gms | German Medical Science

29. Wissenschaftlicher Kongress der Deutschen Hochdruckliga

Deutsche Hochdruckliga e. V. DHL ® - Deutsche Hypertonie Gesellschaft Deutsches Kompetenzzentrum Bluthochdruck

23. bis 25.11.2005, Berlin

The fixed dose combination of valsartan 160/ HCTZ 25 in hypertensive patients not controlled by high dose monotherapy of an angiotensin receptor blocker or combination therapy with HCTZ 12.5

Die Fixkombination aus Valsartan 160/ HCTZ 25 bei hypertensiven Patienten, die unter einer Hochdosis-Monotherapie mit einem Angiotensin-Rezeptoren-Blocker oder unter der Kombinationstherapie mit HCTZ 12,5 keinen kontrollierten Blutdruck erreichen

Meeting Abstract

  • P. Trenkwalder - Klinikum Starnberg (Starnberg, D)
  • H. Samer - Praxis für Allgemeinmedizin, Ghaag
  • R.D. Hempel - Praxis für Innere Medizin Berlin (Berlin, D)
  • G. Weidinger - Novartis Pharma GmbH, Klinische Forschung CR1, Nürnberg
  • S. Klebs - Novartis Pharma GmbH, Klinische Forschung CR1, Nürnberg

Hypertonie 2005. 29. Wissenschaftlicher Kongress der Deutschen Hochdruckliga. Berlin, 23.-25.11.2005. Düsseldorf, Köln: German Medical Science; 2006. Doc05hochP47

The electronic version of this article is the complete one and can be found online at:

Published: August 8, 2006

© 2006 Trenkwalder et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



Introduction: This study investigated whether a fixed combination therapy of valsartan 160mg + high dose HCTZ (25mg) (Val160/ HCTZ25) is able to significantly improve BP reduction in hypertensive patients not adequately controlled by a high dose angiotensin receptor blocker monotherapy (olmesartan 40mg; Olm40) or combination therapy with low dose HCTZ (olmesartan 20 mg + HCTZ 12.5 mg; Olm20/ HCTZ12.5).

Methods: After wash-out of previous antihypertensive medication, 204 patients with mean sitting trough diastolic blood pressure (MSDBP) größer-gleich 100 and <110 mmHg entered a 4-week treatment phase with Olm 40 or Olm20/ HCTZ 12.5 (phase 1, week 0-4) once daily. 158 patients whose BP was still poorly controlled at week 4 (MSDBP größer-gleich 90 mmHg), entered a second 4-week treatment phase (phase 2, week 5-8) with Val160/ HCTZ25 once daily. Primary efficacy parameter was the reduction in MSDBP at trough between week 4 and week 8 in the ITT population (n=158).

Results: Mean age was 59 years and 41% were female. At day 1, MSDBP for Olm40 (n=74) was 102.9±2.3 mmHg and 102.1±1.9 mmHg for Olm20/ HCTZ12.5 (n=84). At week 4 MSDBP decreased to 93.0±3.5 mmHg with Olm40 and to 93.8±3.9 mmHg with Olm20/ HCTZ12.5. Subsequent treatment with Val160/ HCTZ25 for 4 weeks reduced MSDBP to 84.7±6.4 mmHg in patients not controlled by Olm40 after phase 1 and MSDBP to 84.0±8.1 mmHg in patients not controlled by Olm20/ HCTZ12.5. This represented a mean decrease in MSDBP of 8.3±6.5 mmHg and 9.8±7.9 mmHg, respectively. Val 160/ HCTZ25 also reduced mean sitting systolic BP by 14.2±13.4 mmHg and 12.2±13.2 mmHg, respectively. For MSDBP as well as MSSBP, the reductions were statistically significant (p < 0.0001). MSDBP <90 mmHg was achieved in 76% of patients at week 8.

Conclusion: Hypertensive patients not controlled by high dose monotherapy or combination therapy with low dose HCTZ achieve an additional marked BP reduction from valsartan 160 mg + high dose HCTZ (25 mg) with a comparable safety and tolerability profile.