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Comparison of the Efficacy, Safety and Tolerability of Ramipril With Amlodipine in Treatment of Mild to Moderate Hypertension in Nigerians.
Abstract
Study Design: An open randomised, controlled, parallel group, single blind comparison of Ramipril with Amlodipine.
Subject and Methods: Fifty-five intent to treat hypertensive subjects were sequentially recruited for the study from the medical out-patient Clinics of the University of Nigeria Teaching Hospital, Enugu. All had systolic blood pressure (SBP) of 140 – 179 mmHg and Diastolic Blood Pressure (DBP) of 90 – 109 mm Hg. Thirty-three subjects (17 males and 16 females completed the study. They were aged 34 –80 years with mean age of 53.1 ± 33.7 years. There were 14 patients in the Ramipril group (mean age 48.4 ± 7.8 years) and 19 in the Amlodipine group (mean age: 56.05± 10.9). They were treated for 12 weeks. Dose titration from 5mg daily to 10 mg daily was done for both groups at 6 weeks of treatment.
Results: At the end of the treatment period (12 weeks), the mean SBP in the Ramipril group reduced from 152.5 ± 10.1 mmHg to 135.1 ± 21.3 mmHg and in the Amlodipine-treated group from 152.0 ± 12.2 mmHg to 132.1 mmHg. There was no significant change in the pulse rates and body mass indices in both groups before and after treatment. Both haematological and biochemical indices were not significantly affected by treatment with both drugs. There were also no significant adverse effects in all subjects who completed the study although discontinuation rate was higher in the amlodipine treated group (7 vs 4).
Conclusion: Ramipril at 5-10 mg daily and Amlodipine at 5 – 10 mg daily have been shown to produce satisfactory blood pressure control in majority of patients. The study also shows that Ramipril is effective as monotherapy at the doses used in the study for Nigerians with mild to moderate hypertension.
Keywords: Efficacy, tolerability, ramipril, hypertension
Journal of College of Medicine Vol. 12 (2) 2007: pp. 93-98