The Efficacy and Safety of Low‐ and High‐ Dose Fixed Combinations of Irbesartan/Hydrochlorothiazide in Patients With Uncontrolled Systolic Blood Pressure on Monotherapy: The INCLUSIVE Trial
Why the study?
Does sequential treatment with irbesartan/hydrochlorothiazide fixed combinations reduce blood pressure in patients with uncontrolled systolic blood pressure on monotherapy?
Population
1005 adults with uncontrolled systolic blood pressure after at least 4 weeks of antihypertensive…
Design
Cohort, open-label
Follow-up
18 weeks
Authors
Discussion
Loading...
Member takes
Implication
May support titration in monotherapy failures; leaves open randomized comparisons to other regimens.
Key Points
- To evaluate the efficacy and safety of fixed combinations of irbesartan and hydrochlorothiazide in patients with uncontrolled systolic blood pressure despite monotherapy.
- Multicenter, prospective, open-label, single-arm trial enrolled 844 patients (aged 57.3±11.2 years) with baseline systolic blood pressure 140–159 mm Hg (130–159 mm Hg for type 2 diabetes) after ≥4 weeks of monotherapy.
- Patients received sequential treatment: placebo (4–5 weeks), HCTZ 12.5 mg (2 weeks), irbesartan/HCTZ 150/12.5 mg (8 weeks), and irbesartan/HCTZ 300/25 mg (8 weeks) over an 18-week evaluation period.
- Mean systolic blood pressure decreased by -21.5 ± 14.3 mm Hg (p < 0.001) and diastolic blood pressure decreased by -10.4 ± 8.7 mm Hg (p < 0.001) from baseline to Week 18 in the intent-to-treat population (n=736).
- Systolic blood pressure goal (<140 mm Hg; <130 mm Hg for type 2 diabetes) was achieved by 77% (95% CI, 74%–80%) of patients, diastolic goal by 83% (95% CI, 80%–86%), and dual goal by 69% (95% CI, 66%–72%).
- The sequential fixed-dose combination regimens were well tolerated across the diverse cohort.
Structured PICO
Does sequential treatment with irbesartan/hydrochlorothiazide fixed combinations reduce blood pressure in patients with uncontrolled systolic blood pressure on monotherapy?
P
Population
1005 adults (aged ≥18 years) with uncontrolled systolic blood pressure (140-159 mm Hg, or 130-159 mm Hg for type 2 diabetes mellitus) after at least 4 weeks of antihypertensive monotherapy. Enrolled cohort (n=844) mean age 57.3, 52% women.
I
Intervention
Sequential treatment: placebo (4-5 weeks), hydrochlorothiazide 12.5 mg (2 weeks), irbesartan/hydrochlorothiazide 150/12.5 mg (8 weeks), and irbesartan/hydrochlorothiazide 300/25 mg (8 weeks)
O
Outcome
Mean change in systolic blood pressure (SBP) from placebo end to Week 18surrogate
Sequential titration of irbesartan/hydrochlorothiazide fixed combinations effectively reduces blood pressure and achieves targets in over 75% of patients uncontrolled on monotherapy.
Cite This Study
Neutel et al. (2005) studied this question.