Type

Journal Article

Authors

Peter J Kelly
Cathal D Walsh
Killian E T O'Rourke

Subjects

Medicine & Nursing

Topics
bayes theorem prospective studies united states national institute male drug therapy tissue plasminogen activator stroke aged follow up studies neurological disorders injections intravenous fibrinolytic agents humans middle aged administration dosage registries adverse effects treatment outcome female therapeutic use

Safety and efficacy of IV-TPA for ischaemic stroke in clinical practice--a Bayesian analysis. (2009)

Abstract Observational studies of new treatments in routine practice are clinically important but may be limited by bias. We used a Bayesian approach to interpret and sequentially combine phase 4 studies of IV-TPA within 3 h for acute ischaemic stroke to quantify the cumulative evidence for the efficacy and safety of this therapy in clinical practice. Prior probability distributions for favourable outcome (modified Rankin Score, mRS, 0-1), symptomatic intracerebral haemorrhage, and mortality 3 months after IV-TPA were derived from the NINDS trial. Phase 4 studies from observational case series and from regulator-mandated large registries were included. A cumulative analysis was performed to quantify the increase in the total evidence base over time, unadjusted and adjusted for potential bias. The cumulative analysis indicated that IV-TPA <3 h was associated with 3-month favourable outcome in 37.1% (95% credible interval, CrI, 36.1-38.0%, n = 9,578) compared to 26% (95% confidence interval, CI, 19.6-32.9%, n = 165) in placebo-treated patients in NINDS, symptomatic intracranial haemorrhage in 6.6% (95% CrI 5.9-7.4%, n = 10, 834) compared to 6.4% (95% CI 4.0-9.4%) in the NINDS IV-TPA group, and 3-month mortality in 13.6% (95% CrI 12.6-14.8%, n = 9, 901) compared to 20.5% (95% CI 16.0-25.0%, n = 312) in the NINDS placebo group. A Bayesian approach provides further confirmatory evidence of the efficacy and safety of IV-TPA for treatment of acute ischaemic stroke within 3 h in diverse clinical practice settings, after adjusting for potential observational bias.
Collections Ireland -> University College Dublin -> PubMed

Full list of authors on original publication

Peter J Kelly, Cathal D Walsh, Killian E T O'Rourke

Experts in our system

1
Peter J Kelly
University College Dublin
Total Publications: 48
 
2
Cathal Walsh
University of Limerick
Total Publications: 109