Evidence map›Paper›PMID 25144296›Full record

Trial reportJournal of hypertension2014

Nifedipine plus candesartan combination increases blood pressure control regardless of race and improves the side effect profile: DISTINCT randomized trial results.

Sverre E Kjeldsen, Domenic Sica, Hermann Haller, Gloria Cha, Blas Gil-Extremera, Peter Harvey, Frank Heyvaert, Andrew J Lewin, Giuseppe Villa, Giuseppe Mancia and 1 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of hypertension, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.4field-weighted citation impact, top 18% 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

8 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Observational
  7. Follow-up of Antihypertensive Therapy Improves Blood Pressure Control: Results of HYT (HYperTension survey) Follow-up.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2017
    Article
  8. Observational
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

11 authors at 10 institutions in 9 countries.

Sverre E KjeldsenaOslo University Hospital Ullevaal, University of Oslo, Oslo, Norway bVirginia Commonwealth University, Richmond, Virginia, USA cHannover Medical School, Hannover, Germany dKRK Medical Research Institute, Dallas, Texas, USA eHospital Universitario San Cecilio, Granada, Spain fThe Crouch Oak Family Practice, Surrey, UK gHuisartsenpraktijk De Regenboog, Antwerp, Belgium hNational Research Institute, Los Angeles, California, USA iFondazione S. Maugeri - IRCCS, Pavia jUniversity of Milano-Bicocca, Milan, Italy.
Domenic Sica
Hermann Haller
Gloria Cha
Blas Gil-Extremera
Peter Harvey
Frank Heyvaert
Andrew J Lewin
Giuseppe Villa
Giuseppe Mancia
DISTINCT Investigators
Fondazione Salvatore Maugeri · ITGouverneur Kinsbergencentrum · BEInstituto de Investigación Biosanitaria de Granada · ESIRCCS Istituto Auxologico Italiano · ITKrirk University · THMedizinische Hochschule Hannover · DENational Research Institute · USUniversity of Oslo · NOVirginia Commonwealth University · USWikimedia UK · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesDISTINCT (reDefining Intervention with Studies Testing Innovative Nifedipine GITS - Candesartan Therapy) aimed to determine the dose-response and tolerability of nifedipine GITS and/or candesartan cilexetil therapy in participants with hypertension.

methodsIn this 8-week, multinational, multicentre, randomized, double-blind, placebo-controlled study, adults with mean seated DBP of at least 95 to less than 110 mmHg received combination or monotherapy with nifedipine GITS (N) 20, 30 or 60 mg and candesartan cilexetil (C) 4, 8, 16 or 32 mg, or placebo. The primary endpoint, change in DBP from baseline to Week 8, was analysed using the response surface model (RSM); this analysis was repeated for mean seated SBP.

resultsOverall, 1381 participants (mean baseline SBP/DBP: 156.5/99.6 mmHg) were randomized. Both N and C contributed independently to SBP/DBP reductions [P < 0.0001 (RSM)]. A positive dose-response was observed, with all combinations providing statistically better blood pressure (BP) reductions from baseline versus respective monotherapies (P < 0.05) and N60C32 achieving the greatest reduction [-23.8/-16.5 mmHg; P < 0.01 versus placebo (-5.3/-6.7 mmHg) and component monotherapies]. Even very low-dose (N20 and C4) therapy provided significant BP-lowering, and combination therapy was similarly effective in different racial groups. N/C combination demonstrated a lower incidence of vasodilatory adverse events than N monotherapy (18.3 versus 23.6%), including headache (5.5 versus 11.0%; P = 0.003, chi-square test) and peripheral oedema over time (3.6 versus 5.8%; n.s.).

conclusionN/C combination was effective in participants with hypertension and showed an improved side effect profile compared with N monotherapy.

Indexed as

Administration, OralAgedAntihypertensive AgentsBenzimidazolesBiphenyl CompoundsBlood PressureDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsDrug Therapy, CombinationEthnicityFemaleHumansHypertensionMaleMiddle AgedNifedipineAntihypertensive AgentsBenzimidazolesBiphenyl Compoundscandesartancandesartan cilexetilNifedipineTetrazoles

Identifiers

PMID25144296
PMCPMC4227617
OpenAlexW1993914845

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.