PMID- 17523721
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20121002
LR  - 20181113
IS  - 1173-2563 (Print)
IS  - 1173-2563 (Linking)
VI  - 24
IP  - 10
DP  - 2004
TI  - Efficacy and Safety of Valsartan 160mg/Hydrochlorothiazide 25mg Combination in 
      Patients with Hypertension not Adequately Controlled by Valsartan 
      160mg/Hydrochlorothiazide 12.5mg.
PG  - 593-602
AB  - BACKGROUND AND OBJECTIVE: Hypertension guidelines emphasise the need to treat 
      high blood pressure (BP) early and aggressively, giving fixed-dose combinations 
      special consideration. Hitherto, it has not been assessed in a sequential way 
      whether hypertensive patients with inadequately controlled hypertension with an 
      angiotensin II receptor antagonist/hydrochlorothiazide combination benefit from a 
      dose increase of the diuretic. We investigated the efficacy and safety of 
      valsartan 160mg/hydrochlorothiazide 25mg combination in patients with 
      hypertension that was not adequately controlled by valsartan 
      160mg/hydrochlorothiazide 12.5mg. PATIENTS AND METHODS: This was a multicentre, 
      single-group, prospective study of 646 patients with moderate hypertension 
      (diastolic BP [DBP] 100-109mm Hg). Patients were treated for 4 weeks with 
      valsartan 160mg/hydrochlorothiazide 12.5mg (phase 1: weeks 1-4). In case of 
      non-response (DBP >/=90mm Hg; n = 224) patients were treated for a further 4 
      weeks with valsartan 160mg/hydrochlorothiazide 25mg (phase 2: weeks 5-8). The 
      primary efficacy measure was a change in mean sitting trough DBP at study end 
      compared with the beginning of phase 2 in the intention-to-treat (ITT) population 
      (n = 221). RESULTS: Mean age of patients at entry was 58.6 years; 53.7% of 
      patients were female. In phase 1, systolic BP (SBP)/DBP decreased from a baseline 
      value of 161.9/103.3mm Hg by -16.1/-12.4mm Hg (normalisation rate 38.3%, response 
      rate 64.5%). In phase 2, in the ITT non-responder population the additional 
      SBP/DBP decrease was -8.4/-8.3mm Hg. Overall, the normalisation rate in all 
      patients was 55.4% and the responder rate was 76.3%.Tolerability of both the 
      valsartan 160mg/hydrochlorothiazide 12.5mg and the valsartan 
      160mg/hydrochlorothiazide 25mg combinations was very good, and the switch to the 
      higher dose did not result in an increase in adverse events (AEs) or laboratory 
      abnormalities. Only 16.6% of patients in phase 1 and 10.3% of patients in phase 2 
      experienced one or more AEs. CONCLUSION: In patients with moderate hypertension, 
      first-line therapy with the fixed-dose valsartan/hydrochlorothiazide combination 
      leads to high normalisation and response rates. Patients with hypertension not 
      controlled by valsartan 160mg/ hydrochlorothiazide 12.5mg clearly benefit from 
      dose titration to valsartan 160mg/hydrochlorothiazide 25mg with a clinically 
      relevant additional BP response and have excellent tolerability.
FAU - Trenkwalder, Peter
AU  - Trenkwalder P
AD  - Department of Internal Medicine, Starnberg Hospital, Academic Teaching Hospital 
      of the Ludwig Maximilian University, Munich, Germany.
FAU - Ulmer, Hans-Joachim
AU  - Ulmer HJ
FAU - Weidinger, Gottfried
AU  - Weidinger G
FAU - Handrock, Renate
AU  - Handrock R
LA  - eng
PT  - Journal Article
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
EDAT- 2007/05/26 09:00
MHDA- 2007/05/26 09:01
CRDT- 2007/05/26 09:00
PHST- 2007/05/26 09:00 [pubmed]
PHST- 2007/05/26 09:01 [medline]
PHST- 2007/05/26 09:00 [entrez]
AID - 24105 [pii]
AID - 10.2165/00044011-200424100-00005 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2004;24(10):593-602. doi: 10.2165/00044011-200424100-00005.