Letters to the Editor - Quality Improvement in the Diagnosis and Management of Diabetes Melitus in Older Adults

To the Editor,

Dr. Lee et al¹ presented an excellent overview of the diagnosis and management of diabetes mellitus in older adults. As a follow-up, I would like to know if the recent Action to Control CardiOvascular Risk in Diabetes (ACCORD) trial would shade or change the management of lipids and hypertension in the treatment of patients with diabetes.

Frank M. Shanley, FACC
Denville, NJ

The author reports no relevant financial relationships.

Reference

1. Lee PG, Cigolle CT, Blaum CS. Quality improvement in the diagnosis and management of diabetes mellitus in older adults. Clinical Geriatrics 2010;18(5):38-44.
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The authors respond:

We appreciate your question in response to our article.¹ The recently published results of the ACCORD trial have generated confusion and debate about the optimal targets for blood pressure and lipid levels in patients with type 2 diabetes. Neither the ACCORD blood pressure study²  nor the ACCORD lipid study³  found significant differences in their primary composite outcomes between their respective treatment groups. The ACCORD blood pressure study compared subjects with a target systolic blood pressure below 120 mmHg to subjects with a target below 140 mmHg. The ACCORD lipid study compared subjects who received simvastatin plus fenofibrate with subjects receiving simvastatin alone. In both studies, there was no significant between-group difference in the annual rate of the primary outcome: a composite of nonfatal myocardial infarction; nonfatal stroke; or death from cardiovascular causes. Thus, the findings from the ACCORD trial should not change the current blood pressure target recommendation and do not justify addition of fenofibrate to patients already taking a statin.

In the ACCORD blood pressure study, the standard treatment group reached a mean systolic blood pressure of 133.5 mmHg, and the intensivetreatment group reached 119.3 mmHg.²  The lack of improvement in the intensive treatment group appears to argue against the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) recommendation of a blood pressure goal of lower than 130/80 mmHg.⁴ However, the results from the ACCORD study should be interpreted with caution due to its reduced ability to detect a significant difference between the two treatment groups. This reduced power is the result of a less than expected event rate in the study subjects. Further, two secondary outcomes—the rate of total stroke and the rate of nonfatal stroke— were significantly lower in the intensive treatment group (P < 0.05). Thus, results from the ACCORD trial should not be used to counter JNC 7 recommendations.

In the ACCORD lipid study, a pre-specified subgroup analysis of subjects age 65 years and older found no difference between those in the two lipid treatment groups (hazard ratio of nearly 1.0).³  Both the American Diabetes Association⁵ and the National Cholesterol Education Program (NCEP)⁶  have emphasized that treating low-density lipoprotein cholesterol to target with a statin should be the primary aim in lipid management. While they recommend that high-density lipoprotein (HDL) cholesterol should be higher than 40 mg/dLand triglycerides lower than 150 mg/dL, they do not recommend combination therapy of a statin and a fibrate as the first line of treatment. Rather, lifestyle modification remains the first treatment of choice. Another subgroup analysis of the ACCORD lipid study found that subjects who had very high triglyceride levels and low HDL cholesterol levels appeared to benefit from use of fenofibrate. This finding supports the current NCEP recommendation of the use of combination fibrate-statin therapy in patients with substantial dyslipidemia.⁶  Post-hoc analysis of subjects 65 years of age and older with substantial dyslipidemia would help to clarify if these individuals would benefit from a combination fibratestatin therapy over time.

Pearl G. Lee, MD, MS,
Christine T. Cigolle, MD, MPH,
and Caroline S. Blaum, MD, MS
University of Michigan,
Ann Arbor

The authors report no relevant financial relationships.

References

1. Lee PG, Cigolle CT, Blaum CS. Quality improvement in the diagnosis and management of diabetes mellitus in older adults. Clinical Geriatrics 2010;18(5):38-44.

2. ACCORD Study Group; Cushman WC, Evans GW, Byington RP, et al. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med 2010;362(17):1575-1585. Published Online: March 14, 2010.

3. ACCORD Study Group; Ginsberg HN, Elam MB, Lovato LC, et al. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010;362(17):1563-1574. Published Online: March 14, 2010.

4. Chobanian AV, Bakris GL, Black HR, et al; Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003;42(6):1206-1252.

5. American Diabetes Association. Standards of medical care in diabetes—2010 [published correction appears in Diabetes Care 2010;33(3):692]. Diabetes Care 2010;33(suppl 1):S11-S61.

6. Grundy SM, Cleeman JI, Merz CN, et al; National Heart, Lung, and Blood Institute; American College of Cardiology Foundation; American Heart Association. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines [published correction appears in Circulation 2004;110(6):763]. Circulation 2004;110(2): 227-238.