Real-world efficacy and safety of nebivolol in Korean patients with hypertension from the BENEFIT KOREA study

Abstract

Objective: The efficacy and safety of nebivolol in patients with hypertension is well established, but its effect in Asian patients with essential hypertension in the real world has not been studied. Methods: Adult South Korean patients with essential hypertension, with or without comorbidities, were enrolled to participate in this prospective, single-arm, open, observational study; 3011 patients received nebivolol either as monotherapy or add-on therapy. Changes in SBP, DBP and heart rate (HR) at 12 and 24 weeks were evaluated. Subgroup analysis for BP changes in newly diagnosed (de novo) patients and those receiving other antihypertensives at study entry were also conducted. Results: Nebivolol significantly decreased mean SBP and DBP at 12 and 24 weeks compared with baseline (P < 0.0001). A significant reduction in HR was also observed at 12 and 24 weeks (P < 0.0001). The reductions of SBP and DBP were notably greater when nebivolol was used as monotherapy in de novo patients (P < 0.0001) and as add-on therapy to existing antihypertensives (angiotensin II receptor blockers, angiotensin-converting enzyme inhibitors and calcium channel blockers; P < 0.0001). Majority of the reported adverse events were mild; the most common adverse events were dizziness (1.3%), headache (1.0%) and dyspnea (0.9%). Conclusion: Despite the limitations associated with observational studies, this real-world study in Asian patients with essential hypertension with and without comorbidities, demonstrated the efficacy and safety of once daily nebivolol, either as monotherapy or add-on therapy. Clinical trial registration number: NCT 03847350. SDC Callout: Video Abstract, http://links.lww.com/HJH/B172

Efficacy and safety of nebivolol in Korean patients with hypertension by age and sex: a subanalysis from the BENEFIT-KOREA study

“…The prevalence of hypertension is known to differ by age and sex. Nebivolol has been reported to be efficacious and well tolerated for achieving BP control in patients with hypertension in randomized studies as well Values are presented as number (%) AE adverse event, ADR adverse drug reaction real-world observational studies [16,17]. However, studies investigating age and sex differences in the efficacy and safety of nebivolol in patients with hypertension are scarceour age and sex-based subanalysis from the large, observational BENEFIT-KOREA study provides further evidence to support clinicians managing patients with hypertension.…”

“…Details of the study design and methodology are available in the primary manuscript of the BENEFIT-Korea study [17]. The study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki.…”

“…Nebivolol is a vasodilatory β1-adrenergic receptor antagonist which has been reported to be efficacious and well tolerated for achieving BP control in patients with hypertension [16]. The BENEFIT-KOREA (BEnefits after 24 weeks of NEbivolol administration For essential hypertensIon patients wiTh various comorbidities and treatment environments in Korea) study, a noncomparative, non-controlled, prospective, single-arm, multicenter, observational study conducted at 66 sites in South Korea, demonstrated the efficacy and safety of nebivolol in Asian patients with essential hypertension with and without comorbidities in a real-world setting [17]. In this manuscript, we report the results of a subanalysis of the efficacy and safety of nebivolol across age and sex in the BENEFIT-KOREA cohort.…”

Beta-Adrenergic Blockers’ Supportive and Adverse Role in Hypertension: A Review of Three Generations

“…According to the recent Korean study conducted among 3250 participants reported that nebivolol can be utilized to improve BP outcomes in hypertensive patients with and without comorbidities, either alone or in conjunction with other antihypertensive medications. Most side effects were mild such as dizziness (1.3%), headache (1.0%), and dyspnea (0.9%) 60 .…”