"Optimal pharmacologic treatment of patients with HFrEF is carefully scripted by evidence-based guidelines, but GDMTs are heavily underutilized in clinical practice," Dr. Akshay Desai of Brigham and Women's Hospital in Boston told Reuters Health by email.
"Even when clinicians prescribe key medications such as ACE inhibitors, angiotensin receptor blockers, angiotensin-receptor neprilysin inhibitors, beta-blockers, and mineralocorticoid receptor antagonists, they frequently utilize them at lower doses than recommended for maximal treatment benefit," he said.
"Data suggests that the reasons for this lack of optimal treatment are related less to patient factors or tolerability," he noted, "and more to therapeutic inertia or logistical challenges with the systematic initiation and uptitration of an increasingly complex medical program."
As reported in JAMA Cardiology, the researchers compared outcomes of 197 HFrEF patients participating in the GDMT program (mean age, 66; 30% women; 33% atrial fibrillation) and 831 controls who chose to continue usual care (mean age, 68; 30% women; 44% atrial fibrillation). All participants were in New York Heart Association class I and II.
For the remote intervention group, patient navigators contacted participants by phone to direct medication adjustment and monitor laboratory tests, blood pressure, and symptoms under supervision of a pharmacist, nurse practitioner, and heart failure cardiologist.
Patients in the usual care group continued care as directed by their general cardiologists (57%) or heart failure specialists (43%).
At three months, participants in the remote intervention experienced significant increases from baseline in use of renin-angiotensin system antagonists (70.1% to 86.3%) and beta-blockers (77.2% to 91.9%); however, use of mineralocorticoid receptor antagonists did not rise significantly (25.9% to 30.5%).
Doses for each GDMT category also increased from baseline in the intervention group.
By contrast, no changes from baseline were seen in the usual care group in the proportion of patients receiving GDMT or the dose of GDMT in any category.
Dr. Desai said, "We believe this care model is readily scalable to other hospital settings, and may be particularly relevant in the context of enhanced attention to remote patient engagement in the wake of the COVID-19 pandemic."
"Formal cost-effectiveness modelling is in progress," he added, "but we anticipate that the costs associated with the personnel and infrastructure needed to support this approach are likely to be offset by the potential long-term cost savings anticipated from reduced HF hospitalizations and increased lifespan as a consequence of greater utilization of appropriate pharmacologic therapy."
Dr. Michael Rich, Associate Program Director for Research at Washington University School of Medicine in St. Louis and Director, Cardiac Rapid Evaluation Unit at Barnes-Jewish Hospital, told Reuters Health, "I agree with the findings and with the general concept that medication titration can be done by non-physicians at lower cost."
Nonetheless, he said by email, "this is essentially a proof-of-concept study with several major limitations, as acknowledged by the authors. Most importantly, neither physicians nor patients were randomized. As a result, there were significant baseline differences" between the groups.
"Although the authors adjusted for baseline differences in medication utilization, they did not adjust for other differences that may have affected the results," he said. For example, GDMT patients "were younger, had better renal function, and were less likely to have atrial fibrillation. Adjustment for these factors may have attenuated the effect of the intervention."
"It is also likely that there were differences between the physicians who agreed to participate versus those who did not, but no information about this is provided," he said. "The study would have been better, and more compelling, if the patients of the physicians who agreed to participate were then randomized to the intervention or usual care."
"Medication prescription and dose escalation in patients with heart failure, who are often older with multiple other medical problems...requires close monitoring during follow-up, and this was an integral component of this quality-improvement program," he said. "Translation...into clinical practice would require an equally rigorous mechanism to ensure safety...and to avoid potentially serious adverse events, such as acute renal failure and hyperkalemia due to overzealous efforts to comply with GDMT."
The study was funded by a Novartis grant to Brigham and Women's Hospital.
By Marilynn Larkin
SOURCE: https://bit.ly/3cphAIo JAMA Cardiology, online September 16, 2020.
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