Safety, tolerability and efficacy of PN 200-110, a new calcium antagonist in patients with angina and coronary heart disease.

The safety, tolerability and efficacy of PN 200-110, a new calcium antagonist with minimal negative inotropic effects, were studied in twelve patients with stable angina pectoris and coronary artery disease. The study design was single-blind and placebo-controlled and increasing doses of the drug were used on consecutive days to investigate a dose response relationship. Eleven patients completed the trial. Response to the drug was evaluated using symptom limited cycle ergometric exercise. PN 200-110 in all three tested doses of 2.5 mg, 5.0 mg and 10.0 mg significantly increased the resting heart rate (p less than 0.02) and the exercise time to the onset of angina pectoris (p less than 0.02). Doses above 2.5 mg did not appear to improve the exercise parameters evaluated. Four patients had side effects probably due to PN 200-110 but these were mild and included dizziness, headache and flushing. There were no abnormal results from haematological and biochemical screening or from urine testing. We conclude that PN 220-110 can be given safely to patients with coronary artery disease without producing deleterious effects on blood pressure either at rest or during exercise.