PDF(Pubmed)
Abstract：
BACKGROUND: The 2013 ACC/AHA Guideline was a paradigm shift in lipid management and identified the four statin-benefit groups. Many have studied the guideline\'s potential impact, but few have investigated its potential long-term impact on MACE. Furthermore, most studies also ignored the confounding effect from the earlier release of generic atorvastatin in Dec 2011.
METHODS: To evaluate the potential (long-term) impact of the 2013 ACC/AHA Guideline release in Nov 2013 in the U.S., we investigated the association of the 2013 ACC/AHA Guideline with the trend changes in 5-Year MACE survival and three other statin-related outcomes (statin use, optimal statin use, and statin adherence) while controlling for generic atorvastatin availability using interrupted time series analysis, called the Chow\'s test. Specifically, we conducted a retrospective study using U.S. nationwide de-identified claims and electronic health records from Optum Labs Database Warehouse (OLDW) to follow the trends of 5-Year MACE survival and statin-related outcomes among four statin-benefit groups that were identified in the 2013 ACC/AHA Guideline. Then, Chow\'s test was used to discern trend changes between generic atorvastatin availability and guideline potential impact.
RESULTS: 197,021 patients were included (ASCVD: 19,060; High-LDL: 33,907; Diabetes: 138,159; High-ASCVD-Risk: 5,895). After the guideline release, the long-term trend (slope) of 5-Year MACE Survival for the Diabetes group improved significantly (P = 0.002). Optimal statin use for the ASCVD group also showed immediate improvement (intercept) and long-term positive changes (slope) after the release (P < 0.001). Statin uses did not have significant trend changes and statin adherence remained unchanged in all statin-benefit groups. Although no other statistically significant trend changes were found, overall positive trend change or no changes were observed after the 2013 ACC/AHA Guideline release.
CONCLUSIONS: The 2013 ACA/AHA Guideline release is associated with trend improvements in the long-term MACE Survival for Diabetes group and optimal statin use for ASCVD group. These significant associations might indicate a potential positive long-term impact of the 2013 ACA/AHA Guideline on better health outcomes for primary prevention groups and an immediate potential impact on statin prescribing behaviors in higher-at-risk groups. However, further investigation is required to confirm the causal effect of the 2013 ACA/AHA Guideline.
METHODS: To evaluate the potential (long-term) impact of the 2013 ACC/AHA Guideline release in Nov 2013 in the U.S., we investigated the association of the 2013 ACC/AHA Guideline with the trend changes in 5-Year MACE survival and three other statin-related outcomes (statin use, optimal statin use, and statin adherence) while controlling for generic atorvastatin availability using interrupted time series analysis, called the Chow\'s test. Specifically, we conducted a retrospective study using U.S. nationwide de-identified claims and electronic health records from Optum Labs Database Warehouse (OLDW) to follow the trends of 5-Year MACE survival and statin-related outcomes among four statin-benefit groups that were identified in the 2013 ACC/AHA Guideline. Then, Chow\'s test was used to discern trend changes between generic atorvastatin availability and guideline potential impact.
RESULTS: 197,021 patients were included (ASCVD: 19,060; High-LDL: 33,907; Diabetes: 138,159; High-ASCVD-Risk: 5,895). After the guideline release, the long-term trend (slope) of 5-Year MACE Survival for the Diabetes group improved significantly (P = 0.002). Optimal statin use for the ASCVD group also showed immediate improvement (intercept) and long-term positive changes (slope) after the release (P < 0.001). Statin uses did not have significant trend changes and statin adherence remained unchanged in all statin-benefit groups. Although no other statistically significant trend changes were found, overall positive trend change or no changes were observed after the 2013 ACC/AHA Guideline release.
CONCLUSIONS: The 2013 ACA/AHA Guideline release is associated with trend improvements in the long-term MACE Survival for Diabetes group and optimal statin use for ASCVD group. These significant associations might indicate a potential positive long-term impact of the 2013 ACA/AHA Guideline on better health outcomes for primary prevention groups and an immediate potential impact on statin prescribing behaviors in higher-at-risk groups. However, further investigation is required to confirm the causal effect of the 2013 ACA/AHA Guideline.
摘要：
背景：2013年ACC/AHA指南是脂质管理的范式转变，并确定了四个他汀类药物获益组。许多人研究了该指南的潜在影响，但很少有人调查它对MACE的潜在长期影响。此外，大多数研究也忽略了2011年12月阿托伐他汀较早释放的混杂效应.
方法：为了评估2013年11月在美国发布的2013年ACC/AHA指南的潜在（长期）影响，我们调查了2013年ACC/AHA指南与5年MACE生存率和其他三个他汀类药物相关结局趋势变化的相关性(他汀类药物使用,最佳使用他汀类药物，和他汀类药物依从性)，同时使用中断时间序列分析控制通用阿托伐他汀的可用性，称之为周氏测试。具体来说,我们进行了一项回顾性研究,使用美国全国范围内的去识别索赔和OptumLabs数据库仓库(OLDW)的电子健康记录,追踪2013年ACC/AHA指南中确定的4个他汀类药物获益组的5年MACE生存率和他汀类药物相关结局的趋势.然后，Chow检验用于辨别通用阿托伐他汀可用性和指南潜在影响之间的趋势变化。
结果：纳入197,021例患者（ASCVD：19,060；高LDL：33,907；糖尿病：138,159；高ASCVD风险：5,895）。准则发布后，糖尿病组5年MACE生存率的长期趋势(斜率)显著改善(P=0.002).ASCVD组的最佳他汀类药物使用也显示出释放后的立即改善（截距）和长期积极变化（斜率）（P<0.001）。在所有他汀类药物获益组中，他汀类药物的使用没有显著的趋势变化，他汀类药物的依从性保持不变。尽管没有发现其他统计上显著的趋势变化，2013年ACC/AHA指南发布后,观察到总体正趋势变化或无变化.
结论：2013年ACA/AHA指南的发布与糖尿病组的长期MACE生存率和ASCVD组的最佳他汀类药物使用的趋势改善有关。这些显著关联可能表明2013年ACA/AHA指南对一级预防组更好的健康结果具有潜在的积极长期影响，并对高风险组的他汀类药物处方行为具有直接的潜在影响。然而,需要进一步调查以确认2013年ACA/AHA指南的因果效应.
方法：为了评估2013年11月在美国发布的2013年ACC/AHA指南的潜在（长期）影响，我们调查了2013年ACC/AHA指南与5年MACE生存率和其他三个他汀类药物相关结局趋势变化的相关性(他汀类药物使用,最佳使用他汀类药物，和他汀类药物依从性)，同时使用中断时间序列分析控制通用阿托伐他汀的可用性，称之为周氏测试。具体来说,我们进行了一项回顾性研究,使用美国全国范围内的去识别索赔和OptumLabs数据库仓库(OLDW)的电子健康记录,追踪2013年ACC/AHA指南中确定的4个他汀类药物获益组的5年MACE生存率和他汀类药物相关结局的趋势.然后，Chow检验用于辨别通用阿托伐他汀可用性和指南潜在影响之间的趋势变化。
结果：纳入197,021例患者（ASCVD：19,060；高LDL：33,907；糖尿病：138,159；高ASCVD风险：5,895）。准则发布后，糖尿病组5年MACE生存率的长期趋势(斜率)显著改善(P=0.002).ASCVD组的最佳他汀类药物使用也显示出释放后的立即改善（截距）和长期积极变化（斜率）（P<0.001）。在所有他汀类药物获益组中，他汀类药物的使用没有显著的趋势变化，他汀类药物的依从性保持不变。尽管没有发现其他统计上显著的趋势变化，2013年ACC/AHA指南发布后,观察到总体正趋势变化或无变化.
结论：2013年ACA/AHA指南的发布与糖尿病组的长期MACE生存率和ASCVD组的最佳他汀类药物使用的趋势改善有关。这些显著关联可能表明2013年ACA/AHA指南对一级预防组更好的健康结果具有潜在的积极长期影响，并对高风险组的他汀类药物处方行为具有直接的潜在影响。然而,需要进一步调查以确认2013年ACA/AHA指南的因果效应.
