Replicate Studies Evaluating the Effectiveness of Obeticholic Acid on Hepatic Real-World Outcomes in Patients With Primary Biliary Cholangitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,577
- 试验地点
- 1
- 主要终点
- Risk of the First Event of the Composite Events
研究概览
简要总结
This is an observational, retrospective cohort study of patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment, using a real-world data source, the Komodo Health United States (US) claims database. The study is designed to evaluate the effectiveness of obeticholic acid (OCA). All patients who meet diagnostic criteria for PBC in the database between 01 Jun 2015 and 31 Dec 2021 and who meet all eligibility criteria were considered for this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite or probable PBC diagnosis
- •Inadequate response or intolerance to UDCA
- •Age ≥18 years at the index date
- •Continuous enrollment and evaluable data for at least 12 months before the index date (inclusive)
排除标准
- •History or presence of other concomitant liver diseases
- •History of non-skin malignancy or melanoma
- •History of HIV
- •Medical conditions that may cause non-hepatic increases in ALP
- •Patients with laboratory values indicative of hepatic decompensation or significant hepatobiliary injury
- •History of liver transplant
- •Evidence of fenofibrate, or bezafibrate use
- •History or presence of hepatic decompensating events
结局指标
主要结局
Risk of the First Event of the Composite Events
时间窗: Up to 67 months
The primary analysis outcome was assessed with hazard ratio (HR) comparing hazard of first event of the composite endpoint among OCA-treated participants and SMR-weighted non-OCA-treated PBC participants indexes. It included all-cause death, liver transplant, hospitalization for hepatic decompensation based on first occurrence of: variceal bleed, ascites (including hepatic hydrothorax and spontaneous bacterial peritonitis) and hepatic encephalopathy. OCA-treated indexes were censored 90 days after OCA discontinuation, or if fibrates were initiated. Control indexes were censored if a participant-initiated OCA therapy, initiated fibrate therapy, reinitiated UDCA for participants who had discontinued UDCA for \>6 months, or end of study period (31 Dec 2021), whichever came first. The 2.5th and 97.5th percentile of nonparametric bootstrap samples were used to estimate 95% CI for HR and to perform a test of hypothesis. Risk is presented using the number of composite event and components.
次要结局
- Risk of Death(Up to 67 months)
- Risk of Liver Transplantation(Up to 67 months)
- Risk of Hospitalization for Hepatic Decompensation(Up to 67 months)