HYPERLIPIDEMIA IN THE OLDER POPULATION NICOLE 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 GUIDELINES FOUR 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/dl and an estimated 10-year ASCVD risk of 7.5%
2013 ACC/AHA BLOOD CHOLESTEROL GUIDELINES 7.2. 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 High intensity Atorvastatin 40 80mg Rosuvastatin 20 40mg Moderate intensity Atorvastatin 10-20mg Rosuvastatin 5-10mg Simvastatin 20 40mg Pravastatin 40 80mg Low intensity Simvastatin 10mg Pravastatin 10 20mg
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?
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