Evidence map›Paper›PMID 36550424›Full record

Trial reportBMC cardiovascular disorders2022

Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial.

José M Mostaza, Carmen Suárez-Fernández, Juan Cosín-Sales, Ricardo Gómez-Huelgas, Carlos Brotons, Francisco Pestana Araujo, Gabriela Borrayo, Emilio Ruiz, VULCANO investigators

Open access · goldFull text readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cardiovascular disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Review
  3. Article
  4. Polypills in the Management of Cardiovascular Risk-A Perspective.Journal of clinical medicine · 2024 · on this map
    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 8 institutions in 3 countries.

José M MostazaInternal Medicine Service, Hospital Carlos III, Madrid, Spain. josemaria.mostaza@salud.madrid.org.ORCID 0000-0003-1638-6051
Carmen Suárez-FernándezInternal Medicine Department Hospital de la Princesa, Madrid, Spain.
Juan Cosín-SalesCardiology Service, Hospital Arnau de Vilanova, Valencia, Spain.
Ricardo Gómez-HuelgasInternal Medicine Department, Regional University Hospital of Málaga, Malaga, Spain.
Carlos BrotonsSardenya Primary Health Care Center, Barcelona, Spain.
Francisco Pestana AraujoHospital dos Lusíadas, Lisbon, Portugal.
Gabriela BorrayoInstituto Mexicano del Seguro Social (IMSS), Ciudad de Mexico, Mexico.
Emilio RuizCorporate Medical Affairs Department, Ferrer Internacional, Barcelona, Spain.
VULCANO investigators
Lusíada University of Lisbon · PTFerrer Grupo (Spain) · ESHospital Regional Universitario de Málaga · ESHospital Universitario de La Princesa · ESInstituto de Salud Carlos III · ESMadrid Health Service · ESMexican Social Security Institute · MXUniversidad Cardenal Herrera CEU · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCardiovascular (CV) polypills are a useful baseline treatment to prevent CV diseases by combining different drug classes in a single pill to simultaneously target more than one risk factor. The aim of the present trial was to determine whether the treatment with the CNIC-polypill was at least non-inferior to usual care in terms of low-density lipoprotein cholesterol (LDL-c) and systolic BP (SBP) values in subjects at high or very high risk without a previous CV event.

methodsThe VULCANO was an international, multicentre open-label trial involving 492 participants recruited from hospital clinics or primary care centres. Patients were randomised to the CNIC-polypill -containing aspirin, atorvastatin, and ramipril- or usual care. The primary outcome was the comparison of the mean change in LDL-c and SBP values after 16 weeks of treatment between treatment groups.

resultsThe upper confidence limit of the mean change in LDL-c between treatments was below the prespecified margin (10 mg/dL) and above zero, and non-inferiority and superiority of the CNIC-polypill (p = 0.0001) was reached. There were no significant differences in SBP between groups. However, the upper confidence limit crossed the prespecified non-inferiority margin of 3 mm Hg. Significant differences favoured the CNIC-polypill in reducing total cholesterol (p = 0.0004) and non-high-density lipoprotein cholesterol levels (p = 0.0017). There were no reports of major bleeding episodes. The frequency of non-serious gastrointestinal disorders was more frequent in the CNIC-polypill arm.

conclusionThe switch from conventional treatment to the CNIC-polypill approach was safe and appears a reasonable strategy to control risk factors and prevent CVD. Trial registration This trial was registered in the EU Clinical Trials Register (EudraCT) the 20th February 2017 (register number 2016-004015-13; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-004015-13 ).

Indexed as

Cardiovascular DiseasesHydroxymethylglutaryl-CoA Reductase InhibitorsAntihypertensive AgentsCholesterolCholesterol, LDLDrug CombinationsHumansAntihypertensive AgentsCholesterolCholesterol, LDLDrug CombinationsHydroxymethylglutaryl-CoA Reductase InhibitorsCardiovascular diseaseCardiovascular risk factorsFixed-dose combinationNon-inferiority trialPolypillPrimary prevention

Identifiers

PMID36550424
PMCPMC9773517
OpenAlexW4313235923

What Socratic holds

Textfull text, public
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.