Artikel
Blood Pressure Reduction with Valsartan 160/HCTZ 25 in Hypertensive Patients Uncontrolled by Valsartan 160/HCTZ 12.5
Blutdrucksenkung mit Valsartan 160/HCTZ 25 bei hypertensiven Patienten ohne ausreichende Blutdruckkontrolle mit Valsartan 160/HCTZ 12,5
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Autoren
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P. Trenkwalder
- Klinikum Starnberg, Ludwigsburg, Novartis Pharma GmbH (Nürnberg, D)
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H.J. Ulmer
- Klinikum Starnberg, Ludwigsburg, Novartis Pharma GmbH (Nürnberg, D)
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H. Wolf
- Klinikum Starnberg, Ludwigsburg, Novartis Pharma GmbH (Nürnberg, D)
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R. Handrock
- Klinikum Starnberg, Ludwigsburg, Novartis Pharma GmbH (Nürnberg, D)
| Veröffentlicht: | 11. November 2004 |
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Gliederung
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Introduction
The percentage of treated hypertensive patients with adequately controlled blood pressure (BP) is still very low (below 30%) due to various reasons. We investigated in a multicenter, open-label study, whether a high dosed fixed combination therapy containing valsartan 160 mg plus hydrochlorothiazide (HCTZ) 25 mg (Val 160/ HCTZ 25) is able to significantly improve BP reduction in hypertensive patients not adequately controlled by the fixed combination of valsartan 160 mg plus HCTZ 12.5 mg (Val 160/ HCTZ 12.5).
Methods
After wash-out of previous antihypertensive medication 646 patients with a mean sitting trough diastolic blood pressure (MSDBP) = 100 and < 110 mmHg entered a 4-week treatment phase with Val 160/ HCTZ 12.5 (phase 1, week 0-4). 224 of those patients, whose BP was still poorly controlled at week 4 (MSDBP = 90 mmHg), entered a second 4-week treatment phase (phase 2, week 4-8) with Val 160/ HCTZ 25. Primary efficacy parameter was the reduction in MSDBP between week 4 and week 8 in the ITT population (n=221).
Results
Mean age was 59 years and 53% were female. At week 0, MSDBP was 103.3±2.7 mmHg. MSDBP decreased from 96.1±4.9 mmHg at week 4 to 87.8±7.4 mmHg at week 8. This represented a mean decrease of 8.27 mmHg (95% confidence interval limits 7.29 - 9.24) achieved by Val 160/ HCTZ 25. A similar effect size was observed for the mean sitting trough SBP. For both variables, the decrease was statistically highly significant (p-value <0.0001). MSDBP decreased to < 90 mmHg in 53% of patients (normalization rate). The incidence of adverse effects was low and laboratory test results were unremarkable in both treatment phases.
Conclusion
In summary, hypertensive patients not controlled by valsartan 160 mg plus HCTZ 12.5 mg considerably benefit from the treatment with valsartan 160 mg plus HCTZ 25 mg by achieving an additional marked BP reduction with an excellent safety and tolerability profile at the same time.
