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P-225: Effective blood-pressure control with valsartan/HCTZ combination therapy in patients with moderate to severe systolic hypertension: The valor trial

Lacoursiere, Yves ; Hebert, Daniel ; Assouline, Linda ; Rehel, Bonita ; Khder, Yasser

In: American Journal of Hypertension, 2004, vol. 17, no. S1, p. 115A-115A

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    Titre
    • P-225: Effective blood-pressure control with valsartan/HCTZ combination therapy in patients with moderate to severe systolic hypertension: The valor trial
    Auteur
    • Lacoursiere, Yves. Director Hypertension Unit, Centre Hospitalier Universite Laval, Sainte Foy, QC, Canada; Medical Department, Novartis Pharma Canada inc., Dorval, QC, Canada; Clinical Development & Medical Affairs, WSJ-202.228A Novartis, Basel, Switzerland.
    • Hebert, Daniel. Director Hypertension Unit, Centre Hospitalier Universite Laval, Sainte Foy, QC, Canada; Medical Department, Novartis Pharma Canada inc., Dorval, QC, Canada; Clinical Development & Medical Affairs, WSJ-202.228A Novartis, Basel, Switzerland.
    • Assouline, Linda. Director Hypertension Unit, Centre Hospitalier Universite Laval, Sainte Foy, QC, Canada; Medical Department, Novartis Pharma Canada inc., Dorval, QC, Canada; Clinical Development & Medical Affairs, WSJ-202.228A Novartis, Basel, Switzerland.
    • Rehel, Bonita. Director Hypertension Unit, Centre Hospitalier Universite Laval, Sainte Foy, QC, Canada; Medical Department, Novartis Pharma Canada inc., Dorval, QC, Canada; Clinical Development & Medical Affairs, WSJ-202.228A Novartis, Basel, Switzerland.
    • Khder, Yasser. Director Hypertension Unit, Centre Hospitalier Universite Laval, Sainte Foy, QC, Canada; Medical Department, Novartis Pharma Canada inc., Dorval, QC, Canada; Clinical Development & Medical Affairs, WSJ-202.228A Novartis, Basel, Switzerland.
    Type de document
    • Postprint
    Identifiant OAI-PMH
    • oai:doc.rero.ch:299570
    Summary
    Increasing evidence shows that combination therapy with at least two antihypertensive agents is needed to achieve appropriate blood-pressure (BP) control in a large part of the hypertensive population. One of the most appealing combinations is that of adding a diuretic to an angiotensin-receptor blocker (ARB). We studied the effects on sitting systolic BP of the combinations valsartan (V; an ARB) 160 mg + HCTZ 12.5 mg and V160 mg + HCTZ 25 mg od, compared with monotherapy V160 mg od. Treatment-naive and previously treated patients (N=767) with moderate to severe systolic hypertension (SBP ≥160 mm Hg and ≤200 mmHg) and with or without co-morbidities, were randomised (after a 2-week washout if previously treated and a 2 week placebo run-in period) to either V80 od (monotherapy group) or V160 od (combination groups) for 4 weeks, with force-tration to V160 mg, V160/HCTZ 12.5 od or V160/HCTZ 25 od for an additional 4 weeks. Endpoints were change in SBP between V160 and V160/HCTZ 25 and between V160/HCTZ 12.5 and V160; changes in DBP between groups, response rates and tolerability. As shown in the Table, all treatments were highly effective and there were additional SBP and DBP reductions in the combination groups. Responder rates were above 50% in all groups and reached 75% in the V160/HCTZ 25 group. Rates of adverse events did not differ significantly between monotherapy and combination therapies. Table 1 V160 V160/HCTZ12.5 V160/HCTZ25 N 261 254 252 Male/female 130/131 141/113 140/112 Mean age 60.4 (10.6) 60.8 (11.5) 60.7 (11.6) Baseline mean SBP/DBP 167.9 (8.0)/93.2 (8.9) 167.4 (8.3)/93.4 (9.6) 167.2 (7.9)/93.7 (8.8) Mean change SBP/DBP −20.7 (15.7)/−6.6 (8.9) −27.9 (13.8) *−10.2 (7.7)* −28.3 (13.1) *−10.1 (7.8)* Response rate¥ 56.9% 74.4% * 75% * Any AE (monotherapy phase/combination phase) 37.3%/27.5% 32.1%/28.6% 32.8%/34.0% Values in brackets are ± SD. *P < 0.05 vs V160; ¥SBP < 140 or decrease in SBP ≥20 mmHg and/or DBP<90 mmHg. V160 mg od is safe and effective in patients with moderate to severe systolic hypertension. Adding HCTZ 12.5 or 25 mg provides significant additional reductions in systolic and diastolic BP and increases responder rates compared with V160 mg monotherapy, with maintained excellent tolerability