AIM-HIGH - Case Study 1

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Written By: 
Maria Pruchnicki, Pharm.D., BCPS, CLS and Andrea Hirsch, Pharm.D., BCPS

In May 2011, the National Heart Lung and Blood Institute (NHLBI) announced the early termination of the Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health (better known as the AIM-HIGH) trial due to lack of benefit from extended release niacin when add to simvastatin (+/- ezetimibe).  AIM-HIGH was a double-blind, randomized, placebo-controlled outcomes trial with over 3000 patients with cardiovascular disease.  The purpose of this study was to evaluate the impact of adding niacin to statin (+/- ezetimibe) therapy in very high-risk patients with near- or at-goal LDL cholesterol but elevated triglycerides and/or low HDL cholesterol levels. 

The Food and Drug Administration issued a statement, but has not made any new recommendations regarding the use of niacin.  Likewise, the National Lipid Association posted a statement which urges caution when interpreting the findings from AIM-HIGH.

The lack of benefit from this frequently used lipid-lowering combination has created a dilemma for many clinical pharmacists who practice in ambulatory settings.

Patient Vignette #1

Patient is a 63 year old white male presenting for dyslipidemia management.  PMH is significant for DM Type 2 (diagnosed 6 months ago), hypertension and dilated cardiomyopathy (diagnosed 10+ years ago; LVEF ~40%), coronary artery disease (PCI x 2 vessels last Spring), sleep apnea (treated with CPAP), and gout (with last flare 11 years ago, in both ankle joints).

Patient takes medications as prescribed.  He leads an active life and is employed part-time as a business development manager.  He travels frequently, but has overall good eating habits and a regular exercise regimen.  He is married with two grown children living outside of the home.  He is a non-smoker, and drinks 1-2 glasses of wine or alcohol 3-4 times per week.

Family history of premature cardiovascular disease.

Physical Exam: unremarkable.

Vital Signs: 225 lbs, BMI 31.5, waist 41.5 in, 
BP 164/67 (R arm; repeat 140/68), HR 58

Adverse Drug Reactions:  Myalgia - simvastastin, pravastatin, and atorvastatin

Medications: Novolog 70/30, 24 u AM and 20u PM; prasugrel 10 mg daily, Aspirin 325 mg daily, losartan 25 mg daily, metoprolol XL 125 mg daily, allopurinol 300 mg daily, rosuvastatin 5 mg on every other day only (started 4 months ago; no reports of muscle aches)

Labs:
4 months ago (off lipid-lowering therapy) 
TC 213, HDL 33, TG 189, LDL 143, non-HDL 175

Today (on rosuvastatin)
TC 139, HDL 31, TG 161, LDL 74, non-HDL 103
          
HgA1c 6.6%; LFTs wnl; SCr 0.9 and TSH 1.505. 

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