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Studies suggest that niacin is better than statins

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Meta-analysis of niacin on cardiovascular events
Studies suggest that niacin is better than statins

Niaspan is an extended release niacin designed to reduce flushing.   Liver toxicity is a major concern—though I have found no quantification of its occurrence.  (See Goodman & Gilman 956)

 

Zetia is exetimibe which inhibits cholesterol uptake. 

(See Goodman & Gilman 959-60)

 

In this study patients continued to take their statins.  What is troubling is that there is no heads up study of a statin to niacin.  And a red flag concerning statins is the lack of the definitive end point death being including in the studies.  Moreover, markers such as HDL and VDL are used far more often than cardiac events as a measure of success.  And the putative claims of lowering cardiac events must been seen in the light of the marketing departments running the studies, frequently ghost writing the articles, that the journals do not see the raw data, and that in studies where the raw data has become available, there is a very significant positive bias.  We have corporate medical science--jk.

 

 

New York Times at http://www.nytimes.com/2009/11/16/health/research/16heart.html?ref=health

Study Raises Questions About Cholesterol Drug’s Benefit by Natasha Singer, 11.15/09 

ORLANDO, Fla. — For patients taking a statin to control high cholesterol, adding an old standby drug, niacin, was superior in reducing buildup in the carotid artery to adding Zetia, a newer drug that reduces bad cholesterol, according to a new study.

The results of the study, published in The New England Journal of Medicine, were presented here Sunday night at an annual meeting of the American Heart Association.

The study has been a polarizing topic here and has also attracted the attention of a powerful senator who has been investigating the conduct of two drug makers, Merck and Schering-Plough, in relation to their sales and marketing of Zetia and a combination cholesterol drug, Vytorin, which includes Zetia. The drug makers merged this month.

The small study, with only 208 patients, has attracted outsize attention because the researchers did a head-to-head comparison of niacin and Zetia, which has been heavily marketed.

The Food and Drug Administration approved Zetia in 2002 to lower bad cholesterol, a risk factor for heart disease. But the drug has not yet proved to have a longer-term clinical benefit in reducing heart attacks and deaths. Merck, the maker of the drug, is conducting a clinical trial on that issue involving up to 18,000 patients. Statins like Lipitor have proved in studies to significantly lower the risk of heart attack.

Some cardiologists here hailed the study as an indication that the popularity of Zetia and Vytorin, which had combined sales last year of about $4.6 billion, has far outstripped their evidence of a concrete benefit on heart health. Other doctors here dismissed the study because it did not directly measure the drugs’ effects on reducing heart attacks.

Nevertheless, this study has the potential to make big waves in the use of cholesterol drugs.

“It will certainly strengthen the idea that, after you give a statin, the weight of the evidence is that, as a second agent, you should give niacin,” said Dr. Roger S. Blumenthal, a professor of medicine at the Johns Hopkins University Medical School. “That is the implication of the study.”

But Dr. Peter S. Kim, the president of Merck Research Laboratories, said Sunday in an interview that the study was limited because it did not compare the groups of patients taking a statin and a second drug to a placebo group. Furthermore, he said, a drug’s ability to improve artery-wall thickness has not been proved to automatically correlate with a reduction in heart attacks.

Zetia, he said, lowers bad cholesterol and lowering bad cholesterol is a known good.

The study results “should be compared to the overwhelming body of evidence that lowering LDL cholesterol is an important thing to do to improve cardiovascular health,” Dr. Kim said.

The study randomly assigned patients who were taking a statin and who had heart disease or a risk of heart disease to additionally take either Zetia or Niaspan.

Statins are a class of drug which lowers LDL, known as bad cholesterol because it can cause arterial thickening and lead to heart problems. The drugs work by inhibiting the production of cholesterol in the liver.

Zetia, which inhibits the absorption of cholesterol in the intestines, lowers bad cholesterol.

Niaspan is a prescription extended-release form of niacin, not the over-the-counter vitamin. Niacin increases HDL, known as “good cholesterol.” Niaspan is made by Abbott Laboratories, which financed the study.

Over the course of the 14-month study, the bad cholesterol of the patients on Zetia decreased by 19.2 percent, but the patients’ arterial wall thickness stayed the same, the study said. In the niacin group, good cholesterol increased by 18.4 percent and the carotid wall thickness decreased.

By itself, the study does not have major significance, said Dr. James H. Stein, a professor at the University of Wisconsin medical school. But taken in the context of more than 30 years of research on and use of niacin, he said, the study adds to the weight of evidence that it can be a great benefit to patients with heart disease, he said. “Compare that to Zetia where there is not a shred of evidence that it does anything good for blood vessels or heart disease,” Dr. Stein said.

On Friday, Senator Charles E. Grassley, Republican of Iowa, wrote to the Department of Health and Human Services, asking its director, Kathleen Sebelius, what action she intended to take in light of the study results. Mr. Grassley sits on the Senate Finance Committee which has jurisdiction over Medicare and its drug spending. In 2006 and 2007, the drug makers made more than $300 million through Medicare Part D in sales of Vytorin, a drug that combines Zetia and a statin, Mr. Grassley wrote.

In response to a query from a reporter, a Merck spokesman said the small trial did not change the company’s belief in the demonstrated ability of Zetia and Vytorin to reduce bad cholesterol.

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Niacin improved cholesterol profile, and it reduced obstruction of carotid artery which Zeta didn’t do--in study by maker of Zetia.  Compared 2000 mgs of niacin to 10 mgs of Zetia.--jk

Extended-Release Niacin or Ezetimibe and Carotid Intima–Media Thickness

N Engl J Med 2009; 361:2113-2122November 26, 2009; full article at http://www.nejm.org/doi/pdf/10.1056/NEJMoa0907569

Background

Treatment added to statin monotherapy to further modify the lipid profile may include combination therapy to either raise the high-density lipoprotein (HDL) cholesterol level or further lower the low-density lipoprotein (LDL) cholesterol level.

Results

The mean HDL cholesterol level in the niacin group increased by 18.4% over the 14-month study period, to 50 mg per deciliter (P<0.001), and the mean LDL cholesterol level in the ezetimibe group decreased by 19.2%, to 66 mg per deciliter (1.7 mmol per liter) (P<0.001). Niacin therapy significantly reduced LDL cholesterol and triglyceride levels; ezetimibe reduced the HDL cholesterol and triglyceride levels. As compared with ezetimibe, niacin had greater efficacy regarding the change in mean carotid intima–media thickness over 14 months (P=0.003), leading to significant reduction of both mean (P=0.001) and maximal carotid intima–media thickness (P≤0.001 for all comparisons). Paradoxically, greater reductions in the LDL cholesterol level in association with ezetimibe were significantly associated with an increase in the carotid intima–media thickness (R=–0.31, P<0.001). The incidence of major cardiovascular events was lower in the niacin group than in the ezetimibe group (1% vs. 5%, P=0.04 by the chi-square test).

Conclusions

This comparative-effectiveness trial shows that the use of extended-release niacin causes a significant regression of carotid intima–media thickness when combined with a statin and that niacin is superior to ezetimibe. (ClinicalTrials.gov number, NCT00397657.)   Myocardia infractions were less in the niacin group.

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