It is a matter of how we, as individuals, wish to address our ailments. I have no reservations about seeing a medical doctor for diagnostic input, yet not choosing to follow their prescribed course of medicine. Different strokes for different folks.
Thank you for the article. I had not seen this information as I typically ignore the lamestream media outlets (regardless of political leanings). This study means nothing to me due to the following observations. Others can decide what they take away from this study.
Although high-dose niacin effectively raised the participants’ HDL cholesterol, it did not affect the overall rate of cardiovascular events,” said Dr. Susan B. Shurin, acting director of NHLBI
Duh! These folks were on statins. Statins deplete the body's levels of COQ10 thus potentially causing muscle problems. The heart is a muscle. Pretty straightforward to me.
I'm not sure that I ever read that niacin was purported to reduce cardiovascular events. Have a favorable effect on cholesterol? Possibly. Perhaps one day cholesterol levels will be decoupled from cardiovascular events. It is arterial inflammation and plaque buildup (which includes oxidation of certain cholesterol), not cholesterol in and of itself that causes problems.
In late April 2011, the study’s data safety and monitoring board concluded that high-dose, extended-release niacin offered no benefits beyond statin therapy alone in reducing cardiovascular events.
The above is a little bit the problem I have with headlines such as “NHLBI Halts Niacin Study Early; No Added Reduction in Cardiovascular Events Seen”. It does not disclose to the reader that a high dose extended-release form of niacin was utilized in conjunction with statins (and in some cases, another medication). This in contrast to niacin in its most unadulterated form and without the inclusion of any other medications. I can only guess that headlines in the lamestream media stories were similar. It is, in my opinion, purposely done to mislead the readers. They count on the majority of readers not reading anything more than the headline to a certain degree. Therefore it makes for easy demonization of niacin in this instance. I recall they did something with a big Vitamin E study some years back. However, the study was largely refuted due to form of the vitamin they used, amount they used, and maybe some other considerations.
During the 32-month follow-up period, there were 28 strokes (1.6%) among patients in the niacin group, compared with 12 strokes (0.7%) reported in the control group. In particular, roughly a third (32%) of the strokes in the niacin group occurred in participants who had discontinued the drug at least 2 months and up to 4 years earlier.
While a doubling in the number of strokes is nothing to disregard, I can't help wonder how much different this is than the number of strokes in the general population regardless of what they ingested. 28 strokes over 32 months is less than one a month. Additionally, I'd really question the safety profile of this particular extended-release form of niacin if they are attributing these stroke events to the Niaspan since niacin is a water soluable vitamin and needs to replenished on a consistent basis. It should have been washed out of their system a long time before.
...researchers enrolled 3,414 participants in the United States and Canada who had a history of cardiovascular disease...
3,414 participants with cardiovascular disease and the, more than, doubling of strokes was due to the niacin. Sure. Ummm...yeah...did someone overlook the term vascular in the word cardiovascular disease?
All participants were prescribed simvastatin (Zocor), and 515 participants were given a second LDL cholesterol–lowering drug, ezetimibe (Zetia), in order to maintain LDL cholesterol levels in the target range of 40-80 mg/dL.
Every individual was on a statin drug. Additionally, some participants were administered a second medication. One, in my opinion can only point fingers at niacin for any adverse health effects (stroke or otherwise) if the vitamin is the only agent PROPERLY administered as part of the study. The administration of the other medications clouds things greatly.
The investigators highlighted that the results of this trial apply only to patients in this specific population and can’t be extrapolated to other groups.
Again, I have a huge problem with the headline when this is buried in the story. Shame on the journalists. Perhaps I should call them entertainers.
...the earlier studies were not designed specifically to evaluate the impact of raising HDL cholesterol on the risk of cardiovascular events while maintaining excellent LDL cholesterol control...
Personally, I'm flummoxed as to why it was important to raise HDL cholesterol while there was “excellent LDL cholesterol control”. It sound like these folks were nothing more than somebody's guinea pigs if they were already happier than pigs in [*bleep*] on their statins.
NIASPAN tablets also contain the inactive ingredients
hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide.
Niaspan, not niacin was administered. Sure, it seems like niaspan is the same thing as niacin (nicotinic acid), but not so fast. One really doesn't know what, if any, influence the inactive ingredients have. It can't be accepted that niacin is a problem when more than niacin was formulated in the agent administered.
Dose range: 500 mg to 2000 mg once daily.
Maintenance dose: 1000 to 2000 mg once daily
Perhaps the dosing is too high. I don't know, I'm not an expert. The RDA for adult males is 16mg; 14mg for females according to the Linus Pauling Institute at Oregon State University. The Tolerable Upper Intake Limit (UL) is listed at 35mg/day per the USDA Dietary Guidance, however this is “based on flushing as the critical adverse effect”. Not sure what I make of that.
However, 500mg is a little over 31 times (3,125%) the daily RDA for males; nearly 36 times (3,571%) for females. 2000mg is 125 (12,500%) times RDA for males; nearly 143 times (14,286%) times for females! My multivitamin contains 50mg of niacin (250% or 2.5 times RDA based on 20mg/day) per dose. My B-Complex contains 100mg (500% of RDA based on 20mg/day) per dose. I'm getting 750% of RDA (based on 20mg/day). Keep in mind that is with other nutrients that may compete for absorption as part of the same supplement.
Granted, the Niaspan theoretically releases about 21mg to 83mg per hour if averaged over a 24 period (one dose). However, what guarantee is there that a perfectly metered dose is administered in every instance? Looking at a sample of some available supplements from a national online retailer, most appear to be in a dose of 500mg. I note one 1,000mg dose formulation. There are a few time release formulations, but at 500mg or less. One of the standard 500mg formulations carries a warning of “Caution: Follow Label Directions. Do not take more than 500mg of niacin per day or switch to 250mg of sustained release per day, except under the supervision of a physician.”. It makes me wonder how prudent it is to take such large doses of a sustained release niacin even if it is recommended by a physician. It also makes me wonder, since niacin is a water soluable vitamin, if niacin is meant to be utilized in sustained release form at such high doses. Perhaps it is too much for the body to continually process. Whether medications (oft synthesized from plants) or synthetic nutrients (i.e. vitamin supplements), more is not necessarily better.
NHLBI Halts Niacin Study Early; No Added Reduction in Cardiovascular Events Seen Niaspan Prescribing Information Linus Pauling Institute - Oregon State University - Niacin USDA Dietary Guidance - Niacin Supplement Retailer - Niacin
