| Part Ⅰ Epidemiological Characteristics and the Use of Statins in Chinese PopulationBackground:The blood lipid level and prevalence of dyslipidemia among Chinese population have been increasing in recent 30 years.It was reported that high low-density lipoprotein cholesterol(LDL-C)had been the third leading cause of cardiovascular deaths in China in 2017.Therefore,effective control of dyslipidemia is important for the prevention and treatment of cardiovascular diseases in China.Assessment of atherosclerotic cardiovascular disease(ASCVD)risk is the basis of the lipid-lowering therapy(LLT)of dyslipidemia.However,recent national data on the level and distribution of blood lipids and the use of statin treatment in Chinese population are lacking,especially based on the risk stratification of ASCVD.Objective:(1)Estimating the proportions of population in different ASCVD risk stratifications.(2)Describing the levels and distribution of blood lipids in the participants overall and at different ASCVD risks,and evaluating the current prevalence of dyslipidemia and the achievement of different LDL-C goals;(3)Estimating the use of statins in Chinese population.Methods:We used the data from the China Patient-centered Evaluative Assessment of Cardiac Events Million Persons Project(China PEACE MPP),a national populationbased screening project which enrolled about 3 million community-dwellings aged 35-75 years from all the 31 provinces in mainland China from 2015 to 2020.We used standard protocol and instruments to perform the physical examination and the rapid measurement of blood glucose and lipids for the participants,and collected their demographic,socioeconomic information,disease and medication history through a questionnaire survey.Individuals’ ASCVD risks were estimated using the 10-year ASCVD risk estimation chart recommended in the 2016 Chinese Guideline for the Management of Dyslipidemia in Adults.And the LDL-C goals were recommended as an LDL-C level of<1.8 mmol/L for very-high-risk patients,<2.6 mmol/L for high-risk patients,and<3.4 mmol/L for lowor moderate-risk individuals.According to the guideline,people requiring statin treatment in our study were defined as:(1)the high-risk population with LDL-C≥2.6 mmol/L(if not on LLT)or irrespective of LDL-C if already on LLT;and(2)all the patients at very-high ASCVD risk.Statin treatment was defined as self-reported use of any statins within 2 weeks.We estimated the levels of blood lipids,the prevalence of dyslipidemia,the attainment of LDL-C goals,and the treatment of statins,and described them as means(standard deviation[SD]),median(interquartile range[IQR]),and proportions as appropriate.And we used multivariable logistic regression models to investigate individual characteristics associated with the use of statins.Results:(1)Our study population contained 2,904,914 participants(60.6%women;mean[SD]age,55.8[9.9]years).After standardizing age and sex,the proportions of population included at low,moderate,high,and very-high risk were 70.8%,15.6%,11.5%,and 2,1%,respectively.Among the 2,902,228 participants with complete blood lipids data,the average level of TC,LDL-C,HDL-C,and TG was 4.56±1.03 mmol/L,2.42 ± 0.87 mmol/L,1.43 ± 0.40 mmol/L,and 1.33(0.97,1.89)mmol/L,respectively.And the average level of TC,LDL-C,HDL-C,and TG in the low-risk individuals was 4.32 ± 0.92 mmol/L,2.24 ± 0.78 mmol/L,1.44 ± 0.39 mmol/L,and 1.23(0.92,1.71)mmol/L,respectively;moderate-risk was 4.95 ± 0.86 mmol/L,2.71 ± 0.77 mmol/L,1.46± 0.40 mmol/L,and 1.46(1.07,2.07)mmol/L,respectively;high-risk was 5.11 ± 1.31 mmol/L,2.84 ± 1.09 mmol/L,1.36 ± 0.43 mmol/L,and 1.64(1.15,2.38)mmol/L,respectively;and in the very-high-risk patients was 4.41± 1.09 mmol/L,2.31±0.92 mmol/L,1.35±0.38 mmol/L,and 1.42(1.04,2.00)mmol/L,respectively.The proportion of participants with borderline high or high TC levels was 17.6%and 6.6%,respectively;borderline high or high LDL-C levels was 8.9%and 3.9%,respectively;low HDL-C was 12.1%;borderline high or high TG levels was 16.5%and 15.2%,respectively;and the prevalence of total dyslipidemia was 30.0%.The proportions achieving the corresponding LDL-C goals were 91.9%,80.4%,46.8%,and 31.8%in participants at low,moderate,high,and very-high risk,respectively.(2)Among the high-risk population,56.4%(232,831 individuals)required statin treatment,in which the actual treatment rate was only 2.8%(6,592 individuals).The rate of statin use in very-high-risk patients(82,227)was only 11.1%(9,119).Atorvastatin and simvastatin were the two statins with the highest proportions of use.The achievement of LDL-C among those receiving statins was only 62.4%,while 31.0%of them were taking low-intensity statins.In the multivariable logistic regression analysis,we identified that younger age,male sex,rural areas,lower income,lower education levels,and farmer occupation were associated with lower use of statins among the high-risk population.And younger age,female sex,rural areas,lower income,lower education levels,farmer occupation,smoking,and alcohol consumption were associated with lower use of statins among the very-high-risk ones.Conclusions:One seventh of Chinese population aged 35-75 years were at high or veryhigh ASCVD risk,and the population at high risk had the highest levels of cholesterol and TG.Around one third of the adults had dyslipidemia,while large gaps exist between recommendations and current practice regarding the achievement of LDL-C goals and the statin treatment.Even among those who were receiving statins,about 40%failed to achieve the LDL-C goals,which could be partly attributed to the use of low-intensity statins in nearly one third of those receiving statins.Part Ⅱ Simulation of Lipid-lowering Therapy Requirement in Chinese PopulationBackground:LLT is one of the key strategies for both primary and secondary prevention of ASCVD.The current guidelines for the management of dyslipidemia recomm end optimizing statin therapy to achieve the LDL-C goals based on individuals’ ASCVD risks,and suggest additional use of ezetimibe or proprotein convertase subtilisin/kexin type 9(PCSK9)inhibitors to attain lower LDL-C levels in population at higher ASCVD risks.Although previous studies have shown that the treatment and control of dyslipidemia in Chinese population were suboptimal,little is known about the requirement of various LLT regimens for the targeted populations to achieve optimal LDL-C goals and the corresponding cost and benefit.Objective:Evaluating the proportions of people requiring various LTT regimens for achieving optimal LDL-C goals based on risk stratifications,and investigating the relevant cost and benefit of the LLT intensification.Methods:We used the data from the China PEACE MPP,a national population-based screening project which enrolled about 3 million community-dwellings aged 35-75 years from all the 31 provinces in mainland China from 2015 to 2020.Individuals’ ASCVD risks were estimated using the 10-year ASCVD risk estimation chart recommended in the 2016 Chinese Guideline for the Management of Dyslipidemia in Adults.And the LDL-C goals were recommended as an LDL-C level of<1.8 mmol/L for very-high-risk patients,<2.6 mmol/L for high-risk patients,and<3.4 mmol/L for low-or moderate-risk individuals.LLT was defined as self-reported use of any lipid-lowering medications within 2 weeks.A Monte Carlo model was used to implement step-wise LLT intensification algorithm to achieve various LDL-C goals based on the participant’s ASCVD risk in different simulation scenarios.Cardiovascular benefit was estimated by the absolute reduction of LDL-C levels after corresponding LLT,calculated as the accumulation of individual’s ASCVD risk at baseline ×[1-0.78(absolute reduction in LDL-C in mmol/L)].And the cost-effectiveness was evaluated as the LLT cost(Chinese yuan,RMB)of one prevented cardiovascular event.Results:People who failed to achieve the corresponding LDL-C goals-8.1%at low risk,19.6%at moderate risk,53.2%at high risk,and 93.6%at very-high risk(also including those achieving the goal but not receiving LLT)-would receive the LLT intensification simulation.After the use of atorvastatin 20 mg was simulated,over 99%of the population at low or moderate risk could achieve LDL-C<3.4 mmol/L;while 11.3%at high and 24.5%at very-high risk would still require additional non-statin therapy,as not achieving the corresponding LDL-C goals.After the additional use of ezetimibe,there were still 4.8%at high risk and 11.3%at very-high risk in need of evolocumab;and 99%of these two groups could achieve the LDL-C goals after the use of evolocumab.In total,43.1%of the overall high-risk patients required statin monotherapy;6.5%statin and ezetimibe;and 4.8%add-on evolocumab.And 75.5%of the overall very-high risk patients required statin monotherapy;13.2%statin and ezetimibe;and 11.3%add-on evolocumab.Such LLT intensification with statin,ezetimibe,and evolocumab would annually cost 15.7 billion,27.4 billion,and 160 billion RMB,respectively;prevent 264,170,18,390,and 17,045 cardiovascular events,respectively.Conclusions:Moderate-intensity statin therapy is pivotal for the attainment of optimal LDL-C goals in China,and around 10-25%of high-or very-high-risk patients would require additional non-statin agents.Optimizing LLT could significantly reduce the ASCVD burden in China,there is an urgent need for relevant strategies to improve the LLT comprehensively. |
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