Effect of Clazosentan in Patients with Aneurysmal Subarachnoid Hemorrhage: A Meta-Analysis of Randomized Controlled Trials

PLoS ONE

Volumn 7, Issue 10, 2012, Pages

  Wang, Xiang ^a   Li, Yi Ming ^a   Li, Wei Qing ^a   Huang, Cheng Guang ^a   Lu, Yi Cheng ^a   Hou, Li Jun ^a  

^a SECOND MILITARY MEDICAL UNIVERSITY   (China)

Author keywords

[No Author keywords available]

Indexed keywords

CLAZOSENTAN; PLACEBO;

ADULT; ANEMIA; ARTICLE; BRAIN INFARCTION; BRAIN VASOSPASM; CARDIOVASCULAR DISEASE; CENTRAL NERVOUS SYSTEM DISEASE; CONTROLLED STUDY; DELAYED ISCHEMIC NEUROLOGICAL DEFICIT; DRUG ACTIVITY; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; FEMALE; FUNCTIONAL ASSESSMENT; HUMAN; HYPOTENSION; INCIDENCE; LUNG DISEASE; MAJOR CLINICAL STUDY; MALE; META ANALYSIS; MORBIDITY; MORTALITY; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK FACTOR; RISK REDUCTION; SUBARACHNOID HEMORRHAGE; SYSTEMATIC REVIEW;

BRAIN ISCHEMIA; CAUSE OF DEATH; CONFIDENCE INTERVALS; DIOXANES; HUMANS; INCIDENCE; PLACEBOS; PYRIDINES; PYRIMIDINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SUBARACHNOID HEMORRHAGE; SULFONAMIDES; TETRAZOLES; TREATMENT OUTCOME; VASOSPASM, INTRACRANIAL;

EID: 84867643040     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0047778     Document Type: Article

References (30)

1. Connolly ES Jr, Rabinstein AA, Carhuapoma JR, Derdeyn CP, Dion J, et al. (2012) Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke 43: 1711-1737.
2. Macdonald RL, Pluta RM, Zhang JH, (2007) Cerebral vasospasm after subarachnoid hemorrhage: the emerging revolution. Nat Clin Pract Neurol 3: 256-263.
3. Barth M, Capelle HH, Munch E, Thome C, Fiedler F, et al. (2007) Effects of the selective endothelin a (ETA) receptor antagonist Clazosentan on cerebral perfusion and cerebral oxygenation following severe subarachnoid hemorrhage- Preliminary results from a randomized clinical series. Acta Neurochirurgica 149: 911-918.
4. Vajkoczy P, Meyer B, Weidauer S, Raabe A, Thome C, et al. (2005) Clazosentan (AXV-034343), a selective endothelin A receptor antagonist, in the prevention of cerebral vasospasm following severe aneurysmal subarachnoid hemorrhage: Results of a randomized, double-blind, placebo-controlled, multicenter Phase IIa study. J Neurosurg 103: 9-17.
5. MacDonald RL, Kassell NF, Mayer S, Ruefenacht D, Schmiedek P, et al. (2008) Clazosentan to overcome neurological ischemia and infarction occurring after subarachnoid hemorrhage (CONSCIOUS-1): Randomized, double-blind, placebo-controlled phase 2 dose-finding trial. Stroke 39: 3015-3021.
6. Macdonald RL, Higashida RT, Keller E, Mayer SA, Molyneux A, et al. (2012) Randomized trial of clazosentan in patients with aneurysmal subarachnoid hemorrhage undergoing endovascular coiling. Stroke 43: 1463-1469.
7. Macdonald RL, Higashida RT, Keller E, Mayer SA, Molyneux A, et al. (2011) Clazosentan, an endothelin receptor antagonist, in patients with aneurysmal subarachnoid haemorrhage undergoing surgical clipping: A randomised, double-blind, placebo-controlled phase 3 trial (CONSCIOUS-2). Lancet Neurol 10: 618-625.
8. Moher D, Liberati A, Tetzlaff J, Altman DG, (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 6: e1000097.
9. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, et al. (1996) Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 17: 1-12.
10. Vergouwen MD, Vermeulen M, van Gijn J, Rinkel GJ, Wijdicks EF, et al. (2010) Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group. Stroke 41: 2391-2395.
11. Vergouwen MD, (2011) Vasospasm versus delayed cerebral ischemia as an outcome event in clinical trials and observational studies. Neurocrit Care 15: 308-311.
12. Jennett B, Bond M, (1975) Assessment of outcome after severe brain damage. Lancet 1: 480-484.
13. Suarez JI, Tarr RW, Selman WR, (2006) Aneurysmal subarachnoid hemorrhage. N Engl J Med 354: 387-396.
14. Wong GK, Poon WS (2011) Clazosentan for patients with subarachnoid haemorrhage: lessons learned. Lancet Neurol 10: 871; author reply 871-872.
15. van Giersbergen PL, Dingemanse J, (2007) Tolerability, pharmacokinetics, and pharmacodynamics of clazosentan, a parenteral endothelin receptor antagonist. Eur J Clin Pharmacol 63: 151-158.
16. Chow M, Dumont AS, Kassell NF, Seifert V, Zimmermann M, et al. (2002) Endothelin receptor antagonists and cerebral vasospasm: An update. Neurosurgery 51: 1333-1342.
17. Kramer A, Fletcher J, (2009) Do endothelin-receptor antagonists prevent delayed neurological deficits and poor outcomes after aneurysmal subarachnoid hemorrhage?: A meta-analysis. Stroke 40: 3403-3406.
18. Vatter H, Konczalla J, Weidauer S, Preibisch C, Raabe A, et al. (2007) Characterization of the endothelin-B receptor expression and vasomotor function during experimental cerebral vasospasm. Neurosurgery 60: 1100-1108; discussion 1108-1109.
19. Kreiter KT, Mayer SA, Howard G, Knappertz V, Ilodigwe D, et al. (2009) Sample size estimates for clinical trials of vasospasm in subarachnoid hemorrhage. Stroke 40: 2362-2367.
20. Ryttlefors M, Enblad P, Ronne-Engstrom E, Persson L, Ilodigwe D, et al. (2010) Patient age and vasospasm after subarachnoid hemorrhage. Neurosurgery 67: 911-917.
21. Ibrahim GM, Weidauer S, Macdonald RL, (2011) Interobserver variability in the interpretation of computed tomography following aneurysmal subarachnoid hemorrhage. J Neurosurg 115: 1191-1196.
22. Etminan N, Vergouwen MD, Ilodigwe D, Macdonald RL, (2011) Effect of pharmaceutical treatment on vasospasm, delayed cerebral ischemia, and clinical outcome in patients with aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis. J Cereb Blood Flow Metab 31: 1443-1451.
23. Crowley RW, Medel R, Dumont AS, Ilodigwe D, Kassell NF, et al. (2011) Angiographic vasospasm is strongly correlated with cerebral infarction after subarachnoid hemorrhage. Stroke 42: 919-923.
24. Woitzik J, Dreier JP, Hecht N, Fiss I, Sandow N, et al. (2012) Delayed cerebral ischemia and spreading depolarization in absence of angiographic vasospasm after subarachnoid hemorrhage. J Cereb Blood Flow Metab 32: 203-212.
25. Vergouwen MD, van Geloven N, de Haan RJ, Kruyt ND, Vermeulen M, et al. (2010) Increased cortisol levels are associated with delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. Neurocrit Care 12: 342-345.
26. Rabinstein AA, (2011) Secondary brain injury after aneurysmal subarachnoid haemorrhage: more than vasospasm. Lancet Neurol 10: 593-595.
27. Dhar R, Scalfani MT, Blackburn S, Zazulia AR, Videen T, et al. (2012) Relationship Between Angiographic Vasospasm and Regional Hypoperfusion in Aneurysmal Subarachnoid Hemorrhage. Stroke43: 1788-1794.
28. Sabri M, Ai J, MacDonald RL, (2011) Dissociation of vasospasm and secondary effects of experimental subarachnoid hemorrhage by clazosentan. Stroke 42: 1454-1460.
29. MacDonald RL, Hunsche E, Schuler R, Wlodarczyk J, Mayer SA, (2012) Quality of life and healthcare resource use associated with angiographic vasospasm after aneurysmal subarachnoid hemorrhage. Stroke 43: 1082-1088.
30. Schubert GA, Schilling L, Thome C, (2008) Clazosentan, an endothelin receptor antagonist, prevents early hypoperfusion during the acute phase of massive experimental subarachnoid hemorrhage: a laser Doppler flowmetry study in rats. J Neurosurg 109: 1134-1140.