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Entries in Niacin (2)

Tuesday
Nov152011

Niacin-Statin Combo Offers No Benefit, Study Finds

Comstock/Jupiterimages/Thinkstock(WASHINGTON) -- Niacin, in combination with a cholesterol-lowering statin, didn’t lower the risk of having a heart attack, stroke, or other cardiovascular “event,” and actually slightly increased the risk of strokes in people with heart disease whose LDL (“bad”) cholesterol is under control, according to a study in this week’s New England Journal of Medicine.

As a result, the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI), which funded the research, stopped the study more than a year early.

In an accompanying editorial, Dr. Robert Giugliano of Brigham and Women’s Hospital in Boston, wrote that it’s time to “retire” niacin, used as a cholesterol reducer since 1955.

“Given the lack of efficacy in this trial...and the unresolved question of an increased risk of ischemic stroke, one can hardly justify the continued expenditure of $800 million per year in the United States for branded extended-release niacin,” he wrote. 

However, he added there could be some benefit in using niacin in patients unable to tolerate statins to lower their LDL cholesterol.

The NHLBI originally reported the findings back in May when the agency announced the end of the clinical trial.  The study investigators presented their data Tuesday at the American Heart Association’s annual meeting.

The trial, known as AIM-HIGH, involved more than 3,414 patients with cardiovascular disease who lowered their LDL cholesterol using statins.  They received either a high dose of extended-release niacin (Niaspan) with simvastatin (Zocor), or Zocor and a placebo for 32 months, when the trial was stopped.

While the niacin-statin combination therapy increased HDL (“good”) cholesterol and lowered the amount of fat in the blood better than the use of a statin-only regimen, it didn’t reduce the number of heart attacks, strokes, or hospitalizations for certain other heart problems.

“The lack of effect on cardiovascular events is unexpected and a striking contrast to the results of previous trials and observational studies,” co-investigator Dr. Jeffrey Probstfield said in an NHLBI statement after initial release of the study results in May.

Prior research has shown significant niacin-associated declines in the rates of death, heart attacks and strokes, but these studies, noted the NHLBI, did not specifically address what happens when HDL is increased and LDL is controlled. Other niacin clinical trials are ongoing.

“The results from AIM-HIGH should not be extrapolated to apply to potentially higher-risk patients such as those with acute heart attack or acute coronary syndromes, or in patients whose LDL cholesterol is not as well-controlled as those in AIM-HIGH,” said Dr William E. Boden, also a co-investigator, in a statement.

But experts not involved in AIM-HIGH stress that people should not stop taking niacin, also known as vitamin B3 and nicotinic acid, or other cholesterol-lowering drugs without consulting their doctor first.
 
Copyright 2011 ABC News Radio

Friday
May272011

Combination Cholesterol Drugs Show No Added Heart Benefits

Jupiterimages/Thinkstock(BETHESDA, Md.) -- The combination of statins and niacin, both cholesterol modifying medications, doesn't reduce the chances of having a heart attack, according to findings by the AIM-HIGH trial conducted by the National Heart Lung and Blood Institute, an arm of the National Institutes of Health.

The findings prompted the NHLBI to stop their trial a year and a half early.

The AIM-HIGH study looked at patients who had lowered their LDL, or so-called bad cholesterol, with the help of statins and tried to see if raising HDL, or good cholesterol, by adding niacin to their therapy would additionally reduce the risk of having a heart attack. But the combined therapy of extended release niacin taken with statins showed no benefit in the patients tested.

Previous studies showed that low HDL cholesterol increases the risk of cardiovascular events in men and women, regardless of LDL cholesterol.

"We have had great clinical data that low HDL levels are bad for decades, but there is no evidence that raising HDL levels does anything to reduce the risk," said Dr. Cam Patterson, chief of the division of cardiology at the University Carolina at Chapel Hill.

Still, many cardiologists believe raising HDL reduces the chance of having a heart attack. In fact, the Framingham Cardiac Risk Score, a risk assessment tool used by cardiologists, looks mainly at the HDL score to assess a patient's risk of heart disease. It's unclear which HDL-raising treatments can reduce the risk of heart disease.

Niacin, found over-the-counter and frequently recommended to be taken two to three times daily, blocks the breakdown of HDL while preventing fat cells from releasing LDL. But niacin, also known as vitamin B3, has also been shown to increase the risk of stroke in some patients.

While many experts said they were surprised by the AIM-HIGH findings, some said they wouldn't abandon their longstanding belief in targeting HDL just yet.

In fact, some patients in the control group of the randomized trial may have had a longstanding history of niacin use before they started the study. The entire group of patients studied also had well-controlled LDL levels, which could indicate that their risk of heart disease or heart attack already may be lower compared to those with uncontrolled cholesterol.

Still, many doctors may be too focused on raising HDL without clear evidence of its benefits, according to Dr. Dean Ornish, founder and president of the preventative medicine research institute at the University of California San Francisco.

"There should be less emphasis on raising HDL and more on lowering LDL via diet and lifestyle, and focus on lipid lowering drugs in combination with diet and lifestyle changes to lower LDL, not raise HDL," said Ornish.

Many experts say patients should not stop taking cholesterol-lowering drugs like niacin or statins without talking to their doctor.

Copyright 2011 ABC News Radio