European Heart Journal (1990)11,1011-1017
P. SANGIORGIO, G. D I PASQUALE, S. SAVONITTO, S. URBINATI, A. RUBBOLI, G. CAVALLOTTI, G. PlNELLI AND D . BRACCHETT1
Divisione di Cardiologia, Ospedale Maggiore, Bologna and Servizio di Cardiologia, Ospedale Bellaria, Bologna, Italy KEY WORDS: Felodipine, dihydropyridines, angina, exercise test. To investigate the antianginal efficacy and tolerability of felodipine, a new dihydropyridine calcium antagonist, 20 patients with stable exertional angina, not completely controlled by beta-blocker monotherapy, entered a randomized, double-blind, placebo-controlled, crossover study. Patients on standard beta-blocker therapy, who had at least 3 weekly anginal episodes and a reproducible exercise test (stoppedfor angina and ECG signs of ischaemia) at the end of 2 weeks placebo treatment, were eligible for the study. They were randomized to one sequence of treatment: felodipine 5 mg twice daily for 2 weeks followed by placebo for a further 2 weeks, or vice versa. Beta-blocker treatment was unchanged throughout the study. A treadmill test was carried out at the end of each crossover period, 2-4 h after drug administration. The number of anginal attacks and nitroglycerin consumption was recorded on a diary card. At rest, felodipine significantly (P< 0-05) reduced standing systolic but not diastolic blood pressure. Heart rate was not modified by the active treatment. At ischaemic threshold and at peak exercise, heart rate, systolic blood pressure and rate-pressure product remained unchanged. Exercise duration was increased by felodipine (P3 mm measured 0-08 s from the J point, exhaustion, severe ventricular arrhythmias or failure of systolic blood pressure to increase during two consecutive steps.
1013
1014 P. Sangiorgio et al.
Table I Blood pressure, heart rale and rale-pressure product during the second baseline test and the two randomized tests' means ( ± SDJ Placebo
Basal
Rest (standing)SBP (mmHg) DBP (mmHg) HR(beats.min-') RPP (mmHg.beats.min ')
129-7 79-5 57 7 7523
(15-3) (8-5) (7-9) (1619)
130-4 75-1 55-1 7199
(180) (7-7) (8 9) (1605)
Felodipine
121-4 79-1 58-7 7142
(12-5)* (8-4) (6-9) (1204)
Peak exercise: SBP (mmHg) HR(beats.min-') RPP (mmHg.beats.min-')
145-6 (23-5) 106-1 (120) 15 482 (3245)
150-8 (23-9) 109-4 (12-7) 16497 (3274)
142-8 (22-2) 111-8 (13-0)* 16034 (3625)
After 2 min: SBP (mmHg) HR(beats.min-') RPP (mmHg.beats.min ')
147-2 (215) 67-6 (11-3) 9994 (2434)
141-0 (220) 681 (12-5) 9560 (2118)
1320 (18 5) 75-4 (12-8)* 10000 (2463)
After 5 min: SBP (mmHg) HR(beats.min-') RPP (mmHg.beats.min -')
1380 (22-5) 63-2 (11-6) 8727 (2253)
138-5 (16-9) 65-0 (10-7) 9009 (1864)
1200 (13-8) 68-2 (8-6) 8242 (1715)
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P. SANGIORGIO, G. D I PASQUALE, S. SAVONITTO, S. URBINATI, A. RUBBOLI, G. CAVALLOTTI, G. PlNELLI AND D . BRACCHETT1
Divisione di Cardiologia, Ospedale Maggiore, Bologna and Servizio di Cardiologia, Ospedale Bellaria, Bologna, Italy KEY WORDS: Felodipine, dihydropyridines, angina, exercise test. To investigate the antianginal efficacy and tolerability of felodipine, a new dihydropyridine calcium antagonist, 20 patients with stable exertional angina, not completely controlled by beta-blocker monotherapy, entered a randomized, double-blind, placebo-controlled, crossover study. Patients on standard beta-blocker therapy, who had at least 3 weekly anginal episodes and a reproducible exercise test (stoppedfor angina and ECG signs of ischaemia) at the end of 2 weeks placebo treatment, were eligible for the study. They were randomized to one sequence of treatment: felodipine 5 mg twice daily for 2 weeks followed by placebo for a further 2 weeks, or vice versa. Beta-blocker treatment was unchanged throughout the study. A treadmill test was carried out at the end of each crossover period, 2-4 h after drug administration. The number of anginal attacks and nitroglycerin consumption was recorded on a diary card. At rest, felodipine significantly (P< 0-05) reduced standing systolic but not diastolic blood pressure. Heart rate was not modified by the active treatment. At ischaemic threshold and at peak exercise, heart rate, systolic blood pressure and rate-pressure product remained unchanged. Exercise duration was increased by felodipine (P3 mm measured 0-08 s from the J point, exhaustion, severe ventricular arrhythmias or failure of systolic blood pressure to increase during two consecutive steps.
1013
1014 P. Sangiorgio et al.
Table I Blood pressure, heart rale and rale-pressure product during the second baseline test and the two randomized tests' means ( ± SDJ Placebo
Basal
Rest (standing)SBP (mmHg) DBP (mmHg) HR(beats.min-') RPP (mmHg.beats.min ')
129-7 79-5 57 7 7523
(15-3) (8-5) (7-9) (1619)
130-4 75-1 55-1 7199
(180) (7-7) (8 9) (1605)
Felodipine
121-4 79-1 58-7 7142
(12-5)* (8-4) (6-9) (1204)
Peak exercise: SBP (mmHg) HR(beats.min-') RPP (mmHg.beats.min-')
145-6 (23-5) 106-1 (120) 15 482 (3245)
150-8 (23-9) 109-4 (12-7) 16497 (3274)
142-8 (22-2) 111-8 (13-0)* 16034 (3625)
After 2 min: SBP (mmHg) HR(beats.min-') RPP (mmHg.beats.min ')
147-2 (215) 67-6 (11-3) 9994 (2434)
141-0 (220) 681 (12-5) 9560 (2118)
1320 (18 5) 75-4 (12-8)* 10000 (2463)
After 5 min: SBP (mmHg) HR(beats.min-') RPP (mmHg.beats.min -')
1380 (22-5) 63-2 (11-6) 8727 (2253)
138-5 (16-9) 65-0 (10-7) 9009 (1864)
1200 (13-8) 68-2 (8-6) 8242 (1715)
*/>
