Tags

Type your tag names separated by a space and hit enter

Evidence for the continued safety and tolerability of fixed-dose isosorbide dinitrate/hydralazine in patients with chronic heart failure (the extension to African-American Heart Failure Trial).
Am J Cardiol. 2007 Aug 15; 100(4):684-9.AJ

Abstract

The benefits of fixed-dose combination isosorbide dinitrate plus hydralazine (ID/H) in African-Americans with heart failure (HF) were established by the African-American Heart Failure Trial (A-HeFT), which was terminated early because of a significant survival benefit of ID/H. The Extension to A-HeFT trial (X-A-HeFT), designed to make ID/H available for ethical reasons after A-HeFT termination, afforded an opportunity to further observe responsiveness and compliance with ID/H. In total 198 patients completing the A-HeFT took ID/H for an additional 209 +/- 116 days. Their age (57 +/- 13 years), cause and duration of HF, and HF medications were not different from all A-HeFT patients. New York Heart Association class at X-A-HeFT baseline was > or =III in 51% of patients versus 100% of all patients at A-HeFT baseline, remained unchanged in most patients, improved in 24%, and worsened in only 9% during X-A-HeFT. The average number of ID/H tablets taken during X-A-HeFT was 3.7 +/- 1.8 per day with compliance averaging 87 +/- 25%. The most common adverse events, headache (34%) and dizziness (16%), were less than in patients taking ID/H in A-HeFT, with only 6% discontinuations for adverse events. The 6% annualized mortality rate in X-A-HeFT was the same as for ID/H in A-HeFT. There were no statistically significant differences in baseline characteristics or outcomes in X-A-HeFT patients analyzed according to their A-HeFT randomization. In conclusion, these results confirm the good compliance, tolerability, and responsiveness, with low mortality and improved symptoms, during treatment with ID/H observed in A-HeFT.

Authors+Show Affiliations

Baylor University Medical Center, Heart and Vascular Institute, Dallas, Texas, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17697829

Citation

Yancy, Clyde W., et al. "Evidence for the Continued Safety and Tolerability of Fixed-dose Isosorbide Dinitrate/hydralazine in Patients With Chronic Heart Failure (the Extension to African-American Heart Failure Trial)." The American Journal of Cardiology, vol. 100, no. 4, 2007, pp. 684-9.
Yancy CW, Ghali JK, Braman VM, et al. Evidence for the continued safety and tolerability of fixed-dose isosorbide dinitrate/hydralazine in patients with chronic heart failure (the extension to African-American Heart Failure Trial). Am J Cardiol. 2007;100(4):684-9.
Yancy, C. W., Ghali, J. K., Braman, V. M., Sabolinski, M. L., Worcel, M., Archambault, W. T., & Franciosa, J. A. (2007). Evidence for the continued safety and tolerability of fixed-dose isosorbide dinitrate/hydralazine in patients with chronic heart failure (the extension to African-American Heart Failure Trial). The American Journal of Cardiology, 100(4), 684-9.
Yancy CW, et al. Evidence for the Continued Safety and Tolerability of Fixed-dose Isosorbide Dinitrate/hydralazine in Patients With Chronic Heart Failure (the Extension to African-American Heart Failure Trial). Am J Cardiol. 2007 Aug 15;100(4):684-9. PubMed PMID: 17697829.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evidence for the continued safety and tolerability of fixed-dose isosorbide dinitrate/hydralazine in patients with chronic heart failure (the extension to African-American Heart Failure Trial). AU - Yancy,Clyde W, AU - Ghali,Jalal K, AU - Braman,Virginia M, AU - Sabolinski,Michael L, AU - Worcel,Manuel, AU - Archambault,W Tad, AU - Franciosa,Joseph A, Y1 - 2007/06/26/ PY - 2007/01/27/received PY - 2007/03/19/revised PY - 2007/03/19/accepted PY - 2007/8/19/pubmed PY - 2007/9/28/medline PY - 2007/8/19/entrez SP - 684 EP - 9 JF - The American journal of cardiology JO - Am. J. Cardiol. VL - 100 IS - 4 N2 - The benefits of fixed-dose combination isosorbide dinitrate plus hydralazine (ID/H) in African-Americans with heart failure (HF) were established by the African-American Heart Failure Trial (A-HeFT), which was terminated early because of a significant survival benefit of ID/H. The Extension to A-HeFT trial (X-A-HeFT), designed to make ID/H available for ethical reasons after A-HeFT termination, afforded an opportunity to further observe responsiveness and compliance with ID/H. In total 198 patients completing the A-HeFT took ID/H for an additional 209 +/- 116 days. Their age (57 +/- 13 years), cause and duration of HF, and HF medications were not different from all A-HeFT patients. New York Heart Association class at X-A-HeFT baseline was > or =III in 51% of patients versus 100% of all patients at A-HeFT baseline, remained unchanged in most patients, improved in 24%, and worsened in only 9% during X-A-HeFT. The average number of ID/H tablets taken during X-A-HeFT was 3.7 +/- 1.8 per day with compliance averaging 87 +/- 25%. The most common adverse events, headache (34%) and dizziness (16%), were less than in patients taking ID/H in A-HeFT, with only 6% discontinuations for adverse events. The 6% annualized mortality rate in X-A-HeFT was the same as for ID/H in A-HeFT. There were no statistically significant differences in baseline characteristics or outcomes in X-A-HeFT patients analyzed according to their A-HeFT randomization. In conclusion, these results confirm the good compliance, tolerability, and responsiveness, with low mortality and improved symptoms, during treatment with ID/H observed in A-HeFT. SN - 0002-9149 UR - https://www.unboundmedicine.com/medline/citation/17697829/Evidence_for_the_continued_safety_and_tolerability_of_fixed_dose_isosorbide_dinitrate/hydralazine_in_patients_with_chronic_heart_failure__the_extension_to_African_American_Heart_Failure_Trial__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9149(07)00922-8 DB - PRIME DP - Unbound Medicine ER -