New heart failure guidelines address aldosterone antagonists and ARBS
Recommendations for use of specific beta-blockers also included
New heart failure guidelines not only recommend specific beta-blockers, but they also include an expanded discussion about the use of aldosterone antagonists and angiotensin II receptor blockers (ARBs).
The guidelines were released in August by the American College of Cardiology (ACC) and the American Heart Association (AHA). Several other health organizations also participated in the effort. The guidelines were updated from 2001 to incorporate important information from recent trials, says guideline co-author Mariell Jessup, MD, FACC, FAHA, medical director of the heart failure and cardiac transplantation program and professor of medicine at the University of Pennsylvania Medical Center in Philadelphia. "The head committee that governs all the ACC/American Heart Guidelines makes the determination, too, when things need to be updated."
The task force that wrote the guidelines used a classification system to "reliably and objectively identify patients during the course of their developing disease." The system also links the patients to treatments that are appropriate to their stage of illness. These stages are:
- Stages A and B: Patients who lack early signs or symptoms of heart failure but are at risk because of risk factors or heart abnormalities, which could include a change in the shape or structure of the heart.
- Stage C: Patients with current or past heart failure symptoms such as shortness of breath.
- Stage D: Patients with refractory heart failure who might be eligible for specialized advanced treatment — including cardiac transplantation — or compassionate end-of-life care such as hospice.
The task force also referred to the condition as "heart failure" rather than "congestive heart failure." Patients can have few or no symptoms of congestion, Jessup says. "Chronic heart failure often involves patients complaining of fatigue rather than congestion itself."
ACC/AHA recommendations for heart failure
The guidelines update several drug therapies for heart failure (HF). Here are some of the highlights of these updates:
• Beta-blockers. Beta-blockers should be prescribed to all patients with stable HF due to reduced left ventricular ejection fraction (LVEF) unless they have a contraindication to use of the drugs or have been shown to be unable to tolerate treatment with them, the guidelines say.
The recommendation for beta-blockers for all patients hasn’t changed all that much, Jessup says. The recommendations of which beta-blockers to use, however, have changed. Three beta-blockers have been shown to be effective in reducing the risk of death in patients with chronic HF: bisoprolol, sustained-release metoprolol (succinate), and carvedilol. "Positive findings with these three agents, however, should not be considered indicative of a beta-blocker class effect, as shown by the lack of effectiveness of bucindolol and the lesser effectiveness of short-acting metoprolol in clinical trials. Patients who have Stage C HF should be treated with one of these three beta-blockers," the guidelines say.
"Between 2001 and now, there was a trial called COMET [Carvedilol Or Metoprolol European Trial] that definitively showed that one beta-blocker was much more efficacious than another," Jessup says. "[These guidelines] are much stronger this time about which beta-blockers to use rather than who to use them in."
• Aldosterone antagonists. Addition of an aldosterone antagonist is reasonable in selected patients with moderately severe to severe symptoms of HF and reduced LVEF who can be carefully monitored for preserved renal function and normal potassium concentration, the guidelines say. Creatinine should be < 2.5 mg/dL in men or < 2.0 mg/dL in women and potassium should be < 5.0 mEq/L. "Under circumstances where monitoring for hyperkalemia or renal dysfunction is not anticipated to be feasible, the risks may outweigh the benefits of aldosterone antagonists."
The problem is there are only two trials looking at the aldosterone antagonists, Jessup says. The first, older trial included some patients who were not on angiotensin-converting enzyme inhibitors (ACEIs) and beta-blockers. The second trial, EPHESUS (Eplerenone Post-AMI Heart Failure Efficacy and Survival Study), had a different patient population.
"We struggled with what to recommend. In addition, there are papers out there saying that physicians are using these drugs sort of indiscriminately and not always monitoring the patients," she says. The 2005 guidelines have a new table outlining what care needs to take place in using these drugs and the potential downsides.
The guidelines also do not recommend the combination of ACEIs, ARBs, and aldosterone antagonists because its safety has not been explored adequately.
• Angiotensin receptor blockers. Experience with ARBs in controlled clinical trials of patients with HF is considerably less than that with ACEIs, the guideline authors say. "Nevertheless, in several placebo-controlled studies, long-term therapy with ARBs produced hemodynamic, neurohormonal, and clinical effects consistent with those expected after interference with the renin-angiotensin system."
For patients unable to tolerate ACEIs because of cough or angioedema, the ARBs valsartan and candesartan have demonstrated benefit by reducing hospitalizations and mortality," the guidelines say. "The combination of an ACEI and ARBs may produce more reduction of LV size than either agent alone. The addition of ARBs to chronic ACEI therapy caused a modest decrease in hospitalization in two studies, with a trend to decreased total mortality in one and no impact on mortality in another."
Some on the task force wanted to use ARBs as first-line therapy without trying ACEIs, Jessup says. "The guidelines were more lenient about that."
• Isosorbide dinitrate/hydralazine combination. "The addition of isosorbide dinitrate and hydralazine to a standard medical regimen for HF, including ace inhibitors and beta-blockers, is reasonable and can be effective in blacks with NYHA (New York Heart Association) functional class III or IV HF. Others may benefit similarly, but this has not yet been tested," the guidelines say.
"People [on the task force] were excited about the results of A-HeFT [the African American Heart Failure Trial]," Jessup says. "There are big questions, though, about whether that combination also works in patients who aren’t African American."
Performance measures, outcomes available
In addition to the guidelines, the ACC and AHA have also published the ACC/AHA Clinical Performance Measures for Adults with Chronic Heart Failure and the ACC/AHA Key Data Elements and Definitions for Measuring Clinical Measurements and Outcomes of Patients with Chronic Heart Failure.
The organizations went out of their way to publish the guidelines, performance measures, and outcomes at the same time as an aid to say, "It doesn’t do any good to [just] send out guidelines," Jessup says. "You need to develop agreed-upon performance measures and outcomes."
The guidelines can be viewed on the web sites of the ACC (www.acc.org) and the AHA (www.americanheart.org) and were to be published in the Sept. 20 issues of the Journal of the American College of Cardiology and Circulation: Journal of the American Heart Association.
New heart failure guidelines not only recommend specific beta-blockers, but they also include an expanded discussion about the use of aldosterone antagonists and angiotensin II receptor blockers (ARBs).You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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