An NIH-sponsored trial enrolled more than 9,300 participants ages 50 and older with high blood pressure. View the results.
For appropriate patients ages 50 and older, more intensive treatment of blood pressure may prevent poor cardiovascular outcomes and death, according to initial results of a landmark clinical trial released at the National Institutes of Health (NIH).
The NIH-sponsored Systolic Blood Pressure Intervention Trial (SPRINT) enrolled more than 9,300 participants ages 50 and older with high blood pressure. Participants were randomized to a systolic blood pressure target of 120 mm Hg or the usual target of 140 mm Hg, then had the amount and type of blood pressure medication adjusted to achieve the different blood pressure targets.
“Preliminary results show that more intensive management of high blood pressure below a currently commonly recommended systolic blood pressure target [140 mm Hg] to a lower target [120 mm Hg] reduced rates of cardiovascular events by almost one third and the risk of death by almost one quarter in adults age 50 years and older,” according to Cora E. Lewis, MD, co-principal investigator of The University of Alabama (UAB) Hub in this trial and professor of preventive medicine, internist and epidemiologist at UAB. “The true earth-shattering finding is the reduced rate of mortality from all causes.”
The SPRINT study, which began in the fall of 2009, recruited approximately 100 medical centers and clinical practices throughout the United States and Puerto Rico. UAB was selected by the NIH as one of five hubs to recruit and direct almost 20 of these clinics from Massachusetts to Puerto Rico; UAB-directed clinics recruited more than 1,950 study participants, surpassing the study’s initial goal for UAB’s network. The study’s blood pressure intervention, which was to finish in summer 2016, has finished earlier after the National Heart, Lung and Blood Institute Director Gary H. Gibbons, MD, took action when the Data and Safety Monitoring Board interpreted the benefits of the lower goal as far outweighing the harms.
In the SPRINT study, patients at baseline were at increased risk of cardiovascular disease based on the Framingham risk equation, had chronic kidney disease, or already had coronary heart disease. The study excluded patients who already had stroke, polycystic kidney disease, or diabetes because other research addressed those patient groups. For the intensive group, three or more drugs on average were required. SPRINT is the largest U.S. randomized clinical trial to study how maintaining systolic blood pressure at a level lower than currently recommended will impact cardiovascular and kidney diseases, and cognitive decline.
“The data are preliminary at this point and should not cause people to change their medications, stop or decrease their medications,” Lewis says. “People with high blood pressure should consult with their own healthcare provider on what their goals of treatment should be.”
The study was conducted “because there was a lack of data on systolic blood pressure goals and recommendations varied due to this evidence gap,” she says. “At the time the study was designed, the commonly recommended target was 140 mm Hg for systolic blood pressure.”
The important public health message now is for patients to consult with their healthcare provider about their own individual goals, according to Lewis. “We have yet to collect and analyze important data on dementia incidence, cognitive function, kidney function, and brain structure changes.”
The detailed results will appear in a paper that Lewis anticipates will be published by late 2015. Providers and patients should await the full publication of results before making changes, according to Lewis.