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Comparative efficacy and safety of aliskiren, an oral direct renin inhibitor, and ramipril in hypertension: a 6-month, randomized, double-blind trial.
J Hypertens. 2008 Mar; 26(3):589-99.JH

Abstract

OBJECTIVES

This double-blind study compared long-term efficacy, safety and tolerability of the oral direct renin inhibitor aliskiren and the angiotensin-converting enzyme inhibitor ramipril alone and combined with hydrochlorothiazide in patients with hypertension.

METHODS

After a 2-4-week placebo run-in, 842 patients [mean sitting diastolic blood pressure (msDBP) 95-109 mmHg] were randomized to aliskiren 150 mg (n = 420) or ramipril 5 mg (n = 422). Dose titration (to aliskiren 300 mg/ramipril 10 mg) and subsequent hydrochlorothiazide addition (12.5 mg, titrated to 25 mg if required) were permitted at weeks 6, 12, 18 and 21 for inadequate blood pressure control. Patients completing the 26-week active-controlled treatment period were re-randomized to their existing regimen or placebo for a 4-week double-blind withdrawal phase.

RESULTS

Six hundred and eighty-seven patients (81.6%) completed the active treatment period. At week 26, aliskiren-based therapy produced greater mean reductions in mean sitting systolic blood pressure (17.9 versus 15.2 mmHg, P = 0.0036) and msDBP (13.2 versus 12.0 mmHg, P = 0.025), and higher rates of systolic blood pressure control (< 140 mmHg; 72.5 versus 64.1%, P = 0.0075) compared with ramipril-based therapy. During withdrawal, blood pressure increased more rapidly after stopping ramipril than aliskiren-based therapy; median blood pressure reached 140/90 mmHg after 1 and 4 weeks, respectively. Blood pressure reductions were maintained with continued active treatment. Aliskiren therapy was well tolerated. Overall adverse event rates were similar with aliskiren (61.3%) and ramipril (60.4%); cough was more frequent with ramipril (9.5%) than aliskiren (4.1%).

CONCLUSIONS

Aliskiren-based therapy was well tolerated and produced sustained blood pressure reductions in patients with hypertension over 6 months, greater than those with ramipril-based therapy.

Authors+Show Affiliations

Department of Medicine, Division of Cardiology, Landspitali University Hospital, Reykjavik, Iceland. cardiac@simnet.isNo 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
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18300872

Citation

Andersen, Karl, et al. "Comparative Efficacy and Safety of Aliskiren, an Oral Direct Renin Inhibitor, and Ramipril in Hypertension: a 6-month, Randomized, Double-blind Trial." Journal of Hypertension, vol. 26, no. 3, 2008, pp. 589-99.
Andersen K, Weinberger MH, Egan B, et al. Comparative efficacy and safety of aliskiren, an oral direct renin inhibitor, and ramipril in hypertension: a 6-month, randomized, double-blind trial. J Hypertens. 2008;26(3):589-99.
Andersen, K., Weinberger, M. H., Egan, B., Constance, C. M., Ali, M. A., Jin, J., & Keefe, D. L. (2008). Comparative efficacy and safety of aliskiren, an oral direct renin inhibitor, and ramipril in hypertension: a 6-month, randomized, double-blind trial. Journal of Hypertension, 26(3), 589-99. https://doi.org/10.1097/HJH.0b013e3282f3ad9a
Andersen K, et al. Comparative Efficacy and Safety of Aliskiren, an Oral Direct Renin Inhibitor, and Ramipril in Hypertension: a 6-month, Randomized, Double-blind Trial. J Hypertens. 2008;26(3):589-99. PubMed PMID: 18300872.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative efficacy and safety of aliskiren, an oral direct renin inhibitor, and ramipril in hypertension: a 6-month, randomized, double-blind trial. AU - Andersen,Karl, AU - Weinberger,Myron H, AU - Egan,Brent, AU - Constance,Christian M, AU - Ali,Mohammed A, AU - Jin,James, AU - Keefe,Deborah L, PY - 2008/2/28/pubmed PY - 2008/4/25/medline PY - 2008/2/28/entrez SP - 589 EP - 99 JF - Journal of hypertension JO - J Hypertens VL - 26 IS - 3 N2 - OBJECTIVES: This double-blind study compared long-term efficacy, safety and tolerability of the oral direct renin inhibitor aliskiren and the angiotensin-converting enzyme inhibitor ramipril alone and combined with hydrochlorothiazide in patients with hypertension. METHODS: After a 2-4-week placebo run-in, 842 patients [mean sitting diastolic blood pressure (msDBP) 95-109 mmHg] were randomized to aliskiren 150 mg (n = 420) or ramipril 5 mg (n = 422). Dose titration (to aliskiren 300 mg/ramipril 10 mg) and subsequent hydrochlorothiazide addition (12.5 mg, titrated to 25 mg if required) were permitted at weeks 6, 12, 18 and 21 for inadequate blood pressure control. Patients completing the 26-week active-controlled treatment period were re-randomized to their existing regimen or placebo for a 4-week double-blind withdrawal phase. RESULTS: Six hundred and eighty-seven patients (81.6%) completed the active treatment period. At week 26, aliskiren-based therapy produced greater mean reductions in mean sitting systolic blood pressure (17.9 versus 15.2 mmHg, P = 0.0036) and msDBP (13.2 versus 12.0 mmHg, P = 0.025), and higher rates of systolic blood pressure control (< 140 mmHg; 72.5 versus 64.1%, P = 0.0075) compared with ramipril-based therapy. During withdrawal, blood pressure increased more rapidly after stopping ramipril than aliskiren-based therapy; median blood pressure reached 140/90 mmHg after 1 and 4 weeks, respectively. Blood pressure reductions were maintained with continued active treatment. Aliskiren therapy was well tolerated. Overall adverse event rates were similar with aliskiren (61.3%) and ramipril (60.4%); cough was more frequent with ramipril (9.5%) than aliskiren (4.1%). CONCLUSIONS: Aliskiren-based therapy was well tolerated and produced sustained blood pressure reductions in patients with hypertension over 6 months, greater than those with ramipril-based therapy. SN - 0263-6352 UR - https://www.unboundmedicine.com/medline/citation/18300872/Comparative_efficacy_and_safety_of_aliskiren_an_oral_direct_renin_inhibitor_and_ramipril_in_hypertension:_a_6_month_randomized_double_blind_trial_ L2 - https://doi.org/10.1097/HJH.0b013e3282f3ad9a DB - PRIME DP - Unbound Medicine ER -