Evidence mapPaperPMID 30349338Full record

ArticleClinicoEconomics and outcomes research : CEOR2018

A single blind, multicenter, randomized controlled trial to evaluate the effectiveness and cost of a novel nutraceutical (LopiGLIK

Andrea Manfrin, Valentina Trimarco, Maria Virginia Manzi, Francesco Rozza, Raffaele Izzo

Registry-linked trialAbstract read
In one paragraph

Article in ClinicoEconomics and outcomes research : CEOR, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02898805 (Effects of a New Combination of Nutraceutics), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
field-weighted citation impact
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.

NCT02898805 nacompletednot on this map

Effects of a New Combination of Nutraceutics (LopiGLIK®) on Cardiovascular Risk

TypeinterventionalSponsorFederico II UniversityRan2016 to 2018Enrolled600ConditionsCardiovascular Risk FactorsArmsPlacebo, Prescribed Diet, LopiGLIK®, Armolipid Plus
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Nutrients · 2019
    Trial
  2. Article
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

5 authors.

Andrea ManfrinSussex Pharmacy, School of Life Sciences, University of Sussex, Falmer, Brighton, UK, a.manfrin@sussex.ac.uk.
Valentina TrimarcoHypertension Research Centre, University of Naples Federico II, Naples, Italy.
Maria Virginia ManziHypertension Research Centre, University of Naples Federico II, Naples, Italy.
Francesco RozzaHypertension Research Centre, University of Naples Federico II, Naples, Italy.
Raffaele IzzoHypertension Research Centre, University of Naples Federico II, Naples, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextCardiovascular disease (CVD) costs the economy €210 billion per year in Europe. There is an association between low-density lipoprotein cholesterol (LDL-C) and CVD risk.

objectiveTo evaluate the cost and effectiveness of LopiGLIK

designSingle blind multicenter randomized controlled trial; patients were divided into two groups, subjected to centralized randomization.

settingFour Italian regions.

participantsThirty-one physicians enrolled 573 adult patients with mild hypercholesterolemia between January 2016 and January 2018.

interventionPatients were treated for 16 weeks either with LOPI (intervention) or Armolipid Plus OUTCOME MEASURES: Primary outcome: percentage of patients who achieved LDL-C <130 mg/dL. Secondary outcomes: reduction of HbA1c, survival analysis and HR linked to 38.67 mg/dL reduction of LDL-C and 1% reduction of HbA1c. Costs were assessed per unit and cure.

resultsThree hundred and seventy patients treated with LOPI and 203 treated with AP were randomized and completed the study. At baseline 8.9% (n=18) patients treated with AP and 9.5% (n=35) treated with LOPI had LDL-C levels <130 mg/dL (

conclusionLOPI appeared more effective and less expensive than AP in lowering LDL-C and CVD risk.

trial registrationNCT02898805, September 8, 2016.

Indexed as

cardiovascular risk reductioneffectivenesshypercholesterolemianutraceuticals

Identifiers

PMID30349338
PMCPMC6181120

What Socratic holds

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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 Socratic graph.