Safety of prostaglandin E₁ for the treatment of peripheral arterial occlusive disease in patients with congestive heart failure

Objectives: To confirm the safety of prostaglandin E₁ (PGE₁) when administered in 100 mL normal saline to patients with severe peripheral occlusive disease (PAOD; Fontaine class III or IV) and concomitant compensated chronic congestive heart failure (CHF) and to explore possible hemodynamic benefits of PGE₁ in CHF. Background: PGE₁ has been found to be effective in the treatment of severe PAOD. The agent may beneficially affect left ventricular performance or hemodynamics in patients with CHF. However, it must be administered intravenously (in saline diluent, adding potential hazard in patients with volume CHF). Methods: In a randomized, double- blinded protocol, 50 patients received intravenous (i.v.) infusion of either 60 μg PGE₁ or placebo, each dissolved in 100 mL saline solution administered over 2 hours each day for 14 days. During the succeeding 14 days, i.v. PGE₁ was administered to all patients in open-label fashion. Safety was assessed by clinical evaluation of symptoms and signs of CHF or other adverse events, by catheter-based and echocardiographic search for objective cardiac functional influences, and by echocardiogram monitoring for cardiac rhythm. PAOD status also was defined. Results: No evidence of clinical or objective cardiac functional influence was detected. With the usual dosage approved in PAOD, no significant influence on cardiac performance was observed. Conclusion: PGE₁ is safe for treatment of PAOD in patients with concomitant chronic, compensated CHF.