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Clinic and ambulatory blood pressure lowering effect of aliskiren/amlodipine/hydrochlorothiazide combination in patients with moderate-to-severe hypertension: a randomized active-controlled trial.
J Hypertens. 2012 Oct; 30(10):2047-55.JH

Abstract

OBJECTIVES

To evaluate the clinic and ambulatory blood pressure (BP)-lowering efficacy and safety of an aliskiren/amlodipine/hydrochlorothiazide (HCT) triple combination compared with the component dual combinations, in patients with moderate-to-severe hypertension.

METHODS

This 8-week, double-blind, randomized, active-controlled study, after 1-4 weeks single-blind placebo run-in period, randomized 1191 patients to receive once-daily aliskiren/amlodipine 150/5 mg (n = 287), aliskiren/HCT 150/12.5 mg (n = 298), amlodipine/HCT 5/12.5 mg (n = 296), or aliskiren/amlodipine/HCT 150/5/12.5 mg (up-titrated from aliskiren/HCT 150/12.5 mg after initial 3 days) (n = 310) for 4 weeks, followed by forced titration to double the initial dose for the next 4 weeks.

RESULTS

Baseline mean sitting SBP and DBP (msSBP/msDBP) was comparable among treatment groups. The aliskiren/amlodipine/HCT combination resulted in significant least squares mean reduction in msSBP/msDBP from baseline to endpoints (week 4, -30.7/-15.9 mmHg; week 8, -37.9/-20.6 mmHg), superior (P < 0.001) to each of the dual combinations. The triple combination was associated with -27.8 mmHg reduction in msSBP at week 2, significantly better than the dual combinations (P < 0.05). Significantly greater mean SBP/DBP-lowering effect for triple vs. dual combinations was also demonstrated through 24-h, daytime, and night-time ambulatory BP measurements. Significantly greater (P < 0.001) BP control (msSBP/msDBP < 140/90 mmHg) was achieved with triple combination in patients with moderate-to-severe (62.3%) and severe (57.5%) hypertension.

CONCLUSION

Aliskiren/amlodipine/HCT at 150/5/12.5 mg (week 4) and 300/10/25 mg (week 8) provided statistically superior reductions in msSBP/msDBP and greater BP control rates vs. the dual combinations, and was well tolerated. The improved efficacy of BP reduction was evident within 2 weeks of initiating triple therapy even at low dose.

Authors+Show Affiliations

Unité de Recherche Sur L'hypertension, Centre Hospitalier Universitaire de Québec (CHUL), Quebec, Quebec, Canada. ylacourcierehta@hotmail.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

22828090

Citation

Lacourcière, Yves, et al. "Clinic and Ambulatory Blood Pressure Lowering Effect of Aliskiren/amlodipine/hydrochlorothiazide Combination in Patients With Moderate-to-severe Hypertension: a Randomized Active-controlled Trial." Journal of Hypertension, vol. 30, no. 10, 2012, pp. 2047-55.
Lacourcière Y, Taddei S, Konis G, et al. Clinic and ambulatory blood pressure lowering effect of aliskiren/amlodipine/hydrochlorothiazide combination in patients with moderate-to-severe hypertension: a randomized active-controlled trial. J Hypertens. 2012;30(10):2047-55.
Lacourcière, Y., Taddei, S., Konis, G., Fang, H., Severin, T., & Zhang, J. (2012). Clinic and ambulatory blood pressure lowering effect of aliskiren/amlodipine/hydrochlorothiazide combination in patients with moderate-to-severe hypertension: a randomized active-controlled trial. Journal of Hypertension, 30(10), 2047-55. https://doi.org/10.1097/HJH.0b013e328356b8ea
Lacourcière Y, et al. Clinic and Ambulatory Blood Pressure Lowering Effect of Aliskiren/amlodipine/hydrochlorothiazide Combination in Patients With Moderate-to-severe Hypertension: a Randomized Active-controlled Trial. J Hypertens. 2012;30(10):2047-55. PubMed PMID: 22828090.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinic and ambulatory blood pressure lowering effect of aliskiren/amlodipine/hydrochlorothiazide combination in patients with moderate-to-severe hypertension: a randomized active-controlled trial. AU - Lacourcière,Yves, AU - Taddei,Stefano, AU - Konis,George, AU - Fang,Hui, AU - Severin,Thomas, AU - Zhang,Jack, PY - 2012/7/26/entrez PY - 2012/7/26/pubmed PY - 2013/1/26/medline SP - 2047 EP - 55 JF - Journal of hypertension JO - J Hypertens VL - 30 IS - 10 N2 - OBJECTIVES: To evaluate the clinic and ambulatory blood pressure (BP)-lowering efficacy and safety of an aliskiren/amlodipine/hydrochlorothiazide (HCT) triple combination compared with the component dual combinations, in patients with moderate-to-severe hypertension. METHODS: This 8-week, double-blind, randomized, active-controlled study, after 1-4 weeks single-blind placebo run-in period, randomized 1191 patients to receive once-daily aliskiren/amlodipine 150/5 mg (n = 287), aliskiren/HCT 150/12.5 mg (n = 298), amlodipine/HCT 5/12.5 mg (n = 296), or aliskiren/amlodipine/HCT 150/5/12.5 mg (up-titrated from aliskiren/HCT 150/12.5 mg after initial 3 days) (n = 310) for 4 weeks, followed by forced titration to double the initial dose for the next 4 weeks. RESULTS: Baseline mean sitting SBP and DBP (msSBP/msDBP) was comparable among treatment groups. The aliskiren/amlodipine/HCT combination resulted in significant least squares mean reduction in msSBP/msDBP from baseline to endpoints (week 4, -30.7/-15.9 mmHg; week 8, -37.9/-20.6 mmHg), superior (P < 0.001) to each of the dual combinations. The triple combination was associated with -27.8 mmHg reduction in msSBP at week 2, significantly better than the dual combinations (P < 0.05). Significantly greater mean SBP/DBP-lowering effect for triple vs. dual combinations was also demonstrated through 24-h, daytime, and night-time ambulatory BP measurements. Significantly greater (P < 0.001) BP control (msSBP/msDBP < 140/90 mmHg) was achieved with triple combination in patients with moderate-to-severe (62.3%) and severe (57.5%) hypertension. CONCLUSION: Aliskiren/amlodipine/HCT at 150/5/12.5 mg (week 4) and 300/10/25 mg (week 8) provided statistically superior reductions in msSBP/msDBP and greater BP control rates vs. the dual combinations, and was well tolerated. The improved efficacy of BP reduction was evident within 2 weeks of initiating triple therapy even at low dose. SN - 1473-5598 UR - https://www.unboundmedicine.com/medline/citation/22828090/Clinic_and_ambulatory_blood_pressure_lowering_effect_of_aliskiren/amlodipine/hydrochlorothiazide_combination_in_patients_with_moderate_to_severe_hypertension:_a_randomized_active_controlled_trial_ L2 - https://doi.org/10.1097/HJH.0b013e328356b8ea DB - PRIME DP - Unbound Medicine ER -