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Efficacy and tolerability of combination therapy with valsartan/hydrochlorothiazide in the initial treatment of severe hypertension.
Curr Med Res Opin. 2008 Aug; 24(8):2303-11.CM

Abstract

OBJECTIVE

Most patients with severe hypertension are at high risk for cardiovascular events and require prompt blood pressure (BP)-lowering and combination therapy to achieve BP goals. This study evaluated the therapeutic efficacy and tolerability of initial treatment with the combination of valsartan and hydrochlorothiazide (HCTZ) compared with valsartan monotherapy in patients with severe hypertension.

RESEARCH DESIGN AND METHODS

This was a 6-week, randomized, double-blind, multicenter, forced titration study that compared initial therapy with the combination of valsartan/HCTZ 160/12.5 mg (force titrated to 160/25 mg after 2 weeks and to 320/25 mg after 4 weeks) to monotherapy with valsartan 160 mg (force titrated to 320 mg after 2 weeks and sham-titrated to 320 mg after 4 weeks). Eligible patients were 18-80 years old with severe essential hypertension (mean sitting diastolic BP > or = 110 mmHg and < 120 mmHg and mean sitting systolic BP > or = 140 mmHg and < 200 mmHg). The Clinical Trial Registry number was NCT00273299.

MAIN OUTCOME MEASURES

The primary efficacy variable was the rate of BP control (mean sitting BP < 140/90 mmHg) at Week 4. Tolerability was evaluated by monitoring all adverse events, vital signs, and laboratory tests including hematology and biochemistry.

RESULTS

A total of 608 patients were randomized to either valsartan/HCTZ (n = 307) or valsartan monotherapy (n = 301). Significantly more patients achieved overall BP control (< 140/90 mmHg) with valsartan/HCTZ compared to monotherapy at Week 4 (primary efficacy variable and timepoint) (39.6% vs. 21.8%; p < 0.0001) and Week 6 (48.2% vs. 27.2%; p < 0.0001). Mean reductions in BP at Week 4 were significantly greater for valsartan/HCTZ (30.8/22.7 mmHg vs. 21.7/17.5 mmHg; p < 0.0001), with further reductions at Week 6. BP control rates were greater with combination therapy as early as Week 2. The overall incidence of adverse events was comparable between the combination therapy (34.9%) and monotherapy (36.7%) treatment groups. A potential limitation of the forced-titration design is that some patients were titrated to higher doses despite having achieved goal BP. This may impact the interpretation of the incidence of dose-dependent adverse events.

CONCLUSIONS

Initial therapy with valsartan/HCTZ is effective and well tolerated in patients with severe hypertension.

Authors+Show Affiliations

University of Alabama at Birmingham, Birmingham, AL 35294, USA. David.Calhoun@ccc.uab.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

18593517

Citation

Calhoun, David A., et al. "Efficacy and Tolerability of Combination Therapy With Valsartan/hydrochlorothiazide in the Initial Treatment of Severe Hypertension." Current Medical Research and Opinion, vol. 24, no. 8, 2008, pp. 2303-11.
Calhoun DA, Glazer RD, Pettyjohn FS, et al. Efficacy and tolerability of combination therapy with valsartan/hydrochlorothiazide in the initial treatment of severe hypertension. Curr Med Res Opin. 2008;24(8):2303-11.
Calhoun, D. A., Glazer, R. D., Pettyjohn, F. S., Coenen, P. D., Zhao, Y., & Grosso, A. (2008). Efficacy and tolerability of combination therapy with valsartan/hydrochlorothiazide in the initial treatment of severe hypertension. Current Medical Research and Opinion, 24(8), 2303-11. https://doi.org/10.1185/03007990802271946
Calhoun DA, et al. Efficacy and Tolerability of Combination Therapy With Valsartan/hydrochlorothiazide in the Initial Treatment of Severe Hypertension. Curr Med Res Opin. 2008;24(8):2303-11. PubMed PMID: 18593517.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of combination therapy with valsartan/hydrochlorothiazide in the initial treatment of severe hypertension. AU - Calhoun,David A, AU - Glazer,Robert D, AU - Pettyjohn,Frank S, AU - Coenen,P D M, AU - Zhao,Yanxing, AU - Grosso,Amie, Y1 - 2008/06/28/ PY - 2008/7/3/pubmed PY - 2008/12/30/medline PY - 2008/7/3/entrez SP - 2303 EP - 11 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 24 IS - 8 N2 - OBJECTIVE: Most patients with severe hypertension are at high risk for cardiovascular events and require prompt blood pressure (BP)-lowering and combination therapy to achieve BP goals. This study evaluated the therapeutic efficacy and tolerability of initial treatment with the combination of valsartan and hydrochlorothiazide (HCTZ) compared with valsartan monotherapy in patients with severe hypertension. RESEARCH DESIGN AND METHODS: This was a 6-week, randomized, double-blind, multicenter, forced titration study that compared initial therapy with the combination of valsartan/HCTZ 160/12.5 mg (force titrated to 160/25 mg after 2 weeks and to 320/25 mg after 4 weeks) to monotherapy with valsartan 160 mg (force titrated to 320 mg after 2 weeks and sham-titrated to 320 mg after 4 weeks). Eligible patients were 18-80 years old with severe essential hypertension (mean sitting diastolic BP > or = 110 mmHg and < 120 mmHg and mean sitting systolic BP > or = 140 mmHg and < 200 mmHg). The Clinical Trial Registry number was NCT00273299. MAIN OUTCOME MEASURES: The primary efficacy variable was the rate of BP control (mean sitting BP < 140/90 mmHg) at Week 4. Tolerability was evaluated by monitoring all adverse events, vital signs, and laboratory tests including hematology and biochemistry. RESULTS: A total of 608 patients were randomized to either valsartan/HCTZ (n = 307) or valsartan monotherapy (n = 301). Significantly more patients achieved overall BP control (< 140/90 mmHg) with valsartan/HCTZ compared to monotherapy at Week 4 (primary efficacy variable and timepoint) (39.6% vs. 21.8%; p < 0.0001) and Week 6 (48.2% vs. 27.2%; p < 0.0001). Mean reductions in BP at Week 4 were significantly greater for valsartan/HCTZ (30.8/22.7 mmHg vs. 21.7/17.5 mmHg; p < 0.0001), with further reductions at Week 6. BP control rates were greater with combination therapy as early as Week 2. The overall incidence of adverse events was comparable between the combination therapy (34.9%) and monotherapy (36.7%) treatment groups. A potential limitation of the forced-titration design is that some patients were titrated to higher doses despite having achieved goal BP. This may impact the interpretation of the incidence of dose-dependent adverse events. CONCLUSIONS: Initial therapy with valsartan/HCTZ is effective and well tolerated in patients with severe hypertension. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/18593517/Efficacy_and_tolerability_of_combination_therapy_with_valsartan/hydrochlorothiazide_in_the_initial_treatment_of_severe_hypertension_ L2 - http://www.tandfonline.com/doi/full/10.1185/03007990802271946 DB - PRIME DP - Unbound Medicine ER -