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The benefits of statin therapy in diabetic patients

February 29, 2016

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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 TherapyLow-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 mgAtorvastatin 10 (20) mgSimvastatin 10 mg
Rosuvastatin 20 (40) mgRosuvastatin (5) 10 mgPravastatin 10 ? 20 mg
Simvastatin 20 ? 40 mgLovastatin 20 mg
Pravastatin 40 (80) mgFluvastatin 20 ? 40 mg
Lovastatin 40 mgPitavastatin 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
AgeRisk factorsRecommended statin dose*Monitoring with lipid panel
<40 yearsNoneNoneAnnually or as needed to monitor for adherence
CVD risk factor(s)Moderate or high 
Overt CVDHigh 
40 – 75 yearsNoneModerateAs needed to monitor for adherence
CVD risk factor(s)High 
Overt CVDHigh 
>75 yearsNoneModerateAs needed to monitor for adherence
CVD risk factor(s)Moderate or high 
Overt CVDHigh 

*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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