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European Heart Journal 1985 6(8):689-694;
Copyright © 1985 by the European Society of Cardiology.
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© 1985 The European Society of Cardiology

Objective evaluation of PY-108–068, a new calcium channel inhibitor for the treatment of chronic stable angina pectoris

M. J. O'HARA*, N. S. KHURMI, M. J. BOWLES and E. B. RAFTERY

The Department of Cardiology and Division of Clinical Sciences, Northwick Park Hospital and Clinical Research Centre Watford Road, Harrow, Middlesex HA1 3UJ, U.K.

Received 12 February 1985; revised 20 May 1985; .

Address for reprints: Dr E. B. Raftery, Department of Cardiology Northwick Park Hospital and Clinical Research Centre, Watford Road, Harrow, Middlesex HA1 3UJ, England.

Abstract

PY-108–068 (PY) has calcium antagonist and coronary dilatory activity in animals, suggesting that it may be useful for the treatment of angina pec tor is. We have studied its effects in 19 patients with stable exertional angina. After a 2-week single-blind placebo run-in phase, patients were randomised double-blind to either 75 mg or 150 mg of the drug (in three divided doses) daily for 2 weeks, crossing over to the alternate dose for a further 2 weeks. Maximal treadmill tests with computer-assisted electrocardiographic analysis were used to evaluate efficacy. The mean±SEM exercise time to onset of angina increased from 61±0.5 min on placebo to 9.3±0.8min on PY 75mg (P<0.001) and to 9.2±0.8 min on PY 150mg (P<0.001) vs placebo; NS vs 75 mg). The time to development of 1 mm ST-segment depression in lead CC5 also increased from 5.0±0.7min on placebo to 6.4±0.9 min on PY 75 mg (P<0.01) and to 7.0±0.8 min on PY 150mg (P<0.01 vs placebo; NS vs 75 mg). Unlike other calcium antagonists, treatment with PY-108–068 did not significantly alter the resting or maximal heart rates or the heart rate gain during exercise. Resting blood pressure was reduced at the higher dose level but peak blood pressure during exercise and peak double product were unaltered by PY-108–068 treatment. With the exception of 1 patient who developed pedal oedema on the 150mg dose and was withdrawn from the study, the drug was well tolerated. The data indicate that PY-108–068 is equally effective at the 75 mg and 150mg daily dose levels in stable angina. Further studies are required to establish its efficacy compared with existing antianginal agents.

Key Words: PY-108–068 • calcium antagonist • angina • exercise testing


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