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The SPRINT Study & Blood Pressure Goals

Darrell Hulisz, RPh, PharmD

June 21, 2016

A recent controversy has emerged regarding optimal blood pressure goals due to the release of landmark hypertension study last fall. The Systolic Blood Pressure Intervention Trial (SPRINT) was a prospective, randomized controlled study that examined the effects of intensive high blood pressure treatment, versus standard treatment. SPRINT randomly assigned 9,361 patients with a systolic BP of 130 mmHg or higher and an increased cardiovascular risk (but without diabetes or prior stroke) to a low systolic BP target of < 120 mmHg, versus a standard target of < 140 mmHg. It is an important to note that SPRINT was an open label trial conducted at 102 sites, 50 years of age or older with an additional cardiovascular disease (CVD) risk. Because of the study design using BP targets, investigators could not be blinded to treatment group. The primary outcome of SPRINT was a composite of the following: first occurrence of acute myocardial infarction (AMI), acute coronary syndrome (ACS), stroke, decompensated heart failure, or death from CVD). The blood pressure was monitored monthly for 3 months and every 3 months thereafter, and medications were titrated based on those readings.

After one-year, the mean BP achieved in the low BP target group was 121/69, versus 136/76 mmHg in the standard BP group. The average number of antihypertensive drugs in the low BP target group was 2.8, versus 1.8 in the standard BP target group. After an average duration of 3.3 years, the primary composite outcome was decreased in the low BP target group at 5.2%, versus 6.8% in the standard BP target group, relative risk (RR) reduction of 0.76%, absolute risk (AR) reduction of 1.6%. The number needed to treat (NNT) was 63 for 3.3 years. This trial was stopped early after 3 years due to the presumed benefits of these findings.

Serious adverse events, including hypotension and syncope were more common in the intensive treatment group. Overall, targeting a systolic BP of less than 120 mmHg resulted in lower rates of fatal and nonfatal major cardiovascular events. However, serious adverse effects were almost twice as common in the low BP target group. This was due mainly to a 1.2% absolute increase in acute kidney injury or acute renal failure in the low BP target group. The reason for the controversy is because the SPRINT trial was released on the heels of the JNC-8 consensus recommendations that support BP targets of <140-90 mmHg in a majority of patients. Critical analysis of the SPRINT trial reveals that benefits of a lower blood pressure target in high-risk, nondiabetic patients may not completely outweigh harms.

1. SPRINT Research Group. A randomized trial of intensive versus standard blood-pressure control. N Eng J Med. 2015; 373: 2103-16. doi: 10.1056/NEJMoa1511939.

2. James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427.

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