Maintenance of low-density lipoprotein goal with step-down pravastatin therapy

Abstract

Study objective: To determine whether patients who had achieved their National Cholesterol Education Program (NCEP)-derived goals for low-density lipoprotein (LDL) cholesterol with pravastatin would benefit from step-down therapy.

Design: Prospective, randomized, open-label study

Setting: Kansas City Veterans Affairs Medical Center.

Patients: One hundred four men who were taking pravastatin once/day and had maintained their NCEP-defined LDL goal for at least 3 months.

Intervention: Fifty-three patients were randomized to group 1, for which the dosing frequency was changed from daily to every other day, and 51 patients were randomized to group 2, for which the daily dose was halved.

Measurements and main results: Fasting lipid profiles and hepatic transaminase levels were analyzed at baseline, 2 months, and 4 months. Lifestyle, concomitant drug therapy, adverse events, weight, and compliance were noted at baseline and month 4. Thirty-one patients (58%) from group 1 and 22 patients (43%) from group 2 did not remain at their LDL goal after step-down pravastatin therapy Mean LDL at study end was 113 mg/dl for group 1 and 104 mg/dl for group 2 (p=0.04).

Conclusion: More than half (51%) of the patients enrolled did not remain at their LDL goal with step-down pravastatin therapy Therefore, we do not recommend a step-down approach for patients who have achieved their LDL goals. If a clinician decides, however, to attempt dosage reduction, the preferred regimen appears to be to halve the current dose once/day (vs administering the current dose every other day). A fasting lipid profile should be evaluated at 2 months and 4 months after step-down therapy begins to ensure that desired outcomes are achieved.