Objective To evaluate the short-term effect of amlodipine plus telmisartan or amiloride on reduction of blood pressure and adverse effect in hypertensive patients with moderate or high risk of cardiovascular event.
Methods In this randomised, blind-end trial, 106 hypertensive patients met inclusion criteria are enrolled. Patients were randomly assigned to A group (amlodipine 2.5 mg plus telmisartan 80 mg group) or B group (amlodipine 2.5 mg plus one tablet of amiloride group); amlodipine 2.5 mg could be added if blood pressure beyond control at 4 week. Follow-up 24 weeks. Primary efficacy parameter was reduction of blood pressure at 24 week. Physical and laboratory characteristics and side effects were recorded.
Results Baseline systolic blood pressure was 160.5±16.5 mm Hg and diastolic blood pressure was 98.7±9.7 mm Hg. After 2 week treatment, mean systolic blood pressure in group A and B was (151.5±14.8) mm Hg and (144.4±13.9) mm Hg, respectively (P 0.05). Blood pressure control rate was 47.2% and 58.1% in group A and B (P 0.05) (DBPs 15.2±9.2 vs 15.7±9.4, p>0.05) or blood pressure control rates (67.9% of vs 71.7%, p>0.05) in two groups. Compared with A and B groups, both of them reported equivalent of adverse effects (7.6% of amiloride vs 9.4% of telmisartan, p>0.05).
Conclusion Amlodipine-based antihypertensive combination strategies achieved satisfactory blood pressure control in hypertensive patients with moderate or high cardiovascular risk. Yet, more predominant efficacy on the reduction of blood pressure and blood pressure control rates shows in the combination of amlodipine and amiloride at 2 week follow-up. Adverse effects and organ benefits beyond reducing blood pressure warrant longer clinical observation.