Home » Drug Information » Recently Approved Drugs » 2001
Medical Areas: Cardiology/Vascular Diseases
Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Kos Pharmaceuticals
Approval Status: Approved December 2001
Treatment Area: Cholesterol disorders
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.
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.
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.
