TROPHY (TRial Of Preventing HYpertension) study data suggest candesartan can reduce risk of progression from high normal blood pressure to hypertension, according to a presentation at the annual meeting of the American College of Cardiology.

"The TROPHY study is groundbreaking because it's the first study to examine the potential to change the natural history of hypertension through early pharmacological intervention in patients diagnosed with prehypertension," said principal investigator Stevo Julius, MD, Professor of Internal Medicine and Physiology, University of Michigan.

For the primary study end point of development of hypertension, there was a highly significant 15.6-percent relative risk reduction for candesartan compared with placebo.

Hypertension is defined as a blood pressure of 140/90 mm Hg or higher and affects an estimated 65 million people in the USA, approximately one in three adults. Most mortality and morbidity occur among people with stage 1 hypertension. The rationale behind TROPHY was that if it were possible to prevent the transition from prehypertension to stage 1 hypertension, there could be a positive benefit on public health.

TROPHY was a four-year, multicenter, randomized, placebo-controlled study in 772 evaluable subjects (average age 48 years, 40 percent women) with prehypertension, defined as blood pressures of less than or equal to 139/85-89 mm Hg or 130-139/less than or equal to 89 mm Hg.

The trial consisted of two years of double-blind treatment with candesartan (16 mg daily) or placebo followed by two years of single-blind treatment with matching placebo in both groups. All subjects continued to receive non- pharmacologic interventions during the study. Blood pressure was measured by an automated device at the beginning of the study and at three-month intervals. The primary objective was to determine whether a two-year period of active treatment would be sufficient to reduce the proportion of subjects developing hypertension over the full four-year duration of the trial.

The primary study end point was development of hypertension. Hypertension was defined as blood pressure greater than or equal to 140/90 mm Hg on any three visits or at the 48-month visit, blood pressure greater than or equal to 160/100 mm Hg at one visit, or clinical need for treatment. Patients reaching the hypertension end point were given active treatment and followed by clinics.