Company:

Abbott

Nicotinic acid deriv. + HMG-CoA reductase inhibitor

Niacin ext-rel 500mg, simvastatin 20mg; tabs.

SIMCOR 750/20

Niacin ext-rel 750mg, simvastatin 20mg; tabs.

SIMCOR 1000/20

Niacin ext-rel 1000mg, simvastatin 20mg; tabs.

Adjunct to diet in primary hypercholesterolemia, mixed dyslipidemia, and hypertriglyceridemia if monotherapy is inadequate.

Simcor combines the HMG-CoA reductase inhibitor, simvastatin, and the nicotinic acid derivative, extended-release niacin (Niaspan, also from Abbott).

Simcor was compared to simvastatin 20mg and 80mg in 641 patients with type II hyperlipidemia or mixed dyslipidemia in a 24-week study. Group A included those with elevated non-HDL levels who had been taking simvastatin 20mg; these patients were randomized to either Simcor 1000/20, Simcor 2000/20, or simvastatin 20mg. The non-HDL-C lowering with Simcor 2000/20 and 1000/20 was significantly greater than that achieved with simvastatin 20mg.

Group B enrolled patients who had been taking simvastatin 40mg and had elevated non-HDL levels; these patients were randomized to either Simcor 1000/40, Simcor 2000/40, or simvastatin 80mg. The non-HDL-C lowering with Simcor 2000/40 and Simcor 1000/40 was non-inferior to that achieved with simvastatin 80mg.

Simcor was not superior to simvastatin in lowering LDL-C in either group. In both groups, Simcor was superior to simvastatin in lowering TG and raising HDL.

Take once daily at bedtime with low-fat snack. Swallow whole. Naive to or switching from immediate-release niacin: initially one 500/20 tab. May increase at 4-wk intervals by up to 500mg/day (ext-rel niacin component); maintenance: 1000/20 to 2000/40 once daily. May substitute for previously-titrated ext-rel niacin at equivalent doses. Retitrate if therapy interrupted ≥7 days. To reduce flushing, pretreat with aspirin or an NSAID.

Not recommended.

Active liver or peptic ulcer disease. Unexplained persistent elevated transaminases. Arterial bleeding. Pregnancy (Cat.X). Nursing mothers.

Do not substitute for equivalent doses of immediate-release niacin. Substantial alcohol consumption. History of liver disease. Monitor transaminases (at baseline, every 12wks for 1st 6 mos, then periodically); discontinue if levels ≥3xULN persist or if signs/symptoms of liver disease occur. Discontinue if myopathy is diagnosed or suspected. Suspend therapy before surgery and if major medical event occurs. Renal dysfunction. Gout. Monitor blood glucose, PT, platelets.

Avoid other niacin, potent CYP3A4 inhibitors (eg, azole antifungals, macrolides, HIV PIs, nefazodone, grapefruit juice >1qt/day), gemfibrozil, fenofibrate, cyclosporine, danazol. Potentiated by amiodarone and verapamil (limit simvastatin to 20mg/day). Separate dosing of bile acid sequestrants by 4–6hrs. Postural hypotension with ganglionic blockers, vasoactive drugs. Monitor warfarin, digoxin, antidiabetics.

Flushing, headache, pruritus, GI upset, back pain; elevated ALT/AST, myopathy, rhabdomyolysis with renal failure.

Tabs—90

4/4/08