Clinical trial NCT06604897: Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension
Official title: Effectiveness of Entresto (Sacubitril/Valsartan) to Blood Pressure Control in Japanese Patients With Hypertension: the Database Analysis of Electronic Medical Records
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Essential Hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-09-20
Enrollment: 1405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a retrospective, noninterventional cohort study.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Patients Achieving the Guideline-recommended Blood Pressure (BP)
timeFrame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
Secondary outcomes:
measure: Percentage of Patients Achieving the Guideline-recommended Blood Pressure (BP) per BP Category
timeFrame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
measure: Percentage of Patients Achieving the Guideline-recommended BP Categorized by Number of Antihypertensive Medicines Taken Before Starting Sacubitril/Valsartan
timeFrame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
measure: Percentage of Patients Achieving the Guideline-recommended BP Categorized by Antihypertensive Drug Classes Prescribed With Sacubitril/Valsartan
timeFrame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
measure: Percentage of Patients Achieving the Guideline-recommended BP Categorized by Patient Characteristics
timeFrame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
measure: Number of Patients Categorized by Place of Residence
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Number of Patients Categorized by Comorbidities
timeFrame: Baseline
measure: Relative Contribution of Baseline Characteristics in Achieving the Guideline-recommended BP
timeFrame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
measure: Persistence on Sacubitril/Valsartan
timeFrame: Up to 16 weeks
measure: Number of Episodes of Hypotension-related Events
timeFrame: Up to 16 weeks
measure: Number of Episodes of Renal Events
timeFrame: Up to 16 weeks
measure: Number of Episodes of Dehydration-related Events
timeFrame: Up to 16 weeks
measure: Number of Episodes of Diuresis-related Events
timeFrame: Up to 16 weeks
measure: Number of Episodes of Edema or Angioedema-related Events
timeFrame: Up to 16 weeks
measure: 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)
timeFrame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: