ARBITER-6 is scheduled to be presented as a late-breaking clinical trial on Monday, November 16 at 11:07 AM. The discussant for the trial will be John Kastelein. Several knowledgeable observers have pointed out that, as the principal investigator of the highly controversial ENHANCE trial, and as a lecturer and consultant for numerous companies, including Merck and Schering Plough, which has a drug directly involved in the trial, Kastelein is an unusual and potentially controversial choice for the discussant.

Update: Readers may be interested to learn that Kastelein is the co-author of an article, “Surrogate markers in clinical trials– Challenges and opportunities,” in the September 2009 atherosclerosis.

In July we reported that the trial, which is comparing ezetimibe to extended-release niacin in 400 patients already taking statins, had been terminated early by an independent steering committee. According to a statement entered on June 16, 2009 on the trial’s page on the clinicaltrials.gov website, the early halt of the trial was “based on results of a prespecified, blinded interim analysis. It was not stopped due to safety concerns.”

Allen Taylor, the principal investigator of the trial, told CardioBrief at the time that “data will be publicly disseminated in a scientific forum at the earliest possible time.” Taylor emphasized that he, along with the sttering committee, were strongly in favor of limiting speculation about the trial.

Jonathan Rockoff wrote in the Wall Street Journal Health Blog that Wall Street analysts believe the ARBITER-6 results will favor niacin over ezetimibe. Rockoff quotes Sanford Bernstein analyst Tim Anderson: ““It is nearly uniform thinking among the industry contacts we know that Niaspan likely beat Zetia.

Click here to read the design and rationale of  the ARBITER 6 Trial (Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol)-6-HDL and LDL Treatment Strategies in Atherosclerosis (HALTS).

Note: The news about ARBITER was first reported by the Sanford Bernstein analyst Tim Anderson and subsequently disseminated on Twitter by CNBC reporter Mike Huckman.