Evidence map›Paper›PMID 19602880›Full record

Trial reportCardiology2009

Flushing profile of extended-release niacin/laropiprant at initiation of therapy in Asian lipid clinic patients.

Debra Kush, Da-Yi Hu, Ping Ye, Hyo-Soo Kim, Erluo Chen, Waheeda Sirah, Christine McCrary Sisk, John F Paolini, Darbie Maccubbin

2 registry-linked trialsAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Cardiology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.2field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01683656 phase4terminatedstarted 2012, after this paper: background citation

ER Niacin/Laropiprant Impact on Cardiovascular Markers and Atheroprogression in HIV-infected Individuals on cART

Ran2012Enrolled4Registered outcomes5Posted comparisons0ConditionsAtherosclerosis, HIVArmsNiacin/laropiprant, Placebo
PMID 19095140PMID 19031552PMID 17302378PMID 17935553PMID 19415282PMID 12014436PMID 19275490PMID 12486414PMID 15843671PMID 16137695PMID 16878047PMID 19425222other papers from this trial
Open the trial in the graph
NCT00533611 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Tolerability and Effect of MK0524A on Niacin-Induced Acute Flushing in Lipid Clinic Patients

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2007 to 2007Enrolled330ConditionsFlushingArmsMK0524A, /Duration of Treatment : 4 Weeks, Comparator : niacin /Duration of Treatment : 1 Weeks
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 17 citations in OpenAlex.

  1. Niacin, an old drug with a new twist.Journal of lipid research · 2013
    Review
  2. Article
  3. Article
  4. Latest drug developments in the field of cardiovascular disease.The International journal of angiology : official publication of the International College of Angiology, Inc · 2010
    Article
  5. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 3 countries.

Debra KushMerck Research Laboratories, Rahway, NJ 07065, USA. debra_kush@merck.com
Da-Yi Hu
Ping Ye
Hyo-Soo Kim
Erluo Chen
Waheeda Sirah
Christine McCrary Sisk
John F Paolini
Darbie Maccubbin
Merck & Co., Inc., Rahway, NJ, USA (United States) · USChinese People's Liberation Army · CNPeking University People's Hospital · CNSeoul National University Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveNiacin 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.

methodsFollowing 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).

resultsCompared 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.

conclusionERN/LRPT produced significantly less flushing than N-ER during the initiation of therapy and was generally well tolerated in Asian patients with dyslipidemia.

Indexed as

AdultAgedAsian PeopleDouble-Blind MethodDrug CombinationsDyslipidemiasFemaleFlushingHumansHypolipidemic AgentsIndolesMaleMiddle AgedNiacinDrug CombinationsHypolipidemic AgentsIndolesMK-0524Niacin

Identifiers

PMID19602880
OpenAlexW1966591614

What OpenQuestion holds

Texttitle and abstract
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.