A randomized controlled clinical trial to evaluate the efficacy, safety, cost-effectiveness and effect on PAI-1 levels of the three low-molecular-weight heparins--enoxaparin, nadroparin and dalteparin. The ESCAPe-END study.
BACKGROUND
Comparative data for efficacy and safety between various low-molecular-weight heparins (LMWHs) in patients with unstable angina is not available. The present study was conducted to compare the efficacy, safety, cost-effectiveness and effects on plasminogen activator inhibitor-1 (PAI-1) levels of three LMWHs--enoxaparin, nadroparin and dalteparin.


METHODS
The study was a prospective, randomized, comparative, open with blinded endpoints (PROBE design) assessment with a 30-day follow-up. The primary endpoint of efficacy was a composite of cardiovascular death, myocardial infarction, recurrent angina and need for intervention. Cost-effectiveness was calculated by calculating the incremental cost-effectiveness ratio. Plasma PAI-1 levels were estimated by ELISA.


RESULTS
A total of 150 patients were available for intention-to-treat analysis. There was no significant difference at 30 days in the primary endpoint or in any of the individual components in the three groups. The secondary endpoint of silent ischemia was also not significantly different. Adverse events were similar in the three groups. The PAI-1 levels were not significantly different in the three groups. The total cost of treatment in the three groups was similar.


CONCLUSIONS
Any of the three LMWHs evaluated in this study were similar with respect to efficacy, safety, PAI-1 levels and cost-effectiveness.
Shafiq
N
N
Department of Pharmacology, Post-Graduate Institute of Medical Education and Research, Chandigarh, India.
Malhotra
S
S
Pandhi
P
P
Sharma
N
N
Bhalla
A
A
Grover
A
A
D000328:Adult; D000368:Aged; D000789:Angina, Unstable / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D003362:Cost-Benefit Analysis; D017985:Dalteparin / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D017984:Enoxaparin / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000097:blood / Q000517:prevention & control*; D017762:Nadroparin / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D017395:Plasminogen Activator Inhibitor 1 / Q000097:blood*; D011446:Prospective Studies
D017984:Enoxaparin; D017762:Nadroparin; D017395:Plasminogen Activator Inhibitor 1; C051321:SERPINE1 protein, human; D017985:Dalteparin