AIM HIGH Trial

AIM HIGH Trial

What are the benefits of adding Niaspan to patients with established atheroclerosis who have been already on high dose statin or high dose statin plus ezetamibe for years with LDL-c kept at 40 to 80 mg/dl? The mean LDL-c before ramdomization was already 71 mg/dl - same as in the COURAGE Trial.

This patient population had already benefitted from the effects of optimal therapies reaching low to very low LDL-c levels. Their plaque biology and morphology had already been modified by aggressive therapy. Even before  the study began, even if there were benefits of adding Niaspan, it will take a long trial because of small benefits - the benefits are probably mostly in those with LDL-c near 80 mg/dl, not those with LDL-c in the 30’s and 40’s and those with shorter previous exposure to statin.  AIM HIGH was stopped prematurely after ony three years because of lack of benefits yet. Not really unexpected.  

This study design was flawed right from the start. It was designed to determine the benefits of Niaspan in unchartered territories where there were no previous indications - those with already low LDL-c (like 45 mg/dl) and only slightly low or normal HDL-c (like 40 mg/dl). This created a backlash against statin and combination therapies that is unfounded and still remains. The media, the public and even physicians became confused. And they have not yet recovered.

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