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This study was to compare the safety in patients with hypertension receiving azilsartan medoxomil as monotherapy or other antihypertensive agents.
The Cochrane library, PubMed, Chinese National Knowledge Infrastructure(CNKI), Wanfang Data were searched from the beginning of the records through September 2015. Eligible studies were prospective randomised controlled trials of azilsartan (including azilsartan medoxomil) vs. any control therapy. Six articles were extracted by two physicians. The pooled risk of serious adverse effects, clinical adverse reactions, laboratory were computed and expressed as odds ratios(ORs) for azilsartan medoxomil 40 mg and 80 mg and relative to any antihypertensive monotherapy.
Difference in total adverse effects, serious adverse effects and adverse leading to discontinuous have no statistical significance between azilsartan medoxomil and the controlled group. Dizziness, urinary tract infection and potassium ≥6.0 mmol/L were more frequent on azilsartan medoxomil 40 mg (respectively: OR=1.44, 95%CI[1.01,2.06]; P=0.04; OR=1.82, 95%CI[1.10,3.01]; P=0.02; OR=5.88, 95%CI[1.53,22.59]; P=0.01) .
Total adverse effects and serious adverse effects were similar in azilsartan medoxomil group and controlled group in patients with hypertension. However, it shoud be used with caution in patients with renal insufficiency and hyperkalemia.