Evidence Based Medicine on FHIR Implementation Guide
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Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Example Citation: 38584159 Efficacy and safety of a four-drug, quarter-dose treatment for hypertension: the QUARTET USA randomized trial.

Page standards status: Informative

version: 1; Last updated: 2025-05-20 18:44:32+0000

Profile: JournalArticleCitation

ArtifactPublicationStatus: Active

url: Citation 38584159 Efficacy and safety of a four-drug, quarter-dose treatment for hypertension: the QUARTET USA randomized trial.

identifier: FEvIR Object Identifier/367878, https://pubmed.ncbi.nlm.nih.gov/38584159, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.15.60

version: 1.0.0-ballot2

title: 38584159 Efficacy and safety of a four-drug, quarter-dose treatment for hypertension: the QUARTET USA randomized trial.

status: Active

date: 2025-09-04 23:28:30+0000

author: Computable Publishing®: MEDLINE-to-FEvIR Converter:

publisher: HL7 International / Clinical Decision Support

contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss

description:

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

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identifier: https://pubmed.ncbi.nlm.nih.gov/38584159, https://www.ncbi.nlm.nih.gov/pmc//PMC11150153, https://doi.org/10.1038/s41440-024-01658-y, pii/10.1038/s41440-024-01658-y

relatedIdentifier: https://clinicaltrials.gov/NCT03640312

Titles

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Efficacy and safety of a four-drug, quarter-dose treatment for hypertension: the QUARTET USA randomized trial.

Abstracts

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New approaches are needed to lower blood pressure (BP) given persistently low control rates. QUARTET USA sought to evaluate the effect of four-drug, quarter-dose BP lowering combination in patients with hypertension. QUARTET USA was a randomized (1:1), double-blinded trial conducted in federally qualified health centers among adults with hypertension. Participants received either a quadpill of candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg or candesartan 8 mg for 12 weeks. If BP was >130/>80 mm Hg at 6 weeks in either arm, then participants received open label add-on amlodipine 5 mg. The primary outcome was mean change in systolic blood pressure (SBP) at 12 weeks, controlling for baseline BP. Secondary outcomes included mean change in diastolic blood pressure (DBP), and safety included serious adverse events, relevant adverse drug effects, and electrolyte abnormalities. Among 62 participants randomized between August 2019-May 2022 (n = 32 intervention, n = 30 control), mean (SD) age was 52 (11.5) years, 45% were female, 73% identified as Hispanic, and 18% identified as Black. Baseline mean (SD) SBP was 138.1 (11.2) mmHg, and baseline mean (SD) DBP was 84.3 (10.5) mmHg. In a modified intention-to-treat analysis, there was no significant difference in SBP (-4.8 mm Hg [95% CI: -10.8, 1.3, p = 0.123] and a -4.9 mmHg (95% CI: -8.6, -1.3, p = 0.009) greater mean DBP change in the intervention arm compared with the control arm at 12 weeks. Adverse events did not differ significantly between arms. The quadpill had a similar SBP and greater DBP lowering effect compared with candesartan 8 mg. Trial registration number: NCT03640312.

© 2024. The Author(s).

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title: Hypertension research : official journal of the Japanese Society of Hypertension

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