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Long-term antihypertensive efficacy and safety of the oral direct renin inhibitor aliskiren: a 12-month randomized, double-blind comparator trial with hydrochlorothiazide.
Circulation. 2009 Jan 27; 119(3):417-25.Circ

Abstract

BACKGROUND

Diuretics are recommended as first-line agents for the treatment of hypertension. This randomized, double-blind, multicenter study assessed the long-term efficacy and safety of the direct renin inhibitor aliskiren in comparison with the diuretic hydrochlorothiazide in patients with essential hypertension.

METHODS AND RESULTS

After a 2- to 4-week placebo run-in, 1124 patients (mean sitting diastolic blood pressure [BP] 95 to 109 mm Hg) were randomized to aliskiren 150 mg (n=459), hydrochlorothiazide 12.5 mg (n=444), or placebo (n=221) once daily. Forced titration (to aliskiren 300 mg or hydrochlorothiazide 25 mg) occurred at week 3; at week 6, patients receiving placebo were reassigned (1:1 ratio) to aliskiren 300 mg or hydrochlorothiazide 25 mg. From week 12, amlodipine 5 mg was added and titrated to 10 mg from week 18 for patients whose BP remained uncontrolled. Efficacy variables were analyzed for the intent-to-treat population with the use of the last observation carried forward method. BP reductions (mean sitting systolic BP/mean sitting diastolic BP) were significantly greater with aliskiren- versus hydrochlorothiazide-based treatment at week 26 (-20.3/-14.2 versus -18.6/-13.0 mm Hg; P<0.05) and were also greater at week 52 (-22.1/-16.0 versus -21.2/-15.0 mm Hg; P<0.05 for mean sitting diastolic BP). At the end of the monotherapy period (week 12), aliskiren 300 mg was superior to hydrochlorothiazide 25 mg in reducing BP (-17.4/-12.2 versus -14.7/-10.3 mm H; P<0.001). Adverse event rates were similar with aliskiren- (65.2%) and hydrochlorothiazide-based therapy (61.5%). Hypokalemia was more frequent with hydrochlorothiazide-based therapy than aliskiren-based therapy (17.9% versus 0.9%; P<0.0001).

CONCLUSIONS

Aliskiren treatment, both as monotherapy and with optional addition of amlodipine, provided significantly greater BP reductions than the respective hydrochlorothiazide regimens. Aliskiren-based therapy was well tolerated. Direct renin inhibition with aliskiren therefore represents an effective option for the long-term treatment of essential hypertension.

Authors+Show Affiliations

Department of Nephrology and Hypertension, University of Erlangen-Nürnberg, Erlangen, Germany. Roland.Schmieder@rzmail.uni-erlangen.deNo affiliation info availableNo affiliation info availableNo 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

19139391

Citation

Schmieder, Roland E., et al. "Long-term Antihypertensive Efficacy and Safety of the Oral Direct Renin Inhibitor Aliskiren: a 12-month Randomized, Double-blind Comparator Trial With Hydrochlorothiazide." Circulation, vol. 119, no. 3, 2009, pp. 417-25.
Schmieder RE, Philipp T, Guerediaga J, et al. Long-term antihypertensive efficacy and safety of the oral direct renin inhibitor aliskiren: a 12-month randomized, double-blind comparator trial with hydrochlorothiazide. Circulation. 2009;119(3):417-25.
Schmieder, R. E., Philipp, T., Guerediaga, J., Gorostidi, M., Smith, B., Weissbach, N., Maboudian, M., Botha, J., & van Ingen, H. (2009). Long-term antihypertensive efficacy and safety of the oral direct renin inhibitor aliskiren: a 12-month randomized, double-blind comparator trial with hydrochlorothiazide. Circulation, 119(3), 417-25. https://doi.org/10.1161/CIRCULATIONAHA.107.750745
Schmieder RE, et al. Long-term Antihypertensive Efficacy and Safety of the Oral Direct Renin Inhibitor Aliskiren: a 12-month Randomized, Double-blind Comparator Trial With Hydrochlorothiazide. Circulation. 2009 Jan 27;119(3):417-25. PubMed PMID: 19139391.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term antihypertensive efficacy and safety of the oral direct renin inhibitor aliskiren: a 12-month randomized, double-blind comparator trial with hydrochlorothiazide. AU - Schmieder,Roland E, AU - Philipp,Thomas, AU - Guerediaga,Javier, AU - Gorostidi,Manuel, AU - Smith,Beverly, AU - Weissbach,Nicole, AU - Maboudian,Mojdeh, AU - Botha,Jaco, AU - van Ingen,Hein, Y1 - 2009/01/12/ PY - 2009/1/14/entrez PY - 2009/1/14/pubmed PY - 2009/2/21/medline SP - 417 EP - 25 JF - Circulation JO - Circulation VL - 119 IS - 3 N2 - BACKGROUND: Diuretics are recommended as first-line agents for the treatment of hypertension. This randomized, double-blind, multicenter study assessed the long-term efficacy and safety of the direct renin inhibitor aliskiren in comparison with the diuretic hydrochlorothiazide in patients with essential hypertension. METHODS AND RESULTS: After a 2- to 4-week placebo run-in, 1124 patients (mean sitting diastolic blood pressure [BP] 95 to 109 mm Hg) were randomized to aliskiren 150 mg (n=459), hydrochlorothiazide 12.5 mg (n=444), or placebo (n=221) once daily. Forced titration (to aliskiren 300 mg or hydrochlorothiazide 25 mg) occurred at week 3; at week 6, patients receiving placebo were reassigned (1:1 ratio) to aliskiren 300 mg or hydrochlorothiazide 25 mg. From week 12, amlodipine 5 mg was added and titrated to 10 mg from week 18 for patients whose BP remained uncontrolled. Efficacy variables were analyzed for the intent-to-treat population with the use of the last observation carried forward method. BP reductions (mean sitting systolic BP/mean sitting diastolic BP) were significantly greater with aliskiren- versus hydrochlorothiazide-based treatment at week 26 (-20.3/-14.2 versus -18.6/-13.0 mm Hg; P<0.05) and were also greater at week 52 (-22.1/-16.0 versus -21.2/-15.0 mm Hg; P<0.05 for mean sitting diastolic BP). At the end of the monotherapy period (week 12), aliskiren 300 mg was superior to hydrochlorothiazide 25 mg in reducing BP (-17.4/-12.2 versus -14.7/-10.3 mm H; P<0.001). Adverse event rates were similar with aliskiren- (65.2%) and hydrochlorothiazide-based therapy (61.5%). Hypokalemia was more frequent with hydrochlorothiazide-based therapy than aliskiren-based therapy (17.9% versus 0.9%; P<0.0001). CONCLUSIONS: Aliskiren treatment, both as monotherapy and with optional addition of amlodipine, provided significantly greater BP reductions than the respective hydrochlorothiazide regimens. Aliskiren-based therapy was well tolerated. Direct renin inhibition with aliskiren therefore represents an effective option for the long-term treatment of essential hypertension. SN - 1524-4539 UR - https://www.unboundmedicine.com/medline/citation/19139391/Long_term_antihypertensive_efficacy_and_safety_of_the_oral_direct_renin_inhibitor_aliskiren:_a_12_month_randomized_double_blind_comparator_trial_with_hydrochlorothiazide_ L2 - https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.107.750745?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -