HYPERLIPIDEMIA IN THE OLDER POPULATIONNICOLE SLATER, PHARMD, BCACP

AUBURN UNIVERSITY, HARRISON SCHOOL OF PHARMACY

JULY 16, 2016

NOTHING TO DISCLOSE

I, Nicole Slater, have no actual or potential conflict of interest in relation to this program.

OBJECTIVES

Determine the most appropriate treatment recommendation for hyperlipidemia in the older population.

Recognize the differences between guideline recommendations for treatment of hyperlipidemia in the older population.

Decide if statin use is appropriate in the older population based on the evidence in the literature.

Provide general instructions for counseling an older patient on their hyperlipidemia treatment regimen.

CONSIDER THIS…

Mr. Malcolm is an 84 yo white male with a history of hypertension. He is taking Lisinopril 10mg daily and HCTZ 25mg daily. His blood pressure is controlled at 138/84. His most recent FLP shows a TC of 188, LDL 124, HDL 32, and Trig 166. He does not smoke.

Should this patient be initiated on a statin?

HYPERLIPIDEMIA

Having high cholesterol, high triglycerides, or both

High LDL

Low HDL

High Triglycerides

Silent killer

Myocardial Infarction (MI), Stroke, and Peripheral Vascular Disease (PVD)

THE RISKS

Smoking

Diabetes

Hypertension

Chronic Kidney Disease (CKD)

Male gender

Age (>45 for men and >55 for women)

Low HDL (< 40 for men and < 50 for women)

SCREENING CONSIDERATIONS

A fasting or non-fasting lipid profile should be measured at least every 5 years, starting at age 20

Should be accompanied by an assessment of ASCVD risk factors and risk stratification when indicated

Total cholesterol levels increase with age primarily from an increase in the LDL-cholesterol

Multiple studies have shown that a high LDL and low HDL in the elderly is associated with significant CHD risk.

THE CONTROVERSY

80% of deaths from coronary heart disease occur in people over the age of 65

A very small percentage of RCT’s represent the older population (> 75 years) when it comes to preventative care of clinical ASCVD, so it is difficult to clinically treat patients who might be considered in need of statin therapy.

QUESTION 1

Which trial was designed to measure a reduction in risk for a primary CHD events specifically in the elderly population?

CARDS

CARE

4S

PROSPER

EVIDENCE: PRIMARY PREVENTION

PROSPER: Pravastatin in elderly individuals at risk of vascular disease

70 – 82 years of age with a history of risk factors

Pravastatin 40mg/day vs. placebo

Reduced risk from coronary death, non-fatal MI, and Stroke

CARDS: The Collaborative Atorvastatin Diabetes Study

40 – 75 years of age without documented cardiovascular disease

Atorvastatin 10mg vs. placebo

Reduced mortality, cardiovascular events, and stroke

OTHER EVIDENCE: SECONDARY PREVENTION

4S: Scandinavian Simvastatin Survival Study

Patients 30 – 70 with coronary heart disease

Simvastatin vs. placebo

Reduced mortality and morbidity

CARE: Cholesterol and Recurrent Events

Patients 21 to 75 who were post-MI

Pravastatin 40mg vs. placebo

Reduced overall mortality from cardiovascular causes and stroke

SAGE: Study Assessing Goals in the Elderly

Patients 65 to 85 > 1 MI

80 mg atorvastatin vs. 40 mg of pravastatin

Greater reduction in major CV events and all-cause mortality with intensive-therapy, but equally efficacious in reducing frequency and duration of myocardial ischemia

QUESTION 2

According to the 2013 ACC/AHA guideline recommendations, older adults:

Should be treated with statin therapy regardless of age

Should be treated with statin therapy up to age 75

Should be treated with statin therapy using clinical judgement

Should not be treated with statin therapy at all

GUIDELINES

European Society of Cardiology and European Atherosclerotic Society (ESC/EAS 2011)

American College of Cardiology and American Heart Association (ACC/AHA 2013)

National Lipid Association Part 2 (NLA 2015)

EUROPEAN SOCIETY OF CARDIOLOGY AND EUROPEAN ATHEROSCLEROTIC SOCIETY (ESC/EAS 2011) SECTION 10.4

Lifestyle interventions should be the first step for managing lipids in all patients

If lipid targets are not met with lifestyle alone, statins are the treatment of choice for lowering LDL cholesterol

Lipid measures in the elderly should not differ from those undertaken in younger subjects

Elderly patients are a high risk group who could benefit significantly from lipid-lowering therapy

2013 ACC/AHA BLOOD CHOLESTEROL GUIDELINESFOUR STATIN BENEFIT GROUPS

1. Individuals with clinical ASCVD

2. Individuals with primary elevations of LDL-C ≥190 mg/dL

3. Individuals 40 to 75 years of age with diabetes and LDL-C 70 to 189 mg/dL without clinical ASCVD

4. Individuals without clinical ASCVD or diabetes who are 40 to 75 years of age and have LDL-C 70 to 189 mg/dLand an estimated 10-year ASCVD risk of ≥7.5%

2013 ACC/AHA BLOOD CHOLESTEROL GUIDELINES7.2. INDIVIDUALS > 75 YEARS OF AGE

RCT evidence does support the continuation of statins beyond 75 years of age in persons who are already taking and tolerating these drugs

A larger amount of data supports the use of moderate-intensity statin therapy for secondary prevention in individuals with clinical ASCVD who are >75 years of age

Few data were available to indicate an ASCVD event reduction benefit in primary prevention among individuals >75 years of age who do not have clinical ASCVD

NATIONAL LIPID ASSOCIATION (NLA 2015: PART 2)

Primary ASCVD prevention:

Age 65 – 79 should be treated like normal adult

Secondary ASCVD preventions:

Ages > 65 but < 80 with ASCVD and/or diabetes should receive moderate to high intensity statin after considering the risk/benefits of treatment

Ages > 80 should consider moderate intensity statin after discussing risk/benefit, DDIs, polypharmacy, comorbidities, and cost

QUESTION 3

Which of the following are considered high intensity statins?

Atorvastatin 10mg

Rosuvastatin 20mg

Pravastatin 80mg

Simvastatin 40mg

THERAPY CONSIDERATIONS

PATIENT CENTERED

Moderate to High intensity statin should be first line option

STATIN THERAPY

• Atorvastatin 40 – 80mg• Rosuvastatin 20 – 40mgHigh intensity

• Atorvastatin 10 - 20mg• Rosuvastatin 5 -10mg• Simvastatin 20 – 40mg• Pravastatin 40 – 80mg

Moderate intensity

• Simvastatin 10mg• Pravastatin 10 – 20mgLow intensity

POTENTIAL RISKS OF STATIN THERAPY

Cognitive impairment

Development of diabetes

Rhabdomyolysis

QUESTION 4

Which of the following might be a reason to initiate non-statin therapy?

To help reduce cardiovascular events in patients

To increase the number of medications a patient takes

To provide therapy for statin intolerant patients

All of the above

NON-STATIN THERAPY

Only use in those who fail statin therapy or have a contraindication to statin therapy

Adding therapy increases the risk of polypharmacy, drug interactions, and adverse effects

Generally not recommended for reduction in cardiovascular events

May be utilized to reach treatment target goals

NON-STATIN THERAPY OPTIONS

Ezetimibe

Moderately lowers LDL

Recent trial with combo simvastatin showed a reduction in cardiovascular events in patients with CKD

Niacin

Lowers triglycerides and raises HDL with some moderate reduction in LDL

Secondary prevention studies did not show any additional benefit of using Niacin with max statin therapy

Fibrates

Lowers triglycerides and VLDL-C

Can lower cardiovascular risk when used alone, but no evidence to support combo therapy and risk reduction

Bile Acid Sequestrants

Mild-moderate lowering of LDL

Can increase triglyceride levels and not well tolerated

COUNSELING/EDUCATION

Assess how the patient feels about taking additional medications

Discuss myopathy and signs of rhabdomyolysis both at baseline and during therapy

Ease concerns regarding cognitive impairment and diabetes development

Provide treatment goals and expectations for therapy

Review important drug interactions

BOTTOM LINE

There is insufficient evidence for statin use in the older population

Particularly those > 75 years of age for primary prevention

Clinical judgement should be utilized to determine treatment appropriateness based on patient characteristics

More studies with proper representation of this population need to be included

Cost-effectiveness should also be determined

Non-statin therapies do not provide any additional benefit in this population

CONSIDER THIS…

Mr. Malcolm is an 84 yo white male with a history of hypertension. He is taking Lisinopril 10mg daily and HCTZ 25mg daily. His blood pressure is controlled at 138/84. His most recent FLP shows a TC of 188, LDL 124, HDL 32, and Trig 166. He does not smoke.

Should this patient be initiated on a statin?

REFERENCES

ACC/AHA ASCVD Risk Estimator (ACC website). 2013. Available at: http://tools.cardiosource.org/ASCVD-Risk-Estimator/. Accessed 2/16/2015.

Stone NJ, Robinson JG, Lichtenstein AH, et al. 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 2014:2889-934.

Jacobsen TA, Ito MK, Maki KC, et al. National Lipid Association recommendations for patient-centered management of dyslipidemia: Part 1 – executive summary. J Clin Lipidol. 2014;8:473-488.

American Heart Association. Older Americans and Cardiovascular Diseases: Statistical Fact Sheet 2013 Update (AHA website). 2013. Available at: http://www.heart.org/idc/groups/heart-public/@wcm/@sop/@smd/documents/downloadable/ucm_319574.pdf. Accessed 2/16/2015.

Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994; 344:1383-9.

Shepherd, J et al. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomized controlled trial. Lancet 2002;360:1623-30

Jacobson TA, Maki KC, Orringer C, Jones P, Kris-Etherton P, Sikand G, et al. National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia: Part 2, Journal of Clinical Lipidology (2015), doi: 10.1016/j.jacl.2015.09.002.

Colhoun, Helen M et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. The Lancet: 364; 9435:685 – 696.

Lewis SJ, Moye LA, Sacks FM, Johnstone DE, Timmis G, Mitchell J, et al. Effect of Pravastatin on Cardiovascular Events in Older Patients with Myocardial Infarction and Cholesterol Levels in the Average Range: Results of the Cholesterol and Recurrent Events (CARE) Trial. Ann Intern Med. 1998;129:681-689.

Prakash D, Stone PH, Bairey Merz CN, et al. Effects of Intensive Versus Moderate Lipid-Lowering Therapy on Myocardial Ischemia in Older Patients With Coronary Heart Disease. Circulation. 2007;115:700-707.