DM: Prevention and Treatment of Cardiovascular Disease (2001)

Citation:
 
Study Design:
Class:
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Quality Rating:
Research Purpose:

This is an American Diabetes Association Position Statement based on a technical review article by Steven M. Haffner in 1998 in Diabetes Care.

Inclusion Criteria:
Not described for included studies.
Exclusion Criteria:
Not described.
Description of Study Protocol:

Recruitment

Not described.

Design

Consensus Report.

Blinding Used (if applicable):

Not applicable.

Intervention (if applicable):

Not applicable.

Statistical Analysis:

None completed.

Data Collection Summary:

Timing of Measurements:

None described.

Dependent Variables

None described - consensus report.

Independent Variables

None described - consensus report.

Control Variables

Description of Actual Data Sample:

Initial N:  not described

Attrition (Final N):  not described

Age:  not described

Ethnicity:  not described

Other relevant demographics:

Anthropometrics:

Location:  Studies from all over the world

Summary of Results:

Rationale for treatment of dyslipidemia

  1. Type 2 diabetes is associated with a 2 to 4 fold excess risk of CHD.
  2. The degree of glycemia in diabetic patients is strongly related to the risk of microvascular complications (retinopathy, renal disease), however, the relation of glycemia to macrovascular disease is more modest

Prevalence of dyslipidemia in type 2 diabetes

The most common pattern is high TG and low HDL cholesterol. Median TG is <200 mg/dL (2.30 mmol/L), and 85% -95% of patients have TG <400 mg/dL (4.5 mmol/L).

Lipoprotein risk factors for CHD

Few prospective studies of lipids as predictors of CHD have been reported in type 2 diabetes and the results have been somewhat contradictory.

Clinical trials of lipid lowering in diabetic subjects

1. No clinical trial has been done on the effects of lipid-lowering agents on subsequent CHD specifically in diabetic subjects.

2. A number of clinical trials have included small numbers of adult type 2 diabetic subjects. a. the Scandinavian Simvastatin Survival Study trial, showed that simvastatin significantly lowered CHD incidence and total mortality in diabetic patients with elevated LDL cholesterol with previous clinical CHD.

b. the Cholesterol and Recurrent Events study, showed that pravastatin lowered CHD incidence in diabetic subjects with average LDL and previous clinical CHD.

c. the Helsinki Heart Study showed an association between fibric acid use and reduced CHD in diabetic subjects without prior CHD, although the results were not statistically significant.

d. the Veterans Affairs HDL cholesterol trial showed a 24% decrease in cardiovascular invents in diabetic subjects with prior CVD with the use of fibric acid.

Modification of lipoproteins by MNT and physical activity

Diabetic patients who are overweight should be given a prescription for MNT and for increased physical activity.

a. weight loss and increased physical activity will lower TG, raise HDL and to a less extent, lower LDL cholesterol.

Modification of lipoproteins by glucose-lowering agents

Interventions to improve glycemia usually lower TG’s and modestly lower LDL cholesterol.

Treatment goals for lipoprotein therapy

Category of risk based on lipoprotein levels in adults with diabetes

Risk LDL-C Mg/dl HDL-C*Mg/dl TG Mg/dl
High >=130 <35 >400
Borderline 100-129 35-45 200-399
Low <100 >45 <200
*for women the HDL-C values should be increased by 10 mg/dL

Initiation of treatment based on LDL cholesterol in adults with diabetes

  MNT Mg/dL Drug Tx Mg/dL
CHD, PVD or CVD >100 >100
No CHD, PVD, CVD >100 >=130

MNT should be attempted before starting pharmacological therapy.

Order of priorities for treatment of diabetic dyslipidemia in adults

Goal Recommendations in order of priority

Lower LDL : Statins Bile acid binding resins

Increase HDL: Lifestyle interventions Nicotinic acid

Lower TG: Glycemic control Fibric acid derivative Statins

Combined hyperlipidemia

Glycemic control + statin

Glycemic control + Statin + fibric acid derivative

Glycemic control + resin + fibric acid derivative

Glycemic control + statin + nicotinic acid

Considerations in the treatment of adults with type 1 diabetes

1. Patients who are in good control tend to have normal levels of lipoprotein.

2. There is very little observational data on lipoproteins and CHD and no clinical trials relating lipoproteins to CHD.

3. Lipoprotein goals for type 2 diabetes can be used for type 1 as well

Author Conclusion:

Aggressive therapy of diabetic dyslipidemia will probably lower the risk of CHD in patients with diabetes. Primary therapy should be directed first at lowering LDL levels. The goal is to decrease LDL to levels recommended for patients with preexisting CHD (<=100 mg/dL [2.60 mmol/L] ). The initiation level for behavioral interventions is also an LDL cholesterol >100 mg/dL (2.60 mmol/L). The initial therapy should be to use statin therapy with the addition of a resin if necessary to reach the LDL goal.

Limited data are available from clinical trials especially in diabetic patients without clinical cardiovascular disease. However, because of the higher mortality for diabetic patients with first MI, aggressive treatment of dyslipidemia is also indicated. For patients without previous CHD, the goal for LDL cholesterol is <=100 mg/dL (2.60 mmol/L); the initiation level for pharmacological therapy is an LDL level >=130 mg/dL (3.35 mmol/L).

For patients with LDL between 100 and 129 mg/dL, a variety of treatment strategies are available, including more aggressive MNT and pharmacological treatment with a statin. MNT should be attempted before starting pharmacological therapy. In addition, if HDL is <40 mg/dL, a fibric acid might be used.

Initial therapy for elevated  TG is improved glycemic control; additional decreases can be achieved with very high doses of statins. 

Funding Source:
Not-for-profit
0
Foundation associated with industry:
Reviewer Comments:

Very complete review of the treatment of dyslipidemia in diabetes. However, very few clinical intervention trials have been conducted in individuals with type 1 or type 2 diabetes.

Treatment guidelines from the Third Report of the Expert Panel on the Detection, Evaluation and Treatment of High Blood Cholesterol in Adults can be used for individuals with diabetes as well.

This review includes results from the UKPDS, which has been analyzed separately for the evidence summary.

Quality Criteria Checklist: Review Articles
Relevance Questions
  1. Will the answer if true, have a direct bearing on the health of patients? Yes
  2. Is the outcome or topic something that patients/clients/population groups would care about? Yes
  3. Is the problem addressed in the review one that is relevant to dietetics practice? Yes
  4. Will the information, if true, require a change in practice? No
 
Validity Questions
  1. Was the question for the review clearly focused and appropriate? Yes
  2. Was the search strategy used to locate relevant studies comprehensive? Were the databases searched and the search termsused described? ???
  3. Were explicit methods used to select studies to include in the review? Were inclusion/exclusion criteria specified andappropriate? Wereselectionmethods unbiased? ???
  4. Was there an appraisal of the quality and validity of studies included in the review? Were appraisal methodsspecified,appropriate, andreproducible? No
  5. Were specific treatments/interventions/exposures described? Were treatments similar enough to be combined? Yes
  6. Was the outcome of interest clearly indicated? Were other potential harms and benefits considered? Yes
  7. Were processes for data abstraction, synthesis, and analysis described? Were they applied consistently acrossstudies and groups? Was thereappropriate use of qualitative and/or quantitative synthesis? Was variation in findings among studies analyzed? Were heterogeneity issued considered? If data from studies were aggregated for meta-analysis, was the procedure described? No
  8. Are the results clearly presented in narrative and/or quantitative terms? If summary statistics are used, are levels ofsignificance and/or confidence intervals included? Yes
  9. Are conclusions supported by results with biases and limitations taken into consideration? Are limitations ofthe review identified anddiscussed? No
  10. Was bias due to the review's funding or sponsorship unlikely? Yes