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Clinical Trial
Journal Article
Randomized Controlled Trial
Is alternate daily dose of atorvastatin effective in treating patients with hyperlipidemia? The Alternate Day Versus Daily Dosing of Atorvastatin Study (ADDAS).
American Heart Journal 2002 October
BACKGROUND: The objective of this pilot study was to evaluate the comparative efficacy of alternate-day dosing of atorvastatin compared with the standard once-daily dose based on mean low-density lipoprotein (LDL) reduction from baseline at 6 and 12 weeks of treatment.
METHODS: In a double-blind, placebo-controlled design, 35 eligible patients who met the National Cholesterol Education Program (NCEP) Adult Treatment Panel II (ATP II) guidelines for drug therapy, depending on their risk factors, were randomly assigned to receive 10 mg of atorvastatin as an initial dose every day or every other day. Patients were assessed at 6 and 12 weeks as to whether they met the LDL-C goal, and the dose was doubled if the goal was not reached.
RESULTS: LDL-C decreased by 27% and 38%, in the every-other-day (n = 15) and every-day (n = 15) groups, respectively, at 6 weeks. At 12 weeks, the LDL-C was reduced by 35% and 38% in the every-other-day and every-day groups, respectively (P =.49). The mean dose was 18 mg (9 mg/d) in the alternate-day group (n = 14) and 12 mg/d in the every-day group (n = 12) at the end of the 12 weeks (P =.001).
CONCLUSIONS: Although higher doses of atorvastatin were used on alternate days, these results suggest that the alternate-day administration of atorvastatin can produce a reduction in LDL-C comparable to that of daily administration in patients with hypercholesterolemia, and yet provide some cost savings.
METHODS: In a double-blind, placebo-controlled design, 35 eligible patients who met the National Cholesterol Education Program (NCEP) Adult Treatment Panel II (ATP II) guidelines for drug therapy, depending on their risk factors, were randomly assigned to receive 10 mg of atorvastatin as an initial dose every day or every other day. Patients were assessed at 6 and 12 weeks as to whether they met the LDL-C goal, and the dose was doubled if the goal was not reached.
RESULTS: LDL-C decreased by 27% and 38%, in the every-other-day (n = 15) and every-day (n = 15) groups, respectively, at 6 weeks. At 12 weeks, the LDL-C was reduced by 35% and 38% in the every-other-day and every-day groups, respectively (P =.49). The mean dose was 18 mg (9 mg/d) in the alternate-day group (n = 14) and 12 mg/d in the every-day group (n = 12) at the end of the 12 weeks (P =.001).
CONCLUSIONS: Although higher doses of atorvastatin were used on alternate days, these results suggest that the alternate-day administration of atorvastatin can produce a reduction in LDL-C comparable to that of daily administration in patients with hypercholesterolemia, and yet provide some cost savings.
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