NEW BRUNSWICK — In a study published in the December issue of Hypertension, a journal of the American Heart Association, investigators have shown that early treatment with blood pressure-lowering medications provides a long-term benefit of reducing the risk of death from cardiovascular disease. The study was conducted by researchers from the Cardiovascular Institute of New Jersey (CVI) at UMDNJ-Robert Wood Johnson Medical School, in collaboration with researchers from Massachusetts General Hospital and the University of Leuven, Belgium.
“Our study indicates that blood pressure-lowering medications used during clinical trials confer a legacy effect for trial participants, reducing the risk of death from cardiovascular disorders,” said John B. Kostis, MD, the John G. Detwiler Chair of Cardiology, chair of the department of medicine, and founding director of The Cardiovascular Institute of New Jersey. “The findings of our study have important implications and denote that earlier intervention would result in better clinical outcomes.”
Medication that is determined to be beneficial to patients even after the conclusion of a clinical trial is considered to have a legacy effect. Based on a meta-analysis (analysis of results of multiple studies on the same topic) of all pertinent trials (132,854 patients in 18 trials, including 11,988 deaths), the researchers found that the benefits of blood pressure-lowering medication persisted after the end of the trial, indicating a legacy effect.
In these clinical trials blood pressure-lowering medication was prescribed for patients with hypertension, myocardial infarction, or left ventricular systolic dysfunction. During the initial phase, 80 percent of the patients randomized to receive active treatment actually received it, compared to 16 percent of those randomized to the control group. The risk of death was lower in the active treatment group during the initial phase by about 16 percent.
Following each clinical trial, patients in both the active medication and the control groups were advised to take active medication. Although persons in both groups received active medication in similar proportions, mortality was about 15 percent lower for patients initially randomized to active medication thereby receiving medication for a longer period of time – the legacy effect.
“The data indicate that long-term follow up should be included in the design of clinical trials,” said Dr. Kostis. “In addition, these studies will help healthcare workers and guideline writers decide on the advisability of early initiation of specific therapies.”
Dr. Kostis will be spearheading a landmark clinical trial expected to provide important information on managing high blood pressure in older adults. SPRINT, as the trial is titled, is a multicenter, randomized clinical trial designed to test whether a treatment program aimed at reducing systolic blood pressure (the higher number in a blood pressure reading) to a lower goal than currently recommended (120 v. 140 mmHg) will reduce cardiovascular disease risk. During a two-year period, 7,500 to 10,000 participants with hypertension or pre-hypertension will be recruited and followed for four to six years.
SPRINT is sponsored by the National Heart Lung and Blood Institute, the National Institute of Neurological Disorders and Stroke, the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute on Aging. Dr. Kostis and his colleagues at the CVI plan to begin recruitment soon for SPRINT; the trial is expected to last 7 to 8 years.
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