IX. DRUG TREATMENT
9. New Agent
a. Aliskiren [renin inhibitor]
Gradman, et al. clinical trial; The antihypertensive effect of aliskiren, the first in a new class of orally effective, nonpeptide, low-molecular-weight renin inhibitors for the treatment of hypertension was compared with the ARB irbesartan.
Methods: The study was a randomized, multicenter, double-blind, placebo-controlled, active-comparator 8-week trial in patients with mean sitting diastolic blood pressure [DBP] > 95 and <110 mm Hg). After a 2-week, single-blind placebo run-in, 652 patients were randomized to receive double-blind treatment with once-daily oral doses of aliskiren (150, 300, or 600 mg), irbesartan 150 mg, or placebo.
Results: Aliskiren 150, 300, and 600 mg lowered both trough mean sitting DBP and systolic blood pressure (SBP) (P < 0.001 versus placebo for both variables). The effect of aliskiren 150 mg was comparable to that of irbesartan 150 mg (8.9 ±0.7 and 12.5 ± 1.2 mm Hg).
Aliskiren 300 and 600 mg lowered mean sitting DBP significantly more than irbesartan 150 mg (P<0.05). Aliskiren showed safety and tolerability comparable to those of placebo and irbesartan, with a similar incidence of adverse events.
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