Evidence map›Paper›PMID 19190658›Full record

Trial reportJournal of human hypertension2009

Efficacy and safety of initial combination therapy with amlodipine/valsartan compared with amlodipine monotherapy in black patients with stage 2 hypertension: the EX-STAND study.

J M Flack, D A Calhoun, L Satlin, M Barbier, R Hilkert, P Brunel

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of human hypertension, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00353912 (A 12-week, Multicenter Study to Evaluate the Efficacy and Safety of Orally Administered Valsartan/Amlodipine Combo Based Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension), which is not on this map. Cited by 26 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 3 pooled it
7.6field-weighted citation impact, top 2% 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.

NCT00353912 phase3completednot on this map

A 12-week, Multicenter Study to Evaluate the Efficacy and Safety of Orally Administered Valsartan/Amlodipine Combo Based Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension

TypeinterventionalSponsorNovartisRan2006 to 2007Enrolled571ConditionsHypertensionArmsvalsartan + amlodipine
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 3 syntheses or guidelines pooled it, 80 citations in OpenAlex.

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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

6 authors at 4 institutions in 2 countries.

J M FlackDepartment of Internal Medicine, Wayne State University School of Medicine, Detroit, MI 48201, USA. jflack@med.wayne.edu
D A Calhoun
L Satlin
M Barbier
R Hilkert
P Brunel
Novartis (Switzerland) · CHNovartis (United States) · USUniversity of Alabama at Birmingham · USWayne State University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The strategy of initiating hypertension treatment with combination versus single-drug therapy was formally tested in a prospective, double-blind, parallel-group trial in blacks with stage 2 hypertension (mean sitting systolic BP (MSSBP) >or=160 and <200 mm Hg). Participants were randomized equally to amlodipine/valsartan (A/V) (n=286) or amlodipine (A) monotherapy (n=286). After 2 weeks, there was forced titration of A/V 5/160 mg to A/V 10/160 mg and of A 5 to A 10 mg followed by 10 additional weeks of treatment. If SBP was >or=130 mm Hg at week 4, the protocol allowed optional titration of A/V to the 10/320 mg dose and, at week 8, hydrochlorothiazide 12.5 mg was optionally added to both A/V and A if SBP >or=130 mm Hg. Amlodipine/valsartan at week 8 lowered MSSBP last observation carried forward significantly>A (33.3 vs 26.6 mm Hg, P<0.0001). Lowering of MSSBP with A/V significantly exceeded that of A in several specified subgroups-the elderly (>or=65 years), isolated systolic hypertension, and those with body mass index (BMI) >or=30 kg/m(2). More patients treated with A/V than A achieved BP control (<140/90 mm Hg) both at weeks 8 (49.8 vs 30.2%; P<0.0001) and 12 (57.2 vs 35.9%; P<0.0001). Both treatment regimens were well tolerated. In conclusion, the strategy of initiating combination antihypertensive drug therapy in blacks with stage 2 hypertension with amlodipine /valsartan achieves greater and quicker reductions in BP as well as significantly higher BP control rates than starting treatment with amlodipine monotherapy.

Indexed as

AdultAgedAmlodipineAmlodipine, Valsartan Drug CombinationAntihypertensive AgentsBlack PeopleDouble-Blind MethodDrug CombinationsFemaleHumansHydrochlorothiazideHypertensionMaleMiddle AgedTetrazolesAmlodipineAmlodipine, Valsartan Drug CombinationAntihypertensive AgentsDrug CombinationsHydrochlorothiazideTetrazoles

Identifiers

PMID19190658
OpenAlexW2072734363

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.