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CLINICAL TRIALS

Will SPRINT Change Our Systolic BP Target in Hypertensive Patients from 140 to 120 mm Hg?

At last week’s Medicine rounds at the Royal Columbia Hospital, I presented the results from the recently published SPRINT trial.

SPRINT Research Group, Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. PMID: 26551272.

 

In short, my thoughts are that this is a very well done study with no concerning methodologic issues that affect the validity of the results.

With a clinically and statistically significant reduction cardiovascular outcomes and mortality, the benefits of a systolic BP target of <120 mm Hg appear to be quite meaningful in the population studied, despite the high NNTs.

It should be clearly noted that this study excludes those with prior stroke, diabetes, nursing home residents, among others.

That being said, it appears to be broadly applicable (with ~17 million Americans fitting the enrollment criteria), including the elderly and many with chronic kidney disease.

As a nephrologist, I was really encouraged to see that almost 30% of patients enrolled had CKD (with GFR 20-60 ml/min, with the exclusion of PKD, GN requiring immunosuppression, and proteinuria > 1 gm/day).  My clinical practice is certainly made up of plenty of patients who would satisfy the inclusion and exclusion criteria of the study.

Caution should be taken before applying the findings of this study to all patients who meet the enrollment criteria given the increased rate of serious adverse events in the intensive BP control arm (<120 mm Hg systolic), especially given that in the real world, adverse events can be higher than in clinical trials.

I take particular note that worsening GFR and acute kidney injury were more common in the intensive BP control arm, though chronic dialysis was not increased.  The rates of temporary dialysis in AKI were not reported, and it would be important to ensure this was not significantly increased in the intensive BP arm.

It’s also important to point out that in real world clinical practice (ie outside a clinical trial), even achieving a BP target of  <140 mm Hg can be quite hard (with at least 1/3 of hypertensive Americans above target), so shooting for a target of  <120 mm Hg may not be achievable in many patients.

All this being said, in those patients who I feel I can safely monitor and follow closely, I will be offering intensive BP control, after reviewing the risks, benefits and alternative.  As with any therapy that offers both potential advantages and risks, a decision on which BP target to use will require a careful discussion with our patients.

For those interested, here are my slides:

 

 

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