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Efficacy of aliskiren/hydrochlorothiazide single-pill combinations in aliskiren non-responders
Georg Nickenig1, Vladimir Simanenkov, Giuseppe Lembo
1Universitätsklinikum Bonn, Bonn, Germany. georg.nickenig@ukb.uni-bonn.de
Insights
Adding hydrochlorothiazide to aliskiren significantly improved blood pressure control in hypertensive patients unresponsive to aliskiren monotherapy. The single-pill combination demonstrated greater efficacy and similar tolerability compared to aliskiren alone.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Clinical Hypertension Research
Background:
- Hypertension remains a global health challenge requiring effective therapeutic strategies.
- Aliskiren, a direct renin inhibitor, is used for hypertension but may require add-on therapy for inadequate responses.
- Assessing combination therapies is crucial for optimizing blood pressure management.
Purpose of the Study:
- To evaluate the efficacy, safety, and tolerability of a single-pill combination of aliskiren and hydrochlorothiazide (HCT).
- To determine if this combination improves blood pressure (BP) control in patients with inadequate response to aliskiren monotherapy.
Main Methods:
- A randomized, double-blind study involving 880 hypertensive patients with inadequate BP response to aliskiren 300 mg.
- Patients received once-daily aliskiren/HCT (300/25 mg or 300/12.5 mg) or aliskiren 300 mg monotherapy.
- BP changes from baseline were analyzed at the 8-week endpoint in the intent-to-treat population.
Main Results:
- Aliskiren/HCT 300/25 mg and 300/12.5 mg yielded significantly greater reductions in systolic/diastolic BP (15.9/11.0 mmHg and 13.5/10.5 mmHg) compared to aliskiren alone (8.0/7.4 mmHg).
- BP control rates (<140/90 mmHg) were significantly higher with aliskiren/HCT combinations (60.2% and 57.9%) versus aliskiren monotherapy (40.9%).
- The tolerability of the aliskiren/HCT single-pill combinations was comparable to aliskiren monotherapy.
Conclusions:
- Single-pill combinations of aliskiren/HCT offer clinically significant additional BP reductions.
- These combinations improve BP control rates in patients non-responsive to aliskiren monotherapy.
- Aliskiren/HCT combination therapy is an effective option for difficult-to-control hypertension.
Objectives:
To evaluate the efficacy, safety and tolerability of a single-pill combination of the direct renin inhibitor aliskiren and hydrochlorothiazide (HCT) in patients with hypertension and an inadequate BP response to aliskiren monotherapy (mean sitting diastolic BP [msDBP] > 90 and < or = 110 mmHg following 4 weeks of aliskiren 300 mg).
Methods:
In this study, 880 patients with hypertension and an inadequate BP response to aliskiren monotherapy were randomized to once-daily, double-blind treatment with a single-pill combination of aliskiren/HCT 300/25 mg or 300/12.5 mg, or aliskiren 300 mg monotherapy. At the week 8 endpoint, least-squares mean changes in mean sitting systolic/diastolic BP (msSBP/DBP) from baseline were analyzed for the intent-to-treat population.
Results:
Aliskiren/HCT 300/25 mg and 300/12.5 mg provided significantly greater msSBP/DBP reductions from baseline (15.9/11.0 mmHg and 13.5/10.5 mmHg, respectively) than aliskiren 300 mg alone (8.0/7.4 mmHg; both p<0.001). Rates of BP control (<140/90 mmHg) were significantly higher with aliskiren/HCT 300/25 mg (60.2%) and 300/12.5 mg (57.9%) than with aliskiren 300 mg alone (40.9%; both p<0.001). Aliskiren/HCT single-pill combination treatment showed similar tolerability to aliskiren monotherapy.
Conclusions:
Aliskiren/HCT single-pill combinations provide clinically significant additional BP reductions and improved BP control rates over aliskiren alone in patients who are non-responsive to aliskiren 300 mg monotherapy.
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