LYCOS RETRIEVER 
Niaspan: Niacin
built 647 days ago
In the double-blind, placebo-controlled treatment phase, patients were randomly assigned to receive either gemfibrozil or Niaspan. Gemfibrozil, 600 mg, or corresponding placebo was given twice daily, 30 minutes before the morning and evening meals. Niaspan or its placebo was administered once, at bedtime, after a low-fat snack. During an initial 3-week titration, Niaspan was given initially at 375 mg and increased at weekly intervals to 500 mg, then to 750 mg. Niaspan was subsequently administered at 1000 mg for 4 weeks, 1500 mg for 4 weeks, and 2000 mg for 8 weeks (Figure 1). Patients were advised to take aspirin, 325 mg, a half hour before the study medication at bedtime on an as-needed basis for prophylaxis of niacin-induced flushing. Gemfibrozil was administered at a total daily dose of 1200 mg for the entire 16-week period.
Source:
The dose escalation study, published in the American Journal of Cardiology, evaluated the safety and efficacy of Niaspan at increasing doses from 500 to 3000 mg per day. The study showed that Niaspan, at the maximum approved dose of 2000 mg, increased HDL cholesterol levels an average of 26 percent, decreased LDL levels by 17 percent and decreased triglycerides by 35 percent. Equally important, at all doses, Niaspan did not show a significant difference from placebo in liver enzyme elevations greater than three times the upper limit of normal. Liver enzyme elevation is a common concern with non-prescription forms of niacin at therapeutic doses.
Source:
Abbott has received FDA approval to market Niaspan (niacin extended-release) coated tablets. Niaspan is indicated for treating lipid disorders and for helping to raise HDL cholesterol. The coated tablets are expected to be available soon.
Source:
Abbott submitted a NDA to the FDA for a fixed-dose combination of Niaspan (extended-release niacin) and simvastatin (the generic version of Zocor). The combination targets multiple lipid parameters in a single pill.
Source:
MORE ABOUT
Niacin