A Real-world Study of the Safety of Hypertension Medication Therapy in Japanese Patients With Naïve Hypertension

Novartis

Status: Completed

Conditions: Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT06683768

CLCZ696AJP03

Details and patient eligibility

About

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.

Enrollment: 40,563 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with essential hypertension or hypertensive heart/kidney disease at the index date.
2. Sitting systolic blood pressure (sSBP) ≥150 millimeters of mercury (mm Hg) at the index date.
3. At least one prescription of angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), angiotensin receptor neprilysin inhibitor (ARNI), calcium channel blocker (CCB), diuretics, or these SPCs for hypertension at the index date.
4. At least one visit and blood pressure (BP) measurement within 12 weeks from the index date.

Exclusion criteria

1. Prescription of hypertensive medication including alpha blocker, beta blocker, alpha-beta blocker, aldosterone antagonist, and renin inhibitor within 24 weeks prior to the index date.
2. Initial prescription of two or more antihypertensive medicines either with or without SPCs at the index date.
3. History of hypotension, hyperkalemia, hypokalemia, or hyponatremia, drug-related or otherwise, or renal failure leading to dialysis, stroke, myocardial infarction, heart failure at the index date or within 24 weeks prior to the index date.
4. History of secondary hypertension (renal parenchymal hypertension, renovascular hypertension [unilateral or bilateral renal artery stenosis] coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension, etc.) at any timepoint.
5. Pregnant women at any timepoint.

Trial design

40,563 participants in 2 patient groups

Monotherapy Cohort

Description:

Adult patients with untreated hypertension who initiated antihypertensive monotherapy (excluding angiotensin receptor neprilysin inhibitor \[ARNI\]).

Single-pill Combination (SPC) Cohort

Description:

Adult patients with untreated hypertension who initiated single-pill combination antihypertensive therapy.