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

Novartis Pharmaceuticals1,405 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,405

Conditions

Essential Hypertension

Eligibility

Sex: ALLMin age: 20 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percentage of Patients Achieving the Guideline-recommended Blood Pressure (BP)

The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.

Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)

Secondary Outcomes

Percentage of Patients Achieving the Guideline-recommended Blood Pressure (BP) per BP Category

The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals. BP categories: * Grade I: 140-159/90-99 millimeters of mercury (mmHg) * Grade II: 160-179/100-109 mmHg * Grade III: 180/110 mmHg or greater

Time frame: 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

The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals. Number of antihypertensive medicines taken before starting sacubitril/valsartan categories: 0, 1, 2, 3-4, and 5 or more.

Time frame: 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

The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals. Antihypertensive drug classes include: * Calcium channel blockers (CCB) * Angiotensin-converting enzyme (ACE) inhibitors * Angiotensin receptor blockers (ARBs) * Diuretics * Alpha and beta blockers * Alpha-beta blockers * Aldosterone blockers * Renin inhibitors * Compounding agents

Time frame: 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

The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals. Patient characteristics include, but are not limited to, age, gender, body mass index (BMI), comorbidities, and combinations of comorbidities.

Time frame: 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

Time frame: Baseline

Height

Time frame: Baseline

Weight

Time frame: Baseline

Number of Patients Categorized by Comorbidities

Comorbidities include: * Heart disease * Diabetes * Dyslipidemia * Renal disease * Cerebrovascular disease * Other, specify

Time frame: Baseline

Relative Contribution of Baseline Characteristics in Achieving the Guideline-recommended BP

The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals. Multivariate logistic regression analysis will be used to determine the association of the following variables in achieving the guideline-recommended BP. * Age * Gender * Comorbidities * Body mass index (BMI) * BP category at index date * Number of classes of antihypertensive medicines taken before starting sacubitril/valsartan

Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)

Persistence on Sacubitril/Valsartan

Proportion of patients remaining on treatment with sacubitril/valsartan and proportion of patients permanently discontinuing sacubitril/valsartan during the study.

Time frame: Up to 16 weeks

Number of Episodes of Hypotension-related Events

Hypotension-related events include: * Orthostatic hypotension * Postural hypotension * Secondary orthostatic hypotension * Hypertension due to the drugs * Episodic hypotension * Hypotension * Vertigo * Feeling dizzy * Dizziness * Sudden dizziness * Syncope

Time frame: Up to 16 weeks

Number of Episodes of Renal Events

Renal events include: * Renal diseases * Chronic kidney disease (CKD) * Estimated glomerular filtration rate (eGFR) reduction of 40% or more

Time frame: Up to 16 weeks

Number of Episodes of Dehydration-related Events

Dehydration-related events include: * Dehydration * Isotonic dehydration

Time frame: Up to 16 weeks

Number of Episodes of Diuresis-related Events

Diuresis-related events include: * Polyuria * Idiopathic polyuria * Frequent urination * Nocturnal polyuria * Nocturia

Time frame: Up to 16 weeks

Number of Episodes of Edema or Angioedema-related Events

Edema or angioedema-related events include: * Angioneurotic edema * Quincke's edema

Time frame: 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)

The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.

Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes