Browsing by Author "Beridze, M."

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    Baseline characteristics of the 4011 patients recruited into the Efficacy of Nitric Oxide in Stroke' (ENOS) trial.
    (Sage Publications, 2014) Bath, P.M.; Adami, A.; Bereczki, D.; Berge, E.; Beridze, M.; Cala, L.; Casado, A.; Caso, V.; Chang, H.M.; Christensen, H.; Collins, R.; Czlonkowska, A.; Dineen, R.A.; El Etribi, A.; Ghani, A. R.; Gommans, J.; Koumellis, P.; Laska, A. C.; Lees, K. R.; Navarro, J.; Ntaios, G.; Ozturk, S.; Phillips, S.; Pocock, S.; Prasad, K.; Scutt, P.; de Silva, H.A.; Szatmari, S.; Díez-Tejedor E; Utton, S.; Wang, Y. J.; Wardlaw, J.M.; Whynes, D.; Wong, L.; Woodhouse, L; Sprigg, N.; ENOS Trial Investigators(36)
    BACKGROUND: High blood pressure is common in acute stroke and associated with a worse functional outcome. Many patients who present with acute stroke are taking prescribed antihypertensive therapy before their stroke. AIMS: ENOS tested whether lowering blood pressure and continuing pre-stroke antihypertensive therapy are each safe and effective. METHODS: This study is an international multi-centre prospective randomized single-blind blinded-endpoint parallel-group partial-factorial controlled trial of transdermal glyceryl trinitrate(a nitric oxide donor, given for seven-days) vs. no glyceryl trinitrate, and of continuing vs. stopping (temporarily for seven-days) pre-stroke antihypertensive drugs if relevant, in patients with acute ischaemic stroke or intracerebral haemorrhage and high systolic blood pressure (140–220 mmHg). RESULTS: Recruitment ran from July 2001 to October 2013. Four thousand eleven patients [2097 (52•3%) in the continue/stop arm] were recruited from 173 sites across 23 countries in 5 continents (Asia 14%, Continental Europe 16%, UK 64%). Baseline characteristics include: mean age 70 (standard deviation 12) years; male 57%; mean time from stroke to recruitment 26 (13) h; mean severity (Scandinavian Stroke Scale) 34(13) of 58; mean blood pressure 167 (19)/90 (13) mmHg; ischaemic stroke 83%; and intracerebral haemorrhage 16%. The main trial results will be presented in May 2014. The results will also be presented in updated Cochrane systematic reviews and included in individual patient data meta-analyses of all relevant randomized controlled trials. CONCLUSION: ENOS is a large completed international trial of blood pressure management in acute stroke and includes patients representative of many stroke services worldwide.
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    Efficacy of nitric oxide, with or without continuing antihypertensive treatment, for management of high blood pressure in acute stroke (ENOS): a partial-factorial randomised controlled trial
    (Lancet Publishing Group, 2015) Bath, P.M.; Woodhouse, L; Scutt, P.; Krishnan, K.; Wardlaw, J.M.; Bereczki, D.; Sprigg, N.; Berge, E.; Beridze, M.; Caso, V.; Chen, C.; Christensen, H.; Collins, R.; El Etribi, A.; Laska, A. C.; Lees, K. R.; Ozturk, S.; Phillips, S.; Pocock, S.; de Silva, H.A.; Szatmari, S.; Utton, S.; ENOS Trial Investigators(955)
    BACKGROUND: High blood pressure is associated with poor outcome after stroke. Whether blood pressure should be lowered early after stroke, and whether to continue or temporarily withdraw existing antihypertensive drugs, is not known. We assessed outcomes after stroke in patients given drugs to lower their blood pressure. METHODS: In our multicentre, partial-factorial trial, we randomly assigned patients admitted to hospital with an acute ischaemic or haemorrhagic stroke and raised systolic blood pressure (systolic 140–220 mm Hg) to 7 days of transdermal glyceryl trinitrate (5 mg per day), started within 48 h of stroke onset, or to no glyceryl trinitrate (control group). A subset of patients who were taking antihypertensive drugs before their stroke were also randomly assigned to continue or stop taking these drugs. The primary outcome was function, assessed with the modified Rankin Scale at 90 days by observers masked to treatment assignment. This study is registered, number ISRCTN99414122. FINDINGS: Between July 20, 2001, and Oct 14, 2013, we enrolled 4011 patients. Mean blood pressure was 167 (SD 19) mm Hg/90 (13) mm Hg at baseline (median 26 h [16–37] after stroke onset), and was significantly reduced on day 1 in 2000 patients allocated to glyceryl trinitrate compared with 2011 controls (difference −7•0 [95% CI −8•5 to −5•6] mm Hg/–3•5 [–4•4 to −2•6] mm Hg; both p<0•0001), and on day 7 in 1053 patients allocated to continue antihypertensive drugs compared with 1044 patients randomised to stop them (difference −9•5 [95% CI −11•8 to −7•2] mm Hg/–5•0 [–6•4 to −3•7] mm Hg; both p<0•0001). Functional outcome at day 90 did not differ in either treatment comparison—the adjusted common odds ratio (OR) for worse outcome with glyceryl trinitrate versus no glyceryl trinitrate was 1•01 (95% CI 0•91–1•13; p=0•83), and with continue versus stop antihypertensive drugs OR was 1•05 (0•90–1•22; p=0•55). INTERPRETATION: In patients with acute stroke and high blood pressure, transdermal glyceryl trinitrate lowered blood pressure and had acceptable safety but did not improve functional outcome. We show no evidence to support continuing prestroke antihypertensive drugs in patients in the first few days after acute stroke. FUNDING: UK Medical Research Council.