Evidence map›Paper›PMID 24496699›Full record

Trial reportBMJ open2014

Rationale and study design of the Prospective comparison of Angiotensin Receptor neprilysin inhibitor with Angiotensin receptor blocker MEasuring arterial sTiffness in the eldERly (PARAMETER) study.

Bryan Williams, John R Cockcroft, Kazuomi Kario, Dion H Zappe, Pamela Cardenas, Allen Hester, Patrick Brunel, Jack Zhang

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01692301 (A Randomized, Double-blind 52-week Study to Evaluate the Safety and Efficacy of an LCZ696 Regimen Compared to an Olmesartan Regimen on Arterial Stiffness Through Assessment of Central Blood Pressure in Elderly Patients With Hypertension), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
7.7field-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.

NCT01692301 phase2completednot on this map

A Randomized, Double-blind 52-week Study to Evaluate the Safety and Efficacy of an LCZ696 Regimen Compared to an Olmesartan Regimen on Arterial Stiffness Through Assessment of Central Blood Pressure in Elderly Patients With Hypertension

TypeinterventionalSponsorNovartis PharmaceuticalsRan2012 to 2015Enrolled454ConditionsHypertensionArmsLCZ696, Olmesartan, LCZ696 matching placebo, Olmesartan matching placebo, amlodipine
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 51 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Review
  6. Review
  7. Article
  8. Hypertension up to date: SPRINT to SPYRAL.Clinical research in cardiology : official journal of the German Cardiac Society · 2017
    Review
  9. Review
  10. Vascular ageing and interventions: lessons and learnings.Therapeutic advances in cardiovascular disease · 2016
    Review
  11. Drug discovery in renin-angiotensin system intervention: past and future.Therapeutic advances in cardiovascular disease · 2016
    Review
  12. Review
  13. Review
  14. Sacubitril/Valsartan.Hospital pharmacy · 2015
    Article
  15. Angiotensin II Receptor Blocker Neprilysin Inhibitor (ARNI): New Avenues in Cardiovascular Therapy.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2015
    Review
  16. Review
  17. Neprilysin inhibition in chronic kidney disease.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2015
    Review
  18. Review
  19. 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

8 authors at 4 institutions in 4 countries.

Bryan WilliamsDepartment of Cardiovascular Sciences and National Institute for Health Research (NIHR) University College London (UCL) Hospitals Biomedical Research Centre, University College London, London, UK.
John R Cockcroft
Kazuomi Kario
Dion H Zappe
Pamela Cardenas
Allen Hester
Patrick Brunel
Jack Zhang
Novartis (United States) · USJichi Medical University · JPNational Institute for Health Research · GBNovartis (Switzerland) · CH

Funding

Medical Research Council MC_PC_13090
6 · The paper itself

Abstract

introductionHypertension in elderly people is characterised by elevated systolic blood pressure (SBP) and increased pulse pressure (PP), which indicate large artery ageing and stiffness. LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor (ARNI), is being developed to treat hypertension and heart failure. The Prospective comparison of Angiotensin Receptor neprilysin inhibitor with Angiotensin receptor blocker MEasuring arterial sTiffness in the eldERly (PARAMETER) study will assess the efficacy of LCZ696 versus olmesartan on aortic stiffness and central aortic haemodynamics. METHODS AND ANALYSIS: In this 52-week multicentre study, patients with hypertension aged ≥60 years with a mean sitting (ms) SBP ≥150 to <180 and a PP>60 mm Hg will be randomised to once daily LCZ696 200 mg or olmesartan 20 mg for 4 weeks, followed by a forced-titration to double the initial doses for the next 8 weeks. At 12-24 weeks, if the BP target has not been attained (msSBP <140 and ms diastolic BP <90 mm Hg), amlodipine (2.5-5 mg) and subsequently hydrochlorothiazide (6.25-25 mg) can be added. The primary and secondary endpoints are changes from baseline in central aortic systolic pressure (CASP) and central aortic PP (CAPP) at week 12, respectively. Other secondary endpoints are the changes in CASP and CAPP at week 52. A sample size of 432 randomised patients is estimated to ensure a power of 90% to assess the superiority of LCZ696 over olmesartan at week 12 in the change from baseline of mean CASP, assuming an SD of 19 mm Hg, the difference of 6.5 mm Hg and a 15% dropout rate. The primary variable will be analysed using a two-way analysis of covariance. ETHICS AND DISSEMINATION: The study was initiated in December 2012 and final results are expected in 2015. The results of this study will impact the design of future phase III studies assessing cardiovascular protection. CLINICAL TRIALS IDENTIFIER: EUDract number 2012-002899-14 and ClinicalTrials.gov NCT01692301.

Indexed as

AgedAminobutyratesAngiotensin II Type 1 Receptor BlockersBiphenyl CompoundsDouble-Blind MethodDrug CombinationsDrug MonitoringFemaleHemodynamicsHumansHypertensionImidazolesMaleMiddle AgedNeprilysinProspective StudiesAminobutyratesAngiotensin II Type 1 Receptor BlockersBiphenyl CompoundsDrug CombinationsImidazolesNeprilysinolmesartansacubitril and valsartan sodium hydrate drug combinationTetrazolesValsartan

Identifiers

PMID24496699
PMCPMC3918996
OpenAlexW2157426398

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.