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This was a non-interventional, secondary use of data, retrospective, cohort study. The data 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. (Tokyo, Japan). JAMDAS is a database that aggregates medical information and is constructed mainly from electronic medical record information of medical institutions, 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 |
|---|---|---|---|
| Monotherapy Cohort | Adult patients with untreated hypertension who initiated antihypertensive monotherapy (excluding angiotensin receptor neprilysin inhibitor [ARNI]). | ||
| Single-pill Combination (SPC) Cohort | Adult patients with untreated hypertension who initiated single-pill combination antihypertensive therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE | Week 8 and Week 24 | |
| Number of Patients With AEs From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE | Week 8 and Week 24 | |
| Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE | Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients. | Week 8 and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Blood Pressure (BP) Category | BP Categories included Grade I, II, III, and (isolated) systolic hypertension. | Week 24 |
| Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BP Category |
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Inclusion criteria:
Exclusion criteria:
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This was 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 Pharmaceuticals | East Hanover | New Jersey | 07936 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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BP Categories included Grade I, II, III, and (isolated) systolic hypertension. |
| Week 24 |
| Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BP Category | BP Categories included Grade I, II, III, and (isolated) systolic hypertension. Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients. | Week 24 |
| Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category | Age group categories:
| Week 24 |
| Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category | Age group categories:
| Week 24 |
| Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category | Age group categories:
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients. | Week 24 |
| Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Body Mass Index (BMI) Category | BMI categories:
| Week 24 |
| Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BMI Category | BMI categories:
| Week 24 |
| Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BMI Category | BMI categories:
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients. | Week 24 |
| Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Estimated Glomerular Filtration Rate (eGFR) Category | eGFR categories:
| Week 24 |
| Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per eGFR Category | eGFR categories:
| Week 24 |
| Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per eGFR Category | eGFR categories:
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients. | Week 24 |
| Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level | Potassium (K) levels:
| Week 24 |
| Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level | Potassium (K) levels:
| Week 24 |
| Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level | Potassium (K) levels:
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients. | Week 24 |
| Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level | Creatinine (Cr) Levels:
| Week 24 |
| Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level | Creatinine (Cr) Levels:
| Week 24 |
| Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level | Creatinine (Cr) Levels:
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients. | Week 24 |
| Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria | Proteinuria:
| Week 24 |
| Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria | Proteinuria:
| Week 24 |
| Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria | Proteinuria:
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients. | Week 24 |
| Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication | Antihypertensive medication classes included calcium channel blockers (CCBs), angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and diuretics. | Week 24 |
| Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication | Antihypertensive medication classes included CCBs, ACE inhibitors, ARBs, and diuretics. | Week 24 |
| Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication | Antihypertensive medication classes included CCBs, ACE inhibitors, ARBs, and diuretics. Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients. | Week 24 |
| Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 | Weeks 4, 8, and 12 |
| Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by BP Category | BP categories included Grade I, II, and III hypertension. | Weeks 4, 8, and 12 |
| Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Age Group Category | Age group categories:
| Weeks 4, 8, and 12 |
| Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by BMI Category | BMI categories:
| Weeks 4, 8, and 12 |
| Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by eGFR Category | eGFR categories:
| Weeks 4, 8, and 12 |
| Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Potassium Level | Potassium (K) levels:
| Weeks 4, 8, and 12 |
| Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Creatinine Level | Creatinine (Cr) Levels:
| Weeks 4, 8, and 12 |
| Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Proteinuria | Proteinuria:
| Weeks 4, 8, and 12 |
| Number of Patients who Achieved the BP Goal at Last Visit Categorized by Subgroup | The BP goal was 130/80 millimeters of mercury (mm Hg). Subgroups:
| Up to 13 weeks |