IMPACT of Nebilet in Blood Pressure Control in Patients With HYpertension: An Observational, Longitudinal Study

Introduction. Hypertension remains one of the leading risk factors for cardiovascular morbidity and mortality worldwide, contributing significantly to the burden of stroke, heart failure, and other cardiovascular diseases. Despite advancements in antihypertensive therapies, real-world data on long-term blood pressure control, treatment adherence, and patient-reported outcomes remain insufficient, particularly in diverse populations across Asia. While clinical trials have established the efficacy of various antihypertensive agents, the applicability of these findings to routine clinical practice remains unclear. Beta-blockers, particularly nebivolol, a third-generation β1-selective adrenergic antagonist with nitric oxide-mediated vasodilatory properties, have demonstrated favorable hemodynamic effects, improved vascular function, and better tolerability compared to traditional beta-blockers. However, there is a lack of robust real-world evidence assessing its long-term impact on blood pressure control and cardiovascular outcomes.

The HYIMPACT study is a multinational, multicenter, observational, longitudinal study designed to evaluate the real-world effectiveness, safety, and adherence of Nebilet® (nebivolol) in hypertensive patients across seven Asian countries. This study will provide insights into the clinical utility of Nebilet® in achieving sustained blood pressure control over time, while also assessing the influence of cardiovascular risk factors on treatment outcomes. By systematically collecting data from patients in routine clinical settings, HYIMPACT aims to bridge the gap between controlled clinical trials and real-world practice, offering valuable evidence to optimize hypertension management strategies.

Study Objectives. HYIMPACT aims to assess the impact of Nebilet®-based treatment on systolic and diastolic blood pressure control from baseline to 12, 24, and 36 months. The study will determine the proportion of patients achieving target blood pressure levels (<140/90 mmHg) and evaluate adherence using the Morisky 8-Item Medication Adherence Scale (MMAS). Additionally, the study will compare the effectiveness of Nebilet® monotherapy versus combination therapy in achieving blood pressure control. Patient-reported outcomes will be analyzed using the SF-36 and MINICHAL questionnaires, providing insights into the impact of treatment on quality of life. The study will also assess the correlation between home and office blood pressure measurements and investigate the association between Nebilet® use and major adverse cardiovascular events (MACE), including myocardial infarction, stroke, and cardiovascular mortality.

Study Design and Population. HYIMPACT is an observational, prospective, longitudinal study enrolling approximately 5,000 hypertensive patients across Malaysia, Indonesia, the Philippines, Korea, Vietnam, Thailand, and Taiwan. Eligible patients will be adults aged 18 years or older with newly diagnosed or uncontrolled hypertension, defined as an office systolic blood pressure of at least 140 mmHg and/or diastolic blood pressure of at least 90 mmHg at screening. Patients may be included if they have either been newly prescribed Nebilet® or have been on Nebilet®-based treatment for no more than two weeks prior to enrollment. Individuals with recent major cardiovascular events within the last three months, severe heart failure classified as NYHA Class IV, or contraindications to Nebilet® as per the Summary of Product Characteristics will be excluded. The study will involve 300 to 500 physicians, ensuring representation across a wide range of real-world clinical settings.

Variables to be Collected. The study will systematically collect patient demographic and clinical data, including medical history, cardiovascular risk factors such as diabetes, obesity, and hypercholesterolemia, and medication use. Blood pressure measurements will be recorded at baseline and at each follow-up visit, with additional data collected on prescription patterns, dose adjustments, and patient adherence. Laboratory parameters, including lipid profiles, glycated hemoglobin (HbA1c), and renal function markers, will be documented when available. Cardiovascular outcomes such as MACE, including myocardial infarction, stroke, and cardiovascular mortality, will be monitored throughout the study.