Evidence table What is the safety and efficacy of measures to manipulate blood pressure versus treatment as usual in patients with acute stroke?

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1 9.3 Blood pressure control Reference Evidence table What is the safety and efficacy of measures to manipulate blood pressure versus treatment as usual in patients with acute? Bath PMW, Willmot M, Leonardi-Bee J et al. Nitric oxide donors (nitrates), L-arginine, or nitric oxide synthase inhibitors for acute. Cochrane Database of Systematic Reviews. 2002; Ref ID: 1947 Study type Evidence level Systematic review 1++ Number of patients N=127 (117 ischemic And 10 haemorrhagic ) Two RCTs characteristics s with acute ischemic or haemorrhagic Treatment initiated 4 to 5 days post Intervention Comparison Length of follow-up Glyceryl trinitrate (GTN 5 to 10 mg daily) / no patch Outcome measures 3 mths Mortality Deterioration Source of funding None reported *Blood pressure GTN statistically lowered 24 hr ambulatory SBP (WMD -7.9 mm HG; 95%CI to -0.1). There was no statistical difference for DBP. NOTE: there were baseline differences in blood pressure in one study (Bath 2001). *Death, deterioration or dependency At the end of the trial, patients treated with GTN showed no statistical differences in mortality rate (NS) or mortality and deterioration combined (NS), death or dependency combined (NS). Horn J, Limburg M. Calcium Systematic N=7521 (28 s with Calcium /control Mortality None reported antagonists for acute ischemic. review 1++ trials) acute antagonists Cochrane Database of Systematic randomised Recurrent Search until within 14 days Reviews. 2000;(2) Ref ID: 2583 March 1999 of onset *Death and dependency (N= trials) At the end of follow-up there was no statistical difference on the outcome of death and dependency when patients with the active treatment were compared with control patients. There were no statistical differences between the different drug types. NOTE: There was significant heterogeneity *Death at end of follow-up (N= trials) There was no statistical difference when comparing patients given calcium antagonists compared with control/placebo *Death at the end of treatment

2 There was no significant difference between patients on calcium antagonists compared with control/placebo. *Recurrence of at the end of follow-up (9 trials) There were no statistical differences between patients on calcium antagonists and the control/placebo group *Time to treatment Early treatment (<= 12 hours after onset) with calcium antagonists was associated with an increase in the odds of a poor outcome, compared to placebo (OR 1.13, 95% CI 0.94/1.36). Treatment after 12 hours gave no effect whatsoever (OR 1.00, 95% CI 0.88/1.14). This analysis may be confounded by route of administration. There was no statistical difference on mortality when early treatment was compared with treatment started later than 24 hrs (NS). * during treatment For the largest flunarizine trial there was a significant increase of adverse in the active intervention group (33 vs 10%; OR 3.73; 95%CI 2.21 to 6.29). There were no statistical differences in adverse in the remaining studies Ahmed N, Nasman P, Wahlgren NG. of intravenous nimodipine on blood pressure and outcome after acute. Stroke. 2000; 31(6): Ref ID: 376 RCT, double blind 1+ N=265 s with acute ischemic (within 24 hrs) Inclusion criteria: 40 yrs or over and functionally independent before the IV Nimodipine 1 mg/h for 5 days plus 30 mg four times daily for 16 days (low dose) N=101 IV Nimodipine 2 mg/h for 5 days plus 30 mg four times daily for 16 days (low dose) N= days BP change Mortality Pharmaceutical company N=94 (high dose) BP was measured every hour for the first 4 hrs, every 4 hrs for the next 44 hrs and then twice daily whilst in hospital

3 107 (40.4%) patients received some kind of hypertensive agents prior to the or after hospitalisation. The number in each group was comparable. Average systolic BP (SBP) during the first two days was reduced 2.1% from baseline with placebo, 6.6% with the low dose (p=0.008 versus placebo), and 11.4% with the high dose nimidopine treatment (p<0.001 versus placebo). Average diastolic (DBP) during the first two days was reduced by 1.7% with placebo, 7.7% with the low dose (p=0.005 versus placebo) and 14.1% with the high dose nimidopine (p<0.001 versus placebo). 21 day follow up In multivariate analysis, a significant correlation between DBP reduction and worsening of the neurological score was found for the high dose group (p=0.048). s with a reduction of 20% in the high dose group had a statistically significant increased adjusted OR for the combined outcome of death or dependency (Barthel Index < 60) (OR 10.16; 95%CI 1.02 to ) and death alone (9/26 (34.6%) ; OR 4.336; 95%CI to ) compared with placebo patients (14/92 (15.2%)). There was no correlation between SBP change and outcome. Barer DH, Cruickshank JM, Ebrahim SB et al. Low dose beta blockade in acute ("BEST" trial): an evaluation. British Medical Journal Clinical Research Ed. 1988;. 296(6624): Ref ID: 639 RCT double blind, multicentre UK 1+ N=302 s diagnosed with hemispheric (48 hrs from onset) Inclusion criteria included: conscious and able to swallow, not previously one a beta-blocker population: Mean age 69 yrs, 56% 70 yrs or older, 24% previous /TIA, mean time from onset of to entry 24 hrs Atenolol 50 mg daily N=101 Propanolol slow release 80 mg daily N=101 Treatment for both three weeks in duration or until discharge, whichever was sooner N=100 As for intervention 6 months Neurological assessment Activities of daily living Rate of discharge ICI Pharmaceuticals and the Wellcome Trust

4 No statistical analysis performed for status (at home, in hospital or dead) or conscious level (alert or drowsy) at 1 week, 1 month or 6 months *Neurological changes (based on neurological assessment) When patients given propranolol or atenolol were combined and compared with placebo, there was a statistical higher number of mean neurological changes associated with placebo compared to beta-blockers at one day to one week (1.9 vs 0.8; p=0.006) and one day to one month (2.6 vs 1.6; p=0.018) *Functional outcome (activities of daily living) At one month, there was a statistical difference in activities of daily living in favour of placebo, compared with atenolol and propranolol (5.1, 4.5 and 3.9 respectively; p=0.05 (between three treatment groups by Kruskal-Wallis)). There was no statistical difference at one week or six months (NS). *Rate of discharge There was no statistical difference in the rate of hospital discharge (NS) * Eight patients experienced definite side effects from beta blockers Horn J, de Haan RJ, Vermeulen M et RCT, al. Very Early Nimodipine Use in double Stroke (VENUS): a randomized, blind, placebo double-blind, placebo-controlled trial. controlled Stroke. 2001; 32(2): Ref ID: trial Horn J, de Haan RJ, Vermeulen M et al. Very Early Nimodipine Use Primary in Stroke (VENUS): a randomized, care study double-blind, placebo-controlled trial. Stroke. 2001; 32(2): Ref ID: 354 GP and neurologist treatment N=454 s with and hemiparesis who had treatment started < 6 hrs after onset Exclusion criteria: Ability to raise leg or arm > 10 seconds age > 18 and < 85, dysphagia, systolic BP < 130 mm Hg, heart rate < 50 bpm Oral Nimodopine 30 mg Administered every six hours for 10 days N=225 Any concurrent medication permitted N=229 3 months Mortality (mrs > 3) Neurological status BP Assessed by telephone Public sector. Intervention medication supplied by pharmaceutical company population: median age 71

5 yrs, 91% female, 12% previous, 50% hospital admission, 58% ischemic and 8% haemorrhagic *Blood pressure No baseline BP statistics. At 24 hr follow-up mean systolic blood pressure was 153 mm Hg and 152 mm Hg in the nimodipine and placebo patients respectively (NS). The diastolic blood pressure 84 and 86 for the nimodipine and placebo patients respectively (NS). *Mortality & dependency (all cause mortality or dependency in daily like (mrs >3) At three months, 71/225 (32%) in the Nimodipine treated group had a poor outcome compared with 62/229 (27%) in the placebo group (RR 1.2; 95%CI 0.9 to 1.6). After 10 days, 14/225 (6%) had died in the nimidopine group compared with 20/229 (9%) placebo patients (NS) *Neurological status At 24 hrs there were no statistical differences between the Nimodipine and placebo groups on neurological status. * 31 patients experienced adverse. Trial medication was stopped in 15 patients (7 nimodipine and 8 placebo) Schrader J, Luders S, Kulschewski A et al. Candesartan The ACCESS Study: evaluation of Acute cilexetil Candesartan Cilexetil Therapy in Stroke Survivors. Stroke. 2003; 34(7): N=173 RCT prospective doubleblind multicentre phase II trials 1+ N=500 Inclusion criteria included: motor deficit, mean of at least 2 blood pressure measurements 200 mm Hg systolic and/or 110 mm Hg diastolic for 6 to 24 hrs after admission or 180 mm Hg 4mg daily on day 1. On day increased to 8 or 16 mg if blood pressure exceeded 160 mm Hg systolic or 100 mm Hg diastolic When blood N=160 In patients showing a hypertensive 24- hr blood pressure profile at day 7, candesartan cilexetil was started and adjusted to lower blood 12 months Mortality Functional outcome Pharmaceutical Company

6 systolic and/or 105 mm Hg diastolic 24 to 36 hrs after admission Exclusion criteria included: > 85 yrs, occlusion > 70% stenosis of the internal carotid artery population: (candesartan cilexetil versus placebo: age 68.3 vs 67.8 trs; male sex 50% vsc 52%; diabetes mellitus 39% vs 35%, coronary heart disease 22% vs 19%; hyperlipidemia in 43% vs 45%; study initiated 29.9 vs 29.7 hrs after symptom recognition respectively) The groups were well pressure was > 230 mm Hg systolic or > 115 mm Hg diastolic for > 30 mins on day 1 or 2 on the following days > 200 mm Hg systolic or 110 mm Hg diastolic for > 30 mins an acute intervention (urapidil) was allowed If patients showed a hypetensive profile at day 7, candesartan as increased or an additional hypertensive initiated Target reduction in blood pressure of 10 to 15% within 24 hrs The reduction in blood pressure was taken as the mean value of 2 measurements within 30 minutes In the first three days, occasional measurements of blood pressure pressure to < 140/90 mm Hg (office blood pressure) or < 135/85 mm Hg (mean daytime blood pressure, automatic blood pressure monitoring). s who showed a normotensive profile (N-2) did not receive antihypertensive medication

7 matched at baseline were taken throughout the day ay 1 to 2 hr intervals and during the night 2 to 3 hr intervals. On day 7 automatic 24 hr recording of blood pressure was performed *Blood pressure During the placebo-controlled phase in the first 7days, there were no statistical differences in blood pressure between the groups. There were no differences at 12 months (NS). In 164/166 patients in the placebo group, candesartan cilexetil was started on day 7 due to a hypertensive 24-hour blood pressure profile. *Functional outcome There were no statistical differences between candesartan cilexetil and placebo on the Barthel Index at three months. *Mortality There was no statistical difference in the cumulative 12-month mortality candesartan cilexetil versus placebo (NS). *Vascular There was a statistical difference in favour of candesartan cilexetil compared with placebo on the number of vascular (17 (9.8%) vs 31 (18.7%); p=0.026). For the combined outcome of cumulative 12-month mortality and the number of vascular, the results were in favour of the candesartan cilextil (OR 0.475; 95%CI to 0.895). *Concomitant medication, drug tolerance, adverse There were no statistical differences between candesartan cilexetil and placebo regarding the use of concomitant medication during follow-up

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