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

Author:

Annane Djillali1,Bellissant Eric1,Pussard Eric1,Asmar Roland1,Lacombe Florence1,Lanata Edouard1,Madonna Olivier1,Safar Michel1,Giudicelli Jean-Franc¸ois1,Gajdos Philippe1

Affiliation:

1. the Service de Re´animation Me´dicale (Universite´ Paris V), Hoˆpital Raymond Poincare´, Garches, France (D.A., P.G.); Laboratoire de Pharmacologie Clinique (Universite´ Rennes I), Faculte´ de Me´decine, Rennes, France (E.B.); Service de Pharmacologie Clinique (Universite´ Paris XI), Hoˆpital de Biceˆtre, Le Kremlin Biceˆtre, France (E.P., J.-F.G.); Service de Me´decine I (Universite´ Paris V), Hoˆpital Broussais, Paris, France (R.A., M.S.); Laboratoires Merck Sharp & Dohme-Chibret, Paris,...

Abstract

Background Converting enzyme inhibitors meet most of the criteria required to be used in acute pulmonary edema. However, they could also induce deleterious effects on renal function and electrolytes. The purpose of this study was to evaluate the efficacy and safety of a single intravenous 2-hour infusion of enalaprilat (1 mg) after an acute pulmonary edema. Methods and Results This was a placebo-controlled, randomized, double-blind study performed in 20 congestive heart failure patients (New York Heart Association class III or IV). Systemic and regional hemodynamic parameters, biological parameters, and blood gases were measured before and repeatedly after the onset of infusion. Compared with placebo, enalaprilat decreased pulmonary capillary wedge pressure (−37% versus −10%, P =.001), diastolic and mean systemic blood pressures (−21% versus 0%, P =.009, and −18% versus −1%, P =.026, respectively), diastolic and mean pulmonary blood pressures (−21% versus −8%, P =.040; −18% versus −9%, P =.046), and brachial and renal resistances (−44% versus −14%, P =.017, and −22% versus −2%, P =.014, respectively); increased brachial and renal blood flows (+77% versus +8%, P =.036, and +12% versus 0%, P =.043, respectively), arterial oxygen tension (+2% versus −16%, P =.041), and arterial oxygen saturation (+1% versus −2%, P =.045); and tended to decrease rate-pressure product (−19% versus −7%, P =.076), increase brachial artery diameter (+13% versus 0%, P =.081), and improve intrapulmonary shunt (−18% versus +16%, P =.080). Enalaprilat did not affect cardiac output or carotid or hepatosplanchnic hemodynamics. Conclusions Early administration of enalaprilat is effective and well tolerated in acute pulmonary edema.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

Reference45 articles.

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2. Opie LH. ACE inhibitors for congestive heart failure. In: Opie LH ed . Angiotensin - Converting Enzyme Inhibitors: Scientific Basis for Clinical Use . New York NY: Wiley-Liss; 1992:107-136.

3. Effects of Enalapril on Mortality in Severe Congestive Heart Failure

4. Effect of Enalapril on Survival in Patients with Reduced Left Ventricular Ejection Fractions and Congestive Heart Failure

5. Effect of Enalapril on Mortality and the Development of Heart Failure in Asymptomatic Patients with Reduced Left Ventricular Ejection Fractions

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