Should the Prepublication SPRINT Results Affect Clinical Practice Right Now?

October 8, 2015

Should the Prepublication SPRINT Results Affect Clinical Practice Right Now?

  1. Allan S. Brett, MD

Let's wait until the complete findings are published.

  1. Allan S. Brett, MD

On September 14, 2015, one of my patients called the office and asked whether we should intensify her antihypertensive drug regimen. She is a 90-year-old, independently living woman who takes one antihypertensive drug; her typical blood pressure (BP) is around 150/75 mm Hg, but, in recent years, her systolic BPs have been as low as 130 mm Hg and as high as 170 mm Hg. What prompted the call? She had watched the evening news and had heard about the just-announced result of the NIH-sponsored Systolic Blood Pressure Intervention Trial (SPRINT). That week, many other patients called our practice with the same question or mentioned the trial during office visits. Thus, a quick review of SPRINT is appropriate.

In SPRINT, more than 9000 patients with hypertension were randomized to intensive treatment (systolic BP goal, 120 mm Hg) or standard treatment (systolic BP goal, 140 mm Hg). Patients were eligible if they were 50 or older, were hypertensive, and had at least one other risk factor; the latter included known clinical or subclinical cardiovascular disease other than stroke, chronic kidney disease (estimated glomerular filtration rate, 20–59 mL/minute/1.73 m2), Framingham 10-year risk score of at least 15%, or age >75. Notably, patients with diabetes were excluded, because the ACCORD Blood Pressure trial (a substudy of the ACCORD Glycemic Control study) was in progress. In ACCORD BP, researchers compared 120 mm Hg with 140 mm Hg targets in hypertensive diabetic patients; the final results showed no advantage for more-intensive blood-pressure lowering in diabetic patients (NEJM JW Cardiol Apr 2010 and N Engl J Med 2010; 362:1575).

On September 11, 2015, an NIH press release announced that SPRINT had been stopped early because of a clear advantage for the intensively treated group. The NIH stated that more-intensive treatment “reduced rates of cardiovascular events… by almost a third and the risk of death by almost a quarter.” However, because the full results of the trial have not been published yet, applying them to patient care remains problematic for now. For example, the relative reductions in adverse cardiovascular events and mortality have been announced, but we don't know the absolute reductions (or the number needed to treat to benefit one patient). We don't know whether specific drug categories were more (or less) beneficial than others. We also don't know yet whether the intensively treated group experienced substantial adverse effects (e.g., symptomatic hypotension) that would make intensive treatment less desirable in certain patient subgroups. We await the findings on whether older patients (e.g., age, ≥75) benefit to the same extent as younger patients. Dr. Harlan Krumholz, Editor-in-Chief of NEJM Journal Watch Cardiology — joined by Dr. Eric Topol — wrote in the New York Times (on September 17, 2015) that “without knowing all this information, it is not possible for doctors and patients to know how to translate these findings into action.” I agree with their position.

So, how did I respond to my patient? As it turned out, she would not have been eligible for SPRINT because she has diabetes (although her diabetes is mild and diet controlled). In addition, she has been plagued for years by vague undiagnosed “dizziness,” and I would think twice before prescribing additional drugs to patients like her. I look forward to seeing the full published results of SPRINT; until then, I will continue to prescribe according to currently accepted standards for BP control.

Editor Disclosures at Time of Publication

  • Disclosures for Allan S. Brett, MD at time of publication Nothing to disclose

Reader Comments (5)

Kamlesh Bhargava Physician, Family Medicine/General Practice, Nationwide Doctors, Bangalore, India.

Stopping the SPRINT study made major news, but we still have to see the results published to know more details of the study. With current rates of only 50% hypertensive patients with optimal control, this would increase it to 75-80%.I will wait and watch rather than jump the gun at this stage with incomplete information.

ALLAN BRETT Physician, Internal Medicine, University of South Carolina School of Medicine

Dr. Baskin, I apologize for the confusion. The ACCORD trial of intensive glycemic control also included a blood pressure substudy known as the "ACCORD blood pressure trial." Its results were published in the NEJM in 2010 (N Engl J Med 2010;362:1575-85). Nearly 5000 hypertensive patients (about half the 10,000 participants in the glycemic-control part of the trial) were also randomized to a systolic BP target of either 120 or 140. The study showed no reduction in cardiovascular events in the more intensively treated group. The existence of the ACCORD BP trial is the reason why the SPRINT trial excluded diabetic patients.
After we see the final published results of the SPRINT study, it will be interesting to speculate why the 2 studies reached different conclusions. Maybe there is a clue in Dr. Holcomb's observations above. Diabetic patients are more likely to have autonomic neuropathy with orthostatic hypotension, and perhaps overly aggressive BP lowering in those patients increases the risk of hypotensive episodes -- with decreased perfusion of vital organs in patients with subclinical atherosclerosis.

Paul Rosman, DO, FACP, FACE Physician, Endocrinology, Manhattan odfice

Agree with this conclusion. Problen is the the information was in the news media in the Ist place. That the news media made it prime time information means confusion for patents, more work for doctors and nurses that is not central to patient care because the implicatins fo the study are not available. Why is trhe news media put it out there, and do they have some fiduciary responsibility not to do so.

JOHN HOLCOMB

A substantial number of older patients have orthostatic hypotension but lying, sitting and standing blood pressures are rarely taken either in the doctor's office or at home so it goes undiagnosed. Over-treatment of these patients can be dangerous.

Lester Baskin Physician, Internal Medicine, private practice

I am confused. Dr Brett mentions the ACCORD trial in his comments on the SPRINT trial, but ACCORD was for aggressive diabetic control, not aggressive BP control. So not sure how it furthers his argument.

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