Takeda presents azilsartan data

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) presented data from two head-to-head Phase III trials comparing azilsartan to angiotensin II type 1 (AT1) receptor antagonists Diovan valsartan and Benicar olmesartan. In the first trial, 80 mg/day azilsartan met the primary endpoint of significantly reducing mean 24-hour systolic blood pressure (SBP) from baseline to week six vs. Benicar, but 20 and 40 mg/day azilsartan missed the endpoint. Specifically, 20, 40 and 80 mg/day azilsartan reduced 24-hour SBP by 10.8, 12.1 and 13.2 mmHg, respectively, vs. 11.2 mmHg for Benicar (p=0.687, p=0.352 and p=0.038, respectively).

In the second trial, 40 and 80 mg/day azilsartan met the primary endpoint of significantly reducing mean 24-hour SBP from baseline to week six vs. Diovan, but only the 80 mg dose met the endpoint vs. Benicar. Specifically, 40 and 80 mg/day azilsartan reduced 24-hour SBP by 13.4 and 14.5 mmHg, respectively, vs. 10.2 mmHg for Diovan (p=0.001 and p<0.001, respectively) and 12 mmHg for Benicar (p=0.14 and p=0.009, respectively). The double-blind, placebo-controlled trials included 1,088 and 1,094 evaluable patients, respectively. ...