Daiichi Sankyo, Inc. announced that data presented at the American Society of Hypertension, Inc. (ASH) Twenty-Fourth Annual Scientific Meeting and Exposition (ASH 2009) in San Francisco from the AZOR(R) Trial Evaluating Blood Pressure Reductions and Control (AZTEC) demonstrated that a stepwise amlodipine and olmesartan medoxomil-based titration regimen provided mean 24-hour ambulatory reductions in systolic blood pressure (SBP) of 21.4 mm Hg and diastolic blood pressure (DBP) of 12.7 mm Hg. In addition, 71 percent of patients in the study were able to safely and effectively achieve a 24-hour ambulatory target blood pressure (BP) of 135/85 mm Hg are nearly twice as likely to have a cardiovascular event as those with BP In AZTEC, the amlodipine and olmesartan medoxomil-based titration regimen was well tolerated, with only three (1 amlodipine patient, 2 AZOR patients) of the 185 patients discontinuing treatment because of drug-related adverse events. In this trial, occurrence of drug-related AEs included: peripheral edema (2.2 percent) and dizziness (1.1 percent).

High blood pressure can cause permanent changes to blood vessels and the heart that may create serious problems elsewhere in the body.(4) Hypertension is one of the most prevalent conditions in the United States, affecting approximately one in three American adults (about 73 million people age 20 and older) and approximately one billion people worldwide. (5),(6) It is often difficult to control, and of those with high blood pressure, approximately 55 percent do not reach recommended BP levels.(7) The number of people with high blood pressure is expected to reach about 1.6 billion worldwide by 2025.(8)

Black Patients

In the U.S., the rate of high blood pressure is disproportionately high in the Black community and affects 41 percent of the population.(9) A further analysis of the AZTEC trial on the basis of race found that treatment with an amlodipine and olmesartan medoxomil-based titration regimen was well tolerated and produced similar 24-hour ambulatory BP reductions from baseline in both Black and non-Black patients. Black patients had a higher mean baseline BP than non-Black patients. The amlodipine and olmesartan medoxomil-based titration regimen produced mean 24-hour ambulatory BP reductions of 20.7/11 mm Hg in Black patients from a baseline of 148.6/85.7 mm Hg. Non-Black patients experienced a mean 24-hour ambulatory BP reduction of 21.5/13 mm Hg from a baseline of 144.2/85.7 mm Hg.

Patients with Diabetes

Seventy five percent of adults diagnosed with diabetes in the U.S. have hypertension.(10),(11) A further analysis of the AZTEC trial found that treatment with an amlodipine and olmesartan medoxomil-based titration regimen was well tolerated and produced similar 24-hour ambulatory BP reductions from baseline in hypertensive patients with and without diabetes. Patients with diabetes treated with the amlodipine and olmesartan medoxomil-based titration regimen also achieved mean 24-hour ambulatory BP reductions of 21.5/12.6 mm Hg from a baseline of 145.6/83.1 mm Hg. Patients without diabetes experienced a mean 24-hour ambulatory BP reduction of 21.3/12.8 mm Hg from a baseline of 144.6/86.6 mm Hg.

Study Design

AZTEC was a 15-16-week (3- to 4-week placebo run-in and 12-week active treatment periods), open label, prospective, single-arm, titrate-to-goal study, conducted in 185 patients with mild to moderate (Stage 1) and challenging (Stage 2) hypertension. The study evaluated the safety and efficacy of an amlodipine and olmesartan medoxomil-based titration algorithm. Of the total study population, 26 patients were Black and 43 patients were diagnosed as having type 2 diabetes (populations are not mutually exclusive). The primary endpoint was change in mean systolic blood pressure (SBP) from baseline after 12 weeks of treatment as measured by 24-hour ABPM. Secondary endpoints included change from baseline in mean 24-hour DBP as measured by ABPM; change from baseline in mean daytime, nighttime, and last 2, 4, and 6 hours ambulatory SBP and DBP; achievement of ABPM prespecified BP targets; change from baseline mean SeSBP and SeDBP at each titration step; and achievement of BP goals.

Following placebo run-in, patients were started on amlodipine (AML) 5 mg, and were up-titrated at three week intervals if mean cuff BP was greater than or equal to 120/80 mm Hg to AML/olmesartan medoxomil (OM) 5/20 mg, AML/OM 5/40 mg then AML/OM 10/40 mg. If BP was