Simcor 500/20- A statin combined with niacin in one pill

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Company:

Abbott

Pharmacologic class:

Nicotinic acid derivative + HMG-CoA reductase inhibitor

Active ingredients:

Niacin extended-release 500 mg, simvastatin 20 mg; tabs.

Also:

Simcor 750/20

Active ingredients:

Niacin extended-release 750 mg, simvastatin 20 mg; tabs.

Also:

Simcor 1000/20

Active ingredients:

Niacin extended-release 1000 mg, simvastatin 20 mg; tabs.

Indication:

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

Pharmacology:

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

Clinical trials:

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

Group B enrolled patients who had been taking simvastatin 40 mg and had elevated non-HDL-C levels; patients were randomized to Simcor 1000/40, Simcor 2000/40, or simvastatin 80 mg. The non-HDL-C lowering with Simcor 2000/40 and Simcor 1000/40 was non-inferior to that achieved with simvastatin 80 mg. Simcor was not superior to simvastatin in lowering LDL in either group. In both groups, Simcor was superior to simvastatin in lowering triglycerides and raising HDL.

Adults:

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 four-week intervals by up to 500 mg/day (extended-release niacin component); maintenance: 1000/20 to 2000/40 once daily. May substitute for previously titrated extended-release niacin at equivalent doses. Retitrate if therapy interrupted ≥7 days. To reduce flushing, pretreat with aspirin or an NSAID.

Children:

Not recommended.

Contraindications:

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

Precautions:

Do not substitute for equivalent doses of immediate-release niacin. Substantial alcohol consumption. History of liver disease. Monitor transaminases (at baseline, every 12 weeks for first six months, then periodically); discontinue if levels ≥3x ULN 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.

Interactions:

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

Adverse reactions:

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

How supplied:

Tabs—90

For more information, call 800.633.9110.

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