Browsing by Author "Matsushita, Kunihiro"

Now showing 1 - 2 of 2
  • Thumbnail Image
    Item
    Ankle-Brachial Index and Risk of Sudden Cardiac Death in the Community: The ARIC Study
    (American Heart Association, 2024) Suzuki, Takeki; Zhu, Xiaoqian; Adabag, Selcuk; Matsushita, Kunihiro; Butler, Kenneth R.; Griswold, Michael E.; Alonso, Alvaro; Rosamond, Wayne; Sotoodehnia, Nona; Mosley, Thomas H.; Medicine, School of Medicine
    Background: Sudden cardiac death (SCD) is a significant global public health problem accounting for 15% to 20% of all deaths. A great majority of SCD is associated with coronary heart disease, which may first be detected at autopsy. The ankle-brachial index (ABI) is a simple, noninvasive measure of subclinical atherosclerosis. The purpose of this study was to examine the relationship between ABI and SCD in a middle-aged biracial general population. Methods and results: Participants of the ARIC (Atherosclerosis Risk in Communities) study with an ABI measurement between 1987 and 1989 were included. ABI was categorized as low (≤0.90), borderline (0.90-1.00), normal (1.00-1.40), and noncompressible (>1.40). SCD was defined as a sudden pulseless condition presumed to be caused by a ventricular tachyarrhythmia in a previously stable individual and was adjudicated by a committee of cardiac electrophysiologists, cardiologists, and internists. Cox proportional hazards models were used to evaluate the associations between baseline ABI and incident SCD. Of the 15 081 participants followed for a median of 23.5 years, 556 (3.7%) developed SCD (1.96 cases per 1000 person-years). Low and borderline ABIs were associated with an increased risk of SCD (demographically adjusted hazard ratios [ HRs ], 2.27 [ 95% CI, 1.64-3.14 ] and 1.52 [ 95% CI, 1.17-1.96 ], respectively) compared with normal ABI. The association between low ABI and SCD remained significant after adjustment for traditional cardiovascular risk factors (HR, 1.63 [ 95% CI, 1.15-2.32 ]). Conclusions: Low ABI is independently associated with an increased risk of SCD in a middle-aged biracial general population. ABI could be incorporated into future SCD risk prediction models.
  • Thumbnail Image
    Item
    Global Phase 3 programme of vadadustat for treatment of anaemia of chronic kidney disease: rationale, study design and baseline characteristics of dialysis-dependent patients in the INNO2VATE trials
    (Oxford University Press, 2021-11-09) Eckardt, Kai-Uwe; Agarwal, Rajiv; Farag, Youssef Mk; Jardine, Alan G.; Khawaja, Zeeshan; Koury, Mark J.; Luo, Wenli; Matsushita, Kunihiro; McCullough, Peter A.; Parfrey, Patrick; Ross, Geoffrey; Sarnak, Mark J.; Vargo, Dennis; Winkelmayer, Wolfgang C.; Chertow, Glenn M.; Medicine, School of Medicine
    Background: Erythropoiesis-stimulating agents (ESAs) are currently the mainstay of treatment for anaemia of chronic kidney disease (CKD). Vadadustat is an investigational oral hypoxia-inducible factor prolyl-hydroxylase inhibitor that stimulates endogenous erythropoietin formation. The INNO2VATE programme comprises two studies designed to evaluate the safety and efficacy of vadadustat versus the ESA darbepoetin alfa in ameliorating anaemia in patients with dialysis-dependent CKD (DD-CKD). Here we describe the trial design along with patient demographics and baseline characteristics. Methods: Two Phase 3, open-label, sponsor-blind, active-controlled trials enrolled adults with anaemia of CKD who recently initiated dialysis and had limited ESA exposure (incident DD-CKD trial) or were receiving maintenance dialysis with ESA treatment (prevalent DD-CKD trial). Study periods include correction/conversion (Weeks 0-23), maintenance (Weeks 24-52), long-term treatment (Weeks 53 to end of treatment) and safety follow-up. The primary safety endpoint is the time to the first major adverse cardiovascular event and the primary efficacy endpoint is the change in haemoglobin (baseline to Weeks 24-36). Results: A total of 369 and 3554 patients were randomized in the incident DD-CKD and prevalent DD-CKD trials, respectively. Demographics and baseline characteristics were similar among patients in both trials and comparable to those typically observed in DD-CKD. Conclusions: The two INNO2VATE trials will provide important information on the safety and efficacy of a novel approach for anaemia management in a diverse DD-CKD population. Demographics and baseline characteristics of enrolled patients suggest that study results will be representative for a large proportion of the DD-CKD population.