Trial Section

Good news on two fronts

ANN ARBOR , MI - HealthDay News noted scientists are reporting what they call promising early results from a major trial they say may change 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% of the more than 11,500 participants in the ACCOMPLISH trial, scientists said. That was achieved using Lotrel, the most prescribed combination brand

for high blood pressure, which isn’t indicated for the initial treatment of high blood pressure. The hope of Novartis, which sells Lotrel and sponsored the trial, is Lotrel 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. Blood pressure isn’t under control in 70% of those people, including the nearly 40% taking medication. Early results of the ACCOMPLISH trial, led by Dr. Kenneth Jamerson, of the University of Michigan Health System , were reported at the American Society of Hypertension annual meeting.

"There are millions of people whose blood pressure isn’t controlled," said Dr. Jamerson, 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 80-90%, 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 add a second drug, noted a statement by Novartis. "We now have significant data which [show] the value of treating high-risk hypertensive patients with a fixed-dose combination from the start," the statement read. "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 medication that combined benazepril with a diuretic, which makes the body lose water. Various groups of patients were given different doses of the drugs.

Meanwhile in Dublin , Elan Corp. PLC (the Irish drug group) and U.S. partner Wyeth said they will start early Phase III clinical trials of AAB-001, their treatment for mild to moderate Alzheimer's disease that analysts say could become a blockbuster drug. With Phase III starting in mid-2007 rather than mid-2008 as expected, analysts say AAB-001 could potentially receive approval by the U.S. Food & Drug Administration (FDA) by late 2008.

"It is important to remember Alzheimer's is a complex and formidable challenge, and our immunotherapeutic programs still contain inherent risks," the companies cautioned. Analysts said the surprise decision to accelerate the advanced clinical trials for bapineuzumab raised confidence the drug was on course for FDA approval in 2008.