Evidence map›Paper›PMID 12959631›Full record

SynthesisDrug safety2003

Adverse effects of ACE inhibitors in patients with chronic heart failure and/or ventricular dysfunction : meta-analysis of randomised clinical trials.

Antònia Agustí, Sara Bonet, Josep Maria Arnau, Xavier Vidal, Joan-Ramon Laporte

Registry-linked trialAbstract readMeta-Analysis
PubMed Publisher
In one paragraph

Synthesis in Drug safety, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01409837 (A 5-year Prospective, Placebo-controlled, Crossover Evaluation of the Efficacy and Tolerability of Low-dose Lisinopril in Normotensives With Idiopathic Oligospermic Infertility), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 19% 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.

NCT01409837 phase2completednot on this map

A 5-year Prospective, Placebo-controlled, Crossover Evaluation of the Efficacy and Tolerability of Low-dose Lisinopril in Normotensives With Idiopathic Oligospermic Infertility

TypeinterventionalSponsorUniversity Of Nigeria Teaching HospitalRan1998 to 2006Enrolled33ConditionsOligospermiaArmsLisinopril
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Heart failure.BMJ clinical evidence · 2011
    Pooled it
  2. Heart failure.BMJ clinical evidence · 2010
    Pooled it
  3. Review
  4. Review
  5. Article
  6. Review
  7. Article
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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

5 authors at 3 institutions in 1 country.

Antònia AgustíFundació Institut Català de Farmacologia; Servei de Farmacologia Clínica, Hospital Universitari Vall d'Hebron, and Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Barcelona, Spain.
Sara Bonet
Josep Maria Arnau
Xavier Vidal
Joan-Ramon Laporte
Universitat Autònoma de Barcelona · ESVall d'Hebron Institut de Recerca · ESSociedad Española de Farmacología Clínica · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe evidence-based benefit/risk evaluation of therapeutic interventions in randomised clinical trials should include both the assessment of the benefits and of the adverse outcomes. There is ample evidence that ACE inhibitors improve the symptoms and prognosis of chronic heart failure (CHF) and ventricular dysfunction. However, there is little systematic information on the tolerability and adverse effects associated with their use in these conditions.

objectiveTo estimate the adverse events related to ACE inhibitor use in the treatment of CHF and ventricular dysfunction. DESIGN AND

methodsDescription of adverse events in reports of randomised clinical trials of ACE inhibitors in CHF or ventricular dysfunction was examined, and a meta-analysis was performed. Trials were included if they were placebo- or standard treatment-controlled, and if the treatment duration was at least 8 weeks. Relative risks and their 95% CIs were estimated with a random effects model.

resultsOnly 22 (43%) of 51 original reports contained information on the number of withdrawals and their causes. Missing information from the remaining 29 trials was obtained from the authors. The weighted mean duration of treatment was 100.2 weeks. After excluding administrative reasons, heart failure, myocardial infarction and hypertension, the withdrawal rates attributed to adverse events were 13.8% and 9.4% for the ACE inhibitor and control groups, respectively (RR = 1.54 [95% CI 1.30-1.83]; weighted difference = 3.1 per 100 treated patients [95% CI 1.8-4.4]). Cough, hypotension, renal dysfunction, dizziness, hyperkalaemia, and impotence were all significantly more prevalent among patients treated with ACE inhibitors than among those in the control groups.

conclusionsAmong patients with CHF or ventricular dysfunction enrolled in randomised clinical trials, treatment with an ACE inhibitor for an average of 2 years leads to an additional 3% of treatment withdrawals. In a significant proportion of the reports on these randomised clinical trials, information on adverse events leading to treatment withdrawal was inadequate. Proper evidence-based evaluation of the benefit/risk of therapeutic interventions needs a more systematic approach to reporting of adverse events experiences recorded in clinical trials.

Indexed as

Angiotensin-Converting Enzyme InhibitorsFemaleHeart FailureHumansMaleRandomized Controlled Trials as TopicTreatment OutcomeVentricular DysfunctionAngiotensin-Converting Enzyme Inhibitors

Identifiers

PMID12959631
OpenAlexW96309337

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.