LIpid Response to Statins ± Ezetimibe In Mumbai (LIRIM): A Cross-sectional Observational Study Presentation by Dr Amar SR Junior Resident Moderate - Dr Latha Assistant Professor Department of General Medicine, ESIC
Published in Journal of Association of Physicians of India Published on 25th June 2024 Shah VT for the LIRIM study
Introduction 17.9 million lives are lost due to CVDs every year, accounting for 32% of all deaths. Heart Attacks & Strokes: 80% of CVD-related deaths. 2019 Global Burden of Disease Study: IHD and stroke among top causes of morbidity in India. Higher prevalence and mortality rates in Low and Middle Income Countries. Rising cases in younger populations. High Mortality Rates notably in individuals under 50. Myocardial Infarctions (MIs): 1 in 4 MIs occur in individuals <40 years old Coronary Artery Disease (CAD) Mortality: Over 50% in those under 50 with high risk of recurrence.
Introduction The Role of Cholesterol Proven link between high LDL-C levels and ASCVD risk Statin Therapy is recommended to lower LDL-C in high-risk patients. Non-HDL-C as a Risk Indicator Emerging Research says Non-HDL-C may predict coronary heart disease risk more effectively than LDL-C
Guideline-Directed Therapy for Secondary ASCVD Prevention Optimal cholesterol management is crucial after PCI to reduce future cardiovascular events. Progressive nature of ASCVD highlights the need for aggressive therapeutic strategies. Various guidelines recommend LDL-C reduction as the primary therapeutic target. Lipid Association of India (LAI) 2020 Guidelines advocate for more aggressive LDL-C goals in the Indian context due to a more severe disease pattern. High-Intensity Statin Therapy: Remains the first-line intervention for secondary prevention according to AHA/ACC and ESC/EAS.
ASCVD patients in India are typically younger and experience more aggressive disease progression. LAI 2020 Guidelines recommend High Intensity statin therapy based on risk stratification while statins may not eliminate residual CV risk. Emerging Evidence shows that Non-HDL-C levels may predict cardiovascular risk better than LDL-C alone. Atherogenic Lipid Fraction: Includes VLDL-C, IDL-C, LDL-C, Lp(a), and chylomicrons.
ESC/EAS Goal: Non-HDL-C goal of <85 mg/dL for very high-risk individuals which is 30mg/dL higher than LDL-C goal ( <55 mg /dL). Non HDL -C has a strong correlation with coronary plaque progression and adverse outcomes. In patients with Metabolic syndrome - LDL-C may be normal while non HDL -C is elevated,
Objective To document the dose of statin ± ezetimibe required to achieve the European Society of Cardiology (ESC) goals of LDL-C <55 mg/dL in Indian patients with established atherosclerotic cardiovascular disease (ASCVD).
Materials and Methods STUDY DESIGN Type: Single-center, cross-sectional, observational study. Location: Mumbai. Duration: 2017 - 2022. Participants: All patients attending outpatient department.
Inclusion Criteria Patients on atorvastatin (A) or rosuvastatin (R) ± ezetimibe (E) therapy. Regardless of baseline LDL-C levels.
EXCLUSION CRITERIA History of: Excessive alcohol intake Liver disease Renal dysfunction Rheumatologic disease Recent substantial weight change Patients on medications affecting lipoprotein metabolism or immune system, PCSK9 inhibitors, or with statin intolerance.
Outcomes Primary Outcome Goal: Determine the dose of high-intensity statin ± E achieving LDL-C <55 mg/dL. Final Data Set: 340 patients. Secondary Outcome Measure: Impact on non-HDL-C levels and achievement of goals (<85 mg/dL).
Additional Analyses Subgroup Evaluations: Type II diabetes Obesity Assessment: Incremental impact of E10 addition on LDL-C levels.
Results
Conclusion High doses of R40 ± E10 are effective in lowering LDL-C in the Indian population Adding Ezetimibe provides significant LDL-C reduction for patients not reaching goals with statins alone Clinicians should consider additional therapies to address residual risk in high-risk ASCVD patients
Limitations This study was a retrospective, single-center, cross-sectional, observational, all-comers study where the study population was treated with statins and ezetimibe obtained from multiple pharmaceutical sources. Therapeutic adherence was assessed through patient history and by reviewing the samples of consumed medication strips brought in during follow-up visits. Lifestyle modifications, such as diet, exercise, and weight management, these protocols were not supervised.
baseline lipid levels in a statin-naïve population were not available. Follow-up LDL-C estimations were conducted at a minimum of 3 months; however, in some cases, this period extended beyond 3 months due to patients’ inability to attend follow-up appointments, particularly because of COVID-19 restrictions. A significant number of patients who did not achieve their LDL-C goals (n = 202) were lost to follow-up.
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References Journal of Association of Physicians of India