Evidence map›Paper›PMID 26829251›Full record

Trial reportJournal of clinical pharmacology2016

Nifedipine GITS/Candesartan Combination Therapy Lowers Blood Pressure Across Different Baseline Systolic and Diastolic Blood Pressure Categories: DISTINCT Study Subanalyses.

Sverre E Kjeldsen, Gloria Cha, Giuseppe Villa, Giuseppe Mancia, DISTINCT Investigators

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

Trial report in Journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01303783 (A Multicenter, Multifactorial, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of Nifedipine GITS and Candesartan in Combination Compared to Monotherapy in Adult Patients With Essential Hypertension), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 40% 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.

NCT01303783 phase2completednot on this map

A Multicenter, Multifactorial, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of Nifedipine GITS and Candesartan in Combination Compared to Monotherapy in Adult Patients With Essential Hypertension

TypeinterventionalSponsorBayerRan2011 to 2012Enrolled1,381ConditionsHypertension, EssentialArmsCandesartan cilexetil (Atacand), 4 mg, Candesartan cilexetil (Atacand), 8 mg, Nifedipine GITS (Adalat, BAYA1040), 20 mg, Nifedipine GITS (Adalat, BAYA1040), 30 mg, Nifedipine GITS (Adalat, BAYA1040), 60 mg
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Trial
  2. 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

5 authors at 5 institutions in 3 countries.

Sverre E KjeldsenOslo University Hospital Ullevaal, University of Oslo, Oslo, Norway.
Gloria ChaKRK Medical Research Institute, Dallas, Texas, USA.
Giuseppe VillaFondazione S. Maugeri-IRCCS, Pavia, Italy.
Giuseppe ManciaUniversity of Milano-Bicocca, IRCCS Istituto Auxologico Italiano, Milan, Italy.
DISTINCT Investigators
Fondazione Salvatore Maugeri · ITOslo University Hospital · NOResearch Institute of Dallas · USUniversity of Milano-Bicocca · ITUniversity of Oslo · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

DISTINCT was an 8-week, double-blind, randomized study to investigate the antihypertensive efficacy and safety of various nifedipine gastrointestinal treatment system (GITS)/candesartan cilexetil (N/C) dose combinations, vs respective monotherapies or placebo, in patients with diastolic blood pressure (DBP) ≥95 to <110 mm Hg. The current prespecified analysis compared BP reduction in participants with mild vs moderate baseline hypertension (ie, systolic [S]BP <160 mm Hg vs ≥160 mm Hg and DBP <100 mm Hg vs ≥100 mm Hg). A total of 1362 patients were analyzed by descriptive statistics. In all patient subgroups investigated, the NC combinations (ie, N: 20, 30, or 60 mg; C: 4, 8, 16, or 32 mg daily) provided greater SBP and DBP lowering and higher rates of BP control (defined as BP <140/90 mm Hg) than respective monotherapies or placebo, with greatest absolute BP reductions observed in the moderately elevated SBP or DBP subgroups. A trend to dose-response relationship was observed in each subgroup. In each SBP and DBP subgroup, treatment-related vasodilatory events (flushing, headache, or edema) were less frequent for patients receiving NC combination therapy than N monotherapy. These analyses support the use of calcium antagonist and angiotensin receptor blocker combination therapy in patients with both mild and moderate hypertension, for whom effective BP normalization and good drug tolerance would greatly reduce the risk of cardiovascular events.

Indexed as

AdultAgedAntihypertensive AgentsBenzimidazolesBiphenyl CompoundsBlood PressureCalcium Channel BlockersDouble-Blind MethodDrug Therapy, CombinationFemaleHumansHypertensionInternationalityMaleMiddle AgedNifedipineAntihypertensive AgentsBenzimidazolesBiphenyl CompoundsCalcium Channel Blockerscandesartan cilexetilNifedipineTetrazolescandesartan cilexetilcombination therapyDISTINCT studyessential hypertensionnifedipine GITSvasodilatory side effects

Identifiers

PMID26829251
PMCPMC5111757
OpenAlexW2277301759

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.