Randomised controlled trials of antihypertensive therapy: does exclusion of orthostatic hypotension alter treatment effect? A systematic review and meta-analysis.


Journal

Age and ageing
ISSN: 1468-2834
Titre abrégé: Age Ageing
Pays: England
ID NLM: 0375655

Informations de publication

Date de publication:
01 04 2023
Historique:
received: 28 08 2022
medline: 5 4 2023
entrez: 4 4 2023
pubmed: 5 4 2023
Statut: ppublish

Résumé

Management of antihypertensive therapy is challenging in patients with symptomatic orthostatic hypotension, a population often excluded from randomised controlled trials of antihypertensive therapy. In this systematic review and meta-analysis, we sought to determine whether the association of antihypertensive therapy and adverse events (e.g. falls, syncope), differed among trials that included or excluded patients with orthostatic hypotension. We performed a systematic review and meta-analysis of randomised controlled trials comparing blood pressure lowering medications to placebo, or different blood pressure targets on falls or syncope outcomes and cardiovascular events. A random-effects meta-analysis was used to estimate a pooled treatment-effect overall in subgroups of trials that excluded patients with orthostatic hypotension and trials that did not exclude patients with orthostatic hypotension, and tested P for interaction. The primary outcome was fall events. 46 trials were included, of which 18 trials excluded orthostatic hypotension and 28 trials did not. The incidence of hypotension was significantly lower in trials that excluded participants with orthostatic hypotension (1.3% versus 6.2%, P < 0.001) but not incidences of falls (4.8% versus 8.8%; P = 0.40) or syncope (1.5% versus 1.8%; P = 0.67). Antihypertensive therapy was not associated with an increased risk of falls in trials that excluded (OR 1.00, 95% CI; 0.89-1.13) or included (OR 1.02, 95% CI; 0.88-1.18) participants with orthostatic hypotension (P for interaction = 0.90). The exclusion of patients with orthostatic hypotension does not appear to affect the relative risk estimates for falls and syncope in antihypertensive trials.

Sections du résumé

BACKGROUND AND PURPOSE
Management of antihypertensive therapy is challenging in patients with symptomatic orthostatic hypotension, a population often excluded from randomised controlled trials of antihypertensive therapy. In this systematic review and meta-analysis, we sought to determine whether the association of antihypertensive therapy and adverse events (e.g. falls, syncope), differed among trials that included or excluded patients with orthostatic hypotension.
METHODS
We performed a systematic review and meta-analysis of randomised controlled trials comparing blood pressure lowering medications to placebo, or different blood pressure targets on falls or syncope outcomes and cardiovascular events. A random-effects meta-analysis was used to estimate a pooled treatment-effect overall in subgroups of trials that excluded patients with orthostatic hypotension and trials that did not exclude patients with orthostatic hypotension, and tested P for interaction. The primary outcome was fall events.
RESULTS
46 trials were included, of which 18 trials excluded orthostatic hypotension and 28 trials did not. The incidence of hypotension was significantly lower in trials that excluded participants with orthostatic hypotension (1.3% versus 6.2%, P < 0.001) but not incidences of falls (4.8% versus 8.8%; P = 0.40) or syncope (1.5% versus 1.8%; P = 0.67). Antihypertensive therapy was not associated with an increased risk of falls in trials that excluded (OR 1.00, 95% CI; 0.89-1.13) or included (OR 1.02, 95% CI; 0.88-1.18) participants with orthostatic hypotension (P for interaction = 0.90).
CONCLUSIONS
The exclusion of patients with orthostatic hypotension does not appear to affect the relative risk estimates for falls and syncope in antihypertensive trials.

Identifiants

pubmed: 37014001
pii: 7099147
doi: 10.1093/ageing/afad044
pii:
doi:

Substances chimiques

Antihypertensive Agents 0

Types de publication

Meta-Analysis Systematic Review Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : Wellcome Trust
Pays : United Kingdom

Informations de copyright

© The Author(s) 2023. Published by Oxford University Press on behalf of the British Geriatrics Society.

Auteurs

Catriona Reddin (C)

HRB-Clinical Research Facility, National University of Ireland Galway, Galway D02 V583, Ireland.
Galway University Hospital, Newcastle Road, Galway H91 T861, Ireland.
Wellcome Trust-HRB, Irish Clinical Academic Training, London NW1 2BE, UK.

Robert Murphy (R)

HRB-Clinical Research Facility, National University of Ireland Galway, Galway D02 V583, Ireland.
Galway University Hospital, Newcastle Road, Galway H91 T861, Ireland.

Caoimhe Hanrahan (C)

HRB-Clinical Research Facility, National University of Ireland Galway, Galway D02 V583, Ireland.
Galway University Hospital, Newcastle Road, Galway H91 T861, Ireland.

Elaine Loughlin (E)

HRB-Clinical Research Facility, National University of Ireland Galway, Galway D02 V583, Ireland.
Galway University Hospital, Newcastle Road, Galway H91 T861, Ireland.

John Ferguson (J)

HRB-Clinical Research Facility, National University of Ireland Galway, Galway D02 V583, Ireland.

Conor Judge (C)

HRB-Clinical Research Facility, National University of Ireland Galway, Galway D02 V583, Ireland.
Galway University Hospital, Newcastle Road, Galway H91 T861, Ireland.

Ruairi Waters (R)

HRB-Clinical Research Facility, National University of Ireland Galway, Galway D02 V583, Ireland.
Galway University Hospital, Newcastle Road, Galway H91 T861, Ireland.

Michelle Canavan (M)

HRB-Clinical Research Facility, National University of Ireland Galway, Galway D02 V583, Ireland.
Galway University Hospital, Newcastle Road, Galway H91 T861, Ireland.

Rose Anne Kenny (RA)

Mercer's Institute for Successful Ageing (MISA), St James's Hospital, Dublin D08 X9HD, UK.
Department of Medical Gerontology, Trinity College Dublin, Dublin 2 D02 PN40, Ireland.

Martin O'Donnell (M)

HRB-Clinical Research Facility, National University of Ireland Galway, Galway D02 V583, Ireland.
Galway University Hospital, Newcastle Road, Galway H91 T861, Ireland.

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