Evidence mapPaperPMID 26817604Full record

Trial reportClinical and experimental hypertension (New York, N.Y. : 1993)2016

Safety and tolerability of azilsartan medoxomil in subjects with essential hypertension: a one-year, phase 3, open-label study.

Alison Handley, Eric Lloyd, Andrew Roberts, Bruce Barger

Abstract readClinical Trial, Phase III
In one paragraph

Trial report in Clinical and experimental hypertension (New York, N.Y. : 1993), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
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.

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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
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

4 authors.

Alison Handleya Takeda Pharmaceuticals International, Inc. , Deerfield , IL , USA and.
Eric Lloydb Takeda Development Center Americas, Inc. , Deerfield , IL , USA .
Andrew Robertsb Takeda Development Center Americas, Inc. , Deerfield , IL , USA .
Bruce Bargerb Takeda Development Center Americas, Inc. , Deerfield , IL , USA .

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This 56-week phase 3, open-label, treat-to-target study, involving 2 consecutive, non-randomized cohorts, evaluated the safety and tolerability of azilsartan medoxomil (AZL-M) in essential hypertension (mean baseline blood pressure [BP] 152/100 mmHg). All subjects (n = 669) initiated AZL-M 40 mg QD, force-titrated to 80 mg QD at week 4, if tolerated. From week 8, subjects could receive additional medications, starting with chlorthalidone (CLD) 25 mg QD (Cohort 1) or hydrochlorothiazide (HCTZ) 12.5-25 mg QD (Cohort 2), if required, to reach BP targets. Adverse events (AEs) were reported in 75.9% of subjects overall in the two cohorts (73.8% Cohort 1, 78.5% Cohort 2). The most common AEs were dizziness (14.3%), headache (9.9%) and fatigue (7.2%). Transient serum creatinine elevations were more frequent with add-on CLD. Clinic systolic/diastolic BP (observed cases at week 56) decreased by 25.2/18.4 mmHg (Cohort 1) and 24.2/17.9 mmHg (Cohort 2). These results demonstrate that AZL-M is well tolerated over the long term and provides stable BP improvements when used in a treat-to-target BP approach with thiazide-type diuretics.

Indexed as

AdultAgedBenzimidazolesChlorthalidoneCohort StudiesDizzinessDrug Therapy, CombinationEssential HypertensionFatigueFemaleHeadacheHumansHydrochlorothiazideHypertensionMaleMiddle Agedazilsartan medoxomilBenzimidazolesChlorthalidoneHydrochlorothiazideOxadiazolesSodium Chloride Symporter Inhibitorsangiotensin receptor blockerazilsartanchlorthalidonediuretichydrochlorothiazideHypertension

Identifiers

PMID26817604
PMCPMC4819839

What Socratic holds

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LicenceCC BY-NC-ND
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.