Document Detail


Flushing profile of extended-release niacin/laropiprant at initiation of therapy in Asian lipid clinic patients.
MedLine Citation:
PMID:  19602880     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Debra Kush; Da-Yi Hu; Ping Ye; Hyo-Soo Kim; Erluo Chen; Waheeda Sirah; Christine McCrary Sisk; John F Paolini; Darbie Maccubbin
Publication Detail:
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:
Title:  Cardiology     Volume:  114     ISSN:  1421-9751     ISO Abbreviation:  Cardiology     Publication Date:  2009  
Date Detail:
Created Date:  2009-09-29     Completed Date:  2009-12-21     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  1266406     Medline TA:  Cardiology     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  192-8     Citation Subset:  IM    
Copyright Information:
Copyright 2009 S. Karger AG, Basel.
Affiliation:
Merck Research Laboratories, Rahway, NJ 07065, USA. debra_kush@merck.com
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MeSH Terms
Descriptor/Qualifier:
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:
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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