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Clinical Trial to Test Varied Hypertension Drug Dosage

Taking blood pressure (


Researchers at University of Rochester Medical Center in New York are testing if a lower dose of an common blood pressure medicine can provide the same benefits as a standard dose in people with mild hypertension. The new clinical trial is funded with a $1.9 million grant from the National Heart Lung and Blood Institute, part of National Institutes of Health.

The Centers for Disease Control and Prevention says one in three adults in the U.S. have high blood pressure, which increases the risk for heart disease and stroke, among the leading causes of death in the U.S. In 2010, says CDC, high blood pressure was projected to cost the United States $93.5 billion in health care services, medications, and missed days of work.

The drug under study is carvedilol, an FDA-approved beta blocker compound marketed under the brand name Coreg by GlaxoSmithKline. Beta blockers relax blood vessels and slow the heart rate to improve blood flow and decrease blood pressure. Side effects associated with the drug include include shortness of breath, a slow heartbeat, weight gain, fatigue, hypotension (low blood pressure), diarrhea, increases in blood sugar, dizziness, faintness, runny nose, and sore throat.

The research team led by Rochester’s John Bisognano aims to better understand if and how varying amounts of the medication, including doses lower than typically prescribed, affect patients with mild cases of hypertension, those with systolic (top number) pressure of 140 to 160 millimeters of mercury (mm Hg). People at this stage in the development of hypertension, notes Bisognano, are often advised to try lifestyle changes, such as eating a healthier diet and exercising, for six months to a year before starting drug therapy.

The trial offers an opportunity for these early stage patients to try a safe and effective drug that, even at varying doses, may help bring their blood pressure back to healthy levels. “We may be able to meet the medical need with less medication in this low-risk population,” says Bisognano, “and potentially decrease side effects in the process.”

Participants in the trial will receive different daily amounts of carvedilol for at least three weeks and up to eight weeks. Participants will be checked weekly, and asked to monitor their blood pressure every morning and evening. They will also record their results and any side effects in a blood pressure diary, and fill out weekly questionnaires regarding how they feel and any noteworthy events or changes that take place.

Disclosure: The author takes medication for high blood pressure, but not carvedilol.

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