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Regional variation in patients and outcomes in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) trial.
Circulation. 2015 Jan 06; 131(1):34-42.Circ

Abstract

BACKGROUND

Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) patients with heart failure and preserved left ventricular ejection fraction assigned to spironolactone did not achieve a significant reduction in the primary composite outcome (time to cardiovascular death, aborted cardiac arrest, or hospitalization for management of heart failure) compared with patients receiving placebo. In a post hoc analysis, an ≈4-fold difference was identified in this composite event rate between the 1678 patients randomized from Russia and Georgia compared with the 1767 enrolled from the United States, Canada, Brazil, and Argentina (the Americas).

METHODS AND RESULTS

To better understand this regional difference in clinical outcomes, demographic characteristics of these populations and their responses to spironolactone were explored. Patients from Russia/Georgia were younger, had less atrial fibrillation and diabetes mellitus, but were more likely to have had prior myocardial infarction or a hospitalization for heart failure. Russia/Georgia patients also had lower left ventricular ejection fraction and creatinine but higher diastolic blood pressure (all P<0.001). Hyperkalemia and doubling of creatinine were more likely and hypokalemia was less likely in patients receiving spironolactone in the Americas with no significant treatment effects in Russia/Georgia. All clinical event rates were markedly lower in Russia/Georgia, and there was no detectable impact of spironolactone on any outcomes. In contrast, in the Americas, the rates of the primary outcome, cardiovascular death, and hospitalization for heart failure were significantly reduced by spironolactone.

CONCLUSIONS

This post hoc analysis demonstrated greater potassium and creatinine changes and possible clinical benefits with spironolactone in patients with heart failure and preserved ejection fraction from the Americas.

CLINICAL TRIAL REGISTRATION URL

http://www.clinicaltrials.gov. Unique identifier: NCT00094302.

Authors+Show Affiliations

From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.). mpfeffer@rics.bwh.harvard.edu.From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).From the Cardiovascular Division, Brigham and Women's Hospital, Boston, MA (M.A.P., B.C., A.S.D., E.F.L., S.D.S.); New England Research Institutes, Inc, Watertown, MA (S.F.A., S.M.M.); National Heart, Lung, and Blood Institute, Bethesda, MD (R.B., J.L.F.); VA Medical Center and University of Minnesota, Minneapolis, MN (I.S.A.); Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (N.C.); Estudios Clinicos Latinoamerica, Rosario, Argentina (R.D.); Pirogov Russian National Research Medical University, Moscow, Russia (I.G.); New York Methodist Hospital, Brooklyn, NY (J.F.H.); Montreal Heart Institute, Montreal, QC, Canada (E.O., J.L.R.); University of Washington Medical Center, Seattle (J.L.P.); Diagnostic Services Clinic, Tbilisi, Georgia (T.S.); Northwestern University, Chicago, IL (S.J.S.); University of Wisconsin, Madison (N.K.S.); and University of Michigan School of Medicine, Ann Arbor (B.P.).

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

25406305

Citation

Pfeffer, Marc A., et al. "Regional Variation in Patients and Outcomes in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) Trial." Circulation, vol. 131, no. 1, 2015, pp. 34-42.
Pfeffer MA, Claggett B, Assmann SF, et al. Regional variation in patients and outcomes in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) trial. Circulation. 2015;131(1):34-42.
Pfeffer, M. A., Claggett, B., Assmann, S. F., Boineau, R., Anand, I. S., Clausell, N., Desai, A. S., Diaz, R., Fleg, J. L., Gordeev, I., Heitner, J. F., Lewis, E. F., O'Meara, E., Rouleau, J. L., Probstfield, J. L., Shaburishvili, T., Shah, S. J., Solomon, S. D., Sweitzer, N. K., ... Pitt, B. (2015). Regional variation in patients and outcomes in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) trial. Circulation, 131(1), 34-42. https://doi.org/10.1161/CIRCULATIONAHA.114.013255
Pfeffer MA, et al. Regional Variation in Patients and Outcomes in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) Trial. Circulation. 2015 Jan 6;131(1):34-42. PubMed PMID: 25406305.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Regional variation in patients and outcomes in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) trial. AU - Pfeffer,Marc A, AU - Claggett,Brian, AU - Assmann,Susan F, AU - Boineau,Robin, AU - Anand,Inder S, AU - Clausell,Nadine, AU - Desai,Akshay S, AU - Diaz,Rafael, AU - Fleg,Jerome L, AU - Gordeev,Ivan, AU - Heitner,John F, AU - Lewis,Eldrin F, AU - O'Meara,Eileen, AU - Rouleau,Jean-Lucien, AU - Probstfield,Jeffrey L, AU - Shaburishvili,Tamaz, AU - Shah,Sanjiv J, AU - Solomon,Scott D, AU - Sweitzer,Nancy K, AU - McKinlay,Sonja M, AU - Pitt,Bertram, Y1 - 2014/11/18/ PY - 2014/11/20/entrez PY - 2014/11/20/pubmed PY - 2015/3/27/medline KW - heart failure KW - randomized controlled trials KW - spironolactone SP - 34 EP - 42 JF - Circulation JO - Circulation VL - 131 IS - 1 N2 - BACKGROUND: Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) patients with heart failure and preserved left ventricular ejection fraction assigned to spironolactone did not achieve a significant reduction in the primary composite outcome (time to cardiovascular death, aborted cardiac arrest, or hospitalization for management of heart failure) compared with patients receiving placebo. In a post hoc analysis, an ≈4-fold difference was identified in this composite event rate between the 1678 patients randomized from Russia and Georgia compared with the 1767 enrolled from the United States, Canada, Brazil, and Argentina (the Americas). METHODS AND RESULTS: To better understand this regional difference in clinical outcomes, demographic characteristics of these populations and their responses to spironolactone were explored. Patients from Russia/Georgia were younger, had less atrial fibrillation and diabetes mellitus, but were more likely to have had prior myocardial infarction or a hospitalization for heart failure. Russia/Georgia patients also had lower left ventricular ejection fraction and creatinine but higher diastolic blood pressure (all P<0.001). Hyperkalemia and doubling of creatinine were more likely and hypokalemia was less likely in patients receiving spironolactone in the Americas with no significant treatment effects in Russia/Georgia. All clinical event rates were markedly lower in Russia/Georgia, and there was no detectable impact of spironolactone on any outcomes. In contrast, in the Americas, the rates of the primary outcome, cardiovascular death, and hospitalization for heart failure were significantly reduced by spironolactone. CONCLUSIONS: This post hoc analysis demonstrated greater potassium and creatinine changes and possible clinical benefits with spironolactone in patients with heart failure and preserved ejection fraction from the Americas. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00094302. SN - 1524-4539 UR - https://www.unboundmedicine.com/medline/citation/25406305/Regional_variation_in_patients_and_outcomes_in_the_Treatment_of_Preserved_Cardiac_Function_Heart_Failure_With_an_Aldosterone_Antagonist__TOPCAT__trial_ L2 - http://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.114.013255?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -