In a blatant attempt to capitalize on the MIRACL study sponsored by Pfizer, it seems that Merck’s attempts have blown up in their faces. As a reminder, the MIRACL study reported a 16% lower rate of death and nonfatal major cardiac events 4 months after acute coronary syndrome (ACS) in patients receiving 80 mg/d of atorvastatin compared with placebo. This is contrast to the current Zocor study, named the A to Z study:
Conclusions The trial did not achieve the prespecified end point. However, among patients with ACS, the early initiation of an aggressive simvastatin regimen resulted in a favorable trend toward reduction of major cardiovascular events . . .
[MIRACL's conclusions are] a finding that is in contrast to the A to Z trial, in which no effect of aggressive statin therapy was observed for the end point of readmission for ACS.
Worse, episodes of myopathy in the intensive Zocor dose were significantly more than the lower dose. I do not believe that myopathy was seen during higher doses of Lipitor in the MIRACL study.
What this suggests is that statins are not interchangeable. Merck obviously wanted this to be the “me too” study, emulating what the MIRACL study did for Lipitor. This is clearly not the case, and probably will lead to some hesitation in future high-dose Zocor use.
As an aside to patients – this does not mean that Zocor is an unsafe medication. This study only applies to 80mg doses, which is an extremely high, uncommon dose for this drug.