Characterization of Mineralocorticoid Receptor Antagonist Therapy Initiation in High-Risk Patients with Heart Failure

Circulation: Cardiovascular Quality and Outcomes

Volumn 10, Issue 1, 2017, Pages

  Cooper, Lauren B ^a,b   Hammill, Bradley G ^c   Peterson, Eric D ^b,c   Pitt, Bertram ^d   MacIejewski, Matthew L ^b,e   Curtis, Lesley H ^b,c   Hernandez, Adrian F ^b,c  

^a INOVA HEART AND VASCULAR INSTITUTE   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^d UNIVERSITY OF MICHIGAN SCHOOL OF PUBLIC HEALTH   (United States)

^e DURHAM VA MEDICAL CENTER   (United States)

Author keywords

Aldosterone antagonist; Heart failure; Medication adherence; Mineralocorticoid receptor antagonist; renal insufficiency

Indexed keywords

CREATININE; MINERALOCORTICOID ANTAGONIST; POTASSIUM; BIOLOGICAL MARKER;

ABNORMAL LABORATORY RESULT; ACUTE KIDNEY FAILURE; AGED; ARTICLE; CHRONIC KIDNEY FAILURE; CREATININE BLOOD LEVEL; FEMALE; FOLLOW UP; HEART FAILURE; HIGH RISK PATIENT; HOSPITALIZATION; HUMAN; HYPERKALEMIA; MAJOR CLINICAL STUDY; MALE; MEDICARE; OUTCOME ASSESSMENT; OUTPATIENT CARE; POTASSIUM BLOOD LEVEL; PRIORITY JOURNAL; RETROSPECTIVE STUDY; SIDE EFFECT; ACUTE KIDNEY INJURY; ADMINISTRATIVE CLAIMS (HEALTH CARE); BLOOD; CHEMICALLY INDUCED; CLINICAL PRACTICE; COMPLICATION; DRUG EFFECTS; DRUG MONITORING; FACTUAL DATABASE; KIDNEY; KIDNEY FAILURE; PATHOPHYSIOLOGY; PRACTICE GUIDELINE; PROTOCOL COMPLIANCE; RISK ASSESSMENT; RISK FACTOR; TIME FACTOR; TREATMENT OUTCOME; UNITED STATES; VERY ELDERLY;

ACUTE KIDNEY INJURY; ADMINISTRATIVE CLAIMS, HEALTHCARE; AGED; AGED, 80 AND OVER; BIOMARKERS; DATABASES, FACTUAL; DRUG MONITORING; FEMALE; GUIDELINE ADHERENCE; HEART FAILURE; HOSPITALIZATION; HUMANS; HYPERKALEMIA; KIDNEY; MALE; MEDICARE; MINERALOCORTICOID RECEPTOR ANTAGONISTS; POTASSIUM; PRACTICE GUIDELINES AS TOPIC; PRACTICE PATTERNS, PHYSICIANS'; RENAL INSUFFICIENCY; RETROSPECTIVE STUDIES; RISK ASSESSMENT; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES;

EID: 85009986203     PISSN: 19417713     EISSN: 19417705     Source Type: Journal    
DOI: 10.1161/CIRCOUTCOMES.116.002946     Document Type: Article

References (30)

1. Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, Palensky J, Wittes J. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999;341:709-717. doi: 10.1056/ NEJM199909023411001
2. Pitt B, Remme W, Zannad F, Neaton J, Martinez F, Roniker B, Bittman R, Hurley S, Kleiman J, Gatlin M; Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study Investigators. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med. 2003;348:1309-1321. doi: 10.1056/NEJMoa030207
3. Zannad F, McMurray JJ, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pocock SJ, Pitt B; EMPHASIS-HF Study Group. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011;364:11-21. doi: 10.1056/NEJMoa1009492
4. Vizzardi E, D'Aloia A, Giubbini R, Bordonali T, Bugatti S, Pezzali N, Romeo A, Dei Cas A, Metra M, Dei Cas L. Effect of spironolactone on left ventricular ejection fraction and volumes in patients with class I or II heart failure. Am J Cardiol. 2010;106:1292-1296. doi: 10.1016/j. amjcard.2010.06.052
5. Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;62:e147-e239. doi: 10.1016/j.jacc.2013.05.019
6. Albert NM, Yancy CW, Liang L, Zhao X, Hernandez AF, Peterson ED, Cannon CP, Fonarow GC. Use of aldosterone antagonists in heart failure. JAMA. 2009; 302:1658-1665
7. Chamsi-Pasha MA, Dupont M, Al Jaroudi WA, Tang WH. Utilization pattern of mineralocorticoid receptor antagonists in contemporary patients hospitalized with acute decompensated heart failure: a single-center experience. J Card Fail. 2014;20:229-235. doi: 10.1016/j.cardfail.2014.01.017
8. Krantz MJ, Ambardekar AV, Kaltenbach L, Hernandez AF, Heidenreich PA, Fonarow GC; Get With the Guidelines Steering Committee and Hospitals. Patterns and predictors of evidence-based medication continuation among hospitalized heart failure patients (from Get With the Guidelines-Heart Failure). Am J Cardiol. 2011;107:1818-1823. doi: 10.1016/j.amjcard.2011.02.322
9. Eschalier R, McMurray JJ, Swedberg K, van Veldhuisen DJ, Krum H, Pocock SJ, Shi H, Vincent J, Rossignol P, Zannad F, Pitt B; EMPHASISHF Investigators. Safety and efficacy of eplerenone in patients at high risk for hyperkalemia and/or worsening renal function: analyses of the EMPHASIS-HF study subgroups (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure). J Am Coll Cardiol. 2013;62:1585-1593. doi: 10.1016/j.jacc.2013.04.086
10. Bozkurt B, Agoston I, Knowlton AA. Complications of inappropriate use of spironolactone in heart failure: when an old medicine spirals out of new guidelines. J Am Coll Cardiol. 2003;41:211-214
11. Cooper LB, Hammill BG, Peterson ED, Pitt B, Maciejewski ML, Curtis LH, Hernandez AF. Consistency of laboratory monitoring during initiation of mineralocorticoid receptor antagonist therapy in patients with heart failure. JAMA. 2015;314:1973-1975
12. Chaudhry SI, McAvay G, Chen S, Whitson H, Newman AB, Krumholz HM, Gill TM. Risk factors for hospital admission among older persons with newly diagnosed heart failure: findings from the Cardiovascular Health Study. J Am Coll Cardiol. 2013;61:635-642. doi: 10.1016/j.jacc.2012.11.027
13. Chronic Conditions Data Warehouse (CCW) Medicare Administrative Data User Guide: Buccaneer, Computer Systems and Service, Inc; 2014 [cited 2014 December 22]. http://www.ccwdata.org/cs/groups/public/ documents/document/ccw-userguide.pdf. Accessed April 20, 2016
14. Hammill BG, Curtis LH, Qualls LG, Hastings SN, Wang V, Maciejewski ML. Linkage of laboratory results to Medicare fee-for-service claims. Med Care. 2015;53:974-979. doi: 10.1097/MLR.0000000000000420
15. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999;130:461-470
16. Curtis LH, Mi X, Qualls LG, Check DK, Hammill BG, Hammill SC, Heidenreich PA, Masoudi FA, Setoguchi S, Hernandez AF, Fonarow GC. Transitional adherence and persistence in the use of aldosterone antagonist therapy in patients with heart failure. Am Heart J. 2013;165:979-986.e1. doi: 10.1016/j.ahj.2013.03.007
17. Vardeny O, Wu DH, Desai A, Rossignol P, Zannad F, Pitt B, Solomon SD; RALES Investigators. Influence of baseline and worsening renal function on efficacy of spironolactone in patients With severe heart failure: insights from RALES (Randomized Aldactone Evaluation Study). J Am Coll Cardiol. 2012;60:2082-2089. doi: 10.1016/j.jacc.2012.07.048
18. Bianchi S, Bigazzi R, Campese VM. Long-term effects of spironolactone on proteinuria and kidney function in patients with chronic kidney disease. Kidney Int. 2006;70:2116-2123. doi: 10.1038/sj.ki.5001854
19. Bomback AS, Kshirsagar AV, Amamoo MA, Klemmer PJ. Change in proteinuria after adding aldosterone blockers to ACE inhibitors or angiotensin receptor blockers in CKD: a systematic review. Am J Kidney Dis. 2008;51:199-211. doi: 10.1053/j.ajkd.2007.10.040
20. Bolignano D, Palmer SC, Navaneethan SD, Strippoli GF. Aldosterone antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2014;4:Cd007004
21. Juurlink DN, Mamdani MM, Lee DS, Kopp A, Austin PC, Laupacis A, Redelmeier DA. Rates of hyperkalemia after publication of the Randomized Aldactone Evaluation Study. N Engl J Med. 2004;351:543-551. doi: 10.1056/NEJMoa040135
22. Vardeny O, Claggett B, Anand I, Rossignol P, Desai AS, Zannad F, Pitt B, Solomon SD; Randomized Aldactone Evaluation Study (RALES) Investigators. Incidence, predictors, and outcomes related to hypo-and hyperkalemia in patients with severe heart failure treated with a mineralocorticoid receptor antagonist. Circ Heart Fail. 2014;7:573-579. doi: 10.1161/CIRCHEARTFAILURE.114.001104
23. Rossignol P, Cleland JG, Bhandari S, Tala S, Gustafsson F, Fay R, Lamiral Z, Dobre D, Pitt B, Zannad F. Determinants and consequences of renal function variations with aldosterone blocker therapy in heart failure patients after myocardial infarction: insights from the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study. Circulation. 2012;125:271-279. doi: 10.1161/ CIRCULATIONAHA.111.028282
24. Rossignol P, Dobre D, McMurray JJ, Swedberg K, Krum H, van Veldhuisen DJ, Shi H, Messig M, Vincent J, Girerd N, Bakris G, Pitt B, Zannad F. Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results from the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF). Circ Heart Fail. 2014;7:51-58. doi: 10.1161/ CIRCHEARTFAILURE.113.000792
25. Wei L, Struthers AD, Fahey T, Watson AD, Macdonald TM. Spironolactone use and renal toxicity: population based longitudinal analysis. BMJ. 2010;340:c1768
26. Schiff GD, Klass D, Peterson J, Shah G, Bates DW. Linking laboratory and pharmacy: opportunities for reducing errors and improving care. Arch Intern Med. 2003;163:893-900. doi: 10.1001/archinte.163.8.893
27. Raebel MA, Lyons EE, Chester EA, Bodily MA, Kelleher JA, Long CL, Miller C, Magid DJ. Improving laboratory monitoring at initiation of drug therapy in ambulatory care: a randomized trial. Arch Intern Med. 2005;165:2395-2401. doi: 10.1001/archinte.165.20.2395
28. Morrell RM, Tooze JA, Harmon MS, Carter AF, DeTroye AT, Lesser GJ. An automated system for detecting nonadherence in laboratory testing and monitoring for myelosuppression in patients receiving self-administered oral chemotherapy. J Oncol Pract. 2013;9:e268-e271. doi: 10.1200/ JOP.2012.000834
29. Johnson SG, Canty K, Billups S, Schimmer J. Adherence to amiodarone monitoring recommendations before and after implementation of a centralized pharmacy service: a cohort study. J Pharm Pract. 2010;23:536-539. doi: 10.1177/0897190009358770
30. Snider M, Kalbfleisch S, Carnes CA. Initial experience with antiarrhythmic medication monitoring by clinical pharmacists in an outpatient setting: a retrospective review. Clin Ther. 2009;31:1209-1218. doi: 10.1016/j.clinthera.2009.06.014