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)
| Autor: | Joseph A. Franciosa, W. Tad Archambault, Michael L. Sabolinski, Clyde W. Yancy, Manuel Worcel, Jalal K. Ghali, Virginia M. Braman |
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| Rok vydání: | 2007 |
| Předmět: |
Male
medicine.medical_specialty Administration Oral Isosorbide Dinitrate law.invention Double-Blind Method Randomized controlled trial law Internal medicine medicine Humans Adverse effect Survival rate Heart Failure Dose-Response Relationship Drug business.industry Stroke Volume Middle Aged Hydralazine medicine.disease United States Black or African American Survival Rate Drug Combinations Treatment Outcome Tolerability Heart failure Quality of Life Cardiology Patient Compliance Female Isosorbide dinitrate Cardiology and Cardiovascular Medicine business Isosorbide dinitrate/hydralazine Follow-Up Studies medicine.drug |
| Zdroj: | The American Journal of Cardiology. 100:684-689 |
| ISSN: | 0002-9149 |
| DOI: | 10.1016/j.amjcard.2007.03.086 |
| Popis: | 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 wasor =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. |
| Databáze: | OpenAIRE |
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