AIM-HIGH - Case Study 2

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 #2
Patient is a 54 year old African American female presenting for follow up appointment in the lipid clinic.  She has a history of elevated LFTs secondary to non-alcoholic steatohepatitis ("fatty liver").  The patient is not known to have coronary artery disease (normal nuclear stress test 1 month ago).  Her only other medical problems are vitamin B12 deficiency and hypothyroidism.  She has no family history of premature cardiovascular disease.

This patient is generally adherent to her prescribed medications, admitting that she does not like taking medications and will occasionally (every 2-3 months) take a short "holiday" off of all her medicines.  The last of these occurred about 3 months ago. 

Patient is a non-smoker, and has been working to improve her eating habits and has a fairly regular exercise regimen.  She used to be physically active with her job, as a dance teacher at the local College; she also does private lessons during the summer months.  However, she does not danced much in last few years.  She rarely drinks alcohol.  She has gained about 2 lbs since her last visit six months ago.

The patient recently had a normal nuclear stress test.  An abdominal ultrasound about 2 years ago confirmed hepatic parenchymal disease consistent with fatty liver.

Physical Exam: unremarkable

Vital Signs:  135 lbs, BMI 24.7, waist 34 in
BP 100/72, HR 60

Adverse Drug Reactions:  NKDA

Niacin extended-release (Niaspan) 1000 mg once daily, simvastatin 40 mg daily, fenofibrate 200 mg daily, ezetimibe 5 mg daily, plant stanols/sterols daily; Vit B12 OTC; levothyroxine 75 mcg daily.

6-months ago (Niaspan added at this visit)
TC 251, HDL 48, TG 225, LDL 158, non-HDL 203, LDL-P 2189
ALT 70;  BG 84

TC 189, HDL 52, TG 124, LDL 112, non-HDL 137, LDL-P 2018
ALT 88; TSH 1.825; BG 91; vit B12 454

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