Efficacy, safety and cost-effectiveness of 40 mg versus 80 mg atorvastatin in a Sri Lankan cohort with acute coronary syndrome: a protocol for a single-centre randomised controlled clinical trial

Abstract

BACKGROUND: Most guidelines recommend high-intensity statins for the secondary prevention of acute coronary syndrome (ACS). However, several studies from other Asian populations suggest enhanced sensitivity to statins, with effective low-density lipoprotein cholesterol (LDL-C) reduction seen at lower doses and possible higher incidence of adverse effects at higher statin doses. However, there is no published data from Sri Lanka. Therefore, we aimed to explore this hypothesis by comparing the efficacy, safety and cost-effectiveness of atorvastatin at doses of 40 mg and 80 mg in a cohort of South Asian individuals presenting with ACS from Sri Lanka. METHODS: This single-centre, prospective, randomised, controlled, open-label clinical trial is being conducted among patients naïve for statins admitted with incident ACS to a tertiary care setting in Sri Lanka. All patients will have LDL-C measured at baseline and are randomised to receive atorvastatin 40 mg or 80 mg in addition to standard of care. Data are collected using an interviewer-administered proforma. Patients are evaluated at 6, 12 and 24 weeks for adverse drug reactions and LDL-C level. The primary endpoint is the percentage of patients achieving LDL-C ≤ 70 mg/dL at 12 weeks. This outcome will be analysed by the intention-to-treat analysis. Secondary outcomes include safety assessments and a cost-effectiveness evaluation. For the latter, data on medication costs, including the number of tablets consumed, will be collected to calculate the average cost-effectiveness ratio and incremental cost-effectiveness ratio between the two dosing regimens. DISCUSSION: This will be the first head-to-head comparison of atorvastatin 40 mg and 80 mg in a South Asian cohort. The findings will provide evidence on efficacy and safety of prescribing atorvastatin 40 mg dose in South Asians with ACS.