Evidence map›Paper›PMID 25693859›Full record

Trial reportHypertension research : official journal of the Japanese Society of Hypertension2015

Safety and efficacy of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Japanese patients with hypertension and renal dysfunction.

Sadayoshi Ito, Minoru Satoh, Yuko Tamaki, Hiromi Gotou, Alan Charney, Naoko Okino, Mizuki Akahori, Jack Zhang

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Hypertension research : official journal of the Japanese Society of Hypertension, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01593787 (A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction), which is not on this map. Cited by 58 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 3 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.

NCT01593787 phase3completednot on this map

A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction

TypeinterventionalSponsorNovartis PharmaceuticalsRan2012 to 2013Enrolled32ConditionsHypertension With Renal DysfunctionArmsLCZ696
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Angiotensin receptor neprilysin inhibitor for the treatment of hypertension: a systematic review and meta-analysis.Hypertension research : official journal of the Japanese Society of Hypertension · 2026
    Pooled it
  2. The Japanese Society of Hypertension Guidelines for the management of elevated blood pressure and hypertension 2025 (JSH2025).Hypertension research : official journal of the Japanese Society of Hypertension · 2026
    Guideline
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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

8 authors.

Sadayoshi ItoDivision of Nephrology, Endocrinology and Vascular Medicine, Tohoku University Hospital, Miyagi, Japan.
Minoru SatohKawasaki Medical School Hospital, Okayama, Japan.
Yuko TamakiNovartis Pharma K.K., Tokyo, Japan.
Hiromi GotouNovartis Pharma K.K., Tokyo, Japan.
Alan CharneyNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Naoko OkinoNovartis Pharma K.K., Tokyo, Japan.
Mizuki AkahoriNovartis Pharma K.K., Tokyo, Japan.
Jack ZhangNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This 8-week, multi-center, open-label study assessed the safety and efficacy of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Japanese patients with hypertension and renal dysfunction. Patients (n=32) with mean sitting systolic blood pressure (msSBP) ⩾140 mm Hg (after a 2-5-week washout of previous antihypertensive medications) and estimated glomerular filtration rate (eGFR) ⩾15 and <60 ml min(-1) 1.73 m(-2) received LCZ696 100 mg with an optional titration to 200 and 400 mg in a sequential manner starting from Week 2 in patients with inadequate BP control (msSBP ⩾130 mm Hg and mean sitting diastolic blood pressure (msDBP) ⩾80 mm Hg) and without safety concerns. Safety was assessed by monitoring and recording all adverse events (AEs) and change in potassium and creatinine. Efficacy was assessed as change from baseline in msSBP/msDBP. The mean baseline BP was 151.6/86.9 mm Hg, urinary albumin/creatinine ratio (UACR) geometric mean was 7.3 mg mmol(-1) and eGFR was ⩾30 and <60 in 25 (78.1%) patients and was ⩾15 and <30 in 7 (21.9%) patients. Fourteen (43.8%) patients reported at least one AE, which were mild in severity. No severe AEs or deaths were reported. There were no clinically meaningful changes in creatinine, potassium, blood urea nitrogen and eGFR. The geometric mean reduction in UACR was 15.1%, and the mean reduction in msSBP and msDBP was 20.5±11.3 and 8.3±6.3 mm Hg, respectively, from baseline to Week 8 end point. LCZ696 was generally safe and well tolerated and showed effective BP reduction in Japanese patients with hypertension and renal dysfunction without a decline in renal function.

Indexed as

AgedAminobutyratesAngiotensin Receptor AntagonistsAntihypertensive AgentsAsian PeopleBiphenyl CompoundsBlood PressureDose-Response Relationship, DrugDrug CombinationsFemaleGlomerular Filtration RateHumansHypertensionKidney DiseasesKidney Function TestsMaleAminobutyratesAngiotensin Receptor AntagonistsAntihypertensive AgentsBiphenyl CompoundsDrug CombinationsNeprilysinsacubitril and valsartan sodium hydrate drug combinationTetrazolesValsartan

Identifiers

PMID25693859
PMCPMC4396400

What OpenQuestion holds

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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.