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Published on: May 26, 2022
Valsartan/hydrochlorothiazide is effective in hypertensive patients inadequately controlled by valsartan monotherapy
Jean-Michel Mallion1, Renzo Carretta, Peter Trenkwalder
1Department de Cardiologie et Hypertension Artérielle, CHU Grenoble, France.
Insights
Adding hydrochlorothiazide to valsartan significantly improves blood pressure control in patients with essential hypertension. Fixed-dose combinations of valsartan/hydrochlorothiazide offer effective and well-tolerated treatment options.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Essential hypertension is a prevalent cardiovascular condition requiring effective management.
- Valsartan monotherapy may not achieve adequate blood pressure control in all patients.
- Combination therapy is often necessary for achieving target blood pressure goals.
Purpose of the Study:
- To compare the efficacy and safety of fixed-dose valsartan/hydrochlorothiazide (HCTZ) combinations versus valsartan monotherapy.
- To evaluate treatment outcomes in patients with essential hypertension inadequately controlled by valsartan 160 mg.
- To assess the effectiveness of valsartan 160 mg/HCTZ 12.5 mg and valsartan 160 mg/HCTZ 25 mg in mild-to-moderate hypertension.
Main Methods:
- A double-blind, parallel-group, randomized trial involving 2002 patients.
- Patients received 8 weeks of treatment with valsartan 160 mg, valsartan 160 mg/HCTZ 12.5 mg, or valsartan 160 mg/HCTZ 25 mg.
- Blood pressure reduction and responder rates were primary efficacy endpoints.
Main Results:
- All treatment groups showed significant blood pressure reductions (p < 0.001).
- The valsartan 160 mg/HCTZ 25 mg group achieved the greatest reductions in both systolic and diastolic blood pressure.
- Responder rates were 49% (valsartan), 62% (valsartan/HCTZ 12.5), and 68% (valsartan/HCTZ 25), with 70% in elderly patients on valsartan/HCTZ 25.
Conclusions:
- Fixed-dose combinations of valsartan plus HCTZ are effective and well-tolerated for patients not controlled on valsartan monotherapy.
- Valsartan 160 mg/HCTZ 25 mg demonstrated superior efficacy in blood pressure reduction.
- Combination therapy provides a valuable treatment option for managing essential hypertension.
Objective:
This double-blind parallel-group randomized trial compared the efficacy and safety of fixed combination valsartan 160 mg/hydrochlorothiazide 12.5 mg (Val 160/HCTZ 12.5) once daily (o.d.) and Val 160/hydrochlorothiazide 25 mg (Val 160/HCTZ 25) o.d. vs Val 160 o.d. monotherapy in patients with mild-to-moderate essential hypertension not adequately controlled with valsartan monotherapy.
Method:
A total of 2002 patients whose BP was inadequately controlled with 4 weeks of Val 160 mg o.d. monotherapy were randomized to treatment for 8 weeks with Val 160 (n = 666), Val 160/HCTZ 12.5 (n = 670) or Val 160/HCTZ 25 (n = 666).
Results:
Active treatment significantly reduced BP in all groups over the 12 weeks of the study (p < 0.001). The greatest reductions were achieved with Val 160/HCTZ 25. Reductions were 10.8, 12.8 and 14.2 mmHg (sitting diastolic blood pressure) and 15.7, 19.4 and 21.8 mmHg (sitting systolic blood pressure), for the Val 160, Val 160/HCTZ 12.5 and Val 160/HCTZ 25 groups, respectively. Responder rates were high in all groups (49%, 62% and 68%). In elderly patients (> or = 65 years) responder rates of 70% were achieved with Val 160/HCTZ 25. All treatments were well tolerated, in all patient groups.
Conclusions:
The combination of Val 160 plus HCTZ 12.5 or HCTZ 25 provides effective and well-tolerated treatment in patients inadequately controlled after 4 weeks of monotherapy. In elderly patients a responder rate of 70% was achieved with Val 160/HCTZ 25.
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