Safety of HMG-CoA Reductase Inhibitors in the Megatrials

Safety of HMG-CoA Reductase Inhibitors in the Megatrials A. Noncardiovascular Deaths 

In the five statin megatrials, the reductions in plasma cholesterol were greater than in the earlier trials, which had raised concerns about a possible increase in noncardiac mortality associated with cholesterollowering therapy. Thus, if these concerns were applicable to choles- 

In the five statin megatrials, which collectively randomized over 30,000 patients and had treatment periods of approximately 5 years, new cancers were recorded in over 2000 patients. The numbers of patients with cancer in the active treatment and placebo groups were very similar, as shown in Table III. There was an excess of breast cancer in the pravastatin group in CARE (12 cases vs. 1 in the placebo group), but this is probably an anomalous finding in a small subgroup, as it was not replicable in 4S, LIPID, or AFCAPS, all of which included an appreciable number of female patients (WOS excluded women). The total number of breast cancers in these 

Patients with Cancer in 4S,a U I i.S. CARE,C LIPID,d and AFCAPS (excluding nonmelanoma skin cancer) 

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