Clinical Trials
Pre hypertension best managed by early pharmacological intervention
By The American College of Cardiology
Mar 19, 2006, 02:43

Patients experiencing high normal blood pressure (HNBP), a precursor to hypertension, may benefit from early treatment with pharmacological therapy, according to new research presented today at the American College of Cardiology's 55th Annual Scientific Session. HNBP, often referred to as "prehypertension," is associated with double the normal risk of heart attacks and strokes. ACC.06 is the premier cardiovascular medical meeting, bringing together more than 30,000 cardiologists to further breakthroughs in cardiovascular medicine.

The Trial of Preventing Hypertension (TROPHY) is a four-year, multi-center trial evaluating the safety and potential benefit of early drug therapy in patients with high normal blood pressure (HNBP, 130 to 139 mm Hg and/or 85-89). A total of 785 patients in the trial (average entry blood pressure of 134/84.8) were randomized to 16 mg of candesartan or placebo and underwent regular blood pressure screenings, along with non-pharmacological blood pressure lowering techniques. After two years, the drug-treated group was switched to placebo, and all continued on placebo for the remaining two years. Of the enrolled patients, 448 developed hypertension.

The study endpoints measured for the frequency of diagnosed hypertension in the patients and the time to that diagnosis. Hypertension was diagnosed in patients who met the following criteria over four years: a) blood pressure was at least or greater than 140 and/or 90 mm Hg at three different clinic visits, b) clinic blood pressure was >/= 160 and/or 100 mm Hg at any single visit, c) physicians detected organ damage or other conditions requiring active treatment. Serious adverse events on the drug were low, including only 1.2 percent cardiovascular events, deeming the protocol safe.

"Prehypertension is currently treated by lifestyle modification, but this form of treatment has had little effect on public health," said Stevo Julius, M.D., Professor Emeritus of Medicine and Physiology at the University of Michigan, Ann Arbor and principal investigator of the TROPHY Trial. "It was therefore appropriate to investigate whether treatment with blood pressure-lowering drugs in this early phase of hypertension is feasible and whether it would slow down the transition from "prehypertension" to treatment-requiring hypertension."

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