Cho Kyoung Im, Jeon Dong Woon, Ahn Hyo Seung, Jin Dong Kyu, Lee Hyun Sang, Lee Jong-Young, Lim Hong-Seok, Manolis Athanasios J, Rha Seung-Woon, Park Sang Won
Division of Cardiology, Kosin University Gospel Hospital, Busan, Republic of Korea.
Division of Cardiology, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea.
Clin Hypertens. 2021 Mar 15;27(1):9. doi: 10.1186/s40885-021-00165-3.
BENEFIT-KOREA (BEnefits after 24 weeks of NEbivolol administration For essential hypertensIon patients wiTh various comorbidities and treatment environments in Korea) study, an observational study in South Korea, demonstrated the efficacy and safety of nebivolol in Asian patients with essential hypertension with and without comorbidities in real-world settings. We present a subanalysis of the efficacy and safety of nebivolol across age and sex in the BENEFIT-KOREA cohort.
Adult South Korean patients with essential hypertension participated in the prospective, single-arm, open, observational BENEFIT-KOREA study; 3011 patients received nebivolol as monotherapy or add-on therapy. Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP), and pulse rate at 12 and 24 weeks were evaluated. Participants were divided into three age groups-young males and females: < 50 years; middle-aged males and females: ≥50 years to < 70 years; and older males and females: ≥70 years.
The mean age of study participants was 63.5 ± 12.9 years; majority were between 50 and 69 years of age and 40.4% were females. A significant decrease was observed in mean SBP, DBP, and pulse rate from baseline at 12 and 24 weeks in males and females across all age groups analyzed (all P < 0.001 vs. baseline), with no significant difference in mean reduction in SBP and DBP from baseline between sex within the age groups. Majority of reported adverse events were mild. The incidence of adverse events was lower in young participants versus middle-aged and older participants.
Our subanalysis from the real-world BENEFIT-KOREA study in Asian patients with essential hypertension demonstrated the efficacy and safety of once-daily nebivolol across age groups with no between-sex differences.
Name of the registry: clinicaltrials.gov.
NCT03847350 . Date of registration: February 20, 2019 retrospectively registered.
BENEFIT-KOREA（韩国奈必洛尔治疗24周后对患有各种合并症和处于不同治疗环境的原发性高血压患者的益处）研究是韩国的一项观察性研究，证实了奈必洛尔在现实环境中对有或无合并症的亚洲原发性高血压患者的疗效和安全性。我们对BENEFIT-KOREA队列中奈必洛尔在不同年龄和性别的疗效及安全性进行了亚组分析。
成年韩国原发性高血压患者参与了前瞻性、单臂、开放、观察性的BENEFIT-KOREA研究；3011例患者接受奈必洛尔单药治疗或联合治疗。评估了12周和24周时收缩压（SBP）、舒张压（DBP）和脉搏率的变化。参与者分为三个年龄组——年轻男性和女性：<50岁；中年男性和女性：≥50岁至<70岁；老年男性和女性：≥70岁。
研究参与者的平均年龄为63.5±12.9岁；大多数年龄在50至69岁之间，40.4%为女性。在所有分析的年龄组中，男性和女性在12周和24周时的平均SBP、DBP和脉搏率较基线均显著降低（与基线相比，所有P<0.001），各年龄组内性别间SBP和DBP较基线的平均降低幅度无显著差异。报告的不良事件大多为轻度。年轻参与者的不良事件发生率低于中年和老年参与者。
我们对亚洲原发性高血压患者进行的现实世界BENEFIT-KOREA研究的亚组分析表明，每日一次服用奈必洛尔在各年龄组均有效且安全，无性别差异。
注册机构名称：clinicaltrials.gov。
NCT03847350。注册日期：2019年2月20日（追溯注册）
