Safety and Tolerability of the Direct Renin Inhibitor Aliskiren in Combination with Angiotensin Receptor Blockers and Thiazide Diuretics: A Pooled Analysis of Clinical Experience of 12942 Patients

摘要

Combinations of the direct renin inhibitor aliskiren with angiotensin receptor blockers (ARBs) or diuretics are effective therapeutic regimens for the treatment of hypertension. A large database of safety information has become available during the past several years with aliskiren in combination trials. Data were pooled from nine short-term (8-week) and four longer-term (26–52-week) randomized, controlled trials of aliskiren in patients with hypertension. Adverse event (AE) rates were assessed for aliskiren combination therapy compared to component monotherapies. In short-term studies, overall AE rates were similar for those receiving aliskiren/valsartan or aliskiren/diuretic combinations (32.2–39.8%) and those receiving the component monotherapies (30.0–39.6%). In longer-term studies, AE rates with aliskiren/losartan (55.5%) and aliskiren/diuretic (45.0%) combination therapy were similar to those with losartan (53.9%) and diuretic (48.9%) alone. Angioedema and hyperkalemia occurred in similar proportions of patients on combination therapies versus monotherapy. In conclusion, the safety and tolerability profile of aliskiren in combination with the ARBs valsartan or losartan, or diuretic is similar to aliskiren, ARBs or diuretic alone.