Statin use in a "real-world" clinical setting: aggressive lipid lowering compared with usual care in the Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE) trial.
Clinical trials that incorporate elements of "real-world" experience are of great value to practicing physicians. Using a trial design adapted to approximate clinical settings, the Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE) trial compared a focused treatment strategy using atorvastatin with usual medical care. Patients eligible for study participation were predefined based on diagnosis codes for coronary heart disease from US managed care database records; 66% of these patients were taking lipid-lowering medications at study entry. In contrast to standard clinical trials, ALLIANCE maintained a real-world environment by limiting the interactions of investigators with patients after dose titration of aggressive treatment to a low-density lipoprotein (LDL) cholesterol goal < 80 mg/dL (2.1 mmol/L) or maximum atorvastatin dose of 80 mg/day. After 51.5 months of follow-up, the study showed that aggressive treatment with atorvastatin was associated with significantly lower LDL cholesterol levels (147 mg/dL [3.8 mmol/L] to 95 mg/dL [2.5 mmol/L]) over usual care (146 mg/dL [3.8 mmol/L] to 111 mg/dL [2.9 mmol/L]). This greater reduction in LDL cholesterol was accompanied by improved outcomes in the composite primary end point of cardiovascular events (-17% with atorvastatin vs. usual care; P = 0.02) and particularly in the end point of nonfatal myocardial infarction (-47% with atorvastatin vs. usual care; P = 0.0002). No safety difference was noted between the 2 treatment groups. These results indicate that usual-care treatment was not equivalent to targeted statin therapy, even in a trial conducted to minimize potential bias owing to traditional patient selection and trial design methods.
Koren
Michael J
MJ
Jacksonville Center for Clinical Research, Jacksonville, Florida 32216, USA. michaelkoren@jaxresearch.com
D000293:Adolescent; D000328:Adult; D000368:Aged; D000069059:Atorvastatin; D003327:Coronary Disease / Q000097:blood / Q000517:prevention & control; D005260:Female; D006538:Heptanoic Acids / Q000627:therapeutic use; D006801:Humans; D006949:Hyperlipidemias / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011758:Pyrroles / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic / Q000379:methods*
D006538:Heptanoic Acids; D000960:Hypolipidemic Agents; D011758:Pyrroles; D000069059:Atorvastatin