2022 Saudi Guidelines for the Management of Dyslipidemia

Abstract

PREAMBLE Since its establishment in 2014, the Saudi Health Council (SHC) has stepped up to embrace a core mission of “establishing regulations that ensure coordination and integration among health stakeholders to improve health care in Saudi Arabia, and to be an inspirational reference to a world-class Saudi health system.” In light of this mission, SHC took over the responsibility to put forward efficient health-care strategies, regulations, and policies in the kingdom to ensure that hospitals run by the Ministry of Health (MOH) and other government agencies are operated in adherence to the principles of economic management as well as performance and quality standards. In light of the alarming status of atherosclerotic cardiovascular disease (ASCVD), risk factors in Saudi Arabia and recent data about serious gaps in the quality of health-care delivery, specifically in areas of clinical effectiveness, patient-centered care, and patient safety,[1,2] SHC has taken the worrying status of dyslipidemia in Saudi patients very seriously and assigned a task force to develop national guidelines for dyslipidemia management to be a cornerstone for the development of subsequent guidelines addressing other ASCVD risk factors among the Saudi population. INTRODUCTION The current recommendations state that adherence to lifestyle modifications and the use of lipid-lowering medications are the cornerstones for reducing the risk for ASCVD in patients with dyslipidemia. Nonetheless, the management of dyslipidemia has undergone a number of significant changes over recent years, leading to revisions in both European and US guidelines.[3,4] Such revisions include new thresholds and goals, changes in primary and secondary preventive approaches, the new classification of the risk-enhancing factors, and new definitions for risk groups; these changes are also influenced by new equation values, recommendations, and actions.[3,4,5] However, the published international guideline cannot be directly applied to the Saudi population who differs in a number of aspects from European and American populations.[6] In Saudi Arabia, the mean age of the population is younger, with 72.5% aged between 15 and 64 years. The Saudi population is multiethnic, and disparities between groups are prevalent due also to geographical and cultural factors. The annual growth rate of the Saudi population is 2.3%, with a median life expectancy of 75 years. There is a high prevalence of obesity (24.7%), and approximately 25.2% of the total population have diabetes mellitus (DM). In addition, there is a lack of primary health-care units (0.6 PHC per 10,000 population).[7,8,9,10] In Saudi Arabia, over the past years, ischemic heart disease has persisted in ranking first as the top cause of death from 2000 to 2019, followed by stroke.[11] Furthermore, cardiovascular diseases (CVDs) collectively remained as the leading cause of disability-adjusted life years (DALYs quantifies the health loss due to specific diseases and injuries[150]) in Saudi Arabia from 1990 to 2017 [Figure 1].[12] The prevalence of ASCVD risk factors has been consistently high over the past decades, and multiple surveys have shown the continued high prevalence of dyslipidemia, unhealthy diet, hypertension, smoking, obesity, physical inactivity, and diabetes in Saudi Arabia across different age groups.[7,8,13,14,15,16]Figure 1: Top 10 causes of DALYs in Saudi Arabia for the periods 1990–2010 and 2010–2017, both sexes. Adapted from Tyrovolas et al.[12] *Percentage change in the number of age-standardized DALYs, 1990–2007, **Percentage change in the number of age-standardized DALYs, 2010–2017. DALYs: Disability-adjusted life-yearsThese Saudi clinical practice guidelines provide recommendations applicable to Saudi patients with or at risk of developing CVD. The guidelines summarize and evaluate available evidence with a focus on the Saudi published literature and the best available up-to-date research evidence from other international research and guidelines. It is worth emphasizing that the European Society of Cardiology Guideline recommendations, categorizations, targets, and cutoffs were the main guide while developing these Saudi dyslipidemia guidelines since it is strongly believed that the tighter control imposed by the European Society of Cardiology is the most appropriate to be implemented in Saudi Arabia given our population’s biochemistry. METHODS Consensus approach The task force recruited Saudi experts and specialists from different regions of the kingdom, including the Director General of the National Heart Center and other members representing various health sectors, to typify professionals involved with managing patients with dyslipidemia. One member representing the Drug Policy and Regulation at the Saudi MOH ensured all recommendations are in line with the health economic considerations that consider both clinical-and cost-effectiveness perspectives. In addition to European experts who extensively reviewed the guidelines as well as the endorsement process. Members of the assigned task force have volunteered their time and effort to produce these recommendations with the highest level of proficiency. Scope In this document, the Saudi experts have provided recommendations and guidance for detailed risk assessment, the position of newer cholesterol-lowering drugs within the management algorithm, and the need for special attention to patient subgroups. Besides, the experts recommended treatment algorithms using an evidence-based approach. The guideline updated the patient risk assessment and treatment options in primary and secondary prevention using the most up-to-date evidence to inform the clinicians during the process of shared decision-making, aiming to align these decisions with the recent recommendations of the international guidelines. This document has been developed for health-care professionals to facilitate informed communication with individuals about their cardiovascular (CV) risk and the benefits of adopting and sustaining a healthy lifestyle and early modification of their lipid-related CV risk. This guideline has the potential to promote up-to-date management strategies and to translate them into locally delivered health-care services, in line with the recommendations of the World Health Organization (WHO).[6] Literature review A literature search was made in English language to identify published articles related to ASCVD and or lipids related to Saudi, Gulf, or Arab populations. Where local data or published material was found, it was always used. The designated steering committee also reviewed the previously published international guidelines and related statements deemed pertinent to these guidelines; thus, obviating the need to implement existing guideline recommendations of different regions. Different authors had the responsibility to research specific sections of the guidelines and produce a draft that was discussed in a series of virtual meetings. During these meetings, different recommendations were considered and a consensus was reached, or voting was made on the adoption for each recommendation based on the strength of available evidence for that recommendation and its applicability to practice conditions within Saudi Arabia. The level of evidence and the strength of the recommendation are adapted from the 2019 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) Guidelines for the management of dyslipidemia,[3] where management options were graded as per predefined scales [Table 1].Table 1: Classes of recommendations and levels of evidenceA third party coordinated the preparation of these new guidelines and provided professional writing and editorial support. After appropriate revisions, the final document was approved by all task force members. The overall aim of the present document is, therefore, to provide a nationwide, evidence-based policy, and guidelines to implement a unified approach for the management of dyslipidemia in Saudi Arabia. All experts involved in the development of these guidelines declared no real or potential sources of conflicts of interest. CARDIOVASCULAR DISEASE RISK AND RISK GROUPS Total cardiovascular risk estimation CV risk is the likelihood of a person to develop an atherosclerotic CV event over a defined period of time, and the total risk of developing CVD, i.e. total CV risk estimation, is determined by the combined effect of multiple risk factors which commonly coexist and act multiplicatively.[3] Risk assessment systems are used to improve management decisions by way of providing a 10-year estimate of an individual’s risk for ASCVD events, and therefore, many systems have been developed and comprehensively reviewed.[17,18,19,20,21,22,23,24,25,26] Ideally, risk charts should be based on country-specific cohort data since estimating risk based on cohorts that differ greatly from the target population could jeopardize the benefit of risk charts in practical terms. However, these are not available for most countries, including Saudi Arabia.[27,28] A recent expert opinion was published in 2018 by Alshamiri et al.,[28] in which an expert panel had convened to review the commonly used international guidelines in Asia and the Middle East and to determine their applicability in the region. There was agreement that existing risk calculators may not be suitable for Asia and the Middle East, with many concerns about the validity of these calculators in local populations. However, disparities on which risk to use across the the panel the of using to CV risk. In the Risk is the most in Saudi Arabia not for the Saudi population. It a and for for use in different populations. However, it the risk of and the total which at a the development of a new risk that is for the Saudi and that risk factors in of to the Saudi risk is a that to be to ensure all patients are and for risk estimation in Saudi Arabia are in for cardiovascular disease risk estimation in Saudi this it should be that the mean age of with in Saudi Arabia is 10 years the age in developed countries, and this is due to the high prevalence of ASCVD risk risk in Saudi Arabia, including the should be considered recommended in developed [Table Risk The used to different risk in the 2019 and guidelines for the management of are recommended to be in Saudi Arabia and are in a practical individuals with conditions as patients with CVD, individuals with disease and or or are at high or very high risk of risk in the Saudi across total cardiovascular disease risk have been defined in with an overall ASCVD risk the 10-year risk of CV In it is that the in levels should as the is with a of ASCVD The evidence has not a level of which benefit or The of is to with lipid-lowering management on the of both the patients and it is to target an level that is as as However, in to have been with evidence of risk. It is, therefore, to the treatment across total risk are in across total cardiovascular disease risk applied to the Saudi population. cardiovascular Risk diabetes diabetes Total with are at high CV and the treatment is or at a in However, early and prevention of are the real in the management of this population. Risk factors The risk factors for ASCVD are and hypertension, and lifestyle factors and obesity, unhealthy diet, physical and [Figure to risk factors in ASCVD Total risk on the individual’s overall risk of cardiovascular risk factors in Saudi Arabia. Adapted from et et et et for in Saudi for treatment for in Saudi for cardiovascular disease prevention in Saudi and and are the main of risk. and years of age are always at high 10-year In Saudi Arabia, from a the population from all the health regions of the kingdom aged between 15 and 64 years that and the of total were in while and were in significant in to were dyslipidemia prevalence of and was in 1: for atherosclerotic cardiovascular disease risk age and and their in Saudi is and the is a for ASCVD and the risk of CV events, and both and risk are with the of of is the of the management of ASCVD the between which all i.e. and CV risk is at as as the with have a in the and of and of directly the number of in In Saudi Arabia, dyslipidemia is the most prevalent ASCVD risk and the prevalent is and high which is different from many other regions in the The high prevalence of and is the main this in the to hypertension, a national in the kingdom including that for and for and were or is and of the main health in Saudi Arabia, with about of of the Saudi population has which is to by the Saudi Arabia in the prevalence of in the Middle East and in the In Saudi Arabia a where is considered an dyslipidemia is of the risk factors for in with which about have or and in with obesity and or prevalence in Saudi Arabia has shown to be prevalent in the high in the population at in among aged between and years and among Heart and were present and in and among in that et a prevalence of from to among of their The prevalence among between and data have shown alarming evidence of high among Saudi and and obesity The prevalence of and obesity in the Saudi population across different age groups is or lack of preventive [Figure to World Saudi Arabia is among The of Risk for that both to and obesity were with a risk of heart disease and with to with of the risk of and of the risk of obesity for by and of obesity in Saudi Arabia by age Adapted from et of or of or all with of in and and of and among the Saudi population are with an risk of et a in of Saudi individuals aged years. guideline recommendations were by of individuals for for for and for The of are not to the recommended guidelines for physical were in of were assigned based on the of physical and the of physical for per physical and per physical and for Saudi and The prevalence of physical to with The most to physical are the lack of time, followed by lack of appropriate for and lack of and is with obesity and in and is a to the of and for and of all and in was the risk for with high high physical inactivity, or is a and of in and from is for the of the disease its on ischemic heart disease and In Saudi Arabia, have the between and CVD, as well as the of involved in and Risk factors are of other with for risk-enhancing factors guide decisions about preventive in at or risk and to the of [Table of ASCVD age years and age is a risk-enhancing that should be considered for risk [Table for management in Saudi risk is by the of obesity, dyslipidemia, and A that Saudi a high prevalence of in Saudi Arabia that in and in The most of was levels of followed by patients with as about its prevalence and to treatment in Saudi Arabia are ASCVD risk-enhancing factors, and recommendations in Saudi ASCVD risk and recommendations in Saudi is an that of and the risk of many among is risk factors for CV and disease into and the risk for CVD. of in and the risk of by to is the leading cause of death in with In Saudi Arabia, data about is However, from a in that the prevalence of is in Risk Risk are risk factors or that the risk. of risk is the individual’s risk is to a in or very is to management [Table and cardiovascular disease The CV of disease 2019 are well in A recent by et used of individuals with individuals as and individuals as to estimate and of CV The that individuals with are at risk of CV disease including ischemic and heart heart and the first were among all or not during the of the the evidence that CV disease risk and in of are and care of should include attention to CV management has been to improve CV in specific clinical as and other very and [Table for dyslipidemia management in different clinical in Saudi to early a clinical event a significant early evidence has the benefit with early of that is, and continued Furthermore, in all patients with is recommended of the an it is well that levels therefore, should be within the first the event are The recommended target for is a and a level of individuals in a different within years, a of for is very the treatment is recommended to include in with the target is not reached, the addition of is high risk of other of should be considered the a in all and a in all events, including and mellitus is to as an ASCVD It an risk for multiple CV that is other has a with the risk of disease at all including i.e. the for with as and and have a risk of CV risk factors at an risk of CV with disease have a and an and management are data a risk of development of diabetes with the in the with The of the of levels CV events, should be and potential risk of data from the and no in the risk of diabetes with the use of In their et an in and levels in patients who were and this not in a of Furthermore, the The of the not to diabetes with these disease is considered and is considered very high risk. rate of and an of or are of a is recommended in with or with an to the with appropriate is as this population has an overall risk of CV in patients with In addition, in patients with with were with a of ASCVD and death across all of In the in the CV with is with This the need to lipid-lowering and consider have been in prevention However, and data for both and an benefit of and in preventive are not recommended during or due to the of evidence benefit or However, with including and a are at overall CV risk assessment and lipid-lowering should be in has been to have a which is related to this in its it be as There are different of among is the of dyslipidemia dyslipidemia is an where both and are by in for age and This a population where research on the prevalence and to treatment in Saudi Arabia is it and in the with an prevalence of based on the In addition to patients with present with the of high levels of and CV events, and in the and are to ASCVD and data are available about and various that is with are in most In the of a years patients had and patients had or recruited from over a period a prevalence of in the to the first and in are among the highest in the and are believed to be the factors to the high prevalence of worrying a for in Saudi Arabia, in addition to the need for of a and management treatment with and have been approved for their for management in Saudi Arabia are in for management in Saudi and approved lifestyle are to the risk of atherosclerotic treatment an of the overall in addition to lifestyle should be considered for patient The treatment include or and and and approved that are for different clinical who have developed or not risk individuals are at very high and is recommended to their risk to the in addition to appropriate lifestyle an assessment of overall ASCVD risk. is recommended for with or that have an 10-year atherosclerotic risk. are the drugs of for all patients considered for The of the be based on the level of risk and the level of are to between and while could this by who not the target should have with are to with a a and or that have or up to with should be considered for with which has been shown to the risk of ischemic events, including CV with are at high risk for and of lipid-lowering with with be in the way as patients with of these patients also have that may be related to these patients of control in addition to lifestyle these are to the or the the addition of or should be of lipids and for patients on lipid-lowering the risk of from and the of to during treatment has and strategies for [Figure strategies for different lipid-lowering for in patients with ASCVD during the The risk of in patients with previously high and patients with or and to care in Saudi Arabia Saudi Arabia is of the Arab in the Middle East with a population that has been over years, as by the Saudi This is the main for on all aspects of health many other countries, Saudi Arabia is to provide quality health-care to its and this to be to their while at the time the quality of in the kingdom is by the MOH and by other the health with a from the which is consistently that there are and health-care this also efficient coordination and of In line with this Saudi the Health the of care and has assigned that focus on including health to improve to all health and and geographical of cardiovascular diseases in Saudi Arabia and health assessment In Saudi Arabia, a economic with each patient with CVD, the per event were to be in for of all in Saudi A for the use of in with for the treatment of in or patients in Saudi Arabia was published in The aim was to evaluate the of as an to for the management of levels among patients with in the Saudi MOH over years. The of in an of where the of the was the to the total The use of was with a in the annual number of CV from in to in to other The CV event was by with the addition of to no over published cost-effectiveness were based on Saudi between and which the need to develop a of in Saudi per the health assessment is of of health It is a process to evaluate the and of a health or health The main of an assessment is to inform In Saudi to and the in in related to on the national MOH has on and to to it and the review Saudi MOH has which be a cornerstone for the including the of the Saudi and a cost-effectiveness the multiple agencies and the that the process differs between is determined by clinical that are on economic and who a it is to the agencies which could be used as a for Saudi Arabia. recommendations in many as and or recommendations with in and recommendations in or recommendations with in the for dyslipidemia in Saudi Arabia are in for dyslipidemia in Saudi AND In addressing it is to identify the in Saudi Arabia. and there are no data that provide a for risk CV and the of local to preventive there is a lack of into the of ASCVD as well as the of international guidelines This is both at the level of patients and health-care an to a unified has been the health-care in Saudi Arabia. multiple there are multiple care and health-care and are to across these for this of national guidelines to the by emphasizing the of prevention and for both patients and health-care [Figure to the adoption of these guidelines include the to the adoption of preventive in Saudi of clinical that are shared across all and by [Figure of primary prevention and that and treatment of a unified that adoption of preventive national that the of ASCVD patients in Saudi Arabia. the is available with no is cardiovascular national data to guide and recommendations to the local population in to experts in the to the of preventive on and government agencies as the Saudi and Drug to provide and to improve to that lifestyle modification and and physical in have light on the alarming status of ASCVD risk factors in Saudi Arabia. and including lifestyle are recommended to the ASCVD risk The development of a new risk that is for the Saudi population and that all factors is a current that to be be used for it is the should be using to the and the should be continued for approach is to the with the since this is a and has a be directly and and risk or be used as an to as the primary for and management Risk are risk factors or that the risk in the individual’s risk is to a Risk are other factors with for risk-enhancing factors guide decisions about preventive in at or risk and to the of assessment with should be considered in individuals at or risk in the is not with lifestyle management has been to improve CV in different clinical as and other very and national and policies national Saudi up of and is recommended for early of in Saudi Arabia, which is among are the drugs for dyslipidemia. the treatment is not with a with the other treatment options is has been with with have shown a in ASCVD risk in patients who are in high or very high risk Furthermore, have to levels in the groups combined with the treatment is to ensure that treatment of the patients the by both a and an treatment of for very patients and of in the in the Saudi it is to a approach that the and government to the adoption of these guidelines include and AND The recommended evidence based and to in dyslipidemia management are [Table and to and of There are no conflicts of interest. The authors to and from for their editorial support. The authors also and from for their review and

Topics & Concepts