【medical-news】I-PRESERVE trial: 依贝沙坦不能改善射血功能正常的心衰患者的预后
发布于 2008-11-13 · 浏览 1319 · IP 上海上海
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I-PRESERVE trial: Irbesartan fails to improve outcomes in preserved-EF HF
12 November 2008
MedWire News: The angiotensin receptor blocker (ARB) irbesartan does not improve outcomes in well-treated patients with heart failure (HF) and a preserved ejection fraction (EF), a major trial has shown.
I-PRESERVE is the largest trial conducted in patients with this form of HF and is consistent with two earlier trials in detecting neither benefit nor harm from adding an ARB to optimal medical therapy in patients with the clinical syndrome of HF but an EF ≥45%.
The I-PRESERVE (Irbesartan in HF with preserved EF) trial was presented by Peter Carson (Georgetown University and Washington DC Veterans Affairs Medical Center, Washington, DC) at the American Heart Association 2008 Scientific Sessions in New Orleans, Louisiana.
The trial focused on HF with preserved EF (also known as diastolic HF), a form of the syndrome that accounts for around 50% of all cases of HF but is little-studied and poorly understood. It affects mainly women and older patients and usually has a hypertensive etiology; despite carrying substantial morbidity and mortality there is no effective evidence-based treatment.
The trial enrolled 4128 patients aged ≥60 years, in New York Heart Association Class II–IV, and with an EF ≥45%. All patients had either a recent hospitalization for HF or corroborative evidence of HF, such as pulmonary congestion or left-ventricular hypertrophy. They were randomized to receive irbesartan 300 mg/day or placebo and followed-up for a median of 49.5 months.
The subjects were well-treated at baseline, said Carson, and spironolactone and beta-blocker use increased markedly during the study period. Less than one-third of subjects were receiving an angiotensin converting enzyme inhibitor at baseline, although this rose to around 40% by the end of follow-up.
The study’s primary endpoint was death or cardiovascular (CV) hospitalization, defined as hospitalization for HF, myocardial infarction (MI), stroke, or arrhythmia. This did not differ between the groups, with a nonsignificant hazard ratio of 0.95 (p=0.35).
Subgroup analyses found no indication of a treatment benefit in any patient group, said Carson. Furthermore, all secondary endpoints – including death, CV death, HF death/HF hospitalization, CV death/MI/stroke, six-minute hall-walk, and NT-pro-BNP – were neutral, indicating no significant effect of irbesartan as compared with placebo.
Irbesartan therapy was well tolerated and was not associated with an excess of any side effects.
“For this large group of patients constituting up to half of all HF patients, there continues to be no specific evidence-based therapy,” Carson concluded. “In order for this field to move forward, a better understanding is needed of the mechanisms underlying this syndrome and additional potential targets for treatment.”
I-PRESERVE was discussed by Maggie Redfield (Mayo Clinic, 200 First St. SW, Rochester, MN 55), who said it was a “carefully designed and well-performed study with unambiguous findings”.
She said the results of I-PRESERVE echo those of the CHARM-PRESERVED and PEP-CHF in demonstrating no benefit of add-on ARBs in patients with HF and a preserved EF. ARBs remain useful for controlling blood pressure in these patients, she added.
12 November 2008
MedWire News: The angiotensin receptor blocker (ARB) irbesartan does not improve outcomes in well-treated patients with heart failure (HF) and a preserved ejection fraction (EF), a major trial has shown.
I-PRESERVE is the largest trial conducted in patients with this form of HF and is consistent with two earlier trials in detecting neither benefit nor harm from adding an ARB to optimal medical therapy in patients with the clinical syndrome of HF but an EF ≥45%.
The I-PRESERVE (Irbesartan in HF with preserved EF) trial was presented by Peter Carson (Georgetown University and Washington DC Veterans Affairs Medical Center, Washington, DC) at the American Heart Association 2008 Scientific Sessions in New Orleans, Louisiana.
The trial focused on HF with preserved EF (also known as diastolic HF), a form of the syndrome that accounts for around 50% of all cases of HF but is little-studied and poorly understood. It affects mainly women and older patients and usually has a hypertensive etiology; despite carrying substantial morbidity and mortality there is no effective evidence-based treatment.
The trial enrolled 4128 patients aged ≥60 years, in New York Heart Association Class II–IV, and with an EF ≥45%. All patients had either a recent hospitalization for HF or corroborative evidence of HF, such as pulmonary congestion or left-ventricular hypertrophy. They were randomized to receive irbesartan 300 mg/day or placebo and followed-up for a median of 49.5 months.
The subjects were well-treated at baseline, said Carson, and spironolactone and beta-blocker use increased markedly during the study period. Less than one-third of subjects were receiving an angiotensin converting enzyme inhibitor at baseline, although this rose to around 40% by the end of follow-up.
The study’s primary endpoint was death or cardiovascular (CV) hospitalization, defined as hospitalization for HF, myocardial infarction (MI), stroke, or arrhythmia. This did not differ between the groups, with a nonsignificant hazard ratio of 0.95 (p=0.35).
Subgroup analyses found no indication of a treatment benefit in any patient group, said Carson. Furthermore, all secondary endpoints – including death, CV death, HF death/HF hospitalization, CV death/MI/stroke, six-minute hall-walk, and NT-pro-BNP – were neutral, indicating no significant effect of irbesartan as compared with placebo.
Irbesartan therapy was well tolerated and was not associated with an excess of any side effects.
“For this large group of patients constituting up to half of all HF patients, there continues to be no specific evidence-based therapy,” Carson concluded. “In order for this field to move forward, a better understanding is needed of the mechanisms underlying this syndrome and additional potential targets for treatment.”
I-PRESERVE was discussed by Maggie Redfield (Mayo Clinic, 200 First St. SW, Rochester, MN 55), who said it was a “carefully designed and well-performed study with unambiguous findings”.
She said the results of I-PRESERVE echo those of the CHARM-PRESERVED and PEP-CHF in demonstrating no benefit of add-on ARBs in patients with HF and a preserved EF. ARBs remain useful for controlling blood pressure in these patients, she added.
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