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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion criteria:
Exclusion criteria:
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This is a retrospective, noninterventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41530466 | Derived | Katsuya T, Nakatsu F, Eguchi S, Nakamura Y, Matsukawa M, Iekushi K, Hiramitsu S. Impact of treatment strategies incorporating sacubitril/valsartan on achievement of guideline-recommended blood pressure targets and representative safety outcomes. Hypertens Res. 2026 Apr;49(4):1232-1244. doi: 10.1038/s41440-025-02537-w. Epub 2026 Jan 14. |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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. | 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:
| 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. | 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 | Comorbidities include:
| 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.
| 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. | Up to 16 weeks |
| Number of Episodes of Hypotension-related Events | Hypotension-related events include:
| Up to 16 weeks |
| Number of Episodes of Renal Events | Renal events include:
| Up to 16 weeks |
| Number of Episodes of Dehydration-related Events | Dehydration-related events include:
| Up to 16 weeks |
| Number of Episodes of Diuresis-related Events | Diuresis-related events include:
| Up to 16 weeks |
| Number of Episodes of Edema or Angioedema-related Events | Edema or angioedema-related events include:
| 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. | Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12) |