins and aspirin among patients with diabetes and hyperlipidemia in Taiwan.¹⁰ The authors used information culled from the Taiwan National Health Insurance Database, and analyzed the prescription of statins and aspirin in two calendar periods: period 1 (September 1998 to June 2002) and period 2 (July 2002 to April 2006). They found an increase in the prescription of statins and aspirin in period 2 compared with period 1. However, the prescription rates were suboptimal in both periods. For patients with the highest risk (diabetes plus coronary heart disease), the prescription of statins increased from 30.3% (period 1) to 42.6% (period 2); the prescription of aspirin increased from 43.5% (period 1) to 52.5% (period 2). In contrast, the prescription rate of fibrates decreased from 15.3% (period 1) to 11.7% (period 2). Only 25.9% of patients received both statins and aspirin. The decrease in utilization in fibrate is expected, due to the failure of fibrate use to show any tangible benefit in the FIELD and the ACCORD trials.^{6, 7} The major limitation of this study is that the level of LDL-C for each patient was unknown, and the rate of attainment of the goal could not be ascertained. Interestingly, there was a decrease in the use of these medications in the year 2002–2003, probably due to the implementation of the Global Budget Program in Taiwan in 2002.

In conclusion, the authors should be congratulated for their important findings regarding unmet needs in diabetes management in Taiwan, especially for those patients with concomitant coronary heart disease. These patients have the highest cardiovascular risk, yet they may be the group of patients who can most cost-effectively benefit from optimal medical therapy, which includes statins and aspirin. The health authority and medical society should work together to improve this grave condition.

Chern-En Chiang

Kang-Ling Wang

General Clinical Research Center, Department of Medical Research and Education, Taipei Veterans General Hospital and National Yang-Ming University School of Medicine, Taipei, Taiwan, ROC

Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital and National Yang-Ming University School of Medicine, Taipei, Taiwan, ROC