EARLY BLOOD PRESSURE CONTROL BY THE NIFEDIPINE GITS/TELMISARTAN COMBINATION: HT.1.01

Abstract

Background: Guidelines recommend combination treatment to be used as initial step in hypertensive patients at high cardiovascular(CV) risk because in this condition the earlier blood pressure (BP) control (and CV protection) achievable by two vs. one antihypertensive drug administration may be desirable. Goals: To determine whether initial treatment with telmisartan plus nifedipine GITS provides an earlier office and ambulatory BP control compared to initial treatment with the combination components in monotherapy and to verify whether initiating treatment with a combination allows a better long-term BP control, compared to use of combination treatment after initial monotherapy. Methods: 405 subjects with office systolic BP at inclusion ≥ 135 mmHg and with a high CV risk because of diabetes, metabolic syndrome and/or organ damage were randomized to initial administration of telmisartan plus nifedipine GITS (80 mg and 20 mg daily, respectively), to telmisartan alone or nifedipine GITS alone in a 2:1:1 ratio. Treatment was continued for 24 weeks shifting the monotherapy groups to combination treatment after 8 weeks. Office and ambulatory blood pressure were measured respectively after 2, 8, 16 and 24 and after 8, 16 and 24 weeks of treatment. Results: The main results for the per-protocol population (N = 327) are shown in the Table.Table. Systolic (S) and diastolic (D) office and ambulatory BP (least square means±SE; mmHg) in the three study groups: Telmisartan 80 mg (N = 74), Nifedipine GITS 20 mg (N = 89); their combination (N = 164). All subjects were on combination therapy starting from week 8. No significant differences were found between groups at baseline. Conclusion: Combination and monotherapy treatments all lowered systolic and diastolic BP substantially, the 24 h data showing that the effect was long lasting. Compared to the monotherapy, initiating treatment with the calcium antagonist/angiotensin receptor blocker combination allowed BP reduction and control to be achieved earlier, this being the case both for office and for ambulatory BP. Longer term BP control, on the other hand, was similar irrespective of the initial (combination or monotherapy) treatment strategy.