EFFECT OF GALLOPAMIL ON MYOCARDIAL MICROPERFUSION IN PATIENTS WITH STABLE EFFORT ANGINA - A RANDOMIZED, CROSS-OVER, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

We evaluated the efficacy and safety of daily administration of gallop amil 150 mg/day and its effects on myocardial perfusion in a medium-te rm, randomized, double-blind, cross-over, placebo-controlled trial. We studied 19 patients (17 males and 2 females; mean age 57 +/- 6.8 year s) with stable effort angina, angiographically documented coronary art ery disease and reversible perfusion defects during exercise thallium- 201 myocardial scintigraphy of at least one segment of the left ventri cle. After 2 weeks of a single-blind placebo run-in period, during whi ch each patient underwent at least 2 exercise tests and a 48-hour Holt er ECG recording, all patients were treated with either placebo or gal lopamil 50 mg t.i.d. for 28 days. At the end of this period, patients crossed over to the alternate regimen. This phase was double blind. Af ter treatment with placebo or gallopamil, patients underwent exercise tests, 24-hour Holler ECG recording and thallium-201 myocardial scinti graphy. Weekly angina frequency and trinitroglycerin (TNT) consumption and safety were also evaluated. No patients dropped out of the study because of major side effects. The number of total ischemic and sympto matic events recorded at 24-hour ECG monitoring, weekly angina frequen cy and TNT consumption were significantly reduced during gallopamil tr eatment. After gallopamil administration, exercise duration significan tly increased (run-in: 419 +/- 116 s, placebo: 420 +/- 118 a, gallopam il: 511 +/- 144 s; p < 0.05), and ST segment depression was significan tly reduced (run-in: -1.3 +/- 0.3 mm, placebo: -1.3 +/- 0.3 mm, gallop amil: -0.94 +/- 0.68 mm; p < 0.01), while heart rate, systolic blood p ressure and rate-pressure product were unchanged at rest, at submaxima l and at peak exercise. Qualitative and quantitative evaluation of myo cardial perfusion and the myocardial uptake percentage of thallium-201 in ischemic zones were significantly improved by gallopamil treatment . These findings demonstrate that gallopamil can improve myocardial pe rfusion and reduce myocardial oxygen consumption.