Janssen Research & Development LLC, Titusville, NJ, USA.
Janssen Research & Development LLC, Spring House, PA, USA.
Curr Med Res Opin. 2021 Aug;37(8):1275-1281. doi: 10.1080/03007995.2021.1913109. Epub 2021 Apr 23.
This study aimed to determine rates of hospitalization and in-hospital mortality in the first year following amyloidosis diagnosis with cardiac involvement using observational databases.
Three administrative claims databases, IBM MarketScan Commercial Claims and Encounters (CCAE), IBM MarketScan Multi-State Medicare Database (MDCR), and Optum's de-identified Clinformatics Data Mart Database (Optum) were analyzed. Adults ≥18 years old, with a diagnosis of amyloidosis and evidence of cardiac involvement (i.e. heart failure, heart block, or cardiomyopathy) but no hepatic/renal failure prior to amyloidosis diagnosis were included for analysis. The primary analyses identified patients between 01-01-2010 and 31-12-2017 period. We calculated the rates of hospitalization and in-hospital mortality within 1 year after the initial diagnosis of amyloidosis. A sensitivity analysis was conducted for patients identified in Optum database during 2004-2011 period, which provided additional mortality information.
A total of 419, 654, and 922 patients from CCAE, MDCR, and Optum were identified during 2010-2017 period, with mean age of 55.6, 77.8, and 74.2 years, respectively. Within 1 year following initial amyloidosis diagnosis, incidence rates (95% confidence interval [CI]) of hospitalization were 78.4 (66.3, 90.4), 78.6 (69.2, 87.9), and 61.2 (54.4, 68.0) per 100 person-years, rates of in-hospital mortality were 16.5 (11.8, 21.3), 8.4 (5.7, 11.0), and 17.7 (14.5, 21.0) per 100 person-years, in CCAE, MDCR, and Optum, respectively. The mortality rate from the sensitivity analysis among patients identified in Optum 2004-2011 period was higher compared with Optum 2010-2017 period.
The results from this study indicate that amyloidosis with cardiac involvement is a condition with high rates of hospitalization and mortality in the first year after initial diagnosis. Future studies are needed to further evaluate the outcomes within the subtypes of amyloidosis and understand the risk factors associated with poor prognoses.
本研究旨在使用观察性数据库确定心脏受累淀粉样变性诊断后第一年的住院率和院内死亡率。
分析了三个行政索赔数据库，即 IBM MarketScan 商业索赔和遭遇数据库（CCAE）、IBM MarketScan 多州医疗保险数据库（MDCR）和 Optum 的去标识 Clinformatics 数据集市数据库（Optum）。纳入分析的成年人年龄≥18 岁，有淀粉样变性诊断和心脏受累证据（即心力衰竭、心脏传导阻滞或心肌病），但在淀粉样变性诊断前无肝/肾功能衰竭。主要分析确定了 2010 年 1 月 1 日至 2017 年 12 月 31 日期间的患者。我们计算了初始诊断后 1 年内的住院率和院内死亡率。对 Optum 数据库中 2004 年至 2011 年期间确定的患者进行了敏感性分析，该分析提供了额外的死亡率信息。
在 2010-2017 年期间，分别从 CCAE、MDCR 和 Optum 中确定了 419,654 和 922 名患者，平均年龄分别为 55.6、77.8 和 74.2 岁。在初始淀粉样变性诊断后 1 年内，住院发生率（95%置信区间[CI]）分别为 78.4（66.3，90.4）、78.6（69.2，87.9）和 61.2（54.4，68.0）/100 人年，住院死亡率分别为 16.5（11.8，21.3）、8.4（5.7，11.0）和 17.7（14.5，21.0）/100 人年，在 CCAE、MDCR 和 Optum 中。Optum 2004-2011 年期间确定的患者的敏感性分析死亡率高于 Optum 2010-2017 年期间。
本研究结果表明，心脏受累淀粉样变性是一种在初始诊断后第一年住院率和死亡率均较高的疾病。需要进一步研究以评估淀粉样变性各亚型的预后，并了解与不良预后相关的风险因素。
