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Do Niacin And Statins Together Increase Stroke Risk?
Written by Wellness Club on June 13, 2011 – 5:49 pm -Do Niacin And Statins Together Increase Stroke Risk?
Nurse Mark answers your questions:
It seems that a recently released study done by the National Heart, Lung, and Blood Institute (NHLBI) has lots of folks worried. It further seems that the press has reported the results of the study in exactly the way that some in Big Pharma wanted them to – that is, to give the impression that statins are good and niacin is bad – even dangerous.
Nurse Mark
Recently saw an article on increase in strokes with statins and niacin. I do take no flush niacin and am on a statin. Does Dr. Myatt feel that is no longer a good thing to do? Thank you, Ann
Strangely enough, that is not what the study actually reports – that is just the spin that has been put on it.
Here is the “short course” or “Cliff-Notes” regarding the study:
The idea was to see if using niacin to raise HDL could reduce the rate of heart attacks and other adverse events.
Researchers recruited some 3400 subjects for the study – all of whom had previous and severe cardiovascular disease. According to the National Institutes for Health:
“The average age of the participants was 64 years. Pre-existing medical conditions included coronary artery disease (92 percent); metabolic syndrome, which is a cluster of risk factors for heart disease (81 percent); high blood pressure (71 percent); and diabetes (34 percent). More than half of participants reported having a heart attack prior to entering the study.”
These were all very advanced, medically-at-high-risk people!
Half the subjects got high-dose Niaspan – a prescription form of time-release niacin. The other half got a placebo.
All the subjects got Zocor – a cholesterol-lowering drug. (Yes, Zocor – the drug that the FDA has finally admitted causes dangerous problems when taken in larger doses – and they are now reluctantly recommending that doctors not prescribe the high doses previously considered acceptable.)
A smaller group of subjects also got yet another cholesterol-lowering drug, Zetia, on top of the Zocor. (While Zetia is not a “statin” drug it has a long list of similar and just-as-devastating side effects.)
A goal of the study appeared to be to drive the participants LDL cholesterol to crazy, dangerously low levels.
About 2 1/2 years into the study the researchers found that even though the Niaspan was doing what niacin is supposed to do – that is, raising HDL levels and lowering triglycerides – they decided that the rates of cardiovascular events in the Niaspan and non-Niaspan groups were not much different.
Additionally, the researchers noted a tiny increase in strokes in the Niaspan group – there were 28 strokes [1.6%] in the Niaspan group versus 12 [0.7%] in the placebo group.
Based on these findings, that increasing HDL levels did not somehow magically prevent cardiac events in this high-risk group of patients and that there was a statistically tiny increase in risk of stroke (and the FDA admits that “it is unclear what role, if any, niacin contributed to this imbalance in ischemic stroke.”) the researchers stopped the study early.
According to Dr. Susan B. Shurin, acting director of the National Heart, Lung, and Blood Institute the Niaspan did exactly what it was supposed to do – it raised HDL and lowered LDL. She says that the study was stopped early because the question that the study was designed to address had been answered – that is, that simply raising HDL cholesterol levels in high-risk cardiac patients did not significantly lower the risk of additional cardiac events. She goes on to say that “we do not believe that there are significant risks to continuing to take the niacin, but you should have a conversation with your doctor.”
Here at The Wellness Club we are aware of a number of studied that do show a benefit to raising HDL levels – but we agree that simply raising HDL levels in high-risk cardiovascular patients, without correcting other risk factors, is not going to be a “magic bullet cure” that the researchers were looking for. One such study is included at the end of this article.
We also agree with the FDA statement “it is unclear what role, if any, niacin contributed to this imbalance in ischemic stroke.” It is very unclear what role Niacin might have played in the tiny increase in strokes in this study – remember, the participants were all chosen because they were at high-risk for just this kind of thing!
So, here is the short-course part:
This study proved what it was designed to prove – that simply raising HDL does not prevent cardiovascular events in advanced cardiovascular disease patients.
This study did not prove anything else.
Actually, this study DID prove other things – just not medical things. It proved that the Big Pharma wars of domination and profit continue unchecked – moments after the press release detailing the study findings was released Big Pharma giant Abbott saw it’s stock prices and thus it’s profits, fall. It also proved that the spin-meisters in Big Pharma are hard at work telling the press what to report and how to report it. Much of the study is reported out of context or not reported at all.
For those who are interested in the facts regarding this story, here is the press release that started this whole affair: http://public.nhlbi.nih.gov/newsroom/home/GetPressRelease.aspx?id=2792
And here is a statement from the FDA about the study: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm256841.htm
And finally, here is a video of Dr. Susan B. Shurin explaining why the National Heart, Lung, and Blood Institute halted the study early: http://www.youtube.com/nhlbi#p/a/u/0/SgkIvuRBMJA
Niacin, and it’s prescription sister Niaspan (a “slow release” niacin) are great substances with many beneficial effects. We do not see any reason to stop using niacin. Given the well-known dangers of statin drugs (that we have written about often!) we do recommend discussing statin use with your doctor – ask him if niacin alone might do the trick.
Here is just one of many research articles describing the benefits, effectiveness and safety of niacin when used for treating high cholesterol:
Multiple-dose efficacy and safety of an extended-release form of niacin in the management of hyperlipidemia.
Goldberg A, Alagona P Jr, Capuzzi DM, Guyton J, Morgan JM, Rodgers J, Sachson R, Samuel P.
Source: Lipid Research Clinic, Washington University School of Medicine, St. Louis, MO 63110, USA.
Abstract:
This multicenter trial evaluated the safety and efficacy of escalating doses of Niaspan (niacin extended-release tablets) and placebo (administered once-a-day at bedtime) in patients with primary hyperlipidemia on the percent change from baseline in levels of low-density lipoprotein (LDL) cholesterol and apolipoprotein B. Extended-release niacin was initiated at a dose of 375 mg/day, raised to 500 mg/day, and further increased in 500-mg increments at 4-week intervals to a maximum of 3,000 mg/day. A total of 131 patients (n = 87, extended-release niacin; n = 44, placebo) were treated for 25 weeks with study medication after a 6-week diet lead-in/drug washout phase and 2-week baseline LDL cholesterol stability phase. Significant decreases from baseline in levels of LDL cholesterol and apolipoprotein B became apparent with the 500-mg/day dose and were consistent at all subsequent doses (p < or =0. 05), reaching 21% and 20%, respectively, at the 3,000-mg/day dose. Significant increases from baseline in levels of high-density lipoprotein cholesterol became apparent with the 500-mg/day dose and were consistent at all subsequent doses (p < or = 0.05), reaching 30% at the 3,000-mg dose. Significant decreases from baseline in triglycerides and lipoprotein(a) occurred at the 1,000-mg dose and were apparent at all subsequent doses (p < or =0.05), reaching 44% and 26%, respectively, at the 3,000-mg dose. The most common adverse events were flushing and gastrointestinal disturbance. Transaminase increases were relatively small, and the proportion of patients who developed liver function abnormalities on extended-release niacin was not significantly different from placebo. Thus, extended-release niacin was generally well tolerated and demonstrated a dose-related ability to alter favorably most elements of the lipid profile.
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