Stroke: gavestinel, a glycine antagonist, did not reduce mortality or disability

Clinical bottom line (level 1b)

  1. Patients with an acute stroke who received gavestinel compared with placebo were not less likely to die nor more likely to have a better functional outcome.
  2. There was no clear difference in adverse effects between the two groups.
Lees et al: Lancet 2000; 355 : 1949-1954
Expires November 2003

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: 173 acute hospitals in 21 countries in Europe, Australia, South Africa

1804 patients (aged mean 70, 57% male) with an acute stroke (confirmed on CT within first 18 hours) involving limb weakness

Excluded if
  • aged < 18
  • coma
  • rapid resolution of symptoms (completely resolved within 24 hours)
  • suspected subarachnoid haemorrhage
  • symptoms consistent with chronic heart failure
  • malignant hypertension
  • history of significant hepatic or renal impairment
  • women of child-bearing age not on contraception
  • not previously independent

Control Group: (n = 896, 896 analysed): placebo
Experimental Group: (n = 892, 892 analysed): gavestinel iv bolus 800 mg within 6 hours of stroke onset followed by 200 mg every 12 hours for 5 doses

97% followed for 3 months

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
death 3 months 170
(19.0%)		 175
(19.6%)		 -3%
(-25% to 14%)		 -0.65%
(-4.30% to 3.01%)		 -160
(NNT = 33 to infinity;
NNH = 23 to infinity)
adverse effects 3 months 159
(17.8%)		 174
(19.5%)		 -10%
(-33% to 9%)		 -1.76%
(-5.37% to 1.85%)		 -57
(NNT = 54 to infinity;
NNH = 19 to infinity)

Comments

  1. No difference in functional outcome was noted between the two groups.

Citation

  1. Lees KR, Asplund K, Carolei A, et al: glycine antagonist (gavistinel) in neuroprotection (GAIN international) in patients with acute stroke: a randomised controlled trial. Lancet 2000; 355 : 1949-1954
Search Terms: from ACP Journal Club other articles noted
Contributor: Chris Ball, November 2001
Reviewer:

Clinical Question.
Patient acute stroke
Intervention or Exposure gavestinel
Comparison placebo
Outcome death, functional outcome, adverse effects