gms | German Medical Science

28. Wissenschaftlicher Kongress der Deutschen Hochdruckliga

24. bis 27.11.2004, Hannover

Valsartan 160/HCTZ 25 in hypertensive patients not controlled by AT1 receptor antagonists + low dose HCTZ

Valsartan 160/HCTZ 25 bei hypertensiven Patienten ohne hinreichende Blutdruckkontrolle durch AT1-Rezeptor Antagonisten mit niedrig dosiertem HCTZ

Meeting Abstract (Hypertonie 2004)

  • R. Fünfstück - Sophien- und Hufeland-Klinikum (Weimar, D)
  • R.-D. Hempel - Sophien- und Hufeland-Klinikum (Weimar, D)
  • A. Ansari - Sophien- und Hufeland-Klinikum (Weimar, D)
  • G. Weidinger - Novartis Pharma GmbH (Nürnberg, D)
  • S. Klebs - Novartis Pharma GmbH (Nürnberg, D)

Hypertonie 2004. 28. Wissenschaftlicher Kongress der Deutschen Hochdruckliga. Hannover, 24.-27.11.2004. Düsseldorf, Köln: German Medical Science; 2005. Doc04hochP98

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/hoch2004/04hoch098.shtml

Veröffentlicht: 10. August 2005

© 2005 Fünfstück et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

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Introduction: Only a minority of treated hypertensive patients (<30%) achieves controlled blood pressure (BP) levels. In a multicenter trial, we investigated the efficacy and safety of the fixed dose combination of valsartan 160mg and HCTZ 25mg (V160/H25) in patients not achieving BP control under treatment with fixed dose combinations of different AT1 receptor antagonists with HCTZ 12.5mg.

Methods: Following wash-out of antihypertensive drugs, 205 patients with a mean sitting diastolic blood pressure at trough (MSDBP) >=100 and <110 mmHg were treated with candesartan 16mg/HCTZ 12.5mg or telmisartan 80mg/HCTZ 12.5mg for 4 weeks (phase 1). In 148 patients BP was still not controlled after 4 weeks (MSDBP >=90 mmHg). These patients were treated with V160/H25 for additional 4 weeks (phase 2). The primary efficacy parameter was the reduction in MSDBP between week 4 and week 8 in the ITT population (n=148).

Results: The mean age at inclusion was 60+/-12.6 years. 49% of the patients were female. MSDBP at day 1 was 103.5+/-2.5 mmHg and decreased from 96.0+/-4.2 mmHg at week 4 (phase 1) to 85.8+/-6.8mmHg at week 8 (phase 2). Respectively, treatment with V160/H25 reduced MSDBP by additional 10.27 mmHg (95% confidence interval limits 9.21-11.32). A similar reduction was observed for the mean sitting systolic BP at trough. The decrease was statistically highly significant (p<0.0001) for both parameters and independent from the combination used in phase 1. MSDBP <90 mmHg (normalization rate) was achieved in 74% of the phase 2 population. In both treatment phases the incidence of adverse events was comparably low and results of laboratory tests were unremarkable.

Conclusion: Treatment with valsartan 160mg/HCTZ 25mg offers a substantial benefit for hypertensive patients not achieving controlled BP by the combinations of candesartan 16mg or telmisartan 80mg with low dose HCTZ. They experience a marked additional BP reduction with preserved excellent safety and tolerability.