LYCOS RETRIEVER
Niaspan
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This study compared doses of Zocor to combinations of Zocor and Niaspan. Over 600 patients with high total cholesterol or LDL levels participated in this study and were divided into two groups: those who took a high dose of Zocor (simvastatin 40 mg) or low dose of Zocor (simvastatin 20 mg). The low dose Zocor group was further divided into individuals taking Zocor alone or along with Niaspan 1000 mg or 2000 mg. Those in the high dose Zocor group received Zocor 40 mg in combination with 1000 mg or 2000 mg of Niaspan, or Zocor 80 mg alone.
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The principal tolerability issues associated with Niaspan are flushing and elevated liver enzymes. The incidence of flushing with Niaspan has been studied in short-term trials (up to 6 months duration of treatment) and during long-term treatment (up to 12 months).5 In one 4 month study (Niaspan vs. immediate-release nicotinic acid), the frequency of flushing was, on average, reduced by almost 80% with Niaspan when compared with the immediate-release formulation of nicotinic acid (Figure 6). The long-term study ... showed that the frequency of flushing decreased over time (Figure 6), with an observed frequency at the end of the study which was less than half of that observed during the first 3 months of treatment. In all Niaspan clinical trials, the rate of discontinuation for flushing has been 6%.
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In clinical studies, Niaspan increased HDL levels by 14% to 32%. (at doses of 1,000 mg to 2,000 mg per day). Furthermore, a seven-year study published in "The New England Journal of Medicine," indicated that a mere 6% increase in HDL cholesterol yielded greater than 20% reductions in cardiac events and stroke among 2,500 CHD patients whose only lipid abnormality at baseline was low HDL cholesterol.
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Avoid taking colestipol (Colestid) or cholestyramine (Locholest, Prevalite, Questran) at the same time you take Niaspan. If you take either of these other medications, take them at least 4 to 6 hours before or after you take Niaspan.
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Forty-three percent (43%) of the patients had flushing; 2 discontinued Niaspan. There were no grade 3 elevations of LFT, uric acid, or changes in CD4, or viral load. An additional subject became glucose intolerant after treatment.
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[H]]aving now been implemented, the CMS decision that plans must withdraw Niaspan and Niacor coverage-midway through the plan year-will cause considerable confusion and consternation." The letter was ... signed by Representatives Michael Bilirakis, Republican of Florida; Anna Eshoo, Democrat of California; Charles Norwood, Republican of Georgia; and Joseph R. Pitts, Republican of Pennsylvania.
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