Evidence map›Paper›PMID 19458624›Full record

Trial reportJournal of human hypertension2010

Maintenance of blood-pressure-lowering effect following a missed dose of aliskiren, irbesartan or ramipril: results of a randomized, double-blind study.

P Palatini, W Jung, E Shlyakhto, J Botha, C Bush, D L Keefe

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of human hypertension, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00343551 (A Nine-week, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren 300 mg Compared to Irbesartan 300 mg and Ramipril 10 mg in the Setting of a Missed Dose in Patients With Essential Hypertension), which is not on this map. Cited by 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
7.1field-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.

NCT00343551 phase3completednot on this map

A Nine-week, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren 300 mg Compared to Irbesartan 300 mg and Ramipril 10 mg in the Setting of a Missed Dose in Patients With Essential Hypertension

TypeinterventionalSponsorNovartisRan2006Enrolled654ConditionsEssential HypertensionArmsAliskiren
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 63 citations in OpenAlex.

  1. Pooled it
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  9. How drug onset rate and duration of action affect drug forgiveness.Journal of pharmacokinetics and pharmacodynamics · 2024
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  15. Observational
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  19. Direct renin inhibition: from pharmacological innovation to novel therapeutic opportunities.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2011
    Review
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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

6 authors at 5 institutions in 5 countries.

P PalatiniDepartment of Clinical and Experimental Medicine, University of Padova, Padova, Italy. palatini@unipd.it
W Jung
E Shlyakhto
J Botha
C Bush
D L Keefe
Novartis (United States) · USInstitute of Cardiology · RUNephrologisches Zentrum Villingen-Schwenningen · DENovartis (Switzerland) · CHUniversity of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Most patients inadvertently miss an occasional dose of antihypertensive therapy, and hence drugs that provide sustained blood-pressure (BP) reduction beyond the 24-h dosing interval are desirable. The primary objective of this study was to compare the 24-h mean ambulatory BP reductions from baseline after a simulated missed dose of the direct renin inhibitor aliskiren, irbesartan or ramipril. In this double-blind study, 654 hypertensive patients (24-h mean ambulatory diastolic BP (MADBP) >or=85 mm Hg) were randomized 1:1:1 to once-daily aliskiren 150 mg, irbesartan 150 mg or ramipril 5 mg. Doses were doubled after 2 weeks. At day 42, patients were again randomized equally within each group to receive 1 day of placebo ('missed dose') on either day 42 or day 49. Patients with a successful 24-h ambulatory BP measurement at baseline and on day 42/49 were included in the analyses. The 24-h mean ambulatory systolic BP (MASBP)/MADBP reductions from baseline after a missed dose of aliskiren 300 mg (9.3/7.0 mm Hg) were similar to irbesartan 300 mg (9.5/7.3 mm Hg) and significantly larger than ramipril 10 mg (7.1/5.0 mm Hg, P<or=0.008). Loss of BP-lowering effect with aliskiren in the 24 h after a missed dose (1.0/0.7 mm Hg for 24-48-h vs 0-24-h MASBP/MADBP) was significantly lower than with irbesartan (3.6/2.2 mm Hg, P<0.01) or ramipril (4.0/2.6, P<0.0001). This equates to maintenance of 91/91% of the MASBP/MADBP-lowering effect with aliskiren, greater than irbesartan (73/77%) or ramipril (64/65%). The incidence of adverse events was similar across treatments (32.9-36.0%), although ramipril treatment was associated with an increased incidence of cough (ramipril, 6.1%; aliskiren, 0.5%; irbesartan, 1.8%). Aliskiren 300 mg provided a sustained BP-lowering effect beyond the 24-h dosing interval, with a significantly smaller loss of BP-lowering effect in the 24-48 h period after dose than irbesartan 300 mg or ramipril 10 mg.

Indexed as

Medication AdherenceAdultAgedAmidesAngiotensin-Converting Enzyme InhibitorsAngiotensin II Type 1 Receptor BlockersAntihypertensive AgentsBiphenyl CompoundsBlood PressureBlood Pressure Monitoring, AmbulatoryBrazilCanadaDouble-Blind MethodDrug Administration ScheduleEuropeFemalealiskirenAmidesAngiotensin-Converting Enzyme InhibitorsAngiotensin II Type 1 Receptor BlockersAntihypertensive AgentsBiphenyl CompoundsFumaratesIrbesartanRamiprilTetrazoles

Identifiers

PMID19458624
OpenAlexW2062244847

What OpenQuestion holds

Textmetadata
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.