A study by the National Institutes of Health was ended 18 months early after finding that adding Niaspan to a statin in people with heart disease did not reduce the risk of cardiovascular events, including heart attacks and strokes. Moreover, Niaspan may have boosted the risk of ischemic events, raising questions about the benefit of raising HDL, or so-called good cholesterol, to fight heart disease.
The 3,414-person study, which added the Abbott Laboratories (ABT) pill to Merck’s (MRK) Zocor, found the combination was linked to stroke in 1.6 percent of patients, compared with 0.7 percent among those given a placebo. The combo failed to reduce heart attacks, heart-related hospitalizations and the need for procedures to reduce chest pain and restore strong blood flow to the heart.
The results of the study, which was dubbed AIM-HIGH, are a blow to Abbott, which paid $3.4 billion for Kos Pharmaceuticals in 2006 in order to gain the rights to Niaspan. The outcome will also likely raise questions about other meds that are being developed to raise HDL by Merck and Roche (OTCQX:RHHBY).
According to Jeff Probstfield, the AIM-HIGH co-principal investigator and professor of medicine and epidemiology at the University of Washington, Seattle:
The lack of effect on cardiovascular events is unexpected and a striking contrast to the results of previous trials and observational studies. The AIM-HIGH findings do not support the trial’s hypothesis that, in the population studied, adding extended-release niacin to simvastatin in participants with well-controlled LDL cholesterol can provide additional clinical benefit.
The study followed patients with a history of heart disease and low levels of good cholesterol for 32 months, instead of the planned 50 months. The purpose was to test the theory that giving Niaspan to patients with HDL levels that were under control would experience an added benefit. The NIH noted that small clinical studies showed that relatively high residual cardiovascular risk exists among patients with cardiovascular disease, low HDL cholesterol, and high triglycerides despite managing LDL levels. But finding treatments to raise HDL while lowering the risk have proved disappointing.
In a statement the FDA says:
At this time, FDA has made no new conclusions or recommendations regarding the use of extended-release niacin alone or in combination with simvastatin or other statins. The Agency will conduct a comprehensive review of the AIM-HIGH trial data as soon as they become available to determine their impact on the approved indications for extended-release niacin [Niaspan].
This is yet another cloud over the Abbott cardiovascular franchise. Last week, an FDA advisory panel recommended that the drugmaker, which sells a combination of Niaspan and simvastatin called Simcor, conduct a new trial of Trilipix after a government study failed to show heart benefits. “Given the benefits seen in earlier but smaller studies with Niaspan, today’s news is a major surprise to us and another setback for ABT’s cholesterol franchise (ACCORD with TriCor/TriLipix was a setback in 2010),” writes Wells Fargo Securities analyst Larry Biegelsen in an investor note.
For its part, Abbott maintains the study population didn’t include everyone who may benefit from Niaspan. “Abbott will reflect the relevant study findings in the label after finalization of the AIM-HIGH study results and appropriate review,” the drugmakers says in a statement. “There are a number of unanswered questions that remain, based on these interim study results.”