In October, Nancy M. Albert, PhD, CCNS, CHFN, CCRN, NE-BC, FAHA, FCCM, FAAN, wrapped up a year-long collaborative research project on the association between initial pharmacotherapy (IPT) and two-year mortality for patients with heart failure and reduced ejection fraction (HFrEF). Dr. Albert, who serves as ACNO of Cleveland Clinic’s Office of Nursing Research and Innovation, teamed up with six other researchers from Comprehensive Health Insights in Louisville, Kentucky, and Novartis Pharmaceuticals Corp. in East Hanover, New Jersey, on the study.
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“Using a retrospective, single cohort design, we examined the association between real-world initial heart failure pharmacotherapy and two-year all-cause mortality in a Medicare managed care cohort of patients with HFrEF,” says Dr. Albert. “Our research methodology allowed us to better understand initial HFrEF pharmacotherapy, defined as prescribed in the first month. The sample was large and diverse, minimizing provider and health system biases.”
Background and methods
Heart failure is a debilitating condition that currently affects approximately 6.5 million adults in the United States, according to a 2017 update from the American Heart Association. Initiation of appropriate medication treatment following HFrEF diagnosis is recommended to optimize clinical outcomes. National guidelines promote HFrEF initial therapy with a renin-angiotensin antagonist and beta-blocker, as well as added aldosterone antagonist or hydralazine/nitrate prescriptions when patients remain symptomatic.
However, there are numerous reports in the literature that highlight healthcare provider prescription nonadherence to evidence-based heart failure pharmacological therapies known to improve survival. Therefore, Dr. Albert and her peers studied the association between initial HFrEF pharmacologic therapies and two-year mortality for patients with HFrEF.
The study utilized claims data from Humana Inc., a large national health insurance provider whose patient population is distributed primarily in the Southern and Midwestern U.S. The research team examined the claims database of 14,359 Medicare patients with HFrEF from August 2010 to July 2015. Patients were included in the study if they had at least two medical claims for heart failure, were between 19 and 89 years old and were continuously enrolled in the health plan for at least one year pre-index date (the date of the first observed heart failure diagnosis) and two years post-index, or until death.
Initial pharmacotherapy was based on the prevailing 2013 American College of Cardiology Foundation/American Heart Association guidelines for managing HFrEF during the enrollment period. Heart failure medications included any mono, dual, triple or higher combination therapy.
Study results and implications for practice
One of the main findings of the study was that 32.4 percent of the 14,359 Medicare managed care beneficiaries with HFrEF did not have heart failure pharmacotherapy initiated within one year of diagnosis. In addition, the use of three medication classes as initial pharmacologic therapy – renin-angiotensin antagonist, beta-blocker and aldosterone antagonist or hydralazine/nitrate – were associated with the lowest all-cause two-year hazard ratio of mortality after controlling for nonpharmacologic factors associated with mortality.
“Healthcare providers need to be more vigilant in prescribing HfrEF pharmacological therapies,” says Dr. Albert. “More research and practice changes are needed to determine rationale for lack of initial therapy and, also, processes and systems to optimize HFrEF pharmacological therapies when gaps in care exist.” She adds that more research is needed to learn if triple therapy should be initiated very early (within one month of initial HFrEF pharmacological therapies), as it was a three-drug class regimen that was associated with the lowest two-year mortality.
New research in real-world patients who are taking HFrEF pharmacologic therapies is ongoing. Results of the initial retrospective study were published in the October 2017 issue of Advances in Therapy.
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