NIASPAN ®, Niacin Extended-Release Tablets

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NIASPAN in combination with lovastatin significantly RAISED HDL-C and lowered LDL-C and TG¹

* Mean percent change from baseline. Combination therapy at doses of 1000 mg/20 mg or higher achieved significantly greater LDL-C lowering than NIASPAN monotherapy (p<0.001) and significantly greater HDL-C raising than NIASPAN and lovastatin monotherapy (p<0.05). †Median percent change from baseline. Combination therapy at doses of 1000 mg/20 mg or higher achieved a significantly greater TG lowering compared with NIASPAN and lovastatin monotherapy (p<0.05). Results from a multicenter, randomized, double-blind, parallel, forced dose-escalation, 28-week trial of a combination tablet of NIASPAN and lovastatin vs. each individual component in patients with Types IIa and IIB hyperlipidemia. Patients received each dose once daily before bedtime for at least 4 weeks. Patients treated with the combination NIASPAN/lovastatin tablet initially received 500 mg/20 mg. The dose was increased by 500 mg at 4-week intervals to a maximum dose of 1000 mg/20 mg in one half of the patients and 2000 mg/40 mg in the other half. The NIASPAN monotherapy had a similar titration from 500 mg to 2000 mg. Patients in the lovastatin monotherapy group received 20 mg for 12 weeks, titrated to 40 mg for up to 16 weeks.

NIASPAN/lovastatin combination therapy achieved significantly greater HDL-C raising compared to lovastatin and NIASPAN monotherapy at all doses.¹

Results from a multicenter, randomized, double-blind, parallel, forced, dose-escalation trial in patients with Types IIa and IIb hyperlipidemia demonstrated that NIASPAN in combination with lovastatin:¹

• Significantly raised HDL-C by as much as 20%
• Significantly lowered LDL-C and TG by as much as 36% and 39%, respectively

Rare cases of rhabdomyolysis have been associated with concomitant administration of lipid-altering doses (> or = to 1g/day) of niacin and HMG-CoA reductase inhibitors. Patients on combined therapy with HMG-Coa reductase inhibitors and NIASPAN should be monitored carefully for any signs and symptoms of muscle pain, tenderness, or weakness particularly during the initial months of therapy and during any periods of upward dosage titration of either drug.

NIASPAN/lovastatin combination therapy achieved significantly greater HDL-C-raising compared to lovastatin and NIASPAN monotherapy at all doses.¹