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Aliskiren, an orally effective renin inhibitor, provides antihypertensive efficacy alone and in combination with valsartan.
Am J Hypertens. 2007 Jan; 20(1):11-20.AJ

Abstract

BACKGROUND

By blocking the renin-angiotensin-aldosterone system (RAAS) at its rate-limiting step, renin inhibition may provide improved RAAS suppression. We investigated the blood pressure (BP)-lowering effects of the oral direct renin inhibitor aliskiren, alone or in combination with the angiotensin receptor blocker valsartan.

METHODS

In this multicenter, randomized, placebo-controlled, 8-week trial, 1123 patients with mild-to-moderate hypertension underwent a 3 to 4 week single-blind placebo run-in and were then randomized in a modified factorial study design to receive once-daily, double-blind oral treatment with placebo, aliskiren monotherapy (75, 150, or 300 mg), valsartan monotherapy (80, 160, or 320 mg), aliskiren and valsartan in combination, or valsartan/hydrochlorothiazide (160/12.5 mg). The primary efficacy variable was the change from baseline in mean sitting diastolic BP (DBP) at endpoint.

RESULTS

Once-daily oral treatment with aliskiren 300 mg significantly (P < .0001) lowered mean sitting DBP and systolic BP (SBP) compared with placebo; aliskiren monotherapy demonstrated a safety and tolerability profile comparable to placebo. Changes in DBP and SBP were fitted to a first-order dose-response surface (lack-of-fit test, P = .65), which showed that aliskiren and valsartan alone and in combination produced dose-related reductions in DBP and SBP. Coadministration of aliskiren and valsartan produced a greater antihypertensive effect than either drug alone, comparable in magnitude to the effect of valsartan/hydrochlorothiazide, with similar tolerability to the component monotherapies and to placebo.

CONCLUSIONS

Aliskiren monotherapy provides antihypertensive efficacy and placebo-like tolerability in patients with hypertension. Aliskiren and valsartan in combination may provide additive BP-lowering effects with maintained tolerability.

Authors+Show Affiliations

Center for Experimental Therapeutics, Department of Medicine, Baylor College of Medicine, Houston, TX 77030, USA. jpool@bcm.tmc.eduNo affiliation info availableNo affiliation info availableNo 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

17198906

Citation

Pool, James L., et al. "Aliskiren, an Orally Effective Renin Inhibitor, Provides Antihypertensive Efficacy Alone and in Combination With Valsartan." American Journal of Hypertension, vol. 20, no. 1, 2007, pp. 11-20.
Pool JL, Schmieder RE, Azizi M, et al. Aliskiren, an orally effective renin inhibitor, provides antihypertensive efficacy alone and in combination with valsartan. Am J Hypertens. 2007;20(1):11-20.
Pool, J. L., Schmieder, R. E., Azizi, M., Aldigier, J. C., Januszewicz, A., Zidek, W., Chiang, Y., & Satlin, A. (2007). Aliskiren, an orally effective renin inhibitor, provides antihypertensive efficacy alone and in combination with valsartan. American Journal of Hypertension, 20(1), 11-20.
Pool JL, et al. Aliskiren, an Orally Effective Renin Inhibitor, Provides Antihypertensive Efficacy Alone and in Combination With Valsartan. Am J Hypertens. 2007;20(1):11-20. PubMed PMID: 17198906.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Aliskiren, an orally effective renin inhibitor, provides antihypertensive efficacy alone and in combination with valsartan. AU - Pool,James L, AU - Schmieder,Roland E, AU - Azizi,Michel, AU - Aldigier,Jean-Claude, AU - Januszewicz,Andrzej, AU - Zidek,Walter, AU - Chiang,Yanntong, AU - Satlin,Andrew, PY - 2006/02/28/received PY - 2006/05/27/revised PY - 2006/06/01/accepted PY - 2007/1/3/pubmed PY - 2007/3/16/medline PY - 2007/1/3/entrez SP - 11 EP - 20 JF - American journal of hypertension JO - Am J Hypertens VL - 20 IS - 1 N2 - BACKGROUND: By blocking the renin-angiotensin-aldosterone system (RAAS) at its rate-limiting step, renin inhibition may provide improved RAAS suppression. We investigated the blood pressure (BP)-lowering effects of the oral direct renin inhibitor aliskiren, alone or in combination with the angiotensin receptor blocker valsartan. METHODS: In this multicenter, randomized, placebo-controlled, 8-week trial, 1123 patients with mild-to-moderate hypertension underwent a 3 to 4 week single-blind placebo run-in and were then randomized in a modified factorial study design to receive once-daily, double-blind oral treatment with placebo, aliskiren monotherapy (75, 150, or 300 mg), valsartan monotherapy (80, 160, or 320 mg), aliskiren and valsartan in combination, or valsartan/hydrochlorothiazide (160/12.5 mg). The primary efficacy variable was the change from baseline in mean sitting diastolic BP (DBP) at endpoint. RESULTS: Once-daily oral treatment with aliskiren 300 mg significantly (P < .0001) lowered mean sitting DBP and systolic BP (SBP) compared with placebo; aliskiren monotherapy demonstrated a safety and tolerability profile comparable to placebo. Changes in DBP and SBP were fitted to a first-order dose-response surface (lack-of-fit test, P = .65), which showed that aliskiren and valsartan alone and in combination produced dose-related reductions in DBP and SBP. Coadministration of aliskiren and valsartan produced a greater antihypertensive effect than either drug alone, comparable in magnitude to the effect of valsartan/hydrochlorothiazide, with similar tolerability to the component monotherapies and to placebo. CONCLUSIONS: Aliskiren monotherapy provides antihypertensive efficacy and placebo-like tolerability in patients with hypertension. Aliskiren and valsartan in combination may provide additive BP-lowering effects with maintained tolerability. SN - 0895-7061 UR - https://www.unboundmedicine.com/medline/citation/17198906/Aliskiren_an_orally_effective_renin_inhibitor_provides_antihypertensive_efficacy_alone_and_in_combination_with_valsartan_ L2 - https://academic.oup.com/ajh/article-lookup/doi/10.1016/j.amjhyper.2006.06.003 DB - PRIME DP - Unbound Medicine ER -