Evaluating the effectiveness of azilsartan medoxomil in patients with essential hypertension

This trial was carried out to examine the effectiveness of azilsartan medoxomil (Edarbi; AZM) on lowering blood pressure (BP) in a Chinese population. The trial found that AZM was similar to valsartan (Diovan) at a 40mg-dose and more effective at a 80mg-dose.

One class of drugs used to treat high blood pressure (hypertension) is called angiotensin II receptor blockers (ARB). AZM is a newer ARB. It is approved for use in 40 countries globally. Valsartan is also an ARB that has been approved to treat high BP. Despite nearly global approval, AZM has not been approved in China as of yet.

There were 612 Chinese patients in this trial. They were randomly assigned to one of 3 groups. 209 patients received AZM 40mg, 199 patients received AZM 80mg, and 204 patients received valsartan 160mg. They were followed up for a period of 8-weeks.

Systolic BP (SBP) is the pressure in the heart during heartbeats. Diastolic BP (DBP) is the pressure in the heart when the heart relaxes (between heartbeats). There was a significantly greater reduction in the AZM 80mg group (-24.2mmHg) when compared to the valsartan 160mg group (20.6mmHg). There was a slightly higher reduction in SBP in the AZM 40mg group (-22.5mmHg) than in the valsartan 160mg group (-20.6mmHg). 

The AZM 80mg group had a significantly higher reduction in DBP (-11.5mmHg) and AZM 40mg had a slightly higher reduction in DBP (-10.1mmHg) when compared to the valsartan 160mg group (-8.6mmHg).

The reduction in the average 24-hour BP was significantly greater for the AZM 80mg (-17mmHg) and AZM 40mg (-14.7mmHg) compared to the valsartan 160mg group (-9.4%). 

Rates of side effect occurrence were similar across the three groups. The most common side effects were high blood lipids (fats) and upper respiratory infections.

The authors concluded that AZM showed clinically meaningful reductions in BP in Chinese patients with high BP and was similar to valsartan at 40mg dosing levels, and better than valsartan at 80mg-dosing levels. 

This trial was funded by Takeda, the manufacturer of AZM.