AIM HIGH review by NIH link
During the study, 145 participants died. No deaths are thought to have occurred due to the treatments being tested.
Statins are generally well tolerated. The most common side effects are headaches and gastrointestinal distress. Serious, but rare, side effects of statins include extreme muscle pain, rhabdomyolysis (when skeletal muscle tissue breaks down and enters the bloodstream), and liver problems.
The most commonly reported adverse effects for high dose, extended-release niacin include flushing, itching, rash, and gastrointestinal upset. These symptoms are usually worse in the early weeks of treatment and improve over time. Taking high dose, extended-release niacin in the evening about half an hour after taking an aspirin or NSAID (non-steroidal anti-inflammatory drug) can reduce symptoms.
High dose, extended-release niacin can also raise blood sugar levels and may cause a flare-up of gout due to increased uric acid. (Notice SERIOUS SIDE EFFECTS not mentioned)
The recommended daily allowance is about 16 mg.
Study participants received a special formulation of niacin that requires a prescription. The study dose was gradually stepped up until participants were taking up to 2,000 mg (2 grams) per day or 100 times what is recommended as a daily vitamin.
People should not take more than 3,000 mg (3 grams) of niacin per day.
Niacin is also known as vitamin B3. It is necessary for proper health.
Niacin is used to treat pellagra (severe niacin deficiency), a potentially fatal disease of inadequate diet, and other medical problems, at a dose of 40 to 250 mg/day.
Immediate- and extended-release preparations of niacin improve lipid (fat) levels in the blood. High dose niacin (1,000 mg to 2,000 mg or 1 to 2 grams) decreases triglyceride levels by 15 to 20 percent and increases HDL cholesterol levels by 15 to 30 percent. Reductions in LDL cholesterol are modest (less than 10 percent).
AIM-HIGH researchers do not yet know why there were more strokes in the niacin group. The overall rate of stroke was less than 1 percent and an increase in stroke has not been found in other niacin studies. One third of niacin group patients who suffered a stroke had stopped niacin for months to years before the event. The significance of strokes observed is uncertain and could be due to chance. The investigators will thoroughly review all study data in hopes of answering this important question.
The trial was stopped early because the study hypothesis was answered, namely there was a lack of efficacy. The addition of high dose, extended release niacin to a statin increased HDL cholesterol, as expected, but did not reduce cardiovascular events in AIM-HIGH participants. The analysis also showed that there was little to no chance that adding high-dose, extended release niacin to statin treatment would show a benefit even if the study continued to its originally planned completion.
My comment in purple
However, the LDLc was lower and if continued it would have shown a significant drop in events as Zetia did when it completed 7 years of study paid for by a private company.
I agree that study hypothesis of raising HDLc did not show a difference, but Tom Dayspring uses this study to show that Niacin has no outcome results. Misleading
There was also an unexplained higher rate of ischemic stroke in the high dose niacin group compared to the group on statins alone that contributed to the decision to stop the trial early. The overall frequency of stroke was less than 1 percent and previous studies of niacin therapy have not shown this increase in stroke.
The trial's Data and Safety Monitoring Board (DSMB), an independent advisory group appointed by the NHLBI that monitors trial’s progress and participant safety, reviewed the data and recommended to the NHLBI that the study be stopped. After reviewing the DSMB recommendation, the NHLBI decided to stop the AIM-HIGH trial.
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