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Effects of force-titrated valsartan/hydrochlorothiazide versus amlodipine/hydrochlorothiazide on ambulatory blood pressure in patients with stage 2 hypertension: the EVALUATE study.
Blood Press Monit. 2009 Jun; 14(3):112-20.BP

Abstract

BACKGROUND

Previous studies using the combination of angiotensin-receptor blockers and hydrochlorothiazide (HCTZ) have shown superior ambulatory blood pressure (ABP) reduction in study participants with stage 2 hypertension compared with monotherapy.

OBJECTIVE

This multicenter, double-blind, parallel group, forced-titration study of individuals with stage 2 hypertension, compared the efficacy of valsartan and amlodipine in combination with HCTZ on ABP reduction.

METHODS

After a 2-week washout period, participants (n=482) with mean office sitting systolic BP >or=160 mmHg and <or=200 mmHg were randomized to receive treatment with either valsartan 160 mg (n=241) or amlodipine 5 mg (n=241), force-titrated to a maximum dose of valsartan/HCTZ 320/25 mg or amlodipine/HCTZ 10/25 mg over 6 weeks and continued through week 10. The primary endpoint was change in mean 24-h ambulatory systolic BP from baseline to week 10.

RESULTS

At week 10, changes from baseline in mean office BP were significantly (P<0.0001) decreased by both valsartan/HCTZ (-34.2/-14.2 mmHg) and amlodipine/HCTZ (-34.1/-14.7 mmHg). Changes from baseline in mean 24-h ABP were significantly (P<0.0001) decreased by both valsartan/HCTZ (-21.1/-12.5 mmHg) and amlodipine/HCTZ (-18.1/-9.9 mmHg). However, treatment with valsartan/HCTZ provided significant additional systolic BP (-3.8 mmHg; P=0.0042) and diastolic BP (-2.7 mmHg; P=0.0002) reduction compared with the amlodipine/HCTZ group. The proportion of individuals reaching the office goal BP (<140/80 mmHg) were similar in the valsartan/HCTZ (55.3%) versus amlodipine/HCTZ (54.9%) group, ABP control rates for the recommended ABP goal (<130/80 mmHg) were greater (P=0.0170) in the valsartan/HCTZ group (54.3%) than the amlodipine/HCTZ group (42.7%). Both treatments were well tolerated.

CONCLUSION

On the basis of ABP monitoring but not office measurements, the fixed-dose combination of valsartan/HCTZ is a significantly more effective treatment regimen than amlodipine/HCTZ, with similar tolerability.

Authors+Show Affiliations

Centre Hospitalier de l'Université Laval, Sainte-Foy, Quebec, Canada. yves.lacourciere@crchul.ulaval.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19384192

Citation

Lacourcière, Yves, et al. "Effects of Force-titrated Valsartan/hydrochlorothiazide Versus Amlodipine/hydrochlorothiazide On Ambulatory Blood Pressure in Patients With Stage 2 Hypertension: the EVALUATE Study." Blood Pressure Monitoring, vol. 14, no. 3, 2009, pp. 112-20.
Lacourcière Y, Wright JT, Samuel R, et al. Effects of force-titrated valsartan/hydrochlorothiazide versus amlodipine/hydrochlorothiazide on ambulatory blood pressure in patients with stage 2 hypertension: the EVALUATE study. Blood Press Monit. 2009;14(3):112-20.
Lacourcière, Y., Wright, J. T., Samuel, R., Zappe, D., Purkayastha, D., & Black, H. R. (2009). Effects of force-titrated valsartan/hydrochlorothiazide versus amlodipine/hydrochlorothiazide on ambulatory blood pressure in patients with stage 2 hypertension: the EVALUATE study. Blood Pressure Monitoring, 14(3), 112-20. https://doi.org/10.1097/MBP.0b013e32832a9da7
Lacourcière Y, et al. Effects of Force-titrated Valsartan/hydrochlorothiazide Versus Amlodipine/hydrochlorothiazide On Ambulatory Blood Pressure in Patients With Stage 2 Hypertension: the EVALUATE Study. Blood Press Monit. 2009;14(3):112-20. PubMed PMID: 19384192.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of force-titrated valsartan/hydrochlorothiazide versus amlodipine/hydrochlorothiazide on ambulatory blood pressure in patients with stage 2 hypertension: the EVALUATE study. AU - Lacourcière,Yves, AU - Wright,Jackson T,Jr AU - Samuel,Rita, AU - Zappe,Dion, AU - Purkayastha,Das, AU - Black,Henry R, AU - ,, PY - 2009/4/23/entrez PY - 2009/4/23/pubmed PY - 2009/8/1/medline SP - 112 EP - 20 JF - Blood pressure monitoring JO - Blood Press Monit VL - 14 IS - 3 N2 - BACKGROUND: Previous studies using the combination of angiotensin-receptor blockers and hydrochlorothiazide (HCTZ) have shown superior ambulatory blood pressure (ABP) reduction in study participants with stage 2 hypertension compared with monotherapy. OBJECTIVE: This multicenter, double-blind, parallel group, forced-titration study of individuals with stage 2 hypertension, compared the efficacy of valsartan and amlodipine in combination with HCTZ on ABP reduction. METHODS: After a 2-week washout period, participants (n=482) with mean office sitting systolic BP >or=160 mmHg and <or=200 mmHg were randomized to receive treatment with either valsartan 160 mg (n=241) or amlodipine 5 mg (n=241), force-titrated to a maximum dose of valsartan/HCTZ 320/25 mg or amlodipine/HCTZ 10/25 mg over 6 weeks and continued through week 10. The primary endpoint was change in mean 24-h ambulatory systolic BP from baseline to week 10. RESULTS: At week 10, changes from baseline in mean office BP were significantly (P<0.0001) decreased by both valsartan/HCTZ (-34.2/-14.2 mmHg) and amlodipine/HCTZ (-34.1/-14.7 mmHg). Changes from baseline in mean 24-h ABP were significantly (P<0.0001) decreased by both valsartan/HCTZ (-21.1/-12.5 mmHg) and amlodipine/HCTZ (-18.1/-9.9 mmHg). However, treatment with valsartan/HCTZ provided significant additional systolic BP (-3.8 mmHg; P=0.0042) and diastolic BP (-2.7 mmHg; P=0.0002) reduction compared with the amlodipine/HCTZ group. The proportion of individuals reaching the office goal BP (<140/80 mmHg) were similar in the valsartan/HCTZ (55.3%) versus amlodipine/HCTZ (54.9%) group, ABP control rates for the recommended ABP goal (<130/80 mmHg) were greater (P=0.0170) in the valsartan/HCTZ group (54.3%) than the amlodipine/HCTZ group (42.7%). Both treatments were well tolerated. CONCLUSION: On the basis of ABP monitoring but not office measurements, the fixed-dose combination of valsartan/HCTZ is a significantly more effective treatment regimen than amlodipine/HCTZ, with similar tolerability. SN - 1473-5725 UR - https://www.unboundmedicine.com/medline/citation/19384192/Effects_of_force_titrated_valsartan/hydrochlorothiazide_versus_amlodipine/hydrochlorothiazide_on_ambulatory_blood_pressure_in_patients_with_stage_2_hypertension:_the_EVALUATE_study_ L2 - https://doi.org/10.1097/MBP.0b013e32832a9da7 DB - PRIME DP - Unbound Medicine ER -