The American Heart Association’s 2009 Scientific Sessions released the results of the Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6: HDL and LDL Treatment Strategies in Atherosclerosis (ARBITER 6-HALTs) trial earlier this week. And now medical office phones are ringing. Patients are asking, should I stay on my current cholesterol lowering medication or should I go on Niaspan?
This study consisted of 363 participants who were on statin (90% were on Lipitor (Atorvastatin) and Zocor (Simvastatin))medications for at least 3 months prior to enrollment into the study. The mean statin dosage was 42 mg. These participants were then divided in half. One group received Ezetimibe (Zetia) 10 mg daily while the other half received Niaspan 2000 mg daily (titrated up over 2 months ).
All participants had the following:
-LDL (bad) Cholesterol less than 100 mg/dL
-HDL (good) Cholesterol less than 50 mg/dL
-Known vascular or coronary disease risk equivalents
Baseline Statistics of both groups:
Mean LDL 84mg/dL and Mean HDL 43mg/dL (Ezetimibe group)
Mean LDL 81mg/dL and Mean HDL 42mg/dL (Niacin group)
After 14 months of treatment – the results:
Mean LDL decreased from 84 mg/dL to 66 mg/dL ; HDL decreased from 43 mg/dL to 40 mg/dL; Triglycerides decreased by 7% in Ezetimibe (Zetia) group.
Mean LDL decreased from 81 mg/dL to 71 mg/dL; HDL increased from 42 mg/dL to 50 mg/dL; Triglycerides decreased by 21%: in the Niacin arm.
Carotid Intima Media Thickness :
-Niaspan (Niacin) arm Statistically significant regression
-Ezetimibe (Zetia) arm Did not have significant regression but did stop progression
Secondary Endpoints Include:
Coronary Heart Disease (CHD) Death, MI(Heart Attack), Coronary Revascularization (heart stent or balloon to open artery or open heart surgery), Unstable Angina (unstable chest pain)
Ezetimibe (Zetia) group had 9 of the secondary endpoint events out of 165 participants. This is 5.5% in the 14 months of the trial.
Niacin group had 2 of the primary endpoint events out of 169 participants. This is 1.2% in the 14 months of the trial.
Dr. James O’Keefe, Cardiologist at the Mid-America Heart Institute in Kansas City, reports “This is a big win for the Niacin + Statin combination treatment. We have had other randomized studies such as HATS and FATS, both of which are smaller studies like ARBITER 6, which although not powered to show event reduction, did find significantly better cardiovascular outcomes with niacin”.
I was able to attend the meeting at the AHA Session earlier this week. The presenter and lead investigator, Dr. Allen Taylor, from Medstar Research Institute, Washington, DC, reported that in 2008 there were 9 million U.S. patients receiving treatment with Zetia and 2.5 million U.S. patients receiving treatment with Niacin. Although niacin isn’t an easy drug to use, due to its’ flushing side effect we should make strong efforts to help our patients tolerate this medication. Over time the flushing becomes less often, less intense and less in duration. In one Niaspan study, participants who took the medication for 6 months had approximately 2 flushes per month. Dr. James O’Keefe reports, “patients should avoid sustained release over the counter (OTC) niacin products, as they are more hepatotoxic (toxic to liver) than the immediate release (IR) OTC niacin or prescription, Niaspan. “
In summary, if you are taking cholesterol medications we recommend you do not stop your medications without speaking with your health care provider. If you are taking an over the counter niacin product make sure it is an immediate release niacin or we recommend taking prescription form Niaspan-which is often more tolerable. “In our experience, which is supported by this recent study, the combination of niacin with a statin such as Simvastatin (Zocor), Rosuvastatin (Crestor), Atorvastatin (Lipitor) is a great way to go both for buffing the cholesterol numbers and improving cardiovascular prognosis,” Dr. James O’Keefe.