Analysis: A New Drug for Blood Pressure?
Posted on: Friday, 16 June 2006, 18:00 CDT
By ED SUSMAN
An investigational drug appears to outperform a standard medication in lowering blood pressure in patients who also have diabetes, international researchers said Friday.
However, when the two drugs are used in combination, doctors said an even greater reduction is possible, allowing more patients to get to a goal known to reduce the risk of heart attacks and strokes.
Aliskiren demonstrated potent antihypertensive efficacy, with superior blood pressure reductions and responder rates when compared to ramipril, said Yagiz Uresin, professor of clinical pharmacology at the Istanbul University in Turkey.
About 73 percent of patients taking aliskiren, currently being reviewed for approval by the Food and Drug Administration, were able to achieve their blood-pressure goals compared to 65 percent of people who were taking ramipril, said Uresin in reporting results at the European Society of Hypertension.
Aliskiren is the first in the class of drugs known as direct renin inhibitors. It is being developed by Novartis of Basel, Switzerland. Novartis funded the study. Ramipril (Altace) is in a class of blood-pressure-lowering drugs known as an angiotensin-converting enzyme (ACE) inhibitors.
Both drugs act on parts of the cascade of molecular signaling events that cause reactions in blood vessels that can increase pressure in blood vessels.
Especially in the case of people with diabetes, these pressure increases lead down the path to blood-vessel damage, kidney disease and blockages or ruptures in the arteries nourishing the heart and the brain.
In the study, Uresin randomly assigned 282 people with diabetes and high blood pressure to receive aliskiren; another 278 patients were assigned to received ramipril; a third group of 277 patients were assigned the combination of the two drugs in an eight-week long study.
Combination therapy was consistently superior to ramipril monotherapy, indicating that aliskiren provides significant additional blood-pressure reductions when combined with ACE-inhibitor treatment in patients with diabetes and hypertension, said Uresin.
Patients were able to lower their average systolic blood pressure 14.7 millimeters of mercury (mmHg) with aliskiren alone compared with 12 mmHg for ramipril alone. Together the average reduction was 16.6 mmHg. The differences reached statistical significance, he said.
The difference in 4-5 mmHg in lowering blood pressure is huge, Dr. Matthew Weir, professor of medicine at the University of Maryland School of Medicine in Baltimore, told United Press International. Over a five-year period that much of a reduction could reduce the risk of cardiovascular events by as much as 20 percent.
Weir did not participate in the study in Europe but said that the research shows that the long half-life of aliskiren gives 24-hour control of blood pressure, a critical factor in avoiding events such as heart attack or stroke.
In addition, he said, We believe there is a theoretical advantage of aliskiren to attenuate the renin system. He explained that by halting the activation of the molecular chain reaction damage to blood vessels may be prevented.
We don't know this as a fact at this point, he told UPI, but we believe that with aliskiren, in addition to blood pressure lowering that is crucial for these patients, we may also prevent blood-vessel damage that often occurs in patients with diabetes.
Furthermore, he said patients tolerated the combination of the treatments with little increase in adverse side effects.
Source: United Press International
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