New Hypertension Guidelines: What’s Next for Hypertension Therapy?

By Toni Bransford, MD, FACC Executive Medical Director, Scientific Solutions, Cardiovascular and Metabolic Division, Worldwide Clinical Trials and Karen Modesto, MD, Senior Medical Director, Medical and Scientific Affairs, Cardiovascular and Metabolic Division, Worldwide Clinical Trials,

 

Heart disease is the No. 1 cause of death in the world and the leading cause of death in the United States, killing about 610,000 people every year–that’s 1 in every 4 deaths, claiming more lives than all forms of cancer combined1, 2. Having high blood pressure puts you at risk for heart disease and stroke, which are leading causes of death. About 75 million American adults (32%) have high blood pressure—that’s 1 in every 3 adults and high blood pressure was a primary or contributing cause of death for more than 410,000 Americans in 2014—that’s more than 1,100 deaths each day1, 3.

Hypertension Guidelines, Cardiovascular Clinical Trial

Using previous blood pressure classifications, about 1 in 3 American adults (30%) had hypertension in 2012 and only about half (52%) of people with high blood pressure had their condition under control3. Hypertension is the most common modifiable risk factor for cardiovascular disease and death, and lowering blood pressure with antihypertensive drugs reduces target organ damage and prevents cardiovascular disease outcomes. Despite a plethora of available treatment options, a substantial portion of the hypertensive population has uncontrolled blood pressure. Therefore an urgent unmet medical need continues to exist for new medications to treat hypertension which can have enormous economic and quality of life effects on the individual and population as a whole.

What do the New Hypertension Guidelines Mean to US patients?

So obviously, physicians, patients, and their caregivers have a stake in effectively treating hypertension, correct? Well, recently an update of the last hypertension guidelines was published. Since 2003, the National Institutes of Health (NIH) has relinquished their purview of developing guideline updates for hypertension (through the Joint National Committee [JNC])4. The American College of Cardiology (ACC) and American Heart Association (AHA) have taken over this role and their first set of hypertension guideline updates was released in 20175. The new guidelines eliminate the prehypertension category from the previous JNC-7 hypertension guidelines and instead use the following new classification system:

Normal: < 120/80 mm Hg

Elevated: 120-129/ less than 80 mm Hg

Stage 1 Hypertension: 130-139/80-89 mm Hg

Stage 2 Hypertension: > 140/> 90 mm Hg

Hypertensive Crisis: > 180 mm Hg/ > 120 mm Hg

With this new hypertension guideline, the prevalence of hypertension is anticipated to increase from 31.9% under JNC-7 criteria to 45.6% with 103 million people now categorized as having high blood pressure. Anti-hypertensive drug therapy will be recommended for 36.2% of US adults, or 81.9 million adults and the number of US adults recommended for drug therapy is expected to increase by 4.2 million.

Instead of 39% not reaching goal, over 50% will no longer reach blood pressure goals. Adults less than 65 years of age and at low cardiovascular risk will be recommended lifestyle modifications. However, it is important to note that US adults 65 years or greater will now be treated similar to those at high cardiovascular risk and recommended for anti-hypertensive drug therapy at the level of Stage 1 Hypertension.

Despite these dramatic changes in hypertension diagnosis and treatment, the response has been more subdued than expected. Some organizations have denounced the document and decried that they would not endorse the new hypertension guidelines. Particularly in those over the age of 60, the American Academy of Family Physicians proposes a target systolic blood pressure of 150 mm Hg. The American College of Physicians came down equally hard on the new blood pressure guidelines6 focusing on hypertension diagnosis in the elderly. “Although the new guideline lowers the blood-pressure goal for people over 65, it suggests that 30-year-olds and 80-year-olds should have the same goal. Achieving that goal is challenging and almost impossible for many people, especially those with poor vascular compliance (i.e., pulse pressures above 80 to 90 mm Hg), who typically have dizziness and poor mentation as their systolic blood pressure approaches 140 mm Hg” suggest Bakris and Sorrentino7.

The Challenge for Hypertension Therapy

What hypertension therapies and treatment options are available to patients now? These subjects will be added to those already in need of chronic health care. For those with health care insurance, they will eventually get into physician waiting rooms although the wait time may be long, varying by specialty or region of the country. Others will fall through the cracks as routine healthcare is summarily removed from the vernacular of uninsured or minimally insured Americans and is replaced by emergency department care. The challenge will be immense to navigate these new waters and insure that subjects are able to obtain adequate care for their blood pressure control.

The Future of Cardiovascular Clinical Trials

The future of hypertension and other cardiovascular disease treatments start within a clinical trial. To see what Worldwide Clinical Trials is doing to further cardiovascular research, read about our therapeutic expertise in Phase I-IV studies.

References

  1. Centers for Disease Control and Prevention, National Center for Health Statistics. Multiple Cause of Death 1999-2015 on CDC WONDER Online Database, released December 2016. Data are from the Multiple Cause of Death Files, 1999-2015, as compiled from data provided by the 57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. Accessed at http://wonder.cdc.gov/mcd-icd10.html.
  2. Mozaffarian D, Benjamin EJ, Go AS, et al on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2015 update: a report from the American Heart Association [published online ahead of print December 17,2014]. Circulation.
  3. Nwankwo T, Yoon SS, Burt V, Gu Q. Hypertension among adults in the US: National Health and Nutrition Examination Survey, 2011-2012. NCHS Data Brief, No. 133. Hyattsville, MD: National Center for Health Statistics, Centers for Disease Control and Prevention, US Dept of Health and Human Services; 2013.
  4. Chobanian AV1Bakris GL, Black HR, et al for the National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood PressureNational High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. 2003;289:2560-72.Farley TA, Dalal MA, Mostashari F, Frieden TR. Deaths preventable in the U.S. by improvements in the use of clinical preventive services. Am J Prev Med. 2010;38(6):600–9.
  5. Carey RM, Whelton PK, Aronow WS, et al. Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Synopsis of the 2017 American College of Cardiology/American Heart Association Hypertension Guideline. Ann Intern MedDOI: 10.7326/M17-3203.
  6. Wilt TJ, Kansagara D, Qaseem Hypertension limbo: Balancing benefits, harms, and patient preferences before we lower the bar on blood pressure. Ann Intern Med 2018; DOI: 10.7326/M17-3293.
  7. Bakris G and Sorrentino M. Perspective: Redefining Hypertension — Assessing the New Blood-Pressure Guidelines. New Engl J Med 2018 DOI: 10.1056/NEJMp1716193.