Comparative Efficacy and Safety of Daily Versus Alternate-Day Dosing of Rosuvastatin in Diabetic Dyslipidemia: An Open-Label Clinical Trial

TL;DR

This study compares daily and alternate-day dosing of rosuvastatin in diabetic patients and finds both regimens are effective and safe for improving cholesterol levels.

Contribution

The study introduces an alternate-day dosing regimen for rosuvastatin as a viable and cost-effective alternative to daily dosing in managing dyslipidemia in diabetic patients.

Findings

Both daily and alternate-day rosuvastatin dosing significantly improved lipid profiles in diabetic patients.

Daily dosing showed slightly more significant improvements in total cholesterol and LDL-C levels.

Alternate-day dosing was found to be economically advantageous and well-tolerated with no serious adverse events.

Abstract

Background: Cardiovascular disease (CVD) is a growing health concern among individuals with diabetes. Cardiovascular conditions tend to present earlier in Indian populations, and the prevalence of diabetes is increasing in the region. Type 2 diabetes (T2DM) is frequently linked to abnormal cholesterol (CH) levels, which can increase the risk of heart problems. Rosuvastatin is a medication often used to manage cholesterol and may offer dosing flexibility due to its long duration of action.

Aims and objectives: To compare the efficacy and safety of daily versus alternate-day dose of rosuvastatin in patients with T2DM.

Materials and methods: The study was a single-center, prospective, open-label, parallel-group, randomized trial conducted over 12 weeks. The study enrolled 60 patients with diabetes-related dyslipidemia who were receiving care at a diabetic clinic within a tertiary care teaching center. Patients were randomized into two groups: group I received a daily dose and group II received an alternate-day dose of rosuvastatin. The primary endpoint was the percentage change in low-density lipoprotein cholesterol (LDL-C). Secondary endpoints included percentage changes in total cholesterol (TC), triglycerides (TGs), high-density lipoprotein cholesterol (HDL-C) levels, and adverse events over 12 weeks of treatment. Appropriate tests were applied, considering a significance level of p<0.05. Paired t-tests were used for within-group comparisons, unpaired t-tests for between-group comparisons, and the Mann-Whitney test was applied to evaluate differences in the percentage changes in lipid profile parameters. The study adhered to the International Council for Harmonisation & Good Clinical Practice (ICH & GCP) guidelines. Approval from the Institutional Ethics Committee (IEC) and informed consent (IC) were obtained.

Results: There was reduction in serum TC, TG, LDL-C, and very-low-density lipoprotein (VLDL) levels and an increase in HDL-C levels in both groups. After 12 weeks, significant improvements in lipid parameters were observed in both treatment groups (p<0.05), with the daily dosing group showing slightly more significant improvements. There was a significant decrease in TC level (p<0.0001) in the daily dose regimen, while significant decrease in LDL-C level (p<0.0001) in the alternate-day regimen of rosuvastatin dosing. Common adverse events included dizziness, palpitations, myalgia, malaise, and uneasiness, with no serious adverse events reported.

Conclusion: Alternate-day rosuvastatin treatment demonstrated comparable efficacy and safety to a daily dosing regimen, with significant reductions in TC, TG, LDL-C, and VLDL levels and an increase in HDL-C level. The alternate-day regimen is economically advantageous and provides an alternative option for patients who are intolerant to daily statin therapy.

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