Evidence mapPaperPMID 40892621Full record

ArticleJACC. Advances2025

Efficacy and Safety of a Novel Triple Single-Pill for Uncontrolled Hypertension: The OPTION TREAT Trial.

Vagner Madrini, Caio A M Tavares, Monica T A Albuquerque, Odilson M Silvestre, João S Felicio, Fabio S Silveira, Miguel N Hissa, Murillo O Antunes, Marco A Mota-Gomes, Maria H Vidotti and 16 more

Registry-linked trialAbstract read
In one paragraph

Article in JACC. Advances, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05920005 (A Multicenter, Double-blind, Controlled, Randomized Trial to Evaluate the Association Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension), 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.

NCT05920005 phase3completednot on this map

A Multicenter, Double-blind, Controlled, Randomized Trial to Evaluate the Association Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension

TypeinterventionalSponsorHospital Israelita Albert EinsteinRan2023 to 2025Enrolled702ConditionsHypertensionArmscandesartan cilexetil + chlorthalidone + amlodipine, Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

26 authors.

Vagner MadriniHospital Israelita Albert Einstein, São Paulo, Brazil.
Caio A M TavaresHospital Israelita Albert Einstein, São Paulo, Brazil; Instituto do Coração (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
Monica T A AlbuquerqueHospital Israelita Albert Einstein, São Paulo, Brazil.
Odilson M SilvestreUniversidade Federal do Acre, Rio Branco, Brazil.
João S FelicioJoão de Barros Barreto University Hospital, Federal University of Pará, Belém, Brazil.
Fabio S SilveiraCentro de Pesquisa Clínica do Coração, Aracaju, Brazil.
Miguel N HissaCentro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas/Clínica Popular Endocrinologia, Fortaleza, Brazil.
Murillo O AntunesHospital Universitário São Francisco de Assis na Providência de Deus da Universidade de São Francisco, Bragança Paulista, Brazil.
Marco A Mota-GomesCentro Universitário CESMAC, Maceió, Brazil.
Maria H VidottiCentro I9 Pesquisa Clínica, Campinas, Brazil.
Flávio D FuchsHospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Fabiana G Marcondes-BragaCentro, CIPES, São José dos Campos, Brazil.
Conrado R H FilhoW&H Cardiologia, Joinville, Brazil.
Charlene Troiani do NascimentoHospital Regional de Presidente Prudente, Presidente Prudente, Brazil.
Rafael A BastosCentro Ruy Azeredo, Goiânia, Brazil.
Andrea A BrandãoFaculdade de Ciências Médicas-Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.
Elizabeth E S CestárioClínica Cardiológica, Votuporanga, Brazil.
Luiz A BortolottoInstituto do Coração (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
Vivienne C CastilhoLibbs Pharmaceuticals, São Paulo, Brazil.
Maura G LapaLibbs Pharmaceuticals, São Paulo, Brazil.
Erida A P MagatonLibbs Pharmaceuticals, São Paulo, Brazil.
Paula B FernandesLibbs Pharmaceuticals, São Paulo, Brazil.
Camila S N AlbuquerqueHospital Israelita Albert Einstein, São Paulo, Brazil.
Lucas R SilvaHospital Israelita Albert Einstein, São Paulo, Brazil.
Otávio BerwangerGeorge Institute for Global Health UK, London, United Kingdom; Imperial College London, London, United Kingdom.
Patricia O GuimarãesHospital Israelita Albert Einstein, São Paulo, Brazil. Electronic address: patricia.oguimaraes@einstein.br.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNovel single-pill combinations with blood pressure (BP)-lowering agents are needed to increase treatment options for hypertension.

objectivesThe purpose of this study was to assess the efficacy and safety of a novel single pill (candesartan cilexetil, amlodipine, and chlorthalidone) compared with an active control (valsartan, amlodipine, and hydrochlorothiazide) for uncontrolled hypertension.

methodsOPTION TREAT (Efficacy and Safety of a Novel Triple Single-Pill Combination Therapy Compared with an Active Control in Patients with Uncontrolled Hypertension) was a randomized, double-blind, double-dummy, noninferiority trial conducted across 19 sites in Brazil. Participants with an office systolic BP of 140 to 180 mm Hg and a diastolic BP of 90 to 110 mm Hg despite dual therapy were randomized in a 1:1 ratio to receive either the experimental treatment or the active control for 12 weeks. The primary outcome was the mean change in office systolic BP from baseline to week 12. The prespecified noninferiority margin was 3 mm Hg. Secondary outcomes included mean changes in diastolic BP and adverse events.

resultsOverall, 703 participants were included (mean age 57.8 years, 62.7% women, baseline office BP of 153.0/95.6 mm Hg). At 12 weeks, the least square mean change in systolic BP was -22.6 mm Hg in the experimental group vs -18.2 mm Hg in the control group (between-group difference -4.4 mm Hg; 90% CI -6.3 to -2.5 mm Hg; P < 0.001). Diastolic BP was also reduced in both groups, with greater reductions in the experimental group (-13.8 mm Hg vs -12.0 mm Hg; P = 0.008). Adherence was high, and serious adverse events were rare.

conclusionsIn patients with uncontrolled hypertension, a novel triple single-pill containing candesartan cilexetil, amlodipine, and chlorthalidone improved BP control at 12 weeks and had a reasonable safety profile. (Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT for Systemic Arterial Hypertension [OPTION TREAT]; NCT05920005).

Indexed as

blood pressure controlfixed-dose combinationhypertensionsingle-pill combinationtriple therapy

Identifiers

PMID40892621
PMCPMC12791868

What Socratic holds

Textmetadata
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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.