"Shame on the NIH for the Sensationalism."

By Jonathan Springston, Associate Managing Editor, AHC Media

Federal officials released the preliminary results of a landmark blood pressure study on September 11, sparking a wide-ranging debate across the healthcare industry and among medical professionals.

Expected to continue until 2017, officials from the NIH said they decided to end the Systolic Blood Pressure Intervention Trial (SPRINT) early after achieving a key milestone ahead of schedule, revealing potentially life-saving information they say doctors need sooner rather than later.

Clinical Cardiology Alert Editor Michael Crawford, MD, chief of Clinical Cardiology at the University of California, San Francisco, was annoyed by the hype.

“It sounds important, but as the [NIH] says the data is preliminary and the full publication won't be out for months,” he said. “What were the adverse events associated with lower BPs? The news report doesn't say. We don't want doctors running out and lowering some 80-year-old [patient’s] blood pressure until she has a stroke. Disseminating this information without the full report could be hazardous to some patients. Shame on the NIH for the sensationalism.”

“This study provides potentially lifesaving information that will be useful to healthcare providers as they consider the best treatment options for some of their patients, particularly those over the age of 50,” said Gary H. Gibbons, MD, director of the National Heart, Lung, and Blood Institute (NHLBI), a division of NIH that served as the primary sponsor of SPRINT, in a statement. “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.”

The intervention in this trial, which 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.

When SPRINT was designed, 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, 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.

Many were excited about the potential to better treat the millions of Americans who suffer from high blood pressure. However, researchers still have to analyze the remaining data and results could evolve over time.

The study population included women, racial/ethnic minorities, and the elderly, but investigators admitted SPRINT did not include patients with diabetes, prior stroke, or polycystic kidney disease. Other research included those populations.

Additionally, SPRINT 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. Publication of the primary results is expected within the next few months.

“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,” says Lawrence Fine, MD, chief, Clinical Applications and Prevention Branch at NHLBI, in a statement. “But patients should talk to their doctor to determine whether this lower goal is best for their individual care.”