Efficacy, Safety and Cost-effectiveness of Atorvastatin 40mg versus 80 mg in South Asian Patients with acute coronary syndrome: A protocol for randomised clinical trial

Abstract

AbstractIntroductionMost guidelines recommend high-intensity statins for the secondary prevention of Acute Coronary Syndrome (ACS). However, it has been observed that South Asians are responsive to lower doses of statins to achieve the recommended target levels of low-density lipoprotein cholesterol (LDL-C). However, published data on this subject is limited. Therefore, we aim to compare the efficacy, safety and cost effectiveness of atorvastatin doses (80mg vs 40mg) in lowering the LDL-c levels to the less than 70 mg/dL within 12 weeks, among patients with incident ACS.Methods and analysisThis single-centre, prospective, randomised, controlled, open-labelled clinical trial is being conducted among patients naïve for statins presenting with incident ACS to the Colombo North Teaching Hospital, Ragama, Sri Lanka. All participants are randomised to two groups, to receive oral atorvastatin 40 mg nocte, or 80 mg nocte. The percentage of patients achieving treatment goals, the percentage with statin induced adverse drug reactions and the mean cost to achieve treatment goals will be compared between the two groups in 6,12 and 24 weeks. Outcome will be analysed for the intention-to-treat population.Ethics and disseminationEthical approval for this study has been obtained from the Ethics Review Committee of the Faculty of Medicine, University of Kelaniya (P/28/05/2022). This trial is registered in the Sri Lanka Clinical Trial Registry (SLCTR/2023/003). The results from this study will be disseminated as scientific publications in reputed journals.Key points of this studyWhat is already known on this topic?While the European guideline recommendation is to initiate atorvastatin at 80 mg dose for ACS, it has been observed that South Asians respond well to lower dose. Additionally, South Asians tend to experience more adverse effects with higher doses of statins. However, reports on differential action of atorvastatin in South Asians is limited.What this study adds?This study explores the efficacy, safety, and cost-effectiveness of a lower dose of atorvastatin (40 mg daily) compared to guideline recommended dose of 80mg in a South Asian cohort.How might this study affect research, practice or policy?The findings may influence statin dose recommendation for South Asians/Sri Lankans which will help to reduce unnecessary side effects and be cost saving as well in secondary prevention of ACS.