SPRINT trial top-line results support goal under 120 mm
Hg for middle age and older adults, but experts raise safety concern
.....More stringent blood pressure targets could save lives and reduce cardiovascular events, according to preliminary results from a large NIH clinical trial.
Cardiologists expect guideline changes but support cautious pace awaiting full trial data
The controversy over the best blood pressure thresholds in hypertension won't be over any time soon despite new evidence from the SPRINT trial, experts told MedPage Today.
"There is no safety data listed here. Is there a risk associated with lower blood pressure targets? We do not know yet based on the top line report."
"I would be concerned about the risk in the elderly population with a broad application of a 120 mm Hg target, in terms of the risk of increasing falls and the risks of polypharmacy."........http://www.medpagetoday.com/Cardiology/Hypertension/53522........http://www.medpagetoday.com/Cardiology/CardioBrief/53497
Top-line results reported today from the landmark trial showed lower major adverse cardiovascular event risk and lower mortality with an under 120 mm Hg systolic blood pressure goal than with an under 140 mm Hg goal in treatment of hypertension in adults ages 50 and older. The lower target reduced rates of a first occurrence of myocardial infarction, acute coronary syndrome, stroke, heart failure, or cardiovascular death by 30% and the risk of death by almost 25%, as compared to the target systolic pressure of less than 140 mm Hg.
SPRINT, the Systolic Blood Pressure Intervention Trial, randomized 9,361 hypertensive patients 50 years of age or older to what was the standard systolic blood pressure target when the trial began - less than 140 mm Hg - or the more intensive target of less than 120 mm Hg.......The lower target reduced rates of a first occurrence of myocardial infarction, acute coronary syndrome, stroke, heart failure, or cardiovascular death by 30% and the risk of death by almost 25%, as compared to the target systolic pressure of less than 140 mm Hg.
The NIH did not provide specific numbers or respond to repeated requests for absolute risk reduction for that primary endpoint.
Blood pressure targets have been the subject of disagreement in recent years. At the start of the trial, guidelines recommended treating most hypertensive patients to a goal of less than 140 mm Hg, with a lower target of less than 130 mm Hg for patients with kidney disease or diabetes.
Patients in the standard treatment group received an average of two separate antihypertensive agents compared with three in the intensive treatment group. Previous observational studies found that risk increases once blood pressure rises above 115/75 mm Hg, but the benefit of a treatment strategy based on that finding has not been previously demonstrated in a randomized controlled trial.
Asked to comment on the press release, Sanjay Kaul, MD, MPH, of Cedars-Sinai Heart Institute in Los Angeles, said that "the treatment effect has to be large and statistically persuasive for the trial to be stopped prematurely. They must have seen a pronounced effect on mortality or an irreversible CV endpoint." The finding will surely "ignite yet another controversy regarding BP treatment targets," he said.
Sripal Bangalore, MD, of NYU Langone Medical Center in New York City, said that it was necessary to see the full results but that "it appears that the intensive BP lowering group was a clear winner." He said the finding "will be practice changing." Since the trial enrolled more than 2,500 patients who were 75 years of age or older it "clearly puts to rest the controversial JNC 8-recommended target of <150 mm Hg for patients 60 years or older."
That target from a 2014 report from some members of a panel appointed to update the Joint National Committee recommendations is commonly but unofficially known as JNC8 and was not endorsed by the National Heart, Lung, and Blood Institute (NHLBI).
Study investigator Suzanne Oparil, MD, of the University of Alabama at Birmingham and writing committee member for both that report and a subsequent AHA/ACC statement reemphasizing the 140 mm Hg target in coronary artery disease, said the SPRINT findings will help settle the controversy and influence guidelines.
"This is a time of enlightenment," she said at a press telebriefing convened by the NHLBI, calling the data "powerful new information that needs to be digested. But I think we need to avoid having patients jump on it and demand that their blood pressure be normalized. That would be premature."
SPRINT senior investigator Jackson Wright, MD, PhD, of University Hospitals Case Medical Center in Cleveland, said at the briefing he was "quite convinced all will be impressed" when the full data are published and predicted they "will have a significant impact on what will finally be recommended but [he] would not make a recommendation at this time."
The NIH said that the main results of the trial will be published later this fall.
The safety data from SPRINT and subgroup analysis for older and elderly adults are still being analyzed. While the first look indicated the intensive treatment target was well tolerated, the risks will be looked at much more closely, Wright noted. "However, I think we have to keep in mind that any adverse profile will have to be compared against the dramatic reduction in cardiovascular events and a 25% reduction in mortality."
Embargoed for Release: Friday, September 11, 2015
Landmark NIH study shows intensive blood pressure management may save lives
Lower blood pressure target greatly reduces cardiovascular complications and deaths in older adults
More intensive management of high blood pressure, below a commonly recommended blood pressure target, significantly reduces rates of cardiovascular disease, and lowers risk of death in a group of adults 50 years and older with high blood pressure. This is according to the initial results of a landmark clinical trial sponsored by the National Institutes of Health called the Systolic Blood Pressure Intervention Trial (SPRINT). The intervention in this trial, which carefully adjusts the amount or type of blood pressure medication to achieve a target systolic pressure of 120 millimeters of mercury (mm Hg), reduced rates of cardiovascular events, such as heart attack and heart failure, as well as stroke, by almost a third and the risk of death by almost a quarter, as compared to the target systolic pressure of 140 mm Hg.
"Our results provide important evidence that treating blood pressure to a lower goal in older or high-risk patients can be beneficial and yield better health results overall."
-Lawrence Fine, M.D.
Chief, Clinical Applications and Prevention Branch at NHLBI
"This study provides potentially lifesaving information that will be useful to health care providers as they consider the best treatment options for some of their patients, particularly those over the age of 50," said Gary H. Gibbons, M.D., director of the National Heart, Lung, and Blood Institute (NHLBI), the primary sponsor of SPRINT. "We are delighted to have achieved this important milestone in the study in advance of the expected closure date for the SPRINT trial and look forward to quickly communicating the results to help inform patient care and the future development of evidence-based clinical guidelines."
High blood pressure, or hypertension, is a leading risk factor for heart disease, stroke, kidney failure, and other health problems. An estimated 1 in 3 people in the United States has high blood pressure.
The SPRINT study evaluates the benefits of maintaining a new target for systolic blood pressure, the top number in a blood pressure reading, among a group of patients 50 years and older at increased risk for heart disease or who have kidney disease. A systolic pressure of 120 mm Hg, maintained by this more intensive blood pressure intervention, could ultimately help save lives among adults age 50 and older who have a combination of high blood pressure and at least one additional risk factor for heart disease, the investigators say.
The SPRINT study, which began in the fall of 2009, includes more than 9,300 participants age 50 and older, recruited from about 100 medical centers and clinical practices throughout the United States and Puerto Rico. It is the largest study of its kind to date to examine how maintaining systolic blood pressure at a lower than currently recommended level will impact cardiovascular and kidney diseases. NIH stopped the blood pressure intervention earlier than originally planned in order to quickly disseminate the significant preliminary results.
The study population was diverse and included women, racial/ethnic minorities, and the elderly. The investigators point out that the SPRINT study did not include patients with diabetes, prior stroke, or polycystic kidney disease, as other research included those populations.
When SPRINT was designed, the well-established clinical guidelines recommended a systolic blood pressure of less than 140 mm Hg for healthy adults and 130 mm Hg for adults with kidney disease or diabetes. Investigators designed SPRINT to determine the potential benefits of achieving systolic blood pressure of less than 120 mm Hg for hypertensive adults 50 years and older who are at risk for developing heart disease or kidney disease.
Between 2010 and 2013, the SPRINT investigators randomly divided the study participants into two groups that differed according to targeted levels of blood pressure control. The standard group received blood pressure medications to achieve a target of less than 140 mm Hg. They received an average of two different blood pressure medications. The intensive treatment group received medications to achieve a target of less than 120 mm Hg and received an average of three medications.
"Our results provide important evidence that treating blood pressure to a lower goal in older or high-risk patients can be beneficial and yield better health results overall," said Lawrence Fine, M.D., chief, Clinical Applications and Prevention Branch at NHLBI. "But patients should talk to their doctor to determine whether this lower goal is best for their individual care."
The study is also examining kidney disease, cognitive function, and dementia among the patients; however, those results are still under analysis and are not yet available as additional information will be collected over the next year. The primary results of the trial will be published within the next few months.
In addition to primary sponsorship by the NHLBI, SPRINT is co-sponsored by the NIH's National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Neurological Disorders and Stroke, and the National Institute on Aging.
Media Telebriefing Information
NHLBI will be hosting a telebriefing for the media on Friday, Sept. 11 at 10:30 a.m. EDT. The briefing will be hosted by NHLBI Director Dr. Gary H. Gibbons. Space is limited, so please register for the telebriefing at:
The National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at http://www.nhlbi.nih.gov.
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