Bempedoic Acid for Management of Dyslipidemia from an Indian Perspective: An Expert Consensus Report

Abstract

ObjectiveBempedoic acid has recently been made available for Indian patients. To formulate a consensus statement to utilize Bempedoic acid in the Indian context based on the contemporary evidence MethodsA virtual collaborative educational initiative was convened from May 17, 2022, to June 14, 2022, through a series of 6 nationwide virtual interactive meetings by leading cardiologists (n=99), who are at the forefront of dyslipidemia management. The cumulative clinical experience was approximately 3,000-man-years, who rated their level of agreement for 9 questions with each item on a 5-point Likert scale. This was preceded by a contemporary evidence-based discussion on the contemporary updates for Bempedoic acid. The focus of the discussion was Bempedoic acid and its pertinent evidence for scientific and therapeutic approaches. The consensus was pre-defined as > 75% of the panel agreeing/disagreeing on any item. There was one objective choice -best-suited response-based question. GraphPad 9.4.0 and ANOVA were used for statistical analysis. ResultsThere was unanimous agreement (100%) for the clinical distinctiveness of Bempedoic acid to cause fewer skeletal muscle side effects. The agreement score (%) in the Indian setting for the clinical relevancy were as follows: CLEAR Wisdom trial for patients on a maximally tolerated dose of statin (93.5%), CLEAR Harmony trial for high CV risk patients (92.8%), CLEAR Serenity trial in statin-intolerant patients (92.3%); evidence from landmark trials of Bempedoic acid can be replicated into patient benefits in the real-world setting (91.1%), minimal drug-drug interactions as an attractive scientific reason to choose Bempedoic acid (90.4%), CLEAR tranquillity for Bempedoic acid as add on to ezetimibe (89.6%), efficacy to lower the TGs (76.6%). (p<0.0001) (table, figure). 63.3 % opined that the efficacy to lower LDL-C was the most promising reason to choose Bempedoic acid. ConclusionsIn this pioneering attempt, our mapping exercise provides expert consensus-based statements to identify the unmet gaps in the management of dyslipidemia, and guide and align clinicians on the appropriate use of Bempedoic acid, including patients with diabetes, who have high cardiovascular risk. Our results shall lay the foundation for developing robust Indian guidelines for the use of Bempedoic acid in Indian settings.