Small niacin imaging study looms large in the run-up to ARBITER-6 Reply

In the context of growing anticipation and speculation about ARBITER-6, observers in the medical community and on Wall Street are taking a close look at a small JACC study evaluating  the impact of niacin on carotid atherosclerosis as assessed by MRI.

The study from the UK by Justin Lee and colleagues compared 2g daily modified release niacin or placebo when added to statins in 71 patients with low HDL and either type 2 diabetes and CHD or carotid/peripheral atherosclerosis. As expected niacin increased HDL by 23% and decreased LDL by 19%. After one year, niacin significantly reduced carotid atherosclerosis when compared to placebo.

An accompanying editorial by Farouc A. Jaffer notes that fewer patients in the niaspan arm completed the trial, reflecting “the known side- effect profile of niacin such as flushing, itching, and gastro-intestinal symptoms.” Jaffer wrote:

While imaging end points are unlikely to result in a candidate drug approval by the Food and Drug Administration, atheroma imaging studies can provide direct evidence of atheroma therapies on the vessel wall, and therefore rationally motivate larger outcome trials.

In a heartwire story by Shelley Wood, Robin Choudhury, the senior author of the study, said that the study “feeds into a bigger understanding of how this drug works, and it is very encouraging”. But Choudhury agreed with the editorialist that the two large outcome studies– HPS2-THRIVE and the the AIM-HIGH Study– are necessary before niacin can gain more widespread acceptance.

Wells Fargo analyst Larry Biegelsen wrote that the study supports his “belief hat Niaspan will be shown to reduce plaque to a greater degree than Zetia in ARBITER 6 HALTS.”

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Click here to see all of CardioBrief’s coverage of ARBITER-6

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