Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension

Novartis

Status: Active, not recruiting

Conditions: Essential Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT06604897

CLCZ696AJP04

Details and patient eligibility

About

This study is a non-interventional, secondary use of data, retrospective, cohort study, and the data to be extracted in this study will be 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.

Enrollment: 1,405 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with essential hypertension (International Classification of Diseases [ICD]-10 code: I10) on the index date.
2. Patients for whom data for the 6 months prior to the index date can be extracted as baseline data.
3. Patients for whom blood pressure (BP) data can be extracted between weeks 8 and 12 after the index date.
4. Patients whose BP data can be extracted on the index date.
5. Patients whose BP value at baseline was 140/90 millimeters of mercury (mmHg) or higher.
6. Patients with the prescription of 100 milligrams (mg) or 200 mg once daily as 100 mg or 200 mg tablets on the index date.

Exclusion criteria

1. 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.
2. 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.
3. Patients diagnosed with angioedema: ICD-10: D84.1 under prescription of ACEi or angiotensin receptor blocker (ARB); ATC code: C09C.
4. Patients diagnosed with diabetes and under treatment with aliskiren fumarate on the index date.
5. Patients with severe impaired liver functions with Child-Pugh classification C.

Trial design

1,405 participants in 2 patient groups

Sacubitril/Valsartan Cohort

Description:

Adult patients with essential hypertension who were prescribed sacubitril/valsartan.

Conventional Drug-control Cohort

Description:

Adult patients with essential hypertension who were prescribed angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEi/ARB).