Efficacy and safety of azilsartan compared with candesartan in patients with hypertension


eMediNexus    12 February 2018

A study published in Hypertension Research explored whether 10 mg/day azilsartan (half of the normal dosage), would be non-inferior to 8 mg/day candesartan cilexetil for controlling blood pressure (BP) in patients with hypertension. This was an open-label, randomized, crossover trial wherein 309 hypertensive adults treated with 8mg candesartan cilexetil were randomized into two arms – they were either given 10mg azilsartan or 8mg candesartan cilexetil in a crossover manner. The margin of non-inferiority was set at 2.5 mmHg. The baseline systolic and diastolic BPs were 127.1±13.2 and 69.7±11.2 mmHg, respectively. The difference in systolic BP between 10mg azilsartan and 8mg candesartan cilexetil treatment group was -1.7 mm Hg during the study period, with the two-sided 95% confidence interval (CI) ranging from -3.2 to -0.2 mm Hg. Of note, the upper boundary of the 95% CI was below the margin of 2.5 mm Hg, thus validating the non-inferiority of 10mg azilsartan to 8mg candesartan cilexetil. The corresponding difference in diastolic BP was -1.4 (95% CI: -2.4 to -0.4) mmHg. Therefore, 10mg azilsartan was non-inferior to 8mg candesartan cilexetil for controlling systolic BP in hypertensive patients who were already being treated with 8mg candesartan cilexetil.

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