DEERFIELD, Ill., Sept. 5, 2012 /PRNewswire/ -- Results of a 10-week, phase 3 study published online in the American Journal of Medicine found the clinic systolic blood pressure (SBP) reductions of a fixed-dose combination of azilsartan medoxomil and chlorthalidone were significantly greater at six and ten weeks than those of azilsartan medoxomil co-administered with hydrochlorothiazide. Data also showed that more patients achieved their target blood pressure levels at the end of six and 10 weeks (secondary endpoints) when taking the azilsartan medoxomil and chlorthalidone fixed-dose combination.

"Hypertension management can be complex, and the use of combination therapy with a diuretic is a common treatment approach," said study co-author William C. Cushman, M.D., professor of preventive medicine at the University of Tennessee College of Medicine in Memphis, Tenn. "While hydrochlorothiazide is more commonly used in clinical practice, this study provides further support for the use of chlorthalidone in fixed-dose combination for patients with hypertension."

About the Study The 10-week, randomized, double-blind, titrate-to-target study compared blood pressure reductions of the fixed-dose combination of azilsartan medoxomil and chlorthalidone to azilsartan medoxomil co-administered with hydrochlorothiazide among 609 patients with stage 2 hypertension. The average age of patients in the study was 56.4 years and the average baseline clinic blood pressure was 164.6/95.4 mm Hg. After two weeks of treatment with azilsartan medoxomil (40 mg) alone, patients received 12.5 mg of either diuretic for four weeks (up to week 6) and were then titrated to 25 mg for another four weeks (up to week 10) if they had not achieved their target blood pressure; otherwise, patients continued their initial dose.

Primary endpoint data showed that at week 6, the clinic SBP reductions of the fixed-dose combination of azilsartan medoxomil and chlorthalidone were -35.1 mm Hg. These data were statistically significantly (P<0.001) greater than those of azilsartan medoxomil and hydrochlorothiazide (-29.5 mm Hg) with a mean difference of -5.6 mm Hg. At the end of 10 weeks, greater clinic SBP reductions were maintained in patients taking the fixed-dose combination of azilsartan medoxomil and chlorthalidone (-37.8 mm Hg) versus those taking azilsartan medoxomil and hydrochlorothiazide (-32.8 mm Hg) with a mean difference of -5.0 mm Hg.

Additionally, secondary endpoint data showed that a greater proportion of patients taking the fixed-dose combination of azilsartan medoxomil and chlorthalidone achieved their target blood pressure versus those taking azilsartan medoxomil and hydrochlorothiazide at the end of both six weeks (64.1 percent vs. 45.9 percent) and 10 weeks (71.5 percent vs. 62.3 percent).

Adverse events leading to permanent drug discontinuation occurred in 9.3 percent of patients taking the fixed-dose combination of azilsartan medoxomil and chlorthalidone and 7.3 percent of patients taking azilsartan medoxomil co-administered with hydrochlorothiazide. The most common adverse events accounting for study drug discontinuation were dizziness (1.0 percent versus 1.7 percent) and increased serum creatinine (4.0 percent versus 2.0 percent) in the fixed-dose combination of azilsartan medoxomil and chlorthalidone and azilsartan medoxomil and hydrochlorothiazide groups, respectively. The most common adverse events (greater or equal to five percent in either group) were increased blood creatinine, dizziness and headache. Serum potassium levels below 3.4 mmol/L were observed in 1.7 percent and 0.3 percent of patients in the fixed-dose combination of azilsartan medoxomil and chlorthalidone and azilsartan medoxomil and hydrochlorothiazide groups, respectively.

Edarbyclor (azilsartan medoxomil and chlorthalidone) was approved by the U.S. Food and Drug Administration in December 2011 for the treatment of hypertension to lower blood pressure in adults. It is the first and only hypertension medication to combine an angiotensin II receptor blocker (ARB) with the diuretic chlorthalidone in a once-daily, single tablet.

About Hypertension Hypertension, or high blood pressure, is a chronic medical condition in which blood pressure is elevated to levels of 140 mm Hg or greater systolic and/or 90 mm Hg or greater diastolic. Hypertension impacts approximately 76 million Americans, or nearly one in three adults. It is estimated that nearly one billion people are affected by hypertension worldwide, and this figure is predicted to increase to 1.5 billion by 2025. Hypertension typically has no symptoms. Adults of all ages and backgrounds can develop hypertension; however, the risk of developing the condition increases with age, with more than half of people over age 60 affected in the U.S.

Elevated systolic or diastolic pressure increases cardiovascular risk, and lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and heart attacks. The absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit.

Hypertension is also costly to the nation's health care system. The American Heart Association recently estimated that direct and indirect expenses associated with hypertension cost the nation more than $73 billion in 2009.

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American Journal of Medicine Publishes Hypertension Study Comparing the Fixed-Dose Combination of Azilsartan Medoxomil ...