Evidence map›Paper›PMID 22621316›Full record

Trial reportBMC research notes2012

Efficacy, safety and tolerability of ongoing statin plus ezetimibe versus doubling the ongoing statin dose in hypercholesterolemic Taiwanese patients: an open-label, randomized clinical trial.

Chih-Chieh Yu, Wen-Ter Lai, Kuang-Chung Shih, Tsung-Hsien Lin, Chieh-Hua Lu, Hung-Jen Lai, Mary E Hanson, Juey-Jen Hwang

2 registry-linked trialsOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC research notes, 2012. 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 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 26% 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.

NCT00652327 phase4completednot on this map

A Multicenter, Randomized, Open-labeled, Parallel Group Comparison Study to Evaluate the Efficacy, Safety and Tolerability of Ezetimibe Added to Ongoing Statin Therapy Versus Doubling the Dose of Ongoing Statin in the Treatment of Hypercholesterolemia.

TypeinterventionalSponsorOrganon and CoRan2005 to 2007Enrolled83ConditionsHypercholesterolemiaArmsEzetimibe + Statin (simvastatin, atorvastatin, or pravastatin), Double Statin (simvastatin, atorvastatin, or pravastatin)
NCT04895059 phase1completednot on this mapstarted 2017, after this paper: background citation

Study of no Pharmacokinetic Interaction Between Rosuvastatin 20 mg and Ezetimibe 10 mg, Open Design, Randomized, Single Dose, 3x6, Crossove, Healthy Volunteers in Fasting, in Fixed Combination Against Individuals Components Managed

TypeinterventionalSponsorLaboratorios Silanes S.A. de C.V.Ran2017 to 2018Enrolled36ConditionsHealthyArmsRosuvastatin (20mg) /Ezetimibe (10mg) in fixed dose, Rosuvastatin 20mg, Ezetimibe 10mg
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. 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

8 authors at 4 institutions in 2 countries.

Chih-Chieh YuNational Taiwan University Hospital, Taipei, Taiwan.
Wen-Ter Lai
Kuang-Chung Shih
Tsung-Hsien Lin
Chieh-Hua Lu
Hung-Jen Lai
Mary E Hanson
Juey-Jen Hwang
Kaohsiung Medical University Chung-Ho Memorial Hospital · TWNational Taiwan University Hospital · TWTri-Service General Hospital · TWMerck & Co., Inc., Rahway, NJ, USA (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundReducing low-density lipoprotein cholesterol (LDL-C) is associated with reduced risk for major coronary events. Despite statin efficacy, a considerable proportion of statin-treated hypercholesterolemic patients fail to reach therapeutic LDL-C targets as defined by guidelines. This study compared the efficacy of ezetimibe added to ongoing statins with doubling the dose of ongoing statin in a population of Taiwanese patients with hypercholesterolemia.

methodsThis was a randomized, open-label, parallel-group comparison study of ezetimibe 10 mg added to ongoing statin compared with doubling the dose of ongoing statin. Adult Taiwanese hypercholesterolemic patients not at optimal LDL-C levels with previous statin treatment were randomized (N = 83) to ongoing statin + ezetimibe (simvastatin, atorvastatin or pravastatin + ezetimibe at doses of 20/10, 10/10 or 20/10 mg) or doubling the dose of ongoing statin (simvastatin 40 mg, atorvastatin 20 mg or pravastatin 40 mg) for 8 weeks. Percent change in total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C) and triglycerides, and specified safety parameters were assessed at 4 and 8 weeks.

resultsAt 8 weeks, patients treated with statin + ezetimibe experienced significantly greater reductions compared with doubling the statin dose in LDL-C (26.2% vs 17.9%, p = 0.0026) and total cholesterol (20.8% vs 12.2%, p = 0.0003). Percentage of patients achieving treatment goal was greater for statin + ezetimibe (58.6%) vs doubling statin (41.2%), but the difference was not statistically significant (p = 0.1675). The safety and tolerability profiles were similar between treatments.

conclusionEzetimibe added to ongoing statin therapy resulted in significantly greater lipid-lowering compared with doubling the dose of statin in Taiwanese patients with hypercholesterolemia. Studies to assess clinical outcome benefit are ongoing.

trial registrationRegistered at ClinicalTrials.gov: NCT00652327.

Indexed as

AdolescentAdultAgedAged, 80 and overAnticholesteremic AgentsAzetidinesDose-Response Relationship, DrugDrug Therapy, CombinationEzetimibeFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaIntention to Treat AnalysisLipidsMaleAnticholesteremic AgentsAzetidinesEzetimibeHydroxymethylglutaryl-CoA Reductase InhibitorsLipids

Identifiers

PMID22621316
PMCPMC3403927
OpenAlexW2160609898

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.