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Diabetes is a chronic metabolic disease that can lead to serious
complications, including cardiovascular disease (CVD). According to the Centers
for Disease Control and Prevention (CDC), an estimated 29 million people in the
United States had diabetes in 2014. Diabetic adults are 2 – 4 times more
likely to have heart disease or stroke than adults without diabetes. In
addition, the risk of death for diabetic adults is 50 percent higher than for
adults without diabetes.1 Primary and secondary prevention of CVD is
crucial for this population. Control of hyperglycemia is not sufficient to
reduce the risk of CVD in diabetic patients. Studies have found that
controlling individual cardiovascular risk factors in diabetic patients is
effective in preventing or slowing CVD.2
Diabetics have increased prevalence of lipid abnormalities, which
contributes to their increased risk of CVD. Diabetic dyslipidemia is the most
frequently seen lipid disorder in diabetic patients. Diabetic dyslipidemia is
characterized by high triglycerides, low HDL, and an increase in small, dense
LDL particles. The levels of LDL could appear to be relatively normal in
diabetics; however, the small dense LDL particles are considered more
atherogenic than the larger LDL particles, leading to the increased risk of CVD
in diabetic patients.3
Guidelines for using statin therapy
Statins are considered first line therapy for diabetic dyslipidemia because
they are the most potent medication to reduce LDL cholesterol
levels.4 The American College of Cardiology/American Heart
Association (ACC/AHA) and the American Diabetes Association guidelines both
recommend using statins in diabetic patients. There have been multiple studies
demonstrating that statin use showed significant primary and secondary
prevention of CVD events and coronary heart disease deaths in diabetic
patients. A meta-analysis by the American College of Physicians on
lipid-lowering therapy for type 2 diabetes patients found that there was a 22
percent reduction of events in primary prevention and 24 percent in secondary
prevention.4 Another meta-analysis demonstrated that there is a 9
percent proportional reduction in all-cause mortality and 13 percent reduction
in vascular mortality, for each mmol/L reduction in LDL
cholesterol.5
The table below provides a list of statin intensities from the ACC/AHA
guidelines.
High-, Moderate-, and Low-Intensity Statin Therapy (used in the RCTs
reviewed by the Expert Panel)*
| High-Intensity Statin Therapy | Moderate-Intensity Statin Therapy | Low-Intensity Statin Therapy |
|---|
| Daily dose lowers LDL-C, on average, by approximately
≥50% | Daily dose lowers LDL-C, on average, by approximately 30% to
<50% | Daily dose lowers LDL-C, on average, by approximately
<30% |
| Atorvastatin (40†) ? 80
mg | Atorvastatin 10 (20) mg | Simvastatin 10
mg |
| Rosuvastatin 20 (40)
mg | Rosuvastatin (5) 10 mg | Pravastatin 10 ?
20 mg |
| Simvastatin 20 ? 40 mg‡ | Lovastatin
20 mg |
| Pravastatin 40 (80) mg | Fluvastatin 20 ? 40
mg |
| Lovastatin 40 mg | Pitavastatin 1 mg |
| Fluvastatin XL 80 mg |
| Fluvastatin 40 mg BID |
| Pitavastatin 2 ? 4 mg |
|
Boldface type indicates specific statins and doses
that were evaluated in RCTs (16-18, 46-49, 64-75, 77) included in CQ1, CQ2, and
the Cholesterol Treatment Trialists 2010 meta-analysis included in CQ3 (20).
All of these RCTs demonstrated a reduction in major cardiovascular events.
Italic type indicates statins and doses that have been approved by the
FDA but were not tested in the RCTs reviewed.
* Individual responses to statin therapy varied in the RCTs and
should be expected to vary in clinical practice. There might be a biological
basis for a less-than-average response.
† Evidence from 1 RCT only: down-titration if unable to
tolerate atorvastatin 80 mg in the IDEAL (Incremental Decrease through
Aggressive Lipid Lowering) study (47).
‡ Although simvastatin 80 mg was evaluated in RCTs,
initiation of simvastatin 80 mg or titration to 80 mg is not recommended by the
FDA because of the increased risk of myopathy, including rhabdomyolsis.
BID: Twice daily; CQ: Critical question; FDA: Food and Drug Administration;
LDL-C: Low density lipoprotein cholesterol; RCTs: Randomized controlled
trials.
|
The recommendations are based on age and other CVD risk factors and not on
LDL cholesterol levels. Both of the guidelines recommend that patients ages 40
? 75 should be on statin therapy regardless of other CVD risk factors.
Currently, the guidelines only recommend using moderate- and high-intensity
statins.5,6 In clinical practice, the intensity of the statin may
need to be adjusted based on side effects and LDL cholesterol
levels.5
The ADA recommendations for statin treatment in diabetics are outlined in
the table below.
Recommendations for statin treatment
| Age | Risk factors | Recommended statin
dose* | Monitoring with lipid panel |
|---|
| <40
years | None | None | Annually
or as needed to monitor for adherence |
| CVD risk factor(s)† | Moderate or
high | |
| Overt CVD‡ | High | |
| 40 – 75
years | None | Moderate | As
needed to monitor for adherence |
| CVD risk factor(s) | High | |
| Overt CVD | High | |
| >75
years | None | Moderate | As
needed to monitor for adherence |
| CVD risk factor(s)† | Moderate or
high | |
| Overt CVD‡ | High | |
*In addition to lifestyle
therapy.
† CVD risk factors include LDL cholesterol =100 mg/dL (2.6
mmol/L), high blood pressure, smoking, and overweight and obesity.
‡ Overt CVD includes those with previous cardiovascular events
or acute coronary syndromes. |
We ask that you consider these guidelines when determining treatment options
for your diabetic patients.
1 Centers for Disease Control and
Prevention. "National Diabetes Statistics Report: Estimates of Diabetes and Its
Burden in the United States, 2014." Atlanta, GA: US Department of Health and
Human Services; 2014. Available from: www.cdc.gov/features/diabetesfactsheet
2 American Diabetes Association. "Standards of Medical
Care in Diabetes?2014." Diabetes Care. 2014;37(1 Suppl): S14-S80.
3 Buse JB, Ginsberg HN, Bakris GL, Clark NG, Costa F,
Eckel R, Fonseca V, Gerstein HC, Grundy S, Nesto RW, Pignone MP, Plutzky J,
Porte D, Redberg R, Stitzel KF, Stone NJ; American Heart Association; American
Diabetes Association. "Primary Prevention of Cardiovascular Diseases in People
with Diabetes Mellitus: A Scientific Statement from the American Heart
Association and the American Diabetes Association." Diabetes Care. 2007
Jan;30(1):162-72.
4 Spratt KA. "Managing Diabetic Dyslipidemia: Aggressive
Approach." J Am Osteopath Assoc. 2009 May;109(5 Suppl): S2-7.
5 American Diabetes Association. "Standards of Medical
Care in Diabetes?2015." Diabetes Care. 2015 Jan;38 Suppl: S49-54.
6 Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN,
Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P,
Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW; American College of
Cardiology/American Heart Association Task Force on Practice Guidelines. "2013
ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce
Atherosclerotic Cardiovascular Risk in Adults: A report of the American College
of Cardiology/American Heart Association Task Force on Practice Guidelines."
J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B): 2889-934.
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