A Randomized Trial of Intensive versus Standard Blood-Pressure Control

Olivia Horga, Mercer University College of Pharmacy

 

According to the Centers for Disease Control and Prevention (CDC), approximately one of three adults in the United States have high blood pressure and only about half of these people have their blood pressure under control. It is suggested that uncontrolled hypertension increases the risk for heart disease and stroke. [1]

 

The Eight Joint National Committee (JNC8) recommends a blood pressure goal of less than 150/90 mmHg for hypertensive persons aged 60 years or older. This set of guidelines also recommends a goal of less than 140/90 mmHg for hypertensive persons younger than 60 years old. [2]

 

It is reported that the main difference between the Seventh Joint National Committee (JNC7) and JNC8 treatment guidelines is the increase in blood pressure target for the elderly and in those with diabetes and chronic kidney disease. Because patient populations are diverse with multiple comorbidities, recommended blood pressure goals may differ from one patient to another. [3]

 

 

 

Title: A Randomized Trial of Intensive versus Standard Blood-Pressure Control
Design Randomized, controlled, open-label; N = 9,361
Objective To determine if systolic blood pressure target of less than 120 mmHg, as compared with a target of less than 140 mmHg, would result in a lower rate of the composite outcome of myocardial infarction, acute coronary syndrome not resulting in myocardial infarction, stroke, acute decompensated heart failure, or death from cardiovascular causes
Study Groups Patients with systolic blood pressure (SBP) of 130 mmHg or higher and an increased cardiovascular (CV) risk, but without diabetes:

 

Intensive treatment group (SBP target less than 120 mmHg), n = 4,678 Standard treatment (SBP target less than 140 mmHg), n = 4,683

Methods Patients assigned to either intensive treatment group (SBP target less than 120 mmHg) or standard treatment (SBP target less than 140 mmHg); antihypertensive regimens adjusted on basis of study-group assignment (all major classes of antihypertensive agents were included on formulary and provided at no cost to participants – investigators could also prescribe other antihypertensive medications not provided by the study); follow-up: monthly for first three months and every three months thereafter; intervention stopped early
Duration Enrollment period between November 2010 and march 2013; median follow-up = 3.26 years
Primary Outcome Measure Major cardiovascular disease (CVD) events, defined as the composite endpoint comprised of the first occurrence of a myocardial infarction (MI), non-MI acute coronary syndrome (non-MI ACS), stroke, heart failure (HF), or death attributable to CVD
Baseline Characteristics Characteristic Intensive Treatment

(n = 4,678)

Standard Treatment

(n = 4,683)

Criterion for increased CV risk    
Age ≥ 75 years, n 1,317 1,319
Chronic kidney disease, n 1,330 1,316
Cardiovascular disease, n 940 937
Female sex, n (%) 1,684 (36) 1,648 (35.2)
Age    
Overall, years 67.9 ± 9.4 67.9 ± 9.5
Among those ≥ 75 years of age, years 79.8 ± 3.9 79.9 ± 4.1
Race or ethnic group    
Non-Hispanic black, n 1,379 1,423
Hispanic, n 503 481
Non-Hispanic white, n 2,698 2,701
Other, n 98 78
Baseline blood pressure    
Systolic, mmHg 139.7 ± 15.8 139.7 ± 15.4
Diastolic, mmHg 78.2 ± 11.9 78.0 ± 12.0
Serum creatinine, mg/dL 1.07 ± 0.34 1.08 ± 0.34
Estimated glomerular filtration rate (GFR), mL/min/1.73 m2 71.8 ± 20.7 71.7 ± 20.5
Fasting total cholesterol, mg/dL 190.2 ± 41.4 190.0 ± 40.9
Fasting plasma glucose, mg/dL 98.8 ± 13.7 98.8 ± 13.4
Statin use, n/total n (%) 1,978/4,645 (42.6) 2,076/4,640 (44.7)
Aspirin use, n/total n (%) 2,406/4,661 (51.6) 2,350/4,666 (50.4)
Smoking status    
Never smoked, n 2,050 2,072
Former smoker, n 1,977 1,996
Current smoker, n 639 601
Missing data, n 12 14
Results Outcome Intensive Treatment

(n = 4678)

Standard Treatment

(n = 4683)

Hazard ratio

(95% confidence interval)

p value
Primary outcome, n (%) 243 (5.2) 319 (6.8) 0.75

(0.64 – 0.89)

< 0.001
Adverse Events Common Adverse Events: not reported
Serious Adverse Events: intensive-treatment group, n = 1,793 (38.3%); standard-treatment group, n = 1,736 (37.1%)
Percentage that Discontinued due to Adverse Events: not reported
Study Author Conclusions Among patients at high risk for cardiovascular events but without diabetes, targeting a systolic blood pressure of less than 120 mm Hg as compared with less than 140 mm Hg resulted in lower rates of fatal and nonfatal major cardiovascular events and death from any cause, although significantly higher rates of some adverse events were observed in the intensive-treatment group.

 

 

 

This study demonstrated that more stringent blood pressure goals result in lower rates of cardiovascular events. [4]

 

Although current guidelines have higher target blood pressure goals, it is suggested that health care providers consider a patient’s cardiovascular risk when treating his or her blood pressure and use the hypertension treatment guidelines appropriately. Good clinical judgment is reported as being crucial in a patient’s therapy plan for the management of his or her hypertension [3]

 

 

References

  1. Centers for disease Control and Prevention. http://www.cdc.gov/bloodpressure/. Accessed November 12, 2015.
  2. James PA, Oparil S, Carter BL, 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;311(5):507-20.
  3. Griffin BR, Schinstock CA. Thinking beyond new clinical guidelines: update in hypertension. Mayo Clin Proc. 2015;90(2):273-9.
  4. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015.
Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s