Tuesday, May 22, 2007

Trial of Blood Pressure Drug Offers Hopeful Early Results

(HealthDay News) -- Researchers are reporting what they call promising early results from a major trial that they say may change the basic tactics for controlling high blood pressure in the most vulnerable people.

Over a six-month period, successful blood pressure control was achieved in 73 percent of the more than 11,500 participants in the ACCOMPLISH (Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension) trial, the researchers said.
That rate was achieved by use of Lotrel, the most prescribed combination brand for high blood pressure, which currently is not indicated for the initial treatment of high blood pressure. The hope of Novartis, the company that sells Lotrel and sponsored the trial, is that the medication will become an accepted first-line treatment.

There are major health implications linked to the study. Some 72 million Americans have high blood pressure, also known as hypertension, a major risk factor for heart attack, stroke and other cardiovascular problems. But blood pressure is not under control in 70 percent of those people, including the nearly 40 percent taking medication.

Early results of the ACCOMPLISH trial, led by Dr. Kenneth Jamerson of the University of Michigan Health System, were to be reported Monday at the American Society of Hypertension annual meeting, in Chicago.

"There are millions on millions of people whose blood pressure is not controlled," said Jamerson, who is professor of internal medicine at Michigan. "Using this strategy, we can expect to double the amount of cases under control. Since the estimated risk of getting high blood pressure at some time in life is 80 to 90 percent, we expect our society will embrace this strategy."

Traditionally, the approach to high blood pressure has been to start with one medication, increase the dose if necessary and then add a second drug, according to a statement issued by Novartis. "We now have significant data which demonstrate the value of treating high-risk hypertensive patients with a fixed-dose combination from the start," the statement said. "This data has the potential to change the current treatment guidelines."

Lotrel combines a calcium channel blocker, amlodipine besylate, with an ACE inhibitor, benazepril. In the trial, the drug was compared with a different combination medication that combined benazepril with a diuretic, which makes the body lose water. Various groups of patients were given different doses of the drugs.

The control rate achieved with Lotrel was lower for people with conditions that put them at higher risk of cardiovascular disease -- 43 percent for those with diabetes and 40 percent for those with kidney disease. But, the report noted, "Of the patients uncontrolled, 61 percent were not on maximum medications, suggesting potential increases in control rates."

Some skepticism has been expressed about the goals of the ACCOMPLISH trial. Those voicing concerns include Dr. Alan B. Weder, a professor of internal medicine at the University of Michigan.

But, in a recent interview, Weder said his criticism, published two years ago in Expert Opinion on Pharmacotherapy, wasn't directed so much at ACCOMPLISH as at clinical trials in general. "In the world of clinical trials, ACCOMPLISH is probably one of the better ones," he said.
Still, Weder said, "without doubt, these trials are done to further the interests of the pharmaceutical industry. But I don't see anything wrong with that."

More information
A complete guide to blood pressure and its control is offered by the U.S. National Heart, Lung, and Blood Institute.

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