Abstract 4423: The AGELESS Study: The Effect of Aliskiren vs Ramipril Alone or in Combination with Hydrochlorothiazide and Amlodipine in Patients ≥ 65 Years of Age with Systolic Hypertension
Background: Indirect renin-angiotensin blockade by ACE-inhibition has shown to be effective in lowering blood pressure (BP) in the elderly hypertensive patient. In contrast, the benefits of direct renin inhibition (DRI) on BP has not been extensively studied in an older hypertensive population.
Aim of the study: The primary aim was to demonstrate non-inferiority between the DRI, aliskiren and ACE-I, ramipril on the change from baseline in systolic BP (SBP) after 12 weeks (w) of treatment with monotherapy among patients ≥ 65 years of age. If non-inferiority was demonstrated, then an analysis for superiority of aliskiren compared with ramipril would be conducted. The secondary aim was to compare aliskiren-based therapy to ramipril-based therapy after 36 w on SBP.
Methods: In this double-blind parallel multi-center study, hypertensive patients with an age ≥ 65 years with a SBP ≥ 160 mmHg either untreated or after a wash-out period were randomized either to aliskiren 150 mg/day or ramipril 5 mg/day for 4 w. If SBP was not at goal at 4 w (< 140 mmHg), study medication doses were doubled to aliskerin 300 mg/day or ramipril 10 mg/day and SBP was evaluated at 12 w. If SBP was not at goal (<140 mmHg), HCTZ (12.5 → 25mg/day) followed by amlodipine (5→10mg/day) regimen were added and SBP was evaluated at 36 w. In the aliskiren group, 457 patients with a mean age of 72.0 years, (51 % females) and in the ramipril group 444 patients with a mean age of 72.2 years, (53 % females) were enrolled. Patients ≥ 75 years of age made up 32.5% of the total population.
Results: Table 1⇓ summarizes the results.
Conclusion: In an elderly population with systolic hypertension, DRI monotherapy with aliskiren provided a greater reduction in SBP than ramipril after 12 w of treatment and was well tolerated. After 36 w an aliskiren-based regimen provided similar SBP lowering efficacy, compared with a ramipril-based regimen. The incidence of adverse and serious events was similar between the two groups.