Please login to the form below

Not currently logged in
Email:
Password:

Abbott's Niaspan disappoints in trial

Abbott's blood lipid treatment Niaspan has failed to meet the primary objective in a study testing whether the drug reduced risk of cardiovascular events in certain patients already receiving Merck's Zocor

Abbott's marketed blood lipid treatment Niaspan (niacin) has failed to meet the primary objective in a government study testing whether the drug reduced the risk of cardiovascular events, including heart attacks and stroke, in certain patients already receiving Merck's Zocor (simvastatin).

As a result of interim findings, the National Institutes of Health's National Heart, Lung and Blood Institute (NHLBI) has halted its study, which was known as the AIM-HIGH trial (for Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health).

The study compared high-dose, extended release Niaspan plus simvastatin to simvastatin alone in patients who had stable, non-acute, pre-existing cardiovascular disease and very well controlled low-density lipoprotein (LDL) on simvastatin. The trial had been planned to continue for another 18 months.

Around 3,400 subjects were enrolled in the US and Canada and followed for 32 weeks. The subjects were considered at risk for cardiovascular events despite well-controlled LDL due to a history of cardiovascular disease and a combination of low high-density lipoprotein (HDL) and high triglycerides.

The trial, which was funded by NHLBI and Abbott, had been intended to confirm positive findings from earlier, smaller studies. However, the combination treatment did not reduce fatal or non-fatal heart attacks, strokes, hospitalisations for acute coronary syndrome, or revascularisation procedures to improve blood flow in the arteries of the heart and brain.

"The lack of effect on cardiovascular events is unexpected and a striking contrast to the results of previous trials and observational studies," said Jeffrey Probstfield, an AIM-HIGH co-principal investigator and professor of medicine and epidemiology at the University of Washington, Seattle.

Abbott issued a statement urging caution in interpreting the study results. "The relevance of these results to patients outside the study population is currently unknown and it would be premature to extrapolate these results to a broader patient population at this time," Abbott said.

"The AIM-HIGH study population does not represent all patient populations in whom the importance of treating low HDL and lowering triglycerides with Niaspan may be significant."

"There are a number of unanswered questions that remain, based on these interim study results," the company added. "Some of these issues may become clearer when the study database closes this Fall and a comprehensive analysis of the complete database can be conducted."

Another disappointing finding of the study was a small and unexplained increase in ischemic stroke rates in the Niaspan group, which was part of the rationale for ending the research early, the NHLBI noted.

"It remains unclear whether this trend in AIM-HIGH arose by chance, or was related to niacin administration or other issues, including the fact that some of the ischemic stroke events reported in the Niaspan arm occurred after patients had stopped taking the medication and that other medications may have influenced the ischemic stroke risk," Abbott said.

The company said that once the study results have been finalized, the relevant findings will be added to Niaspan's labelling.

27th May 2011

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Pegasus

At Pegasus, we specialise in helping deliver healthy messages through integrated communication programmes. In fact, inspiring healthy decisions is all...

Latest intelligence

Products come and go, but a pharma company’s most valuable, durable asset is its reputation, writes Duncan Mackenzie-Reid and Simon Grist
...
Erik
A quest for innovative solutions
UCB looks to the future through a PRISM...
Big data, privacy and the rise of genomic testing
Blue Latitude Health speaks to Johan Christiaanse, Marketing Director at BGI, to find out how the medical profession can overcome one of the major barriers to precision medicine – big...

Infographics