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Use of Hydralazine-Isosorbide Dinitrate combination in African American and Other Race/Ethnic Group Patients with Heart Failure and Reduced Ejection Fraction Harsh Golwala, MD; 1 Udho Thadani, MD; 1 Li Lang, MD, PhD; 2 Stavros Stavrakis, MD, PhD; 1 Javed Butler MD; 3 Clyde W. Yancy, MD; 4 Deepak L. Bhatt, MD, MPH; 5 Adrian Hernandez, MD, MHS; 2 Gregg C. Fonarow, MD 6 1 University of Oklahoma, Oklahoma City, OK; 2 Duke Clinical Research Institute, Durham, NC; 3 Emory University, Atlanta, GA; 4 Northwestern University, Chicago, IL; 5 VA Boston Healthcare System, Brigham and Women’s Hospital, Boston, MA; 6 UCLA Medical Center, Los Angeles, CA Results ACC/AHA and HFSA guidelines recommend the use of Hydralazine-Isosorbide Dinitrate (H-ISDN) in self identified African American patients with heart failure and reduced ejection fraction (HFrEF). In addition, H-ISDN may be considered in non-African American patients with HFrEF who remains symptomatic on optimized standard therapy. Background To determine the contemporary use of H-ISDN use over time in both African American and other racial/ethnic groups, trends in its use over time, as well as patient and hospital factors associated with its use. Objective Methods Conclusions Limitations GWTG-HF is an ongoing, prospective registry and quality improvement program initiated in January 2005 by the American Heart Association (AHA) 122,395 patients admitted with HF were discharged from 207 hospitals participating in GWTG-HF program from April 1, 2008 through March 24, 2012. Of these, patients with missing data on ejection fraction [n=3,868] or ejection fraction >40% [n=63,905] were excluded yielding a population of 54,622 HFrEF patients. Further exclusions included unknown race or ethnicity [n=2,288], and documented contra-indication to H-ISDN therapy [n=2,508]. We also excluded patients who were comfort care only, or those who died, or who had missing information on discharge destination. The final study population thus included 43,898 patients with HFrEF from 195 hospitals Outcomes Sciences, a Quintiles Company, Cambridge, MA served as the data collection center and Duke Clinical Research Institute served as the data analysis center. The data collection is dependent on the accuracy and completeness of data abstraction. Measured and unmeasured confounding factors may impact findings. Data do not include longitudinal follow-up, hence a portion of eligible patients may have been started on H- ISDN as an outpatient, underestimating its real use. However, previous data suggest that if a medication is not started at the time of discharge; subsequent new prescription rate in outpatient setting is low. Finally, GWTG-HF hospitals are self-selected and may not be representative to all hospitals in the US. Hydralazine-isosorbide dinitrate use in eligible African American patients with HFrEF remains very low in real world practice despite clinical trial evidence and guideline recommendations. Although H-ISDN use has increased over time from 2008 through 2011, it has nevertheless remained less than 25% even in the African American patients. Given the substantial morbidity and mortality faced by patients with HFrEF and the established efficacy of H- ISDN among African American patients, aggressive measures to facilitate adherence to H-ISDN should be sought. Table 1.Patient Characteristics by Hydralazine-Isosorbide Dinitrate Use at Hospital Discharge Figure 1. Current Use as Well as Trends in the Use of Hydralazine-isosorbide Dinitrate at Discharge in Eligible Patients from 2008-2011 Table 2. Patient and Hospital Factors Associated with H-ISDN Use in Self-Identified African American Patients Figure 2. H-ISDN Use in African American Patients in Hospitals with at Least 10 Self- Identified African American Patients Hydralazine-Isosorbide dintrate use No. (%) Patient characteristics Total (n=43,898) Yes (n=5,515) No (n=38,383) P value Age, mean (SD), y 68.3 (15)65.4 (15)68.7 (15)<.0001 Male (%) 62.465.861.9<.0001 Race (Median) White 61.343.663.8 <.001 African American 25.445.322.6 Hispanic 8.77.58.8 Others 4.43.44.62 Hypertension (%)74.282.173.1<.0001 Diabetes (%)41.250.539.9<.0001 Hyperlipidemia (%)48.250.147.90.003 Atrial Fibrillation (%)29.926.330.4<.0001 COPD (%)27.629.027.40.018 Peripheral vascular disease (%)11.613.611.3<.0001 Coronary artery disease (%)50.952.150.70.05 CVA (%)13.416.013.1<.0001 ICD (%)19.625.318.8<.0001 Heart failure (%)73.279.572.3<.0001 Pacemaker (%)14.313.514.40.08 CRT-P (%)0.8 0.64 CRT-D (%)8.812.18.3<.0001 Chronic dialysis (%)2.93.92.8<.0001 Smoking (%)21.822.021.810.78 Ejection fraction, mean (SD)24.7 (7.8)24.8 (7.8)24.7 (7.8)0.31 All values listed as mean ± standard deviation or %. Wilcoxon two-sample test performed for continuous variables. Chi-square test performed for categorical variables. Abbreviations: COPD, chronic obstructive pulmonary disease; CVA, cerebrovascular accident; ICD, Implantable cardioverter defibrillator; CRT- D,P= Cardiac resynchronization therapy- pacemaker, defibrillator VariableAdjusted ORP value Age, per 10 y0.90 (0.86-0.95)<0.001 Female vs. Male0.76 (0.68-0.85)<0.001 Uninsured vs Medicare0.82 (0.70-0.76)0.0118 COPD1.19 (1.07-1.31)0.001 Diabetes1.20 (1.07-1.35)0.0025 Hypertension1.30 (1.07-1.58)0.0084 ICD implantation1.36 (1.19-1.55)<0.0001 Heart Failure1.39 (1.23-1.58)<0.0001 Anemia1.27 (1.07-1.50)0.0052 Chronic dialysis0.59 (0.42-0.83)0.0028 Renal insufficiency2.33 (2.01-2.69)<0.0001 Smoking0.82 (0.72-0.93)0.0026 Systolic BP. Per 10 mm Hg1.15 (1.12-1.18)<0.0001 Heart rate, per 10 beats/min0.93 (0.91-0.95)<0.0001 Hospital Bed size, per 500 beds1.77 (1.24-2.52) 0.0018 Abbreviations: COPD, chronic obstructive pulmonary disease; ICD, implantable cardioverter defibrillator Race % of patients with H-ISDN discharge African American22.3 White8.9 Hispanics10.8 Others9.8 Disclosures: GWTG-HF program is provided by the AHA.GWTG-HF has been funded in the past through support from Medtronic, GlaxoSmithKline, Ortho-McNeil, and the American Heart Association Pharmaceutical Roundtable. This project was also supported by Young Investigator Database Research Seed Grant to Dr. Golwala -supported by the Council on Clinical Cardiology.
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