BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Name of the registry: clinicaltrials.gov. TRIAL REGISTRATION NUMBER: NCT03847350 . Date of registration: February 20, 2019 retrospectively registered.
OBJECTIVE: Clopidogrel is indicated for the treatment and prevention of peripheral vascular, cerebrovascular, and coronary artery diseases. This clinical trial was designed to demonstrate that clopidogrel napadisilate (CN) is not inferior to clopidogrel bisulfate (CB) with respect to its effectiveness in inhibiting platelet aggregation. METHODS: This 4 week multi-center, prospective, open-label, randomized trial was conducted at five clinical centers in South Korea. Patients were randomized into the 75 mg CN group or the 75 mg CB group. Platelet aggregation was assessed by the VerifyNow assay. The primary outcome was the difference of the percentage P2Y12 inhibition and the secondary outcome was the baseline and change in P2Y12 reaction units (PRU). RESULTS: There was no significant difference in the percentage P2Y12 inhibition (CN vs. CB, 34.92 ± 21.33% vs. 30.43 ± 17.90%, p=0.203). The mean difference of the percentage P2Y12 inhibition between groups was 4.49%, their two-sided 95% confidence interval was -2.45% to 11.44%, and the lower bound (-2.45%) was greater than the acceptable non-inferiority margin of -9.0%. The baseline PRU was 96.67 ± 76.76 in the CN group and 216.95 ± 68.86 in the CB group (p=0.121), and the change in the PRU was -3.32 ± 51.71 in the CN group and 10.52 ± 43.31 in the CB group (p=0.106). Four subjects experienced AEs (6.3%, 5 events) in the CN group and 7 subjects (11.11%, 13 events) in the CB group without statistical significance (p=0.364). With respect to serious adverse events, 2 events were reported in 2 subjects, 1 in each group. CONCLUSION: Clopidogrel napadisilate was not inferior to clopidogrel bisulfate in terms of antiplatelet efficacy and tolerability, and there were no clinically significant adverse events.
Coronary Restenosis/prevention & control , Platelet Aggregation/drug effects , Ticlopidine/analogs & derivatives , Aged , Clopidogrel , Coronary Artery Disease/diagnosis , Coronary Artery Disease/therapy , Drug Monitoring , Drug-Eluting Stents/adverse effects , Female , Humans , Male , Middle Aged , Platelet Aggregation Inhibitors/administration & dosage , Platelet Aggregation Inhibitors/adverse effects , Platelet Function Tests/methods , Platelet Function Tests/statistics & numerical data , Prospective Studies , Republic of Korea , Ticlopidine/administration & dosage , Ticlopidine/adverse effects , Treatment Outcome
Aseptic endocarditis is an uncommon complication of Behçet's disease (BD). We describe a rare case of a 39-year-old female who had BD with aseptic endocarditis of the tricuspid valve (TV) presenting as tricuspid stenosis. She was diagnosed with BD four years ago. The mucocutaneous lesions were well-controlled with colchicine and short courses of corticosteroids. She remained free of signs and symptoms of BD for one year without any medication. Three months before admission, she gradually developed dyspnea on exertion and peripheral edema. Echocardiography revealed dilated right atrium and markedly thickened TV with severe stenosis. TV replacement was performed. Pathologic examination of the valve showed fibrinoid necrotic material and inflammatory cell infiltration. Blood cultures and cultures of the excised valve were negative for microorganisms.
