In simvastatin patients
Target multiple
lipids with SIMCOR
SIMCOR EFFICACY
CLINICAL STUDIES DATA
FLUSHING
WHAT IT IS & HOW TO HELP MANAGE IT
HEART ALLIANCE
24-HR NURSE SUPPORT, EVERY DAY
References
- SIMCOR [package insert]. North Chicago, IL: Abbott Laboratories.
- FDA statement on the AIM-HIGH trial. http://fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm256841.htm.
Accessed August 25, 2011.
Please see Important Safety Information and full Prescribing Information.
Indication
SIMCOR is indicated as an adjunct to diet to reduce total-C, LDL-C, Apo B, non–HDL-C,
or TG, or to increase HDL-C in patients with primary hypercholesterolemia and mixed
dyslipidemia when treatment with simvastatin monotherapy or niacin extended-release
monotherapy is considered inadequate.1
Limitations of Use: No incremental benefit of SIMCOR on cardiovascular
morbidity and mortality over and above that demonstrated for simvastatin monotherapy
and niacin monotherapy has been established.
The AIM-HIGH study (terminated due to futility) showed no cardiovascular outcome benefit in patients with
well-controlled LDL-C (40-80 mg/dL) using niacin extended-release/simvastatin vs. simvastatin alone.2
Safety Information
- SIMCOR is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases, active peptic ulcer disease, arterial bleeding; in women who are pregnant or may become pregnant; in nursing mothers; and with concomitant administration of strong CYP3A4 inhibitors, gemfibrozil, cyclosporine, danazol, amiodarone, verapamil, or diltiazem.
- SIMCOR is associated with myopathy, rhabdomyolysis, and increases in liver enzymes and glucose levels.
- Severe hepatic toxicity has occurred when substituting sustained-release niacin for immediate-release niacin at equivalent doses.
- The most common adverse reaction with SIMCOR is flushing.