Clinical and hemodynamic effects of long-term administration of gallopamil in patients with coronary artery disease and normal or impaired left ventricular function.

The hemodynamic and clinical profiles of gallopamil, a new calcium antagonist, were evaluated in 20 patients with severe coronary artery disease in a placebo-controlled, single-blind study. The patients were divided into 2 groups depending on baseline ejection fraction (greater than 45 or less than or equal to 45%) and underwent nuclear ventriculography, both at rest and during bicycle exercise under electrocardiographic monitoring, after 3 weeks of therapy (50 mg 3 times daily) and the 1-week run in and washout placebo periods. The mean anginal weekly frequency per patient was significantly reduced, from 3.4 to 0.5 (p less than 0.001). The left ventricular ejection fraction, cardiac volumes, ejection and filling indexes at rest and for the same workload were not altered in the population as a whole or in each of the 2 groups. The rate pressure product during exercise was reduced for the same workload from 18.0 +/- 5.0 X 10(3) to 16.8 +/- 4.7 X 10(3), while the regional ejection fraction in ischemic regions was not significantly changed. Individual variations of ventriculographic parameters in both groups were not related to basal values. Gallopamil increased the total duration of exercise from 432 +/- 201 to 537 +/- 188 s (p less than 0.001). Six patients did not complain of angina and their exercise was interrupted because of muscular weakness. The hemodynamic and clinical responses did not differ when the results in the population as a whole and in each of the 2 groups were compared. Gallopamil was effective and well tolerated, even in patients with very depressed cardiac function.

RCT Entities:   Population Interventions Outcomes