Effectiveness of Entresto (Sacubitril/Valsartan) to Blood Pressure Control in Japanese Patients With Hypertension: the Database Analysis of Electronic Medical Records
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,405
- 试验地点
- 1
- 主要终点
- Percentage of Patients Achieving the Guideline-recommended Blood Pressure (BP)
研究概览
简要总结
This study was a non-interventional, secondary use of data, retrospective, cohort study, and the data to be extracted in this study was used as secondary use of collected patient information in the database (Japan Medical Data Survey [JAMDAS]) owned by M3 Inc. JAMDAS is a database that aggregates medical information and is constructed mainly from electronic medical record information of general practices, allowing real-time extraction of information entered in medical records, such as prescription status including drug switching and continuation, laboratory values, clinical evaluation scores, and comorbidities, etc.
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
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with essential hypertension (International Classification of Diseases [ICD]-10 code: I10) on the index date.
- •Patients for whom data for the 6 months prior to the index date can be extracted as baseline data.
- •Patients for whom blood pressure (BP) data can be extracted between weeks 8 and 12 after the index date.
- •Patients whose BP data can be extracted on the index date.
- •Patients whose BP value at baseline was 140/90 millimeters of mercury (mmHg) or higher.
- •Patients with the prescription of 100 milligrams (mg) or 200 mg once daily as 100 mg or 200 mg tablets on the index date.
排除标准
- •Women with a record of pregnancy-related diagnoses, drugs, or medical procedures before or after the index date, or a record of delivery- or abortion-related diagnoses, drugs, or medical procedures after the index date.
- •Prescription of concomitant angiotensin-converting enzyme inhibitor (ACEi); Anatomical Therapeutic Chemical (ATC) code: C09A on, after, or in the 2 days before the index date.
- •Patients diagnosed with angioedema: ICD-10: D84.1 under prescription of ACEi or angiotensin receptor blocker (ARB); ATC code: C09C.
- •Patients diagnosed with diabetes and under treatment with aliskiren fumarate on the index date.
- •Patients with severe impaired liver functions with Child-Pugh classification C.
研究组 & 干预措施
Sacubitril/Valsartan Cohort
Adult patients with essential hypertension who were prescribed sacubitril/valsartan.
Conventional Drug-control Cohort
Adult patients with essential hypertension who were prescribed angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEi/ARB).
结局指标
主要结局
Percentage of Patients Achieving the Guideline-recommended Blood Pressure (BP)
时间窗: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.
次要结局
- Percentage of Patients Achieving the Guideline-recommended Blood Pressure (BP) per BP Category(Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12))
- Percentage of Patients Achieving the Guideline-recommended BP Categorized by Number of Antihypertensive Medicines Taken Before Starting Sacubitril/Valsartan(Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12))
- Percentage of Patients Achieving the Guideline-recommended BP Categorized by Antihypertensive Drug Classes Prescribed With Sacubitril/Valsartan(Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12))
- Percentage of Patients Achieving the Guideline-recommended BP Categorized by Patient Characteristics(Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12))
- Number of Patients Categorized by Place of Residence(Baseline)
- Height(Baseline)
- Weight(Baseline)
- Number of Patients Categorized by Comorbidities(Baseline)
- Relative Contribution of Baseline Characteristics in Achieving the Guideline-recommended BP(Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12))
- Persistence on Sacubitril/Valsartan(Up to 16 weeks)
- Number of Episodes of Hypotension-related Events(Up to 16 weeks)
- Number of Episodes of Renal Events(Up to 16 weeks)
- Number of Episodes of Dehydration-related Events(Up to 16 weeks)
- Number of Episodes of Diuresis-related Events(Up to 16 weeks)
- Number of Episodes of Edema or Angioedema-related Events(Up to 16 weeks)
- Percentage of Patients Treated With Sacubitril/Valsartan Achieving the Guideline-recommended BP Compared to the Percentage of Patients Treated With Angiotensin-converting Enzyme Inhibitor/Angiotensin Receptor Blocker (ACEi/ARB)(Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12))