Effectiveness and safety of rosuvastatin 10 mg once daily versus every other day in outpatients with hypercholesterolemia

Abstract

Objectives: To compare the effectiveness and safety of rosuvastatin 10 mg once daily with every other day in terms of: (1) serum lipids, hsCRP, and fibrinogen alteration, (2) the percentage of patients who achieved their LDL-C goals according to NCEP-ATP III guidelines, (3) adverse event rates, and (4) monthly cost per %LDL-C reduction. Methods: A randomized, open-labeled, parallel study was conducted during September, 2004 to February, 2005 at outpatient department, Phramongkutklao hospital, Bangkok, Thailand. Eighty patients were randomly assigned equally into the control and study groups by block of four randomization. The patients in the control and study groups received rosuvastatin 10 mg once daily and 10 mg every other day for 8 weeks, respectively. Outcome variables were evaluated in terms of: (1) percentage of change from baseline in serum LDL-C, TC, TG, HDL-C, hsCRP, and fibrinogen, (2) percentage of patients who achieved their LDL-C goals according to NCEP-ATP III guidelines, (3) adverse event rates, and (4) monthly cost per %LDL-C reduction of each patient group. Data were assessed using laboratory data (12-hour fasting blood and urine samples), physical examinations, and patient interviews. Chi-square test, independent t-test, paired t-test, Mann-Whitney U test, Wilcoxon signed-rank test, and Two-way ANOVA with repeated measures on one factor were used to analyze data. Results: There were statistically significant differences in baseline characteristics of mean age and hsCRP between the control and study groups. Mean age and hsCRP in the study group were significantly higher than those in the control group (p < 0.05). The percentage of change in serum TC, TG, and LDL-C in the control group was significantly higher than that in the study group (p < 0.05). But, there was no significant difference in the percentage of change in serum HDL-C, hsCRP, and fibrinogen between the control and study groups (p > 0.05). The percentage of patients who achieved LDL-C goals according to NCEP-ATP III guidelines was not significantly different between the control and study groups (p = 0.180). In addition, the number of patients who experienced adverse events was not significantly different between both groups (p = 0.439). Monthly cost per %LDL-C reduction in the study group was lower than that in the control group (17.77 baht and 28.62 baht, respectively). Conclusions: Every other day dosing of rosuvastatin is an alternative regimen for cost saving. It provides comparable adverse event rates and LDL-C lowering effect with once daily dosing, which allows the patients to achieve their LDLC goals, despite less reduction in LDL-C.