Niacin may sound like an easy and natural way to lower cholesterol. It’s a B vitamin — vitamin B3 — found in food and over-the-counter tablets. And several studies have shown that it can lower “bad” cholesterol and raise “good” cholesterol. 
 
 But two reports published Wednesday show niacin may cause some severe side effects, and in the end it doesn’t seem to reduce rates of stroke, heart attack or chest pain. Cardiologists have been shying away from it for a few years and experts said it may be time to seriously consider dropping it. 
 
 Sign up for top stories direct to your inbox. 
 
 One study done in more than 25,000 people in Europe and China showed that while adding niacin to standard cholesterol treatment did lower low density lipoprotein (LDL or “bad” cholesterol), it also was linked with a 32 percent increase in the rate of diabetes over four years. “There were also highly significant excesses of other recognized adverse effects of niacin, including gastrointestinal, musculoskeletal, and skin-related serious adverse events,” the team at Britain’s Oxford University wrote in their report, published in the New England Journal of Medicine. 
 
 Play Facebook 
 
 Twitter 
 
 Google Plus 
 
 Embed Doctors Issue Warning About Popular Cholesterol-Lowering Drug 1:32 autoplay autoplay Copy this code to your website or blog 
 
 These included bleeding, stomach ulcers, heartburn and diarrhea. The people who took niacin also had slightly more serious infections than people who did not — 8 percent versus 6.6 percent. And they were 9 percent more likely to die, although so few people died that this was hard to measure. 
 
 More analysis of an earlier study showed similar side effects, Dr. Todd Anderson of the Libin Cardiovascular Institute in Calgary, Canada and colleagues wrote in a letter to the journal. 
 
 “On the basis of the weight of available evidence showing net clinical harm, niacin must be considered to have an unacceptable toxicity profile for the majority of patients, and it should not be used routinely,” Dr. Donald Lloyd-Jones of Northwestern University's Feinberg School of Medicine in Chicago wrote in a commentary. “Niacin may still have a role in patients at very high risk for cardiovascular events who truly have contraindications for taking statins,” he added. 
 
 The trouble is, the idea of taking niacin is very attractive. It’s available cheaply and generically and it sounds natural. Studies suggest the use of niacin use tripled from 2002 to 2009, with doctors writing nearly 700,000 prescriptions a month in the U.S., to the tune of $800 million a year. That’s just for the prescription version of niacin, mostly a drug called Niaspan. 
 
 A bodega worker gives a blood sample for a cholesterol check. Two new reports suggest niacin may not be suitable for most people to use to improve cholesterol levels. Chris Hondros / Getty Images file 
 
 There’s no real way to track over-the-counter sales. 
 
 The highly respected Mayo Clinic still recommends that people consider niacin. “Taking niacin — either by itself or along with other cholesterol-lowering medication — may help control your total cholesterol level,” it advises, although the statement also says people should only do so after talking to a doctor. 
 
 Other, less high-profile websites also advocate for niacin. 
 
 “I think we’ve wasted a lot of money, caused a certain amount of harm.” 
 
 “It punctuates this notion that we’ve been prescribing a drug to the tune of one billion dollars a year, with little effect and a number of adverse side effects,” said Dr. Harlan Krumholz, a cardiologist and professor of investigative medicine at Yale. “In this case, millions of people taking it are not getting the benefit they are hoping for and are actually exposing themselves to harm,” he added. “I think we’ve wasted a lot of money, caused a certain amount of harm.” 
 
 But there’s a huge need for cholesterol-lowering drugs, given that 70 million Americans have unhealthy cholesterol levels. Statins can cause serious damage to the muscle, among other side-effects. 
 
 Another cholesterol drug, Zetia, helps block the absorption of cholesterol from the intestine. New cholesterol lowering drugs in the pipeline block PCSK9, helping the liver to filter cholesterol from the blood. 
 
 NBC's Nikita Japra contributed to this report. ||||| Photo 
 
 Recent studies published in The New England Journal of Medicine are adding to concerns about the safety and effectiveness of niacin, a popular drug for the prevention of cardiovascular disease. The studies reveal that although this B vitamin can reduce triglyceride levels, raise “good” cholesterol levels (HDL) and reduce “bad” cholesterol levels (LDL), it does not produce the benefits that patients and their doctors might expect. And the studies are revealing serious harms. Here are three things you need to know about niacin. 
 
 First, these new studies failed to show that niacin reduced the risk of heart disease and stroke. 
 
 The studies found that patients taking niacin had about the same rates of heart disease, stroke and death as those who took a placebo pill with no active ingredients. 
 
 Niacin has been known to affect lipid levels since the 1950s. Scientists have examined it in countless studies, almost all of which were not designed to determine if it led to fewer heart attacks, strokes and deaths. The largest previous study to assess whether niacin reduced the risk of heart disease compared with a placebo started in the 1960s, an era that is hardly relevant to medicine today, when so many patients are taking cholesterol-lowering statins. 
 
 Therefore, scientists designed these two new studies to determine whether niacin helped patients avoid heart disease and stroke in the statin era. The National Institutes of Health sponsored an American study, and the drug company Merck funded a large international study. One tested extended-release niacin, and the other evaluated a combination of extended-release niacin and laropiprant, an agent designed to make the niacin more tolerable. 
 
 Both studies failed to show that niacin reduced the risks of heart disease, stroke and death. Researchers even stopped the American study prematurely because the possibility of finding any benefit became so remote that its continuation seemed futile. Additional follow-up analyses conducted in both studies did not show that niacin provided a convincing benefit to any group of patients. 
 
 Second, niacin causes multiple side effects, many of which are serious. 
 
 Niacin can be hard to tolerate. It frequently causes uncomfortable flushing and itching, the reason the Merck trial tested niacin with another agent designed to block these nuisance effects. 
 
 A disturbing aspect of these recent studies is that in addition to the discomfort that many patients have, they show that niacin can cause more serious side effects. In the international study, niacin increased the risk of gastrointestinal events such as diarrhea and ulcers by 28 percent; musculoskeletal problems such as muscle damage and gout by 26 percent; rashes, skin ulcerations and other serious skin-related problems by 67 percent; infections by 22 percent; and gastrointestinal bleeding or other bleeding by 38 percent. In addition, patients on niacin were 32 percent more likely to receive a diagnosis of diabetes than those not on the drug, and in those with diabetes, niacin increased the risk of serious problems with disease management by 55 percent. Safety problems were also apparent in the American study, in which those taking niacin had a higher risk of gastrointestinal problems and infections than those taking a placebo. It is the concordance of these studies in showing harms that is so convincing. 
 
 But perhaps the most striking finding of the international study occurred before the trial started. Like many large trials, the study was designed to determine if patients would tolerate the drug before they were randomly assigned to receive niacin with laropiprant or a placebo. In this so-called run-in phase of the study, a third of those who were deemed ideal candidates and received the niacin combination withdrew from the study, mainly because of skin, gastrointestinal, musculoskeletal and diabetes side effects. So, under careful study conditions, a third of the patients could not even tolerate the drug. The risks that were discovered seem all the more important, because they occurred among individuals who initially tolerated the medication. 
 
 Third, there are still experts who say that the recent studies do not provide adequate evidence to stop recommending niacin. 
 
 No study is perfect, and for niacin advocates, many of whom have spent their careers promoting and prescribing the drug, the results of the new trials evoked disbelief. I was on a panel with a prevention specialist who told an audience of doctors that it made no sense to believe the published trials when personal experience told them otherwise. He then launched into a defense of treatments like niacin. 
 
 More reasoned critiques have rightly indicated that the trials focused on high-risk patients, almost all of whom were taking statins and had low levels of LDL cholesterol, the bad stuff. They ask whether niacin might be useful in patients with different lipid profiles, or in those who cannot tolerate statins or who had not already had a diagnosis of heart disease, or in patients with an even higher risk of heart disease and stroke. They mostly question whether these trials studied populations that were already receiving intensive treatment and were unlikely to benefit from more drugs. Even the authors of the Merck-sponsored study acknowledge, in the last sentence of their article, that they cannot say whether niacin might be beneficial for patients at even higher risk of having a heart attack or stroke or those with higher LDL levels. 
 
 The predicament is that the pursuit of more trials of niacin, particularly given the harms that were recently shown, is unlikely. Uncertainty about niacin may linger, accompanied by uncertainty about which patients it may benefit. Harder to dispute will be the drug’s serious side effects. Safety issues alone, even if niacin were beneficial, should give many people reason to avoid it. 
 
 Bottom line: If you are taking niacin, talk with your doctor about whether you should continue. Many patients will probably choose to bypass a medication without clear benefit and with documented harms. For those who decide to continue taking the medication, the hope would be for an experience different from those of the tens of thousands of participants in the recent trials. If you are not taking niacin, then realize that there is little reason to start. 
 
 Harlan Krumholz is a cardiologist and the Harold H. Hines, Jr. Professor of Medicine, director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation and a director of the Robert Wood Johnson Foundation Clinical Scholars Program at Yale University School of Medicine. 
 
 ||||| Our general interest e-newsletter keeps you up to date on a wide variety of health topics. 
 
 Niacin to boost your HDL, 'good,' cholesterol Niacin is an important B vitamin that may raise your HDL, ("good"), cholesterol. Find out if you should talk to your doctor about taking niacin alone or with cholesterol medications. By Mayo Clinic Staff 
 
 Niacin, a B vitamin, has long been used to increase high-density lipoprotein (HDL) cholesterol — the "good" cholesterol that helps remove low-density lipoprotein (LDL), the "bad" cholesterol from your bloodstream. 
 
 But niacin isn't for everyone. People who take niacin in addition to common cholesterol medications see very little additional benefit. And niacin can cause uncomfortable and sometimes dangerous side effects. 
 
 What is niacin? 
 
 Niacin (nicotinic acid) is a B vitamin that's used by your body to turn food into energy. Niacin also helps keep your nervous system, digestive system and skin healthy. That's why niacin is often a part of a daily multivitamin, though most people get enough niacin from the food they eat. 
 
 When it's used as a treatment to increase your HDL cholesterol or correct a vitamin deficiency, niacin is sold in higher doses that are prescribed by your doctor. Prescription-strength niacin includes such drugs as Niacor and Niaspan. 
 
 Niacin is also available as an over-the-counter supplement. Supplements sold over-the-counter are not regulated like prescription medications. The ingredients, formulations and effects of over-the-counter niacin can vary widely. 
 
 Don't take niacin without discussing it with your doctor first because niacin can cause serious side effects when taken in high doses. 
 
 What impact does niacin have on cholesterol? 
 
 Niacin can raise HDL cholesterol by more than 30 percent. There's currently some debate about the exact role HDL plays in the body and in the development of heart disease. But HDL has generally been thought to pick up excess "bad" cholesterol in your blood and take it to your liver for disposal, which is why HDL is dubbed the "good" cholesterol. 
 
 Cholesterol levels are measured in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/L): 
 
 For men, HDL levels under 40 mg/dL (1.0 mmol/L) increase the risk of heart disease. 
 
 For women, HDL levels under 50 mg/dL (1.3 mmol/L) increase the risk of heart disease. 
 
 Despite niacin's ability to raise HDL, recent research suggests that niacin therapy isn't linked to lower rates of death, heart attack or stroke. 
 
 What else can be done to increase HDL? 
 
 Lifestyle changes are helpful in boosting HDL: 
 
 Stop smoking if you're a smoker. 
 
 Eat a healthy diet. 
 
 Start an exercise program, with your doctor's OK. 
 
 What side effects are associated with taking high doses of niacin? 
 
 High-dose niacin can cause stomach upset and make your skin flush or itch. More importantly, niacin can increase your risk of: 
 
 High blood sugar levels or type 2 diabetes 
 
 Infection 
 
 Liver damage 
 
 Stroke 
 
 Bleeding 
 
 Who might consider taking niacin? 
 
 In the past, it was thought that HDL levels would increase even more if niacin was added to cholesterol medications called statins, such as atorvastatin (Lipitor) and simvastatin (Zocor). But recent studies indicate that niacin provides little additional benefit when compared with statins alone, and may increase the risks of serious side effects. 
 
 Most doctors no longer recommend niacin for first line cholesterol control — except for people who can't tolerate statins. In those people, the benefits of niacin may outweigh the risk of potentially serious side effects. 
 
 
 

– Niacin sure sounds like a safe drug—it's a B vitamin; you can get it over the counter and in your cereal. And for years, doctors have been prescribing it in the hopes of cutting LDL, or "bad cholesterol," while increasing HDL, or "good cholesterol." But two reports released yesterday indicate that it doesn't reduce the risk of heart attack and stroke at all—but does carry other dangers. One study found that patients who had niacin added to their cholesterol treatments saw their diabetes risk spike 32% over four years, NBC News reports. That's on top of already recognized side effects like stomach ulcers, heartburn, and diarrhea. "I think we've wasted a lot of money, caused a certain amount of harm," by prescribing niacin, one cardiologist said; from 2002 to 2009, niacin prescriptions tripled to 700,000 a month in the US, with sales hitting about $800 million a year. Cardiologists had, however, already begun shying away from the drug in light of earlier research—a 2011 study, for example, indicated that it may increase certain stroke risks. But the Mayo Clinic still recommends niacin, and many doctors agree, Dr. Harlan Krumholz at the New York Times reports. Some doctors point out that the studies focused on high-risk patients, and that niacin could be useful for other patients.