Assessment of the effects of nisoldipine in patients with mild to moderate hypertension

Abstract

Objective: The primary objective of the study is to show that once daily nisoldipine is effective in the control of blood pressure in patients with mild to moderate hypertension. The secondary objectives of the trial are to evaluate safety and the change in treatment in patients taking once daily nisoldipine.

Subjects and Methods: A non-randomized, dose rising trial with a placebo run-in was done in which 20 consenting subjects (11 males and 9 females) with mild to moderate hypertension participated.

Results: Sixteen subjects (80% of total) made up of 9 males and 7 females had a satisfactory response defined as either a mean sitting trough-diastolic blood pressure (DBP) of below 90mmHg or a mean DBP that has decreased by 10mmHg or more from the baseline DBP after placebo run-in. Ten subjects responded at 10mg dose; 3 at 20mg; and 3 responded at 40mg dose. There was no significant mean change in heart rate in the subjects. There was also no significant drug induced adverse events.

Conclusion: This study demonstrated the efficacy, tolerability and safety of Syscor CC^R 10mg, 20mg and 40mg once daily in Nigerian patients with mild to moderate hypertension: Nisoldipine produced significant reduction in blood pressure within twelve weeks of active treatment.

Keywords: hypertension, patients, nisoldipine

Orient Journal of Medicine Vol. 17(3&4) 2005: 17-24