Efficacy and safety of the direct renin inhibitor aliskiren and ramipril alone or in combination in patients with diabetes and hypertension

Üresin, Yağız; Taylor, Addison A.; Kilo, Charles; Tschöpe, D; Santonastaso, Massimo; Ibram, Ghionul; Fang, Hui; Satlin, Andrew

doi:10.3317/jraas.2007.028

Cited by 197 publications

(194 citation statements)

References 28 publications

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“…Ramipril 10 mg was associated with small increases in trough PRA and no Sustained BP reduction beyond 24 h with aliskiren P Palatini et al significant changes in PRC at days 42 and 63. The lack of effect of ramipril on PRC at 24 h after dose is inconsistent with findings from previous studies with ramipril 10 mg, 9,16 and may be a chance finding related to the relatively small number of patients who underwent biomarker assessments in the ramipril group. Previous studies have shown that the BP-lowering effects of aliskiren last beyond the 24-h dosing interval in patients with hypertension.…”

Section: Discussioncontrasting

confidence: 94%

Maintenance of blood-pressure-lowering effect following a missed dose of aliskiren, irbesartan or ramipril: results of a randomized, double-blind study

et al. 2009

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Most patients inadvertently miss an occasional dose of antihypertensive therapy, and hence drugs that provide sustained blood-pressure (BP) reduction beyond the 24-h dosing interval are desirable. The primary objective of this study was to compare the 24-h mean ambulatory BP reductions from baseline after a simulated missed dose of the direct renin inhibitor aliskiren, irbesartan or ramipril. In this double-blind study, 654 hypertensive patients (24-h mean ambulatory diastolic BP (MADBP) X85 mm Hg) were randomized 1:1:1 to once-daily aliskiren 150 mg, irbesartan 150 mg or ramipril 5 mg. Doses were doubled after 2 weeks. At day 42, patients were again randomized equally within each group to receive 1 day of placebo ('missed dose') on either day 42 or day 49. Patients with a successful 24-h ambulatory BP measurement at baseline and on day 42/49 were included in the analyses. The 24-h mean ambulatory systolic BP (MASBP)/MADBP reductions from baseline after a missed dose of aliskiren 300 mg (9.3/7.0 mm Hg) were similar to irbesartan 300 mg (9.5/7.3 mm Hg) and significantly larger than ramipril 10 mg (7.1/5.0 mm Hg, Pp0.008). Loss of BP-lowering effect with aliskiren in the 24 h after a missed dose (1.0/0.7 mm Hg for 24-48-h vs 0-24-h MASBP/MADBP) was significantly lower than with irbesartan (3.6/2.2 mm Hg, Po0.01) or ramipril (4.0/2.6, Po0.0001). This equates to maintenance of 91/91% of the MASBP/MADBP-lowering effect with aliskiren, greater than irbesartan (73/77%) or ramipril (64/65%). The incidence of adverse events was similar across treatments (32.9-36.0%), although ramipril treatment was associated with an increased incidence of cough (ramipril, 6.1%; aliskiren, 0.5%; irbesartan, 1.8%). Aliskiren 300 mg provided a sustained BP-lowering effect beyond the 24-h dosing interval, with a significantly smaller loss of BP-lowering effect in the 24-48 h period after dose than irbesartan 300 mg or ramipril 10 mg.

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Section: Discussioncontrasting

confidence: 94%

Maintenance of blood-pressure-lowering effect following a missed dose of aliskiren, irbesartan or ramipril: results of a randomized, double-blind study

et al. 2009

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“…One study assessed the effects of aliskiren compared with ramipril or the agents combined for 8 weeks in patients with diabetes and hypertension. 28 Aliskiren monotherapy provided a superior reduction in msSBP compared with ramipril monotherapy. Combination therapy with aliskiren and ramipril provided superior msSBP reductions compared with either component monotherapy.…”

Section: Discussionmentioning

confidence: 98%

Aliskiren for Geriatric Lowering of Systolic Hypertension: a randomized controlled trial

et al. 2009

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Efficacy and safety of the direct renin inhibitor aliskiren was compared with ramipril for treatment of essential systolic hypertension in elderly patients. A 36-week, randomized, double-blind, parallel-group, active-controlled, optional-titration study was performed in 901 patients (aliskiren, n ¼ 457; ramipril, n ¼ 444) X65 years of age with systolic blood pressure (SBP) X140 mm Hg. Aliskiren 150-300 mg per day or ramipril 5-10 mg per day for was administered for 12 weeks with optional add-on therapy of hydrochlorothiazide (12.5-25 mg per day) at week 12 and amlodipine (5-10 mg per day) at week 22. The primary end point was non-inferiority of aliskiren vs ramipril monotherapy for change from baseline in mean sitting SBP (msSBP) at week 12. Decreases from baseline msSBP and mean sitting diastolic BP with aliskiren monotherapy (À14.0 and À5.1 mm Hg, respectively) were non-inferior (Po0.001 for both values) and superior to ramipril monotherapy (À11.6, À3.6 mm Hg; P ¼ 0.02, Po0.01, respectively). More patients achieved BP control with aliskiren (42%) than ramipril (33%; Po0.01). At week 36, fewer patients receiving aliskiren-based therapy required add-on treatment with hydrochlorothiazide or amlodipine (P ¼ 0.01 and 0.048, respectively). Tolerability was similar, but more patients receiving ramipril reported cough (Po0.001). In elderly patients with systolic hypertension, aliskiren proved to be more effective and better overall anti-hypertensive therapy compared to ramipril.

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“…14,15,[17][18][19][20][21][22] Data were analysed for aliskiren 150 mg and 300 mg (the US Food and Drug Administration and European Union approved doses for the treatment of hypertension) and placebo after 8 or 12 weeks of treatment for the subgroups of women and men. All of the trials were 8 weeks in duration, except for the aliskiren vs ramipril (6 months) and aliskiren vs HCT (12 months) studies.…”

Section: Methodsmentioning

confidence: 99%

“…For inclusion in the aliskiren/ramipril study, 21 patients also had to have type I or type II diabetes mellitus. In all of the studies, patients with severe hypertension (msDBPX110 mm Hg and/or mean sitting systolic BP (msSBP) X180 mmHg), a history or evidence of secondary hypertension, or a history of severe cerebrovascular or CVD were excluded.…”

Section: Patientsmentioning

confidence: 99%

Efficacy, safety and tolerability of aliskiren, a direct renin inhibitor, in women with hypertension: a pooled analysis of eight studies

et al. 2010

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Hypertension is a major risk factor for cardiovascular disease, which is the leading cause of mortality in women in developed countries. This pooled analysis assessed the antihypertensive efficacy, safety and tolerability of monotherapy with the direct renin inhibitor aliskiren (150 mg and 300 mg) over 8-12 weeks in women with mild-to-moderate hypertension (mean sitting diastolic blood pressure (msDBP)X95 and o110 mm Hg) across eight randomized and double-blind trials. Safety and tolerability were assessed in the five placebo-controlled trials in the analysis. In the 1527 women enrolled in these studies, aliskiren 150 mg and 300 mg produced significantly greater blood pressure (BP) reductions (14.1/11.0 and 16.1/12.3 mm Hg, respectively) compared with placebo (7.2/7.6 mm Hg; Po0.0001). BP reductions with aliskiren monotherapy in women were similar to those observed in men, and consistent across subgroups of age, metabolic syndrome and obesity. The overall incidence of adverse events in women was similar with aliskiren treatment (150 mg, 42.3%; 300 mg, 46.0%) and placebo (39.0%); adverse events with aliskiren were more frequent in women than in men, consistent with previous studies of gender differences in drug tolerability. In conclusion, aliskiren monotherapy at 150 mg and 300 mg doses provided effective, dose-dependent BP-lowering in women with mild-to-moderate hypertension, and it was well tolerated.

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Efficacy and safety of the direct renin inhibitor aliskiren and ramipril alone or in combination in patients with diabetes and hypertension

Cited by 197 publications

References 28 publications

Maintenance of blood-pressure-lowering effect following a missed dose of aliskiren, irbesartan or ramipril: results of a randomized, double-blind study

Maintenance of blood-pressure-lowering effect following a missed dose of aliskiren, irbesartan or ramipril: results of a randomized, double-blind study

Aliskiren for Geriatric Lowering of Systolic Hypertension: a randomized controlled trial

Efficacy, safety and tolerability of aliskiren, a direct renin inhibitor, in women with hypertension: a pooled analysis of eight studies

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