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Niacin is better than the combo of statin and niacin

Rather than take this article down, I am leaving it up for historical value

Two Changes in content coming up

  1. The cholesterol myth.  Numerous critics have pointed out that cardiovascular disease is not caused by higher levels of blood cholesterol or fats.  Pharma promotes the cholesterol myth and ignores the major causes.

  2. Major cause of cardiovascular disease is pathogens living within the middle layer of artery walls.  It initiates the immune response which involves LDL, HDL, and white blood cells.  Reactive chemicals such as simple sugars and carbon monoxide can potentiate the process resulting in the formation of plaque within the artery walls.


For confirmation from journal articles on primary role of infective agent enter into http://scholar.google.com/ terms such as bacteria + atherosclerosis or go to http://healthfully.org/rl/id8.html and id9  for collection of articles

For confirmation of cholesterol myth enter into http://scholar.google.com/ or http://www.amazon.com/ cholesterol myth, or go to http://healthfully.org/rl/id5.html for collection of journal articles. 

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.



Niaspan trounces Zetia, spurring debate

November 16, 2009 — 11:34am ET | By Tracy Staton

NIH stops clinical trial on combination cholesterol treatment
Lack of efficacy in reducing cardiovascular events prompts decision
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped a clinical trial studying a blood lipid treatment 18 months earlier than planned. The trial found that adding high dose, extended-release niacin to statin treatment in people with heart and vascular disease, did not reduce the risk of cardiovascular events, including heart attacks and stroke.

Participants were selected for AIM-HIGH because they were at risk for cardiovascular events despite well-controlled low-density lipoprotein (LDL or bad cholesterol). Their increased risk was due to a history of cardiovascular disease and a combination of low high-density lipoprotein (HDL or good cholesterol) and high triglycerides, another form of fat in the blood. Low HDL and elevated triglycerides are associated with an increased risk of cardiovascular events. While lowering LDL decreases the risk of cardiovascular events, it has not been shown that raising HDL similarly reduces the risk of cardiovascular events.

During the study's 32 months of follow-up, participants who took high dose, extended-release niacin and statin treatment had increased HDL cholesterol and lowered triglyceride levels compared to participants who took a statin alone. However, the combination treatment did not reduce fatal or non-fatal heart attacks, strokes, hospitalizations for acute coronary syndrome, or revascularization procedures to improve blood flow in the arteries of the heart and brain.

"Seeking new and improved ways to manage cholesterol levels is vital in the battle against cardiovascular disease," said Susan B. Shurin, M.D., acting director of the NHLBI. ""This study sought to confirm earlier and smaller studies. Although we did not see the expected clinical benefit, we have answered an important scientific question about treatment for cardiovascular disease. We thank the research volunteers whose participation is key in advancing our knowledge in this critical public health area, and the dedicated investigators who conducted the study."

The AIM-HIGH trial, which stands for Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health, enrolled 3,414 participants in the United States and Canada with a history of cardiovascular disease who were taking a statin drug to keep their LDL cholesterol low. Study participants also had low HDL cholesterol and high triglycerides, which meant that they were at significant risk of experiencing future cardiovascular events. Niacin, also known as Vitamin B3, has long been known to raise HDL and lower triglycerides. Eligible participants were randomly assigned to either high dose, extended-release niacin (Niaspan) in gradually increasing doses up to 2,000 mg per day (1,718 people) or a placebo treatment (1,696 people). 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 at the target range between 40-80 mg/dL.

The NHLBI funded the AIM-HIGH study with additional support from Abbott Laboratories, a pharmaceutical company based in Abbott Park, Ill. Abbott also provided Niaspan and Merck Pharmaceuticals, based in Whitehouse Station, N.J., provided Zocor. All drugs used in the study were approved for marketing in the United States and Canada and have been on the market for many years.

Researchers began recruiting participants in early 2006. The study was scheduled to finish in 2012. 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.

The rationale for the AIM-HIGH study was based in part on a large number of observational studies that consistently showed that low HDL cholesterol increases the risk of cardiovascular events in men and women, independent of high LDL cholesterol. In addition, previous small clinical studies showed that relatively high residual cardiovascular risk exists among patients with cardiovascular disease, low HDL cholesterol, and high triglycerides despite intensive management of LDL cholesterol.

However, efforts to find HDL-raising treatments that actually reduce this residual risk have thus far proved disappointing. Fenofibrate, an HDL-raising drug, failed to reduce the rate of cardiovascular events in patients with diabetes in the Action to Control Cardiovascular Risk in Diabetes (ACCORD trial) despite favorable effects on HDL and triglycerides. Another HDL-raising drug, torcetrapib, actually increased the rate of cardiovascular events in the Investigation of Lipid Level Management to Understand its Impact in Atherosclerotic Events (ILLUMINATE) trial despite lowering LDL and triglycerides and raising HDL levels, as intended.

Earlier studies of niacin had shown more favorable results. Unlike AIM-HIGH, the earlier studies were not designed specifically to evaluate the impact of raising HDL on the risk of cardiovascular events while maintaining excellent LDL control. Several other trials testing this hypothesis, including a large international trial of high dose, extended-release niacin, are still ongoing.

As is customary in clinical trials, the NHLBI established an independent data and safety monitoring board (DSMB) to monitor trial progress and participant safety. At a regularly scheduled meeting on April 25, 2011, the study's DSMB concluded that high dose, extended-release niacin offered no benefits beyond statin therapy alone in reducing cardiovascular-related complications in this trial. The rate of clinical events was the same in both treatment groups, and there was no evidence that this would change by continuing the trial. For this reason, the DSMB recommended that the NHLBI end the study.
The DSMB also noted a small and unexplained increase in ischemic stroke rates in the high dose, extended-release niacin group. This contributed to the NHLBI acting director's decision to stop the trial before its planned conclusion. During the 32-month follow-up period, there were 28 strokes (1.6 percent) reported during the trial among participants taking high dose, extended-release niacin versus 12 strokes (0.7 percent) reported in the control group. Nine of the 28 strokes in the niacin group occurred in participants who had discontinued the drug at least two months and up to four years before their stroke. Previous studies do not suggest that stroke is a potential complication of niacin, and it remains unclear whether this trend in AIM-HIGH arose by chance, was related to niacin administration or some other issue.

All AIM-HIGH study participants have been informed of the results and will be scheduled for clinic visits within the next 2.5 months. Participants will be followed for an additional 12 to 18 months.

"Patients who were not in the AIM-HIGH trial should not stop taking high dose, extended-release niacin without talking to their doctor first," said Shurin.

"The lack of effect on cardiovascular events is unexpected and a striking contrast to the results of previous trials and observational studies," said Jeffrey Probstfield, M.D., AIM-HIGH co-principal investigator and professor of medicine and epidemiology at the University of Washington, Seattle. "The AIM-HIGH findings do not support the trial's hypothesis that, in the population studied, adding extended-release niacin to simvastatin in participants with well-controlled LDL cholesterol can provide additional clinical benefit."

"The results from AIM-HIGH should not be extrapolated to apply to potentially higher-risk patients such as those with acute heart attack or acute coronary syndromes, or in patients whose LDL cholesterol is not as well-controlled as those in AIM-HIGH," said William E. Boden, M.D., AIM-HIGH co-principal investigator and professor of medicine and preventive medicine at the University at Buffalo, N.Y.

The niacin tested in the study is a proprietary formulation used in doses of 500-2,000 milligrams (mg), manufactured by Abbott Laboratories and approved and regulated by the U.S. Food and Drug Administration. Low doses of niacin, typically 20 to 100 mg, can be found in multivitamin formulations available without a prescription. The FDA regulates the use of high doses of niacin (over 500 mg), which is approved by prescription for helping treat low HDL cholesterol and/or high triglycerides. At prescription-level doses, some people experience flushing. The extended-release formulation of niacin tested in AIM-HIGH was intended to help reduce the likelihood of flushing.

An estimated 1 in 7 Americans has high blood cholesterol. It is a major risk factor for cardiovascular disease, which kills 800,000 Americans a year. Cholesterol can build up in the walls of arteries and cause them to narrow, a condition known as atherosclerosis.

"As we continue to search for new approaches to treating cholesterol problems, it is important to remember the value of existing treatments. The key to treating high cholesterol so patients can reduce their risk of cardiovascular disease is to lower the level of LDL cholesterol, through well-established drug treatments such as statins and lifestyle changes," said Patrice Desvigne-Nickens, M.D., NHLBI project officer for the AIM-HIGH trial.

The AIM-HIGH investigators will now focus on completing data collection and analysis. The preliminary outcomes of the study are expected to be reported at scientific meetings in the fall of 2011.

Find more information about this clinical trial (NCT00120289) at www.clinicaltrials.gov.

To arrange an interview with an NHLBI spokesperson, please contact the NHLBI Communications Office at (301) 496-4236 or nhlbi_news@nhlbi.nih.gov. To arrange an interview with Jeffrey Probstfield, M.D., contact University of Washington School of Medicine, Office of Communications at 206-616-6730. To arrange an interview with William E. Boden, M.D., contact Ellen Goldbaum-Kolin in the Public Relations Department at 716-645-4605, or Dr. Boden at 716-859-1784.

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at www.nhlbi.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.



Niaspan trounces Zetia, spurring debate

November 16, 2009 — 11:34am ET | By Tracy Staton  FiercePharma

Well, analysts were right about that much-anticipated cholesterol drug study. Abbott Laboratories' Niaspan pill did indeed beat out Merck's Zetia at unclogging arteries, according to study results presented at the American Heart Association meeting yesterday. Cardiologists expect the data to boost niacin use--and serve as a further drag on sales of Zetia and its sister Merck drug Vytorin.

The trial, which tracked carotid artery narrowing in Zetia and Niaspan patients, was a small one with only 208 patients. Experts acknowledge that the data is hardly definitive. But high-profile cardiologists--even some who question the study methodology--said the trial was compelling enough to prompt doctors to move Zetia down on their lists of go-to drugs. "It's a big win for Niaspan, and yet another disappointment for Zetia," said Roger Blumenthal, who critiqued the new data for the New England Journal of Medicine (as quoted by Forbes).

As Forbes points out, the findings weren't limited to the ultrasound images; outcomes such as heart attacks and heart-disease-related deaths also were lower in the Niaspan patients. And when you look at the sum total of data on Zetia, there's just not enough on the positive side, cardiologists are saying. Niacin has proven helpful over 30 years of research, Dr. James Stein of the University of Wisconsin told the New York Times. "Compare that to Zetia where there is not a shred of evidence that it does anything good for blood vessels or heart disease."

Could this latest study raise more questions about the use of "surrogate markers" rather than outcomes in deciding whether to approve drugs? Well, as Merck officials are emphasizing in the wake of this study, Zetia has proven quite effective at cutting bad cholesterol. Bad cholesterol levels are considered a reliable surrogate marker of heart disease risk. But as Stein and others have pointed out, Zetia hasn't delivered on the outcomes side.

That's partly because Merck's big outcomes study won't be wrapped for a couple of years. But it's also proven the case in the ENHANCE study, which used imaging to gauge Zetia's effectiveness at keeping arteries clear, and at that it did no better than Zocor (simvastatin) by itself. And of course this latest study adds to the doubt. "This is the third strike," Dr. Steven Nissen of the Cleveland Clinic told the Washington Post.


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