Method of Treating Atherosclerosis, Dyslipidemias and Related Conditions
A method of treating atherosclerosis, dyslipidemias and related conditions is disclosed wherein a therapeutic dose of nicotinic acid, approximately 1 gram, is administered to the patient once daily as a starting dose, and the dose is thereafter raised within a few days or weeks to 2 grams for the duration of therapy. The nicotinic acid may be administered in combination with a selective DP receptor antagonist. The selective DP receptor antagonist is administered to reduce, prevent or eliminate flushing that may otherwise occur.
1 . A method of treating atherosclerosis in a human patient in need of such treatment that is comprised of administering to the patient about 800 mg to about 1 gram of nicotinic acid in the absence of substantial flushing, once daily for a period ranging from a few days to about 2 months, and thereafter, administering to the patient about 1.6 grams to about 2 grams of nicotinic acid, once daily, for the duration of therapy.
2 . A method of raising serum HDL levels in a human patient in need of such treatment, that is comprised of administering to the patient about 800 mg to about 1 gram of nicotinic acid in the absence of substantial flushing, once daily, for a period ranging from a few days to about 2 months, and thereafter, administering to the patient about 1.6 grams to about 2 grams of nicotinic acid, once daily, for the duration of therapy.
3 . A method of treating dyslipidemia in a human patient in need of such treatment that is comprised of administering to the patient about 800 mg to about 1 gram of nicotinic acid in the absence of substantial flushing, once daily, for a period ranging from a few days to about 2 months, and thereafter, administering to the patient about 1.6 grams to about 2 grams of nicotinic acid, once daily, for the duration of therapy.
4 . A method in accordance with claim 1 , 2 or 3 wherein the nicotinic acid is administered with a selective DP receptor antagonist compound that selectively modulates the DP receptor and does not substantially modulate the CRTH2 receptor.
5 . A method in accordance with claim 4 , wherein the DP receptor antagonist is selected from the group consisting of:
or a pharmaceutically acceptable salt or solvate thereof.
6 . A method in accordance with claim 5 wherein the selective DP receptor antagonist compound is selected from the group consisting of compounds D, E, F and AA.
7 . A method in accordance with claim 6 wherein the DP receptor antagonist compound that is administered is the following:
or a pharmaceutically acceptable salt or solvate thereof.
8 . A method in accordance with claim 6 wherein the DP receptor antagonist compound that is administered is the following:
or a pharmaceutically acceptable salt or solvate thereof.
9 . A method in accordance with claim 6 or 7 further comprising administering the niacin and DP receptor antagonist compound with simvastatin.
10 . A method in accordance with claim 4 wherein the nicotinic acid ranging from about 800 mg to about 1 gram is in the form of a sustained release bilayer tablet, comprised of a first layer containing nicotinic acid in a sustained release matrix, and a second layer containing an effective amount of a selective DP receptor antagonist.
11 . A method in accordance with claim 9 wherein the 1.6 grams to about 2 grams of nicotinic acid is administered in the form of two sustained release bilayer tablets, each comprised of a first layer containing about 800 mg to about 1 gram of nicotinic acid, and a second layer containing an effective amount of a selective DP receptor antagonist.
12 . A method in accordance with claim 9 wherein the second layer further contains about 20 mg of simvastatin.
13 . A method in accordance with claim 10 wherein the second layer further contains about 20 mg of simvastatin.
14 . A method in accordance with claim 10 wherein the second layer further contains an effective amount of atorvastatin.