Abstract
Background
Hypertension guidelines recommend the use of 2 agents with synergistic action when
>1 agent is needed to achieve blood pressure goals. Newer antihypertensive treatment
combinations include fixed-dose combinations of an angiotensin receptor blocker and
a calcium channel blocker.
Objective
The I-ADD study aimed to demonstrate whether the antihypertensive efficacy of fixed-dose
combination irbesartan 300 mg/amlodipine 5 mg (I300/A5) was superior to that of irbesartan
(I300) monotherapy in lowering home systolic blood pressure after 10 weeks' treatment.
Methods
The I-ADD study was a 10-week, multicenter, Phase III, prospective, randomized, parallel-group,
open-label with blinded–end point study. The main inclusion criterion was essential
uncontrolled hypertension (systolic blood pressure ≥145 mm Hg at office after at least
4 weeks of irbesartan 150 mg [I150] monotherapy administered once daily). Patients
continued to receive I150 for 7 to 10 days and were randomized to either monotherapy
with I150 for 5 weeks then I300 for the next 5 weeks, or to a fixed-dose combination
therapy (I150/A5, then I300/A5). Safety profile was assessed by recording adverse
events reported by patients or observed by the investigator.
Results
Following enrollment, 325 patients were randomized to treatment, and 320 (mean [SD]
age, 56.7 [11.4] years; 41% male) were included in the intention-to-treat analysis:
155 patients treated with I150/A5 then I300/A5, and 165 patients treated with I150
then I300. At randomization, mean home systolic blood pressure was similar in both
groups: 152.7 (11.8) mm Hg in the I150/A5 group and 150.4 (10.1) mm Hg in the I150
group. At week 10, the adjusted mean difference in home systolic blood pressure between
groups was –8.8 (1.1) mm Hg (P < 0.001). The percentage of controlled patients (mean home blood pressure <135 and
85 mm Hg) was nearly 2-fold higher in the I300/A5 group versus the I300 group (P < 0.001). Treatment-emergent adverse events were experienced by 10.5% of I300/A5-treated
patients and 6.6% of I300-treated patients during the second 5-week period. Three
serious adverse events were reported; 2 with monotherapy (1 with I150 and 1 with I300)
and 1 with fixed-dose combination I300/A5. All patients affected by serious adverse
events made a full recovery.
Conclusions
These 10-week data from this patient population suggest a greater antihypertensive
efficacy of the fixed-dose combination I300/A5 over I300 alone in lowering systolic
blood pressure. Both treatments were well tolerated throughout the study. ClinicalTrials.gov identifier: NCT00957554.
Key words
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Article info
Publication history
Published online: August 02, 2012
Accepted:
July 5,
2012
Identification
Copyright
© 2012 Elsevier HS Journals, Inc. Published by Elsevier Inc. All rights reserved.
