title: Characterization of Mineralocorticoid Receptor Antagonist Therapy Initiation in High-Risk Patients With Heart Failure.
abstract: Heart failure guidelines recommend routine monitoring of serum potassium, and renal function in patients treated with a mineralocorticoid receptor antagonist (MRA). How these recommendations are implemented in high-risk patients or according to setting of drug initiation is poorly characterized.
  
  
  
  We conducted a retrospective cohort study of Medicare beneficiaries linked to laboratory data in 10 states with prevalent heart failure as of July 1, 2011, and incident MRA use between May 1 and September 30, 2011. Outcomes included laboratory testing before MRA initiation and in the early (days 1-10) and extended (days 11-90) post-initiation periods, based on setting of drug initiation and the presence of renal insufficiency. Additional outcomes included abnormal laboratory results and adverse events proximate to MRA initiation. Of 10 443 Medicare beneficiaries with heart failure started on an MRA, 19.7% were initiated during a hospitalization. Appropriate follow-up laboratory testing across all time periods occurred in 25.2% of patients with inpatient initiation compared with 2.8% of patients begun as an outpatient. Patients with chronic kidney disease had higher rates of both hyperkalemia and acute kidney failure in the early (1.3% and 2.7%, respectively) and extended (5.6% and 9.8%, respectively) post-initiation periods compared with those without chronic kidney disease.
  
  
  
  Patients initiated on MRA therapy as an outpatient had extremely poor rates of guideline indicated follow-up laboratory monitoring after drug initiation. In particular, patients with chronic kidney disease are at high risk for adverse events after MRA initiation. Quality improvement initiatives focused on systems to improve appropriate laboratory monitoring are needed.
authors.affiliation: From the Inova Heart and Vascular Institute, Falls Church, VA (L.B.C.); Department of Medicine (L.B.C., E.D.P., M.L.M., L.H.C., A.F.H.) and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (B.G.H., E.D.P., L.H.C., A.F.H.); Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); and Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, NC (M.L.M.). lauren.cooper@inova.org.
authors.forename: Lauren B
authors.initials: LB
authors.lastname: Cooper
authors.affiliation: From the Inova Heart and Vascular Institute, Falls Church, VA (L.B.C.); Department of Medicine (L.B.C., E.D.P., M.L.M., L.H.C., A.F.H.) and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (B.G.H., E.D.P., L.H.C., A.F.H.); Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); and Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, NC (M.L.M.).
authors.forename: Bradley G
authors.initials: BG
authors.lastname: Hammill
authors.affiliation: From the Inova Heart and Vascular Institute, Falls Church, VA (L.B.C.); Department of Medicine (L.B.C., E.D.P., M.L.M., L.H.C., A.F.H.) and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (B.G.H., E.D.P., L.H.C., A.F.H.); Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); and Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, NC (M.L.M.).
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
authors.affiliation: From the Inova Heart and Vascular Institute, Falls Church, VA (L.B.C.); Department of Medicine (L.B.C., E.D.P., M.L.M., L.H.C., A.F.H.) and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (B.G.H., E.D.P., L.H.C., A.F.H.); Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); and Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, NC (M.L.M.).
authors.forename: Bertram
authors.initials: B
authors.lastname: Pitt
authors.affiliation: From the Inova Heart and Vascular Institute, Falls Church, VA (L.B.C.); Department of Medicine (L.B.C., E.D.P., M.L.M., L.H.C., A.F.H.) and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (B.G.H., E.D.P., L.H.C., A.F.H.); Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); and Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, NC (M.L.M.).
authors.forename: Matthew L
authors.initials: ML
authors.lastname: Maciejewski
authors.affiliation: From the Inova Heart and Vascular Institute, Falls Church, VA (L.B.C.); Department of Medicine (L.B.C., E.D.P., M.L.M., L.H.C., A.F.H.) and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (B.G.H., E.D.P., L.H.C., A.F.H.); Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); and Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, NC (M.L.M.).
authors.forename: Lesley H
authors.initials: LH
authors.lastname: Curtis
authors.affiliation: From the Inova Heart and Vascular Institute, Falls Church, VA (L.B.C.); Department of Medicine (L.B.C., E.D.P., M.L.M., L.H.C., A.F.H.) and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (B.G.H., E.D.P., L.H.C., A.F.H.); Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); and Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, NC (M.L.M.).
authors.forename: Adrian F
authors.initials: AF
authors.lastname: Hernandez
mesh_terms: D058186:Acute Kidney Injury / Q000209:etiology / Q000503:physiopathology; D000067575:Administrative Claims, Healthcare; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D016208:Databases, Factual; D016903:Drug Monitoring; D005260:Female; D019983:Guideline Adherence; D006333:Heart Failure / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D006760:Hospitalization; D006801:Humans; D006947:Hyperkalemia / Q000097:blood / Q000139:chemically induced / Q000175:diagnosis; D007668:Kidney / Q000187:drug effects / Q000503:physiopathology; D008297:Male; D006278:Medicare; D000451:Mineralocorticoid Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D011188:Potassium / Q000097:blood; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians'; D051437:Renal Insufficiency / Q000150:complications / Q000503:physiopathology; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D015415:Biomarkers; D000451:Mineralocorticoid Receptor Antagonists; D011188:Potassium
keywords: aldosterone antagonist; heart failure; medication adherence; mineralocorticoid receptor antagonist; renal insufficiency