In a combined analysis of in more than 7,000 patients enrolled in seven randomized, controlled trials of aliskiren, perhaps the most notable finding was the new drug's safety, Dr. Matthew R. Weir said at the meeting.
During 6–8 weeks of daily treatment, patients had adverse effect profiles similar to those of the placebo arms, with fewer than 1% having a serious adverse effect or withdrawing from treatment because of adverse effects.
The trial results also showed that treatment with aliskiren led to incremental reductions in diastolic BP in patients who were already treated with an ACE inhibitor (ramipril), a calcium-channel blocker (amlodipine), or a thiazide diuretic. Aliskiren failed to produce additional BP lowering when it was added to an angiotensin-receptor blocker (valsartan), said Dr. Weir, professor of medicine and chief of nephrology at the University of Maryland in Baltimore.
Aliskiren dosages in the studies ranged from 75 to 600 mg/day. Patients enrolled in the seven studies had BPs at baseline of about 100 mm Hg diastolic and 151–157 mm Hg systolic. After 6–8 weeks of treatment with aliskiren, diastolic pressure fell by an average of 7–8 mm Hg, and systolic pressure fell by 10–11 mm Hg. The effect of aliskiren on BP reduction was dose-dependent, with a plateau reached once the dosage was 300–600 mg/day. The age and gender of patients appeared to have no effect on the degree of BP reduction.
All studies included in the analysis were sponsored by Novartis, from which Dr. Weir has received honoraria.
The drug, once available, will be a good choice for both initial therapy and in combination with other antihypertensives, Dr. Weir said. Aliskiren would be an attractive first-line agent given its good safety profile and low rate of interactions with other drugs. “The major question is whether inhibiting the renin-angiotensin system [with aliskiren] gives us an opportunity to better protect blood vessels and target organs,” he said.