Clinical evaluation of isradipino. Open multicentric study

Abstract

Isradipine, a new and potent antihypertensive dihydropyridine calcium antagonist, was evaluated in 132 patients (66.7% females and 33.3% males) withe the clinical diagnosis of mild to moderate hypertension, in an open multicenter study that took place in the hypertension, in an open multicenter study that took place in the hypertension clinics of several peruvian hospitals. The protocol include a wash out or diagnosis confirmation period of two weeks followed by 12 weeks of treatment with 2.5 mg isradipine twice daily. 

The patients mean age was 56.7 (+-6.3), weight 66.9 kg (+- 11.0) and height 160 (+- 9.0). 30.3% of the patients had associated diseases, 86.4% had been previously treated for hypertension and 85.8% had a clinical diagnosis of arterial hypertension for more than one year. 

After 90 days of treatment there was a mean decrease of 28.8 mmHg in the diastolic arterial blood, from 168.5 (+- 16.7) to 140.0 (+- 11.4) mmHg (P< 0000). In relation to the sistolic blood pressure, the difference was also significative (P<0000), from 102.3 +- 5.11) to 84.6 (+-5.9) mmHg, an average of 17.4 mmHg. There were no significant changes in heart rate.

Isradipine was well tolerated. The most frecuent problems were in relation to: flashing and headaches, but they were all transitory and they diminish with the time of treatment, it was only necessary to stop the treatment in 5.3% of the patients because of adverse events. The laboratory test did not show any changes at the end of the 90 days of treatment.

It is concluded that isradipine is a new antihypertensive drug that presents a very good efficacy and is well tolerated in the treatment of mild to moderte arterial hypertension.