Phase Z of A-Z Trial
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Objective
To compare early initiation of an intensive statin regimen with delayed initiation of a less intensive regimen in patients with ACS.
Methods
The Z phase of A-Z trial was a multicentered, randomized, double blinded trial which enrolled 4497 patients with acute coronary syndrome who had an initial total cholesterol level ≤250 mg/dL. All the patients were randomized to treatment with either 40 mg/d of simvastatin for 1 month followed by 80 mg/d thereafter or placebo for 4 months followed by 20 mg/d of simvastatin. All the patients were followed-up for 6 months to 24 months. Primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, readmission for ACS, and stroke.
Results
- In the less intense treatment group, median LDL-C level achieved while taking placebo was 122 mg/dL at 1 month and was 77 mg/dL at 8 months while taking 20 mg/d of simvastatin. Corresponding values in the simvastatin only group were 68 mg/dL at 1 month while taking 40 mg/d of simvastatin and 63 mg/dL at 8 months while taking 80 mg/d of simvastatin.
- Primary endpoint was reached in 16.7% in the placebo plus simvastatin group compared with 14.4% in the simvastatin only group.
- Cardiovascular death occurred in 5.4% and 4.1% of the patients in the 2 groups but no differences were observed in other individual components of the primary end point.
Conclusion
The pre-specified end point was not achieved by the trial. However the early initiation of an aggressive simvastatin regimen, in patients with ACS, resulted in a favorable trend toward reduction of major cardiovascular events.[1][2]
References
- ↑ de Lemos JA, Blazing MA, Wiviott SD; et al. (2004). "Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the A to Z trial". JAMA : the Journal of the American Medical Association. 292 (11): 1307–16. doi:10.1001/jama.292.11.1307. PMID 15337732. Unknown parameter
|month=ignored (help) - ↑ Blazing MA, De Lemos JA, Dyke CK, Califf RM, Bilheimer D, Braunwald E (2001). "The A-to-Z Trial: Methods and rationale for a single trial investigating combined use of low-molecular-weight heparin with the glycoprotein IIb/IIIa inhibitor tirofiban and defining the efficacy of early aggressive simvastatin therapy". American Heart Journal. 142 (2): 211–7. doi:10.1067/mhj.2001.116959. PMID 11479456. Unknown parameter
|month=ignored (help)