Abstract | BACKGROUND: OBJECTIVES: The objective of this review is to assess the effectiveness and safety of lubeluzole given in the acute phase of acute ischaemic stroke. SEARCH STRATEGY: The Cochrane Stroke Group trials register was searched. Additional searches of Cochrane Controlled Trials Register (CENTRAL/CCTR), Medline, Embase, Pascal BioMed (1996-2001) and Current Contents CCSearch reg 7 Editions (1996-2001) were made to supplement the Stroke Group general strategy. We contacted Janssen Research Foundation to identify further studies. SELECTION CRITERIA: All randomised unconfounded trials comparing intravenous lubeluzole with placebo or open control in patients with a clinical syndrome definitely considered as an acute stroke in whom CT scanning showed an infarct or was normal. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion, assessed trial quality and extracted the data. MAIN RESULTS: Five trials involving a total of 3,510 patients were included. The quality of the trials did not vary considerably. Sensitivity/subgroups analysis was not completely performed because of lack of data. Lubeluzole given at the doses of 5, 10 and 20 mg/day for 5 days was tested against a placebo-control group. There was no evidence that Lubeluzole given at any dose either reduced the odds of death from all causes (OR=0.93, 95% CI 0.79-1.09) or reduced the odds of being dead or dependent at the end of follow-up (OR=1.04, 95% CI 0.91-1.19). On the other hand, given at any dose, Lubeluzole was associated with a significant excess of heart-conduction disorders (Q-T prolonged > 450 msec) at the end of follow-up (OR=1.43, 95% CI 1.09-1.87). REVIEWER'S CONCLUSIONS:
Lubeluzole, given in the acute phase of ischaemic stroke, is not associated with a significant reduction of death or dependency at the end of scheduled follow-up period but seems to be associated with a significant increase of heart-conduction disorders (Q-T prolonged >450 msec).
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Authors | C Gandolfo, P Sandercock, M Conti |
Journal | The Cochrane database of systematic reviews
(Cochrane Database Syst Rev)
Issue 1
Pg. CD001924
( 2002)
ISSN: 1469-493X [Electronic] England |
PMID | 11869612
(Publication Type: Journal Article, Review, Systematic Review)
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Chemical References |
- Neuroprotective Agents
- Piperidines
- Thiazoles
- lubeluzole
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Topics |
- Acute Disease
- Brain Ischemia
(drug therapy)
- Humans
- Neuroprotective Agents
(therapeutic use)
- Piperidines
(therapeutic use)
- Thiazoles
(therapeutic use)
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