A multinational clinical trial program, published in the journal "Cardiology" shows that rosuvastatin is well tolerated by a broad range of patients with dyslipidemia, and its safety profile is similar to those of comparator statins investigated in this clinical program.
Following the resurgence of interest in statin safety, this report is an updated comprehensive summary of data from more than 16,800 patients.
The safety and tolerability of rosuvastatin were assessed using data from 16,876 patients who received rosuvastatin 5-40 mg in a multinational phase II/III/IIIb/IV program, representing 25,670 patient-years of continuous exposure to rosuvastatin. An integrated database, consisting of 33 trials whose databases were locked up to and including September 16, 2005, was used to examine adverse events and laboratory data.
In placebo-controlled trials, adverse events irrespective of causality assessment occurred in 52.1% of patients receiving rosuvastatin 5-40 mg (n = 931) and 51.8% of patients receiving placebo (n = 483). In all controlled clinical trials with comparator statins, rosuvastatin 5-40 mg was associated with an adverse event profile similar to profiles for atorvastatin 10-80 mg, simvastatin 10-80 mg, and pravastatin 10-40 mg.