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(Circulation. 1996;94:1316-1324.)
© 1996 American Heart Association, Inc.

Articles

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

Djillali Annane, MD, PhD; Eric Bellissant, MD, PhD; Eric Pussard, PharmD, PhD; Roland Asmar, MD, PhD; Florence Lacombe, MD; Edouard Lanata, MD; Olivier Madonna, MD; Michel Safar, MD; Jean-Francois Giudicelli, MD, PhD; Philippe Gajdos, MD

the Service de Reanimation Medicale (Universite Paris V), Hopital Raymond Poincare, Garches, France (D.A., P.G.); Laboratoire de Pharmacologie Clinique (Universite Rennes I), Faculte de Medecine, Rennes, France (E.B.); Service de Pharmacologie Clinique (Universite Paris XI), Hopital de Bicetre, Le Kremlin Bicetre, France (E.P., J.-F.G.); Service de Medecine I (Universite Paris V), Hopital Broussais, Paris, France (R.A., M.S.); Laboratoires Merck Sharp & Dohme-Chibret, Paris, France (F.L., O.M.); and SAMU 92, Hopital Raymond Poincare, Garches, France (E.L.).

Correspondence to Djillali Annane, MD, Service de Reanimation Medicale, Hopital Raymond Poincare, 104 Boulevard Raymond Poincare, 92380 Garches, France.

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.

Key Words: heart failure • drugs • hemodynamics • pharmacology • regional blood flow

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