title: Influence of Kidney Function Estimation Methods on Eligibility for Edoxaban Population Impact of the US Food and Drug Administration's Approach for Its Product Labeling.
authors.affiliation: From the Division of Cardiology, Duke University Medical Center, Durham, NC (S.D.P., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (S.D.P., P.S., L.T., J.P.P., E.D.P.); Division of Cardiology, University of California Los Angeles (G.C.F.); Lankenau Institute for Medical Research, Wynnewood, PA (P.R.K.); Harvard Medical School, Massachusetts General Hospital, Boston (D.E.S.); Hofstra North Shore/Long Island School of Medicine, Hempstead, NY (J.A.); Mayo Clinic College of Medicine, Rochester, MN (BJ.G.); Department of Medicine, Stanford University School of Medicine, Palo Alto, CA (K.W.M.); Boston University School of Medicine, Boston, MA (E.M.H.); and Kaiser Permanente, Oakland, CA (A.S.G.). sean.pokorney@duke.edu.
authors.forename: Sean D
authors.initials: SD
authors.lastname: Pokorney
authors.affiliation: From the Division of Cardiology, Duke University Medical Center, Durham, NC (S.D.P., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (S.D.P., P.S., L.T., J.P.P., E.D.P.); Division of Cardiology, University of California Los Angeles (G.C.F.); Lankenau Institute for Medical Research, Wynnewood, PA (P.R.K.); Harvard Medical School, Massachusetts General Hospital, Boston (D.E.S.); Hofstra North Shore/Long Island School of Medicine, Hempstead, NY (J.A.); Mayo Clinic College of Medicine, Rochester, MN (BJ.G.); Department of Medicine, Stanford University School of Medicine, Palo Alto, CA (K.W.M.); Boston University School of Medicine, Boston, MA (E.M.H.); and Kaiser Permanente, Oakland, CA (A.S.G.).
authors.forename: Peter
authors.initials: P
authors.lastname: Shrader
authors.affiliation: From the Division of Cardiology, Duke University Medical Center, Durham, NC (S.D.P., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (S.D.P., P.S., L.T., J.P.P., E.D.P.); Division of Cardiology, University of California Los Angeles (G.C.F.); Lankenau Institute for Medical Research, Wynnewood, PA (P.R.K.); Harvard Medical School, Massachusetts General Hospital, Boston (D.E.S.); Hofstra North Shore/Long Island School of Medicine, Hempstead, NY (J.A.); Mayo Clinic College of Medicine, Rochester, MN (BJ.G.); Department of Medicine, Stanford University School of Medicine, Palo Alto, CA (K.W.M.); Boston University School of Medicine, Boston, MA (E.M.H.); and Kaiser Permanente, Oakland, CA (A.S.G.).
authors.forename: Laine
authors.initials: L
authors.lastname: Thomas
authors.affiliation: From the Division of Cardiology, Duke University Medical Center, Durham, NC (S.D.P., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (S.D.P., P.S., L.T., J.P.P., E.D.P.); Division of Cardiology, University of California Los Angeles (G.C.F.); Lankenau Institute for Medical Research, Wynnewood, PA (P.R.K.); Harvard Medical School, Massachusetts General Hospital, Boston (D.E.S.); Hofstra North Shore/Long Island School of Medicine, Hempstead, NY (J.A.); Mayo Clinic College of Medicine, Rochester, MN (BJ.G.); Department of Medicine, Stanford University School of Medicine, Palo Alto, CA (K.W.M.); Boston University School of Medicine, Boston, MA (E.M.H.); and Kaiser Permanente, Oakland, CA (A.S.G.).
authors.forename: Gregg C
authors.initials: GC
authors.lastname: Fonarow
authors.affiliation: From the Division of Cardiology, Duke University Medical Center, Durham, NC (S.D.P., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (S.D.P., P.S., L.T., J.P.P., E.D.P.); Division of Cardiology, University of California Los Angeles (G.C.F.); Lankenau Institute for Medical Research, Wynnewood, PA (P.R.K.); Harvard Medical School, Massachusetts General Hospital, Boston (D.E.S.); Hofstra North Shore/Long Island School of Medicine, Hempstead, NY (J.A.); Mayo Clinic College of Medicine, Rochester, MN (BJ.G.); Department of Medicine, Stanford University School of Medicine, Palo Alto, CA (K.W.M.); Boston University School of Medicine, Boston, MA (E.M.H.); and Kaiser Permanente, Oakland, CA (A.S.G.).
authors.forename: Peter R
authors.initials: PR
authors.lastname: Kowey
authors.affiliation: From the Division of Cardiology, Duke University Medical Center, Durham, NC (S.D.P., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (S.D.P., P.S., L.T., J.P.P., E.D.P.); Division of Cardiology, University of California Los Angeles (G.C.F.); Lankenau Institute for Medical Research, Wynnewood, PA (P.R.K.); Harvard Medical School, Massachusetts General Hospital, Boston (D.E.S.); Hofstra North Shore/Long Island School of Medicine, Hempstead, NY (J.A.); Mayo Clinic College of Medicine, Rochester, MN (BJ.G.); Department of Medicine, Stanford University School of Medicine, Palo Alto, CA (K.W.M.); Boston University School of Medicine, Boston, MA (E.M.H.); and Kaiser Permanente, Oakland, CA (A.S.G.).
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Singer
authors.affiliation: From the Division of Cardiology, Duke University Medical Center, Durham, NC (S.D.P., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (S.D.P., P.S., L.T., J.P.P., E.D.P.); Division of Cardiology, University of California Los Angeles (G.C.F.); Lankenau Institute for Medical Research, Wynnewood, PA (P.R.K.); Harvard Medical School, Massachusetts General Hospital, Boston (D.E.S.); Hofstra North Shore/Long Island School of Medicine, Hempstead, NY (J.A.); Mayo Clinic College of Medicine, Rochester, MN (BJ.G.); Department of Medicine, Stanford University School of Medicine, Palo Alto, CA (K.W.M.); Boston University School of Medicine, Boston, MA (E.M.H.); and Kaiser Permanente, Oakland, CA (A.S.G.).
authors.forename: Jack
authors.initials: J
authors.lastname: Ansell
authors.affiliation: From the Division of Cardiology, Duke University Medical Center, Durham, NC (S.D.P., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (S.D.P., P.S., L.T., J.P.P., E.D.P.); Division of Cardiology, University of California Los Angeles (G.C.F.); Lankenau Institute for Medical Research, Wynnewood, PA (P.R.K.); Harvard Medical School, Massachusetts General Hospital, Boston (D.E.S.); Hofstra North Shore/Long Island School of Medicine, Hempstead, NY (J.A.); Mayo Clinic College of Medicine, Rochester, MN (BJ.G.); Department of Medicine, Stanford University School of Medicine, Palo Alto, CA (K.W.M.); Boston University School of Medicine, Boston, MA (E.M.H.); and Kaiser Permanente, Oakland, CA (A.S.G.).
authors.forename: Bernard J
authors.initials: BJ
authors.lastname: Gersh
authors.affiliation: From the Division of Cardiology, Duke University Medical Center, Durham, NC (S.D.P., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (S.D.P., P.S., L.T., J.P.P., E.D.P.); Division of Cardiology, University of California Los Angeles (G.C.F.); Lankenau Institute for Medical Research, Wynnewood, PA (P.R.K.); Harvard Medical School, Massachusetts General Hospital, Boston (D.E.S.); Hofstra North Shore/Long Island School of Medicine, Hempstead, NY (J.A.); Mayo Clinic College of Medicine, Rochester, MN (BJ.G.); Department of Medicine, Stanford University School of Medicine, Palo Alto, CA (K.W.M.); Boston University School of Medicine, Boston, MA (E.M.H.); and Kaiser Permanente, Oakland, CA (A.S.G.).
authors.forename: Kenneth W
authors.initials: KW
authors.lastname: Mahaffey
authors.affiliation: From the Division of Cardiology, Duke University Medical Center, Durham, NC (S.D.P., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (S.D.P., P.S., L.T., J.P.P., E.D.P.); Division of Cardiology, University of California Los Angeles (G.C.F.); Lankenau Institute for Medical Research, Wynnewood, PA (P.R.K.); Harvard Medical School, Massachusetts General Hospital, Boston (D.E.S.); Hofstra North Shore/Long Island School of Medicine, Hempstead, NY (J.A.); Mayo Clinic College of Medicine, Rochester, MN (BJ.G.); Department of Medicine, Stanford University School of Medicine, Palo Alto, CA (K.W.M.); Boston University School of Medicine, Boston, MA (E.M.H.); and Kaiser Permanente, Oakland, CA (A.S.G.).
authors.forename: Elaine M
authors.initials: EM
authors.lastname: Hylek
authors.affiliation: From the Division of Cardiology, Duke University Medical Center, Durham, NC (S.D.P., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (S.D.P., P.S., L.T., J.P.P., E.D.P.); Division of Cardiology, University of California Los Angeles (G.C.F.); Lankenau Institute for Medical Research, Wynnewood, PA (P.R.K.); Harvard Medical School, Massachusetts General Hospital, Boston (D.E.S.); Hofstra North Shore/Long Island School of Medicine, Hempstead, NY (J.A.); Mayo Clinic College of Medicine, Rochester, MN (BJ.G.); Department of Medicine, Stanford University School of Medicine, Palo Alto, CA (K.W.M.); Boston University School of Medicine, Boston, MA (E.M.H.); and Kaiser Permanente, Oakland, CA (A.S.G.).
authors.forename: Alan S
authors.initials: AS
authors.lastname: Go
authors.affiliation: From the Division of Cardiology, Duke University Medical Center, Durham, NC (S.D.P., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (S.D.P., P.S., L.T., J.P.P., E.D.P.); Division of Cardiology, University of California Los Angeles (G.C.F.); Lankenau Institute for Medical Research, Wynnewood, PA (P.R.K.); Harvard Medical School, Massachusetts General Hospital, Boston (D.E.S.); Hofstra North Shore/Long Island School of Medicine, Hempstead, NY (J.A.); Mayo Clinic College of Medicine, Rochester, MN (BJ.G.); Department of Medicine, Stanford University School of Medicine, Palo Alto, CA (K.W.M.); Boston University School of Medicine, Boston, MA (E.M.H.); and Kaiser Permanente, Oakland, CA (A.S.G.).
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Piccini
authors.affiliation: From the Division of Cardiology, Duke University Medical Center, Durham, NC (S.D.P., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (S.D.P., P.S., L.T., J.P.P., E.D.P.); Division of Cardiology, University of California Los Angeles (G.C.F.); Lankenau Institute for Medical Research, Wynnewood, PA (P.R.K.); Harvard Medical School, Massachusetts General Hospital, Boston (D.E.S.); Hofstra North Shore/Long Island School of Medicine, Hempstead, NY (J.A.); Mayo Clinic College of Medicine, Rochester, MN (BJ.G.); Department of Medicine, Stanford University School of Medicine, Palo Alto, CA (K.W.M.); Boston University School of Medicine, Boston, MA (E.M.H.); and Kaiser Permanente, Oakland, CA (A.S.G.).
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001281:Atrial Fibrillation / Q000188:drug therapy / Q000652:urine; D004348:Drug Labeling; D005260:Female; D006801:Humans; D007677:Kidney Function Tests; D008297:Male; D011446:Prospective Studies; D011725:Pyridines / Q000008:administration & dosage / Q000493:pharmacokinetics; D012042:Registries; D013844:Thiazoles / Q000008:administration & dosage / Q000493:pharmacokinetics; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011725:Pyridines; D013844:Thiazoles; C552171:edoxaban
keywords: anticoagulation; atrial fibrillation; renal function