Back to Search
Start Over
Effect of pexelizumab, an anti-C5 complement antibody, as adjunctive therapy to fibrinolysis in acute myocardial infarction: the COMPlement inhibition in myocardial infarction treated with thromboLYtics (COMPLY) trial.
- Source :
-
Circulation [Circulation] 2003 Sep 09; Vol. 108 (10), pp. 1176-83. Date of Electronic Publication: 2003 Aug 18. - Publication Year :
- 2003
-
Abstract
- Background: Complement activation mediates myocardial damage that occurs during ischemia and reperfusion through multiple pathways. We performed 2 separate, parallel, double-blind, placebo-controlled trials to determine the effects of pexelizumab (a novel C5 complement monoclonal antibody fragment) on infarct size in patients receiving reperfusion therapy: COMPlement inhibition in myocardial infarction treated with thromboLYtics (COMPLY) and COMplement inhibition in Myocardial infarction treated with Angioplasty (COMMA). The COMPLY trial is reported here.<br />Methods and Results: Overall, 943 patients with acute ST-segment elevation myocardial infarction (MI) (20% with isolated inferior MI) receiving fibrinolysis were randomly assigned <6 hours after symptom onset to placebo, pexelizumab 2.0-mg/kg bolus, or pexelizumab 2.0-mg/kg bolus plus 0.05 mg/kg per h for 20 hours. Infarct size determined by creatine kinase-MB area under the curve was the primary analysis, which included patients who received at least some study drug and fibrinolysis (n=920). The median infarct size did not differ by treatment (placebo, 5230; bolus, 4952; bolus plus infusion, 5557 [ng/mL] x h; bolus versus placebo, P=0.85; bolus plus infusion versus placebo, P=0.81), nor did the 90-day composite incidence of death, new or worsening congestive heart failure, shock, or stroke (placebo, 18.6%; bolus, 18.4%; bolus plus infusion, 19.7%). Pexelizumab inhibited complement for 4 hours with bolus-only dosing and for 20 to 24 hours with bolus-plus-infusion dosing, with no increase in infections.<br />Conclusions: When used adjunctively with fibrinolysis, pexelizumab blocked complement activity but reduced neither infarct size by creatine kinase-MB assessment nor adverse clinical outcomes.
- Subjects :
- Aged
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal, Humanized
Area Under Curve
Chemotherapy, Adjuvant
Creatine Kinase analysis
Creatine Kinase, MB Form
Dose-Response Relationship, Drug
Double-Blind Method
Female
Fibrinolytic Agents therapeutic use
Follow-Up Studies
Humans
Isoenzymes analysis
Male
Middle Aged
Myocardial Infarction diagnosis
Single-Chain Antibodies
Treatment Outcome
Antibodies, Monoclonal therapeutic use
Complement C5 antagonists & inhibitors
Fibrinolysis
Myocardial Infarction drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1524-4539
- Volume :
- 108
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Circulation
- Publication Type :
- Academic Journal
- Accession number :
- 12925455
- Full Text :
- https://doi.org/10.1161/01.CIR.0000087404.53661.F8