Effects of rosuvastatin and atorvastatin compared over 52 weeks of treatment in patients with hypercholesterolemia - Effects of rosuvastatin and atorvastatin compared over 52 weeks of treatment in patients with hypercholesterolemia
The goal of the trial was to compare treatment with rosuvastatin versus atorvastatin in reducing low-density lipoprotein cholesterol (LDL-C) and achieving LDL-C goals among patients with primary hypercholesterolemia.
Patients Screened: 1,521
Patients Enrolled: 412
Mean Follow Up: 52 weeks
Mean Patient Age: mean age 56-58 years
Age ≥18 years; and hypercholesterolemia during the lead-in period, defined as fasting LDL-C level of 160 to <250 mg/dl (4.14 and <6.5 mmol/l), fasting triglyceride levels ≤400 mg/dl (≤4.5 mmol/l), and an Eating Pattern Assessment Tool (EPAT) score ≤28
Percentage change from baseline in LDL-C levels at 12 weeks
Changes in LDL-C at 52 weeks; percentage changes in total cholesterol, HDL-C, triglycerides, and lipoprotein ratios (LDL-C/HDL-C, total cholesterol/HDL-C, non-HDL-C/HDL-C), Apo B, Apo A-I, and Apo B/Apo A-I ratio at 12 and 52 weeks; and proportions of patients meeting ATP-II and European LDL-C goals at 12 and 52 weeks
Eligible patients entered the six-week dietary lead-in period and all cholesterol-lowering drugs, dietary supplements, and food additives were discontinued. After the lead-in period, eligible patients were randomized to rosuvastatin 5 mg/day (n=138), rosuvastatin 10 mg/day (n=134), or atorvastatin 10 mg/day (n=140) for 12 weeks.
After the 12-week fixed-dose period, study medication could be doubled (up to 80 mg) at the medical discretion of the investigator at each eight-week visit if National Cholesterol Education Program Adult Treatment Panel II (ATP-II) LDL-C goals were not met.
LDL-C was reduced at 12 weeks compared with baseline in all three arms, although both doses of rosuvastatin were associated with larger reductions in LDL-C versus atorvastatin (46% for 5-mg and 50% for 10-mg rosuvastatin vs. 39%, both p<0.001). Likewise, total cholesterol reductions at 12 weeks were greater with both 5-mg (-32%) and 10-mg (-35%) rosuvastatin compared with atorvastatin (-28%; p<0.001 for both), although there was no difference in high-density lipoprotein (HDL) changes (+6%, +8%, and +6%, respectively, p=NS) or triglycerides (-15%, -19%, -16%, p=NS). ATP-II and European LDL-C goals at 12 weeks were achieved more frequently in both rosuvastatin dosages compared with atorvastatin (86% and 89% vs. 73% for ATP-II; and 75%, and 86% vs. 55%, respectively).
Similar benefit in LDL-C reduction was observed at 52 weeks (-47% and -53% vs. -44%, p<0.05 and p<0.001). At 52 weeks, 82% of patients treated with 10-mg rosuvastatin achieved their LDL-C goal at the starting dosage without the need for titration, compared with 59% of patients treated with atorvastatin. Both treatments were well tolerated over 52 weeks, with myalgia and gastrointestinal complaints the most frequent treatment-related adverse events.
Among patients with primary hypercholesterolemia, rosuvastatin was associated with a reduction in the primary endpoint of LDL-C at 12 weeks compared with atorvastatin, with similar results through one year. The majority of patients in all three treatment arms achieved target LDL-C levels within 12 weeks of treatment, indicating the effectiveness of statin therapy.
Of note, more rosuvastatin-treated patients in both groups achieved target LDL-C levels at starting dosages without the need for upward titration during the one-year follow-up, a potential benefit compared with other existing lipid-lowering therapies. Further trials are warranted to determine how rosuvastatin will compare with other lipid-lowering therapies.
Olsson AG, Istad H, Luurila O, et al., for the Rosuvastatin Investigators Group. Effects of rosuvastatin and atorvastatin compared over 52 weeks of treatment in patients with hypercholesterolemia. Am Heart J 2002;144:1044-51.
Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Homozygous Familial Hypercholesterolemia, Hypertriglyceridemia, Lipid Metabolism, Nonstatins, Novel Agents, Statins, Diet
Keywords: Fluorobenzenes, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Pyrimidines, Heptanoic Acids, Hypercholesterolemia, Food Additives, Pyrroles, Cholesterol, Dietary Supplements, Triglycerides, Fasting, Myalgia, Sulfonamides
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