Clinical and hemodynamic effects of bosentan dose optimization in symptomatic heart failure patients with severe systolic dysfunction, associated with secondary pulmonary hypertension--a multi-center randomized study
| Autor: | Avraham Caspi, Zvi Vered, Leonardo Reizin, Reuven Zimlichman, Marina Leitman, Olga Milo-Cotter, Edo Kaluski, Gad Cotter, Isaac Kobrin, Maurizio Rainisio, Tina Moriconi, Ricardo Krakover |
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| Rok vydání: | 2006 |
| Předmět: |
Male
medicine.medical_specialty Hypertension Pulmonary Secondary pulmonary hypertension Severity of Illness Index law.invention Ventricular Dysfunction Left Randomized controlled trial Double-Blind Method law Internal medicine Severity of illness medicine Humans Pharmacology (medical) Hemodynamic effects Antihypertensive Agents Ultrasonography Sulfonamides business.industry Bosentan medicine.disease Pulmonary hypertension respiratory tract diseases Treatment Outcome Dose optimization Heart failure Anesthesia Cardiology Female Cardiology and Cardiovascular Medicine business medicine.drug Heart Failure Systolic |
| Zdroj: | Cardiology. 109(4) |
| ISSN: | 1421-9751 |
| Popis: | Objective: Toevaluate the effects of bosentan on echo-derived hemodynamic measurements, and clinical variables in symptomatic heart failure (HF) patients. Method: Multi- center, double-blind, randomized (2:1), placebo-controlled study comparing bosentan (8–125 mg b.i.d.) to placebo in patients with New York Heart Association class IIIb–IV HF, left ventricular ejection fraction 40 mm Hg. Primary and secondary endpoints were change from baseline to 20 weeks in SPAP and cardiac index, respectively. Safety endpoints were treatment emergent adverse events (AEs), change in body weight, hemoglobin, hematocrit, systolic blood pressure and diuretic use. Results: Ninety-four patients enrolled: 60 to bosentan, 34 to placebo. There was no significant difference between the 2 arms in SPAP change (0.1 ± 11.5 mm Hg , 95% confidence limit (CL) –5.4 to 5.2, p = 0.97), cardiac index shift (0.12 ± 0.45, 95% CL –0.09 to 0.33 , p = 0.24 ) or any of the other 22 echocardigraphic measurements obtained. Therapy-duration was longer in the placebo arm, while more patients in the bosentan arm experienced adverse and serious AEs. Conclusion: In HF patients with left ventricular dysfunction and secondary pulmonary hypertension, bosentan did not provide any measurable hemodynamic benefit, and was associated with more frequent AEs, requiring drug discontinuation. |
| Databáze: | OpenAIRE |
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