| Flushing profile of extended-release niacin/laropiprant at initiation of therapy in Asian lipid clinic patients. | |
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MedLine Citation:
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PMID: 19602880 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: Niacin is underutilized due to flushing, which occurs in over 90% of niacin-treated patients. Laropiprant (LRPT) reduces flushing associated with niacin. This study compared flushing with a combination tablet of extended-release (ER) niacin (ERN)/LRPT to niacin ER (N-ER; without LRPT) during the first week of therapy among patients in Asia. METHODS: Following a 1-week placebo run-in, 332 patients with dyslipidemia from China, Korea and Singapore were randomized to ERN/LRPT 1 g/20 mg, N-ER 1 g (given as Niaspan(R)) or placebo in a 2:2:1 ratio for 1 week. Patient-reported flushing severity was assessed using the Global Flushing Severity Score (GFSS; none/mild = 0-3; moderate = 4-6; severe = 7-9; extreme = 10). RESULTS: Compared with N-ER, the ERN/LRPT group experienced significantly less flushing (p < 0.001), as measured by maximum GFSS categorized as none/mild, moderate, severe or extreme. Overall, 23.8% of patients in the ERN/LRPT group and 50.0% in the N-ER group (p < 0.001), versus 12.1% in the placebo group, had moderate or greater flushing (GFSS > or =4). Except for flushing, which occurred more frequently in the N-ER group, ERN/LRPT had a safety/tolerability profile similar to that of N-ER. CONCLUSION: ERN/LRPT produced significantly less flushing than N-ER during the initiation of therapy and was generally well tolerated in Asian patients with dyslipidemia. |
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Authors:
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Debra Kush; Da-Yi Hu; Ping Ye; Hyo-Soo Kim; Erluo Chen; Waheeda Sirah; Christine McCrary Sisk; John F Paolini; Darbie Maccubbin |
Publication Detail:
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Type: Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2009-07-15 |
Journal Detail:
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Title: Cardiology Volume: 114 ISSN: 1421-9751 ISO Abbreviation: Cardiology Publication Date: 2009 |
Date Detail:
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Created Date: 2009-09-29 Completed Date: 2009-12-21 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 1266406 Medline TA: Cardiology Country: Switzerland |
Other Details:
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Languages: eng Pagination: 192-8 Citation Subset: IM |
Copyright Information:
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Copyright 2009 S. Karger AG, Basel. |
Affiliation:
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Merck Research Laboratories, Rahway, NJ 07065, USA. debra_kush@merck.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Antilipemic Agents / administration & dosage, adverse effects* Asian Continental Ancestry Group Double-Blind Method Drug Combinations Dyslipidemias / drug therapy* Female Flushing / chemically induced* Humans Indoles / administration & dosage, adverse effects* Male Middle Aged Niacin / administration & dosage, adverse effects* |
| Chemical | |
Reg. No./Substance:
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0/Antilipemic Agents; 0/Drug Combinations; 0/Indoles; 0/MK-0524; 59-67-6/Niacin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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