Advicor (extended-release niacin/lovastatin)
Company: Kos Pharmaceuticals
Approval Status: Approved December 2001
Treatment for: Cholesterol disorders
Areas: Cardiology/Vascular Diseases
| General Information | Clinical Results | Side Effects | Additional Information |
General Information
Advicor is a combination product containing both extended-release niacin and lovastatin. This drug has been approved for the treatment of primary hypercholesterolemia and mixed dyslipidemia. It is indicated for patients who were previously treated with either component of Advicor, but who require additional lipid modification for LDL or HDL cholesterol and triglycerides.
Advicor tablets are available in three different combinations of extended-release niacin and lovastatin. The different strengths combine either 500mg, 750mg or 1000 mg of extended-release niacin with 20mg of lovastatin.
Clinical Results
Results of a multicenter, randomized, double-blind trial in subjects with type IIa and IIb hyperlipidemia supported the approval of Advicor. In this trial, Advicor was compared to monotherapy with Niaspan (extended-release niacin) or lovastatin. Dosage was escalated throughout the trial, with patients receiving each dose for at least four weeks. Subjects in the Advicor group received strengths ranging from 500mg/20mg to 2000mg/40mg. Those in the Niaspan monotherapy group received a similar titration from 500 mg to 2000 mg, and subjects in the lovastatin monotherapy group received 20mg titrated up to 40mg.
Results showed that Advicor decreased LDL-C, triglycerides (TG) and lipoprotein a (Lp(a)), and increased HDL-C, in a dose-dependent fashion.
Advicor produced greater LDL-lowering than lovastatin 40mg after 28 weeks of titration to a dose of 2000mg/40mg. Advicor also produced greater LDL-lowering than Niaspan at doses of 1000mg/20mg or higher. In terms of HDL, Advicor was superior in raising HDL compared to lovastatin and Niaspan monotherapy at all doses. Additionally, Advicor was more effective in lowering TG at doses of 1000 mg/20 mg or greater compared to lovastatin and Niaspan monotherapy.
Side Effects
Advicor was generally well tolerated in clinical trials, with side effects comparable to niacin or lovastatin administered alone. The most frequently reported adverse events include the following:
- Flushing
- Upset stomach
- Rash
Advicor should not be used by women who are pregnant or nursing, or by individuals with liver problems or active peptic ulcer.
Additional Information
For additional information on Advicor, please visit the product web site at www.advicor.com.
If you would like to obtain more information on cholesterol and heart disease, please visit the National Heart, Lung, and Blood Institute.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
