Evidence map›Paper›PMID 25716649›Full record

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

Add-on effect of hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension uncontrolled with losartan 50 mg and amlodipine 5 mg.

Hiromi Rakugi, Takuya Tsuchihashi, Kazuyuki Shimada, Hirotaka Numaguchi, Chisato Nishida, Hiroya Yamaguchi, Masayoshi Shirakawa, Kyoichi Azuma, Kenji P Fujita

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed 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 NCT01302691 (A Phase III, Randomized, Active-Comparator Controlled Clinical Trial to Study the Efficacy and Safety of MK-0954E in Japanese Patients With Essential Hypertension Uncontrolled With Losartan and Amlodipine Co-administration), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 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.

NCT01302691 phase3completednot on this map

A Phase III, Randomized, Active-Comparator Controlled Clinical Trial to Study the Efficacy and Safety of MK-0954E in Japanese Patients With Essential Hypertension Uncontrolled With Losartan and Amlodipine Co-administration

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2011 to 2012Enrolled327ConditionsHypertensionArmslosartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E), Losartan potassium, Amlodipine besylate, Placebo to MK-0954E, Placebo to losartan potassium
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Antihypertensive medication and risk of kidney stones: a Canadian wake-up call.Hypertension research : official journal of the Japanese Society of Hypertension · 2017
    Article
  8. Sacubitril/valsartan in the treatment of arterial hypertension: an unaccomplished promise?Hypertension research : official journal of the Japanese Society of Hypertension · 2017
    Article
  9. Are diuretic additives fit for uncontrolled hypertensive patients receiving telmisartan and amlodipine treatment?Hypertension research : official journal of the Japanese Society of Hypertension · 2017
    Article
  10. Current prescription status of antihypertensive drugs with special reference to the use of diuretics in Japan.Hypertension research : official journal of the Japanese Society of Hypertension · 2017
    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

9 authors.

Hiromi RakugiDepartment of Geriatric Medicine and Nephrology, Osaka University Graduate School of Medicine, Suita, Japan.
Takuya TsuchihashiHypertension Center, Steel Memorial Yawata Hospital, Kitakyushu, Japan.
Kazuyuki ShimadaDepartment of Internal Medicine and Cardiology, Shin-Oyama City Hospital, Oyama, Japan.
Hirotaka NumaguchiMSD K.K., Tokyo, Japan.
Chisato NishidaMSD K.K., Tokyo, Japan.
Hiroya YamaguchiMSD K.K., Tokyo, Japan.
Masayoshi ShirakawaMSD K.K., Tokyo, Japan.
Kyoichi AzumaMSD K.K., Tokyo, Japan.
Kenji P FujitaMerck & Co., Inc., Kenilworth, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study assessed the antihypertensive efficacy of a triple combination, fixed-dose therapy of losartan 50 mg (L50)/hydrochlorothiazide 12.5 mg (H12.5)/amlodipine 5 mg (A5) versus co-administration of L50 plus A5 (L50+A5) in Japanese subjects with uncontrolled essential hypertension. Initially, all subjects received single-blind treatment with L50+A5 for 8 weeks. Subjects whose blood pressure (BP) remained stable within pre-specified limits during the last 4 weeks of L50+A5 administration were randomized (n =3 27) to double-blind treatment with L50/H12.5/A5 or L50+A5 for 8 weeks. Primary and secondary efficacy endpoints were mean change from baseline to Week 8 in trough diastolic BP (DBP) and trough systolic BP (SBP), respectively. Safety was assessed throughout the study. The treatment difference for L50/H12.5/A5 versus L50+A5 in mean change from baseline in DBP at Week 8 was -1.1 mm Hg (95% confidence interval (CI) -2.7, 0.6; P = 0.205). However, the treatment difference in mean change from baseline in SBP at Week 8 was -3.2 mm Hg (95% CI: -5.7, -0.8; P=0.011). A chance imbalance in the change in DBP before randomization between groups was identified in a post-hoc analysis as a major reason for the smaller-than-expected difference in DBP between groups. The overall safety profile was generally similar between groups. In conclusion, treatment with L50/H12.5/A5 for 8 weeks did not demonstrate a significant difference in DBP reduction, but demonstrated a nominally significant difference in SBP reduction, compared with L50+A5. L50/H12.5/A5 was well tolerated. (ClinicalTrials.gov identifier NCT01302691.).

Indexed as

AdultAgedAged, 80 and overAmlodipineAntihypertensive AgentsBlood PressureDouble-Blind MethodDrug Therapy, CombinationEssential HypertensionFemaleHumansHydrochlorothiazideHypertensionJapanLosartanMaleAmlodipineAntihypertensive AgentsHydrochlorothiazideLosartan

Identifiers

PMID25716649

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.