Placebo-Controlled, Randomized, Double-Blind Study of Intravenous Enalaprilat Efficacy and Safety in Acute Cardiogenic Pulmonary Edema

Annane, Djillali; Bellissant, Éric; Pussard, Eric; Asmar, Roland; Lacombe, Florence; Lanata, Edouard; Madonna, O.; Safar, Michel; Giudicelli, Jean-Franc ̧ois; Gajdos, Philippe

doi:10.1161/01.cir.94.6.1316

Cited by 61 publications

(22 citation statements)

References 38 publications

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“…49 One RCT only included responders to a previously given antihypertensive therapy. 50 Two out of 27 excluded trials involved a b-blocker arm and 18/27 excluded trials involved a calcium channel blocker arm. One excluded trial studied exclusively patients with acute aortic dissection.…”

Section: Resultsmentioning

confidence: 99%

Pharmacological interventions for hypertensive emergencies: a Cochrane systematic review

Perez

Musini

2008

J Hum Hypertens

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Hypertensive emergencies occur when high blood pressure is associated with the presence of acute endorgan damage, such as hypertensive encephalopathy. There is controversy as to when and which antihypertensive drugs to use in these situations. Using a comprehensive search strategy in electronic sources, MEDLINE, EMBASE and Cochrane clinical trial register, we conducted a systematic review to look all randomized control trials (RCTs) that compare an antihypertensive drug versus placebo, no treatment or another antihypertensive drug. Fifteen RCTs (representing 869 patients) met the inclusion criteria. Two trials included a placebo arm. All studies (except one) were open-label trials. Seven drug classes were evaluated in those trials: nitrates (nine trials), angiotensin-converting enzyme inhibitors (seven), diuretics (three), calcium channel blockers (six), a-1 adrenergic antagonists (four), direct vasodilators (two) and dopamine agonists (one). Mortality event data were reported in seven trials. Due to insufficient data, no meta-analysis was performed for clinical outcomes. Differences in blood pressure changes between antihypertensives were minor. There is no RCT evidence demonstrating that antihypertensive drugs reduce mortality or morbidity in patients with hypertensive emergencies. Furthermore, there is insufficient RCT evidence to determine which drug or drug class is most effective in reducing mortality and morbidity. There were some minor differences in the degree of blood pressure lowering when one class of antihypertensive drug is compared to another. However, the clinical significance is unknown. RCTs are needed to assess different drug classes to determine initial and longer-term mortality and morbidity outcomes.

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Section: Resultsmentioning

confidence: 99%

Pharmacological interventions for hypertensive emergencies: a Cochrane systematic review

Perez

Musini

2008

J Hum Hypertens

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“…High-dose enalaprilat lowers tissue perfusion pressure and negatively influences microcirculation, which may be important in the development of organ failure. Annane et al [11]showed that when MAP remains in the normal limits, enalaprilat has no influence on hemodynamics of internal carotid arteries and hepatosplanchnic arterial system, but it improves musculocutaneous and renal perfusion.…”

Section: Discussionmentioning

confidence: 99%

Bolus versus Continuous Low Dose of Enalaprilat in Congestive Heart Failure with Acute Refractory Decompensation

Podbregar

Voga²,

Horvat³

et al. 1999

Cardiology

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The first dose of angiotensin-converting enzyme (ACE) inhibitors may trigger a considerable fall of blood pressure in chronic heart failure. The response may be dose-related. To determine hemodynamic and systemic oxygenation effects of low-dose enalaprilat, we administered intravenous enalaprilat (0.004 mg/kg) as bolus (group B) or continuous 1-hour infusion (group C) in 20 patients with congestive heart failure due to ischemic heart disease with acute decompensation refractory to inotropic, vasodilator and diuretic therapy. Hemodynamic and systemic oxygenation variables were recorded at baseline (+0 min), +30, +60, +120, +180, and +360 min after the start of intervention. Mean arterial pressure (MAP) (p < 0.001), mean pulmonary artery pressure (MPAP) (p < 0.001), pulmonary artery occlusion pressure (PAOP) (p < 0.001), oxygen extraction ratio (ER) (p < 0.026) decreased regardless of enalaprilat application. Compared to group B, there was in group C prolonged decrease of MAP, MPAP, PAOP, ER and increase of pulmonary artery oxyhemoglobin saturation in regard to baseline values. Cardiac index, heart rate, central venous pressure and oxygen consumption index did not change. A low dose of intravenous enalaprilat (0.004 mg/kg) can be used to safely improve hemodynamics and systemic oxygenation in congestive heart failure due to ischemic heart disease with acute refractory decompensation.

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“…en el edema pulmonar agudo, en comparació n con placebo. El enalaprilato produjo mayor reducció n de la presió n capilar pulmonar enclavada y mejora del flujo sanguíneo renal, pero se administró entre 6 y 18 h despué s de la llegada de los pacientes al SU, lo cual impide que estos datos sean ú tiles en el contexto de un tratamiento de emergencia 47 . En otro estudio sobre la eficacia de enalaprilato en pacientes con crisis hipertensivas en el SU, se evaluó su efecto en una cohorte pequeñ a de pacientes con ICA, y se demostró que no tenía efectos adversos graves y que el fá rmaco es ú til en el tratamiento de la ICA 48 .…”

Section: Inhibidores De La Enzima De Conversió N De La Angiotensinaunclassified

Tratamiento farmacológico en la insuficiencia cardiaca aguda

Somma¹,

Magrini²

2015

Revista Española de Cardiología

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Placebo-Controlled, Randomized, Double-Blind Study of Intravenous Enalaprilat Efficacy and Safety in Acute Cardiogenic Pulmonary Edema

Abstract: Early administration of enalaprilat is effective and well tolerated in acute pulmonary edema.

Cited by 61 publications

References 38 publications

Pharmacological interventions for hypertensive emergencies: a Cochrane systematic review

Pharmacological interventions for hypertensive emergencies: a Cochrane systematic review

Bolus versus Continuous Low Dose of Enalaprilat in Congestive Heart Failure with Acute Refractory Decompensation

Tratamiento farmacológico en la insuficiencia cardiaca aguda

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