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European Heart Journal 1992 13(3):404-410;
Copyright © 1992 by the European Society of Cardiology.
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© 1992 The European Society of Cardiology

Gallopamil and diltiazem: a double-blind, randomized, cross-over trial in effort ischaemia

P. MARRACCINI*,, E. ORSINI*, C. BRUNELLI{dagger}, G. NASSI*, G. GHIGLIOTTI{dagger}, M. IANNETTI{dagger}, S. CAPONNETTO{dagger} and A. L'ABBATE*

*Istituto di Fisiologia Clinica del CNR e Istituto di Patologia Medica, Universitá di Pisa
{dagger}Cattedra di Cardiologia, Universitá di Genova

Received 21 June 1990; revised 30 January 1991; .

Correspondence Paolo Marraccini. MD. Istituto di Fisiologia Clinica del CNR. via Savi 8,56100 Pisa, Italy

Abstract

The aim of this study was to evaluate the efficacy and possibly the mechanism of action of gallopamil and diltiazem in a double-blind crossover trial in patients with effort ischaemia. Twenty male patients (mean age 57±6 years) with documented coronary atherosclerosis and exercise-induced ischaemia (ST depression ≥ 0.15 mV) completed the study, which consisted offour 7 day periods. At the end of each period a multistage bicycle exercise stress test was performed under placebo (first and third periods) and randomly under gallopamil (50 mg t.i.d.) or diltiazem (90mg t.i.d.) in the second and fourth periods. Both drugs significantly increased time to ischaemia (0.15 m VST depression) as compared toplacebo, from 7.9 ± 1.7 min to 8.9 ± 1.1 min (diltiazem) and 9.1 ± 1.6 min (gallopamil) with no significant dfference between the two drugs, and reduced the maximal extent of ST shift from 0.18 ± 0.08 mV to 0.13 ± 0.04 mV (diltiazem) and0 12 ± 0.05 mV (gallopamil). Analysis of the results from the whole population showed that the beneficial effect did not appear to be related to any specific parameter. Individual analysis showed that 13/20 patients under gallopamil and 13/20 under diltiazem increased time to ischaemia, while this was unchanged or reduced in the remainder. A positive correlation between changes in time to ischaemia and changes in rate x pressure product at ischaemia was found in both those administered gallopamil (R 0.80, P <0.01) and diltiazem (R 0.65, P <0.01). Multiple regression of all considered parameters andstepwise analysis showed that changes in rate x pressure product at ischaemia were the independent variables that accounted for the longer time to ischaemia. In conclusion, both gallopamil and diltiazem at the doses used in the present study did not significantly reduce myocardial oxygen demand and were possibly effective by improving oxygen supply.

Key Words: Angina pectoris • exercise stress test • gallopamil • diltiazem


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