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. What is niacin? What is it typically used to treat and at what dose?
Immediate- and extended-release preparations of niacin improve lipid fat levels in the blood. High dose niacin 1, mg to 2, 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. What is the recommended daily amount of niacin? 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, mg 2 grams per day or times what is recommended as a daily vitamin. Am I at risk for a stroke if I take niacin?
Further analysis of the study data is needed to answer this question. Niacin taken at recommended doses such as in multivitamins appears to be safe. Any potential risks of taking niacin in larger doses with regard to ischemic stroke will need to be further studied.
I take niacin as part of a vitamin or other supplement. The niacin dose up to 2, mg used in AIM-HIGH was up to times greater than the amount found in a typical multivitamin, which is around 20 mg. There is no known risk of adverse cardiovascular events due to taking a multivitamin that includes small amounts of niacin. Talk with your health care provider if you have concerns. Statins are very effective in lowering LDL cholesterol and reducing cardiovascular risk and are safe for most people.
If you are worried about your health or any medications you are taking, please consult your primary care provider or cardiologist. What do the study results mean for people with low HDL and high triglyceride levels?
Researchers are still analyzing the trial results and will not have any recommendations until all of the data have been analyzed. In the meantime, people with low HDL and high triglycerides should continue their treatment plans as recommended by their doctors. What are the potential side effects of niacin? 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.
What are the potential side effects and of statins? 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. Will study investigators be conducting any participant follow-up?
If so, how long will participants be followed? We have notified all participants about the preliminary results from the study and the reason for stopping the trial. Participants will be instructed to stop taking the study medication which contains either niacin or placebo , but to continue taking simvastatin. The NHLBI has recommended investigators continue to conduct follow-ups over the phone with each participant for 12 to 18 months after the final study visit to ascertain patient health and well-being.
In addition to financial support, Abbott supplied the study with the Niaspan tablets. Abbott had no role in either the conduct of the trial or the decision to stop the study. Merck Pharmaceuticals provided the Zocor. How did you address participant safety in this trial? Participants underwent exams at the study sites every six months. During these visits, they had laboratory tests and were asked about any adverse effects they might be experiencing.
Liver function tests AST were done every six months, while glucose tests and electrocardiograms ECGs were done every 12 months. Other laboratory tests were completed as needed for participants experiencing adverse side effects. A major function of the DSMB is to review and protect participant safety over the course of the trial. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads.
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