Search

Introduction: There are limited data on ivabradine therapy in black patients and none in African Americans. We performed an open-label, prospective study at two centers in the United States. African American patients with heart failure (HF) (N = 30), left ventricular ejection fraction ≤ 35%, and in sinus rhythm with resting heart rate (HR) ≥ 70 bpm received ivabradine 2.5–7.5 mg twice daily for 57 days. Methods: The primary endpoint was change in HR from baseline to day 57, compared with the −5 bpm change observed in the absence of ivabradine in the placebo group of the SHIFT study. The safety endpoint was treatment-emergent adverse events (TEAEs). Exploratory endpoints were change from baseline to day 57 in 6-minute walk test (6MWT) distance, HR difference during a 6MWT (i.e. HR at minute 6 − resting HR), and physical activity counts. Results: At day 57, the estimated least squares mean change from baseline in HR was −9.5 bpm (95% CI −13.0, −6.0). The estimated mean treatment difference with ivabradine versus a presumed −5 bpm change from baseline HR, as seen in the placebo group of the SHIFT study, was −4.5 bpm (95% CI −8.0, −1.0; p = 0.013). The mean (SE) changes in 6MWT distance and HR difference during the 6MWT were 16.3 (10.8) meters and 2.3 (3.7) bpm, respectively. Ivabradine therapy did not result in greater physical activity. TEAEs were reported in 11 (36.7%) patients. Conclusion: These data support ivabradine use in African American patients with HF with reduced ejection fraction who meet typical treatment criteria. Trial Registration: ClinicalTrials.gov identifier, NCT03456856 [ABSTRACT FROM AUTHOR]

Objectives: To evaluate long-term mortality rates among aerospace material manufacturing workers as follow-up to an earlier observed excess of nephritis/nephrosis., Methods: Subjects were 2020 workers ever employed in the facility during 1963-2014. Vital status through 2014 was determined for all subjects and cause of death for 99.2% of 492 deaths. We computed standard mortality ratios (SMR) and internal relative risks., Results: SMRs for nephritis/nephrosis were unremarkable. We observed statistically significant elevated SMRs for kidney cancer among all workers and for the category "other lymphatic hematopoietic tissue cancer" (4/5 deaths from multiple myeloma) among long-term workers with potential plant exposure., Conclusions: We found no evidence of elevated mortality rates for nephritis/nephrosis. Study limitations precluded robust evaluation of whether the elevated rates for kidney cancer and other lymphatic hematopoietic tissue cancer were related to occupational factors at the study site. Our findings for these two cancers warrant continued mortality follow-up., (© 2019 Wiley Periodicals, Inc.)