Extended-release niacin (nicotinic acid)/laropiprant.
Extended-release (ER) niacin (nicotinic acid)/laropiprant is a once-daily fixed-dose combination tablet that has been evaluated (with or without an HMG-CoA reductase inhibitor [statin]) in the treatment of adults with dyslipidaemia or primary hypercholesterolaemia. Niacin (vitamin B3) is a lipid-modifying drug and laropiprant is an anti-flushing agent, which reduces flushing induced by niacin. In a randomized, double-blind, placebo-controlled, multicentre, 24-week trial, a significant (p < 0.001) reduction (18.4%) in plasma low-density lipoprotein cholesterol (LDL-C) levels (primary endpoint) was achieved with ER niacin/laropiprant 2000 mg/40 mg once daily (after an initial 4-week 1000 mg/20 mg once-daily regimen) compared with placebo (weeks 12-24) in adults with primary hypercholesterolaemia or mixed dyslipidaemia. ER niacin/laropiprant 2000 mg/40 mg plus simvastatin 20 mg or 40 mg once daily (after an initial 4-week lower-dose regimen) produced significant (p < 0.05) improvements, from baseline, in LDL-C levels (primary endpoint) compared with once-daily ER niacin/laropiprant 2000 mg/40 mg or simvastatin alone at week 12 in a randomized, double-blind, multicentre, factorial trial in adults with primary hypercholesterolaemia or mixed dyslipidaemia. The incidence and intensity of flushing (an efficacy endpoint) were significantly (p < 0.05) reduced with ER niacin/laropiprant compared with ER niacin in randomized trials. ER niacin/laropiprant, alone or in combination with a statin, was generally well tolerated for up to 24 weeks by adults with dyslipidaemia or primary hyercholesterolaemia.
Perry
Caroline M
CM
Wolters Kluwer Health/Adis, 41 Centorian Drive, Mairangi Bay, North Shore 0754, Auckland, New Zealand. demail@adis.co.nz
D002626:Chemistry, Pharmaceutical; D008078:Cholesterol, LDL / Q000097:blood; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D004347:Drug Interactions; D005483:Flushing / Q000139:chemically induced / Q000517:prevention & control; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009525:Niacin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D011982:Receptors, Prostaglandin / Q000037:antagonists & inhibitors
D008078:Cholesterol, LDL; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D007211:Indoles; C518174:MK-0524; D011982:Receptors, Prostaglandin; D009525:Niacin
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