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Fixed-Dose Versus Off-Label Combination of Isosorbide Dinitrate Plus Hydralazine Hydrochloride: Retrospective Propensity-Matched Analysis in Black Medicare Patients with Heart Failure.
Adv Ther. 2017 08; 34(8):1976-1988.AT

Abstract

INTRODUCTION

Based upon the findings of the African-American Heart Failure Trial, the US Food and Drug Administration approved the fixed-dose combination of isosorbide dinitrate (ISDN) and hydralazine hydrochloride (HYD) (FDC-ISDN/HYD) as a new drug for treatment of heart failure (HF) in self-identified African Americans. According to the FDA, FDC-ISDN/HYD has no therapeutic equivalent. However, off-label combinations of the separate generic drugs ISDN and HYD (OLC-ISDN+HYD) or isosorbide mononitrate (ISMN) and HYD (OLC-ISMN+HYD) are routinely substituted without any supporting outcome data. We conducted an exploratory retrospective propensity-matched cohort study using Medicare data to determine whether a survival difference exists between these treatments in medication-adherent patients.

METHODS

Black Medicare beneficiaries with HF were matched with Medicare Part D data to identify patients with prescriptions to FDC-ISDN/HYD or the off-label combinations. Only patients with 1-year adherence levels ≥80% were included in the analysis. Propensity-matched scoring created two sets of matched cohort pairs on a 1:1 basis, each set comparing FDC-ISDN/HYD with one of the off-label combinations. Kaplan-Meier (KM) survival curves with the log-rank test were then calculated for each pair for the year of medication adherence.

RESULTS

The analysis population was relatively older (77 years) and mainly female (66.7%), with a high burden of comorbid disease. The KM estimates of 1-year survival were 87.9% (95% CI 85.6-89.9%) and 83.0% (95% CI 80.3-85.3%) (log rank p = 0.0024), respectively, for the matched cohorts FDC-ISDN/HYD and OLC-ISDN+HYD (n = 886 in each group) and 88.2% (95% CI 85.9-90.2%) and 84.8% (95% CI 82.2-87.0%) (log rank p = 0.0320), respectively, for the matched cohorts FDC-ISDN/HYD and OLC-ISMN+HYD (n = 868 in each group).

CONCLUSION

The 1-year survival advantage for FDC-ISDN/HYD compared with off-label combinations in adherent black Medicare beneficiaries with HF suggests a genuine difference between these medications and warrants prospective investigation.

Authors+Show Affiliations

Morehouse School of Medicine, Atlanta, GA, USA. eofili@msm.edu.University of Minnesota Medical School, VA Medical Centers, Minneapolis, MN, USA.UCLA School of Medicine, Los Angeles, CA, USA.Mount Sinai Medical Center, New York, NY, USA.National Minority Quality Forum, Washington, DC, USA.National Minority Quality Forum, Washington, DC, USA.

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

28707284

Citation

Ofili, Elizabeth, et al. "Fixed-Dose Versus Off-Label Combination of Isosorbide Dinitrate Plus Hydralazine Hydrochloride: Retrospective Propensity-Matched Analysis in Black Medicare Patients With Heart Failure." Advances in Therapy, vol. 34, no. 8, 2017, pp. 1976-1988.
Ofili E, Anand I, Williams RA, et al. Fixed-Dose Versus Off-Label Combination of Isosorbide Dinitrate Plus Hydralazine Hydrochloride: Retrospective Propensity-Matched Analysis in Black Medicare Patients with Heart Failure. Adv Ther. 2017;34(8):1976-1988.
Ofili, E., Anand, I., Williams, R. A., Akinboboye, O., Xu, L., & Puckrein, G. (2017). Fixed-Dose Versus Off-Label Combination of Isosorbide Dinitrate Plus Hydralazine Hydrochloride: Retrospective Propensity-Matched Analysis in Black Medicare Patients with Heart Failure. Advances in Therapy, 34(8), 1976-1988. https://doi.org/10.1007/s12325-017-0584-x
Ofili E, et al. Fixed-Dose Versus Off-Label Combination of Isosorbide Dinitrate Plus Hydralazine Hydrochloride: Retrospective Propensity-Matched Analysis in Black Medicare Patients With Heart Failure. Adv Ther. 2017;34(8):1976-1988. PubMed PMID: 28707284.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fixed-Dose Versus Off-Label Combination of Isosorbide Dinitrate Plus Hydralazine Hydrochloride: Retrospective Propensity-Matched Analysis in Black Medicare Patients with Heart Failure. AU - Ofili,Elizabeth, AU - Anand,Inder, AU - Williams,Richard Allen, AU - Akinboboye,Ola, AU - Xu,Liou, AU - Puckrein,Gary, Y1 - 2017/07/13/ PY - 2017/05/19/received PY - 2017/7/15/pubmed PY - 2018/2/2/medline PY - 2017/7/15/entrez KW - African American KW - BiDil KW - Black KW - Heart failure KW - Hydralazine hydrochloride KW - Isosorbide dinitrate KW - Isosorbide mononitrate KW - Medicare KW - Mortality KW - Race SP - 1976 EP - 1988 JF - Advances in therapy JO - Adv Ther VL - 34 IS - 8 N2 - INTRODUCTION: Based upon the findings of the African-American Heart Failure Trial, the US Food and Drug Administration approved the fixed-dose combination of isosorbide dinitrate (ISDN) and hydralazine hydrochloride (HYD) (FDC-ISDN/HYD) as a new drug for treatment of heart failure (HF) in self-identified African Americans. According to the FDA, FDC-ISDN/HYD has no therapeutic equivalent. However, off-label combinations of the separate generic drugs ISDN and HYD (OLC-ISDN+HYD) or isosorbide mononitrate (ISMN) and HYD (OLC-ISMN+HYD) are routinely substituted without any supporting outcome data. We conducted an exploratory retrospective propensity-matched cohort study using Medicare data to determine whether a survival difference exists between these treatments in medication-adherent patients. METHODS: Black Medicare beneficiaries with HF were matched with Medicare Part D data to identify patients with prescriptions to FDC-ISDN/HYD or the off-label combinations. Only patients with 1-year adherence levels ≥80% were included in the analysis. Propensity-matched scoring created two sets of matched cohort pairs on a 1:1 basis, each set comparing FDC-ISDN/HYD with one of the off-label combinations. Kaplan-Meier (KM) survival curves with the log-rank test were then calculated for each pair for the year of medication adherence. RESULTS: The analysis population was relatively older (77 years) and mainly female (66.7%), with a high burden of comorbid disease. The KM estimates of 1-year survival were 87.9% (95% CI 85.6-89.9%) and 83.0% (95% CI 80.3-85.3%) (log rank p = 0.0024), respectively, for the matched cohorts FDC-ISDN/HYD and OLC-ISDN+HYD (n = 886 in each group) and 88.2% (95% CI 85.9-90.2%) and 84.8% (95% CI 82.2-87.0%) (log rank p = 0.0320), respectively, for the matched cohorts FDC-ISDN/HYD and OLC-ISMN+HYD (n = 868 in each group). CONCLUSION: The 1-year survival advantage for FDC-ISDN/HYD compared with off-label combinations in adherent black Medicare beneficiaries with HF suggests a genuine difference between these medications and warrants prospective investigation. SN - 1865-8652 UR - https://www.unboundmedicine.com/medline/citation/28707284/Fixed_Dose_Versus_Off_Label_Combination_of_Isosorbide_Dinitrate_Plus_Hydralazine_Hydrochloride:_Retrospective_Propensity_Matched_Analysis_in_Black_Medicare_Patients_with_Heart_Failure_ L2 - https://dx.doi.org/10.1007/s12325-017-0584-x DB - PRIME DP - Unbound Medicine ER -