Proposed low-density lipoprotein cholesterol goals for secondary prevention and familial hypercholesterolemia in India with focus on PCSK9 inhibitor monoclonal antibodies: Expert consensus statement from Lipid Association of India

Abstract

BACKGROUND: Rates of atherosclerotic cardiovascular disease (ASCVD) are strikingly high in India compared to Western countries and are increasing. Moreover, ASCVD events occur at a younger age with only modest hypercholesterolemia, most commonly with low levels of high-density lipoprotein cholesterol. The course of ASCVD also appears to be more fulminant with higher mortality.OBJECTIVE: In light of these issues, the Lipid Association of India (LAI) endeavored to develop revised guidelines with more aggressive low-density lipoprotein cholesterol (LDL-C) goals in secondary prevention and for patients with familial hypercholesterolemia compared to guidelines in the United States and other countries.METHODS: Owing to the paucity of clinical outcomes data in India, it was necessary to place major emphasis on expert opinion as a complement to randomized placebo-controlled data generated mostly in non-Indian cohorts. To facilitate this process, the LAI conducted a series of 19 meetings among 162 lipid specialists in 13 cities throughout India over a period of 11 months before formulating this expert consensus statement.RESULTS: The LAI recommends an LDL-C goal ,50 mg/dL in all patients in secondary prevention or very high-risk primary prevention but proposes an optional goal #30 mg/dL in category A extreme-risk patients (eg, coronary artery disease 1 familial hypercholesterolemia) and a recommended goal #30 mg/dL in category B extreme-risk patients [coronary artery disease 1 (1) diabetes and polyvascular disease/$3 major ASCVD risk factors/end organ damage, or (2) recurrent acute coronary syndrome within 12 months despite LDL-C ,50 mg/dL, or (3) homozygous familial hypercholesterolemia].CONCLUSIONS: More aggressive LDL-C goals are needed for prevention of ASCVD in India, as described in this expert consensus statement. Use of statins and ezetimibe needs to increase in India in combination with improved control of other ASCVD risk factors. Proprotein convertase subtilisin kexin type 9 inhibitors can improve LDL-C goal achievement in patients with refractory hypercholesterolemia.

Guidelines for dyslipidemia management in India: A review of the current scenario and gaps in research

“…The LAI released a two-part consensus statement in the year 2016 followed by an updated third part in 2018. 21 , 23 , 24 The recommendations are based on cardiovascular risk factor assessment, treatment goals and targets, treatment recommendations, follow-up monitoring, and safety assessments. 25 …”

Cardiovascular risk in newly diagnosed type 2 diabetes patients in India

“…In addition, where the ESC mainly considers LDL as a major ASCVD risk factor, LAI mainly considers low HDL values as a major risk factor, especially for females [ 10 ]. Of the current population, 56% had lower HDL values than the recommended LAI threshold.…”

“…Lipid abnormalities were determined according to recommendations of LAI [ 10 , 11 ]. The following cut-offs were used to identify abnormal levels: HDL < 40 mg/dL for males HDL<50 mg/dL for females, LDL ≥130 mg/dL, total cholesterol ≥200 mg/dL, TG ≥150 m/dL.…”

“…Patient’s ASCVD risk classification was determined based on available parameters using the criteria of the LAI [ 10 , 11 ]. Patients were classified as “high risk” (HR) and “very high risk” (VHR).…”

“…Optimum lipid lowering therapy treatment leads to a significant CVD risk reduction. Therefore, the Lipid Association of India (LAI) has recently proposed more strict and better structured treatment goals based on the Indian patients’ individual CVD risk [ 10 , 11 ]. The present study aims at investigating the CVD risk and recommended management of dyslipidaemia following these LAI recommendations in a population newly diagnosed T2DM patients in India.…”