Evidence map›Paper›PMID 25653536›Full record

Observational studyVascular health and risk management2015

Real-world effectiveness of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide in high-risk patients and other subgroups.

Samir Helmy Assaad-Khalil, Robert Najem, Jorge Sison, Asad Riaz Kitchlew, Belong Cho, Kwo-Chang Ueng, Shelley DiTommaso, Abhijit Shete

Open access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Vascular health and risk management, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 27% 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

1 citing paper in PubMed, 8 citations in OpenAlex.

  1. Trial
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

8 authors at 7 institutions in 7 countries.

Samir Helmy Assaad-KhalilDepartment of Diabetology, Lipidology and Metabolism, Alexandria Faculty of Medicine, Alexandria University, Alexandria, Egypt.
Robert NajemLebanese University Hospital, Beirut, Lebanon.
Jorge SisonMedical Center Manila, Manila, Philippines.
Asad Riaz KitchlewPakistan Institute of Medical Sciences, Islamabad, Pakistan.
Belong ChoSeoul National University College of Medicine, Seoul, South Korea.
Kwo-Chang UengChung Shan Medical University Hospital, Taichung City, Taiwan.
Shelley DiTommasoNovartis Pharma AG, Basel, Switzerland.
Abhijit SheteNovartis Pharma AG, Basel, Switzerland.
Novartis (Switzerland) · CHAlexandria University · EGChung Shan Medical University · TWJosé R. Reyes Memorial Medical Center · PHLebanese University · LBPakistan Institute of Medical Sciences · PKSeoul National University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe clinical EXCITE (EXperienCe of amlodIpine and valsarTan in hypErtension) study reported clinically relevant blood pressure (BP) reductions across all doses of amlodipine/valsartan (Aml/Val) and Aml/Val/hydrochlorothiazide (HCT) single-pill combinations. The study prospectively observed a multiethnic population of hypertensive patients for 26 weeks who were treated according to routine clinical practice. Here, we present the results in high-risk subgroups including the elderly, obese patients, and patients with diabetes or isolated systolic hypertension. In addition, we present a post hoc analysis as per prior antihypertensive monotherapy and dual therapy.

methodsPatients prescribed Aml/Val or Aml/Val/HCT were assessed in this 26±8 week, noninterventional, multicenter study across 13 countries in the Middle East and Asia. Changes in mean sitting systolic BP, mean sitting diastolic BP, and overall safety were assessed.

resultsOf a total of 9,794 patients analyzed, 8,603 and 1,191 patients were prescribed Aml/Val and Aml/Val/HCT, respectively. Among these, 15.5% were elderly, 32.5% were obese, 31.3% had diabetes, and 9.8% had isolated systolic hypertension. Both Aml/Val and Aml/Val/HCT single-pill combinations, respectively, were associated with clinically relevant and significant mean sitting systolic/diastolic BP reductions across all subgroups: elderly patients (-32.2/-14.3 mmHg and -38.5/-16.5 mmHg), obese patients (-32.2/-17.9 mmHg and -38.5/-18.4 mmHg), diabetic patients (-30.3/-16.1 mmHg and -34.4/-16.6 mmHg), and patients with isolated systolic hypertension (-25.5/-4.1 mmHg and -30.2/-5.9 mmHg). Incremental BP reductions with Aml/Val or Aml/Val/HCT single-pill combinations were also observed in patients receiving prior monotherapy or dual therapy for hypertension. Overall, both Aml/Val and Aml/Val/HCT were generally well tolerated.

conclusionThis large, multiethnic study supports the evidence that Aml/Val and Aml/Val/ HCT single-pill combinations are effective in diverse and clinically important subgroups of patients with hypertension.

Indexed as

Administration, OralAdultAgedAmlodipineAngiotensin II Type 1 Receptor BlockersAntihypertensive AgentsAsiaBlood PressureCalcium Channel BlockersDrug CombinationsFemaleHumansHydrochlorothiazideHypertensionMaleMiddle AgedAmlodipineAngiotensin II Type 1 Receptor BlockersAntihypertensive AgentsCalcium Channel BlockersDrug CombinationsHydrochlorothiazideTabletsTetrazolesValineValsartanamlodipinehydrochlorothiazidereal worldsingle-pill combinationsvalsartan

Identifiers

PMID25653536
PMCPMC4309775
OpenAlexW2041252917

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.