| The comparative bioavailability of an extended-release niacin and lovastatin fixed dose combination tablet versus extended-release niacin tablet, lovastatin tablet and a combination of extended-release niacin tablet and lovastatin tablet. | |
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MedLine Citation:
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PMID: 17571283 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Lovastatin and extended-release (ER) niacin in a fixed dose combination (Advicor) is approved for the treatment of dyslipidemia. Since both drugs are extensively metabolized, this study investigated the bioavailability and pharmacokinetics of their co-administration following single-dose administration. In a 4-way crossover study 40 subjects received: two 1000/20 Advicor tablets (ADV), two 1000 mg niacin ER tablets (NSP), two 20mg lovastatin tablets (Mevacor; MEV), and two niacin ER 1000 mg tablets with two lovastatin 20mg tablets (NSP+MEV). Plasma was assayed for niacin, nicotinuric acid (NUA), lovastatin, lovastatin acid and HMGCoA reductase inhibition. Urine was assayed for niacin and its metabolites, NUA, N-methylnicotinamide and N-methyl-2pyridone-5-carboxamide. Least square mean ratios and 90% confidence intervals for C(max) and AUC((0-t)) were determined for NSP+MEV versus MEV or NSP, ADV versus MEV or NSP, and ADV versus NSP+MEV. Co-administration of niacin and lovastatin did not significantly influence C(max) and AUC((0-t)) of lovastatin, niacin, NUA and total urinary recovery of niacin and metabolites. A 22 to 25% decrease in lovastatin acid C(max) was observed while lovastatin acid AUC((0-t)) was not affected. The HMGCoA reductase inhibition C(max) and AUC((0-t)) were not affected indicating that the difference in lovastatin acid C(max) was not clinically relevant. |
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Authors:
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R Menon; D Tolbert; E Cefali |
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Publication Detail:
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Type: Comparative Study; Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: Biopharmaceutics & drug disposition Volume: 28 ISSN: 0142-2782 ISO Abbreviation: Biopharm Drug Dispos Publication Date: 2007 Sep |
Date Detail:
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Created Date: 2007-08-21 Completed Date: 2007-12-20 Revised Date: 2011-01-14 |
Medline Journal Info:
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Nlm Unique ID: 7911226 Medline TA: Biopharm Drug Dispos Country: England |
Other Details:
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Languages: eng Pagination: 297-306 Citation Subset: IM |
Affiliation:
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Kos Pharmaceuticals Inc, Weston, FL 33326, USA. menonrm2000@yahoo.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Antineoplastic Agents / metabolism, pharmacokinetics Area Under Curve Biological Availability Cross-Over Studies Delayed-Action Preparations / adverse effects, pharmacokinetics* Drug Combinations Female Flushing / chemically induced Humans Lovastatin / blood, pharmacokinetics*, urine Male Metabolic Clearance Rate Middle Aged Nausea / chemically induced Niacin / blood, pharmacokinetics*, urine Niacinamide / analogs & derivatives, metabolism Nicotinic Acids / metabolism Pyridones / urine Tablets Time Factors Vitamin B Complex / blood, pharmacokinetics, urine |
| Chemical | |
Reg. No./Substance:
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0/Antineoplastic Agents; 0/Delayed-Action Preparations; 0/Drug Combinations; 0/N-methyl-2-pyridone-5-carboxamide; 0/Nicotinic Acids; 0/Pyridones; 0/Tablets; 114-33-0/N-methylnicotinamide; 12001-76-2/Vitamin B Complex; 583-08-4/nicotinuric acid; 59-67-6/Niacin; 75330-75-5/Lovastatin; 98-92-0/Niacinamide |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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