EFFECT OF PIMOBENDAN ON EXERCISE CAPACITY IN PATIENTS WITH HEART-FAILURE - MAIN RESULTS FROM THE PIMOBENDAN IN CONGESTIVE-HEART-FAILURE (PICO) TRIAL

Primary objective - To determine the effects of pimobendan 2.5 and 5 m g daily on exercise capacity in patients with chronic heart failure. D esign - A randomised, double blind, placebo controlled trial of the ad dition of pimobendan to conventional treatment with a minimum follow u p of 24 weeks. Setting - Outpatient cardiology clinics in six European countries. Patients - 317 patients with stable symptomatic heart fail ure, objectively impaired exercise capacity, and an ejection fraction of 45% or lower who were treated with at least an angiotensin converti ng enzyme inhibitor and a diuretic and who tolerated a test dose of pi mobendan. Results - Compared with placebo, both pimobendan 2.5 and 5 m g daily improved exercise duration (bicycle ergometry) by 6% (P = 0.03 and 0.05) after 24 weeks of treatment. At that time 63% of patients a llocated to pimobendan and 59% of those allocated to placebo were aliv e and able to exercise to at least the same level as at entry (P = 0.5 ). No significant effects on oxygen consumption (assessed in a subgrou p of patients) and on quality of life (assessed by questionnaire) were observed. Pimobendan was well tolerated. Proarrhythmic effects (24-ho ur electrocardiography) were not observed. In both pimobendan groups c ombined the hazard of death was 1.8 (95% confidence interval 0.9 to 3. 5) times higher than in the placebo group. Conclusions - Pimobendan im proves exercise capacity in patients with chronic heart failure who ar e also on conventional treatment. The balance between benefit and risk of treatment with this compound remains to be established however.